Viewing Study NCT01421069

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Ignite Creation Date: 2025-12-24 @ 10:49 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
Study NCT ID: NCT01421069
Status: COMPLETED
Last Update Posted: 2022-11-14
First Post: 2011-08-18
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}, {'id': 'C563250', 'term': 'Salivary Gland Adenoma, Pleomorphic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '18007181021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as non-serious in another subject, or one subject may have experienced both a serious and non-serious event during the study. AEs and SAEs were analysed for full analysis set.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study.", 'otherNumAtRisk': 109, 'deathsNumAtRisk': 109, 'otherNumAffected': 85, 'seriousNumAtRisk': 109, 'deathsNumAffected': 0, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Eustachian tube disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tympanic membrane disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Maculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Scleral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pneumoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Diarrhoea infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gastrointestinal viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pertussis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pharyngotonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pulpitis dental', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Suspected COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tinea versicolour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 28}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vaginal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Viral tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Animal bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Chillblains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Post-traumatic neck syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Aspartate aminotransferase abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Intraocular pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 11}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Bone swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Groin pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Haematoma muscle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Intervertebral disc disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Scar', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Joint laxity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Juvenile idiopathic arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Muscle contracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tendonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dysmenorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acne conglobata', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acne cystic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Osteopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'seriousEvents': [{'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Fractured coccyx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Attention deficit hyperactivity disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Varicocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Knee operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 109, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Malignancy: All Periods of Parent and Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the parent and extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the parent and extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Infections: All Periods of Parent and Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the parent and extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Medically important infections were defined as an infection requiring parenteral (intravenous \\[IV\\], intramuscular \\[IM\\]) anti-infective agent(s) and/or hospitalization.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the parent and extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infections: All Periods of Parent and Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the parent and extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Treatment emergent infections', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}]}]}, {'title': 'Injection site reactions', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)', 'description': 'Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infections: Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Infections', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Infections considered preventable by vaccination', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)', 'description': 'Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Withdrawal analysis set (WAS) included those participants who entered the withdrawal period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Due to infections', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Due to other adverse events', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the parent and extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)', 'description': 'Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included those participants who entered the withdrawal period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Grade 3', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)', 'description': 'Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all participants who were enrolled in the extension study.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.26', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '1.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study', 'description': 'Growth parameters including weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, greater than (\\>) 0 a greater mean, and less than (\\<0) a lesser mean than the standard.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.21', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.25', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.09', 'spread': '0.35', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.47', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.46', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study', 'description': 'Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, \\>0 a greater mean, and \\<0 a lesser mean than the standard.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96: Height', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.15', 'spread': '0.43', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.36', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.33', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96: Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.27', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '0.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96: BMI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study', 'description': 'Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, \\>0 a greater mean, and \\<0 a lesser mean than the standard.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Re-treatment analysis set (RTAS) included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.78', 'spread': '0.88', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.02', 'spread': '0.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.35', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.69', 'spread': '1.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.44', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.25', 'spread': '1.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study', 'description': 'Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study', 'description': 'Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.11', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.52', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.52', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.27', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study', 'description': 'Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '99.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '100'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '99.6'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '93.5', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.6', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '99.5'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '87.7', 'upperLimit': '99.9'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '100'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR30PR: \\>=30% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '99.9'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '100'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '100'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '100'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR30PR: \\>=30% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period:', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': "ACR30PR: \\>=30% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '99.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '91.1', 'upperLimit': '100'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '99.6'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.2', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.1', 'groupId': 'OG000', 'lowerLimit': '89.9', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '92.5', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '98.6'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.6', 'groupId': 'OG000', 'lowerLimit': '87.4', 'upperLimit': '99.9'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '86.3', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '85.8', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '100'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '84.6', 'upperLimit': '100'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR50PR: \\>=50% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '97.2'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '78.2', 'upperLimit': '100'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR50PR: \\>=50% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '73.5', 'upperLimit': '100'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': 'ACR50PR:\\>=50% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria:1)PGA of disease activity(DA),2)PtGA of arthritis pain,3) CHAQ 4)number(no.) of active joints5)no. of joints with limited range of motion 6)C-reactive protein.PGA of DA: 21-circle VAS ranging 0-10, with 0=\\&10=maximumDA,higher score=more severe disease.PGA:21-circle VAS ranging 0-10,0=very well,10=very poor,higher scores=worsening condition.CHAQ: assessment of functional disability,discomfort. Ability to perform activities:dressing,arising,eating,walking,hygiene,reach,grip, common activities distributed in total of 30 items. Ranging 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do.Highest score for each domain:score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered.Ranged 0=no difficulty to 3=extreme difficulty;higher scores indicated more functional disability and discomfort. Participants \\>18 years assessed using CHAQ.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '99.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.1', 'groupId': 'OG000', 'lowerLimit': '76.1', 'upperLimit': '94.3'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.7', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '95.3'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '78.1', 'upperLimit': '96.0'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.5', 'groupId': 'OG000', 'lowerLimit': '76.6', 'upperLimit': '95.6'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.4', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '96.5'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '74.9', 'upperLimit': '96.1'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '83.5', 'upperLimit': '99.4'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '90.5', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '80.4', 'upperLimit': '99.9'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '85.2', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '100'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '70.8', 'upperLimit': '98.9'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '99.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR70PR: \\>=70% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.3', 'groupId': 'OG000', 'lowerLimit': '54.6', 'upperLimit': '92.2'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '99.8'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '58.7', 'upperLimit': '99.8'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000', 'lowerLimit': '42.1', 'upperLimit': '99.6'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR70PR: \\>=70% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '99.8'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '97.9'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '97.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '97.7'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '96.8'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '92.5'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': "ACR70PR: \\>=70% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '82.0'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.2', 'groupId': 'OG000', 'lowerLimit': '56.6', 'upperLimit': '81.6'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.6', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '83.1'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.8', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '77.3'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '76.4'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '55.7', 'upperLimit': '83.6'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '80.9'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '49.4', 'upperLimit': '79.9'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '90.4'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.7', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '97.8'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '97.3'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '53.3', 'upperLimit': '90.2'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': '93.6'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '98.8'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '98.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR90PR: \\>=90% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '43.0', 'upperLimit': '85.4'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '91.6'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '93.3'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '96.8'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '96.8'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR90PR: \\>=90% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '89.1'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '90.1'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '90.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '93.3'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '96.8'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '91.5'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': "ACR90PR: \\>=90% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '65.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000', 'lowerLimit': '37.8', 'upperLimit': '65.7'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '41.6', 'upperLimit': '67.9'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '32.0', 'upperLimit': '59.4'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.4', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '54.9'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '35.5', 'upperLimit': '69.6'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '31.9', 'upperLimit': '65.6'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '31.4', 'upperLimit': '66.0'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '56.7', 'groupId': 'OG000', 'lowerLimit': '37.4', 'upperLimit': '74.5'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '40.6', 'upperLimit': '81.2'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '78.2'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '64.3'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '47.6', 'upperLimit': '92.7'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '78.7'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '91.6'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '81.9'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '87.2'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '89.1'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '92.5'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '92.5'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '99.5'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '28.4', 'upperLimit': '99.5'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '19.4', 'upperLimit': '99.4'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '83.3'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '78.9'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '89.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '91.5'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '96.8'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '90.1'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '94.7'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '80.6'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '100'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.51', 'spread': '1.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.66', 'spread': '1.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.71', 'spread': '2.10', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.67', 'spread': '1.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.69', 'spread': '1.94', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.75', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.71', 'spread': '2.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.80', 'spread': '1.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.05', 'spread': '1.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.19', 'spread': '1.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '1.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.21', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.15', 'spread': '1.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.17', 'spread': '1.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.15', 'spread': '1.67', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.11', 'spread': '1.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study', 'description': 'PGA of disease activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.92', 'spread': '2.35', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'spread': '2.40', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.50', 'spread': '1.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.09', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.30', 'spread': '2.14', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.15', 'spread': '2.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.88', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.33', 'spread': '2.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.13', 'spread': '2.10', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.33', 'spread': '2.52', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.67', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.00', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period", 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.73', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.19', 'spread': '1.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.13', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.82', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.85', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.81', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.94', 'spread': '2.30', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.11', 'spread': '2.16', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.14', 'spread': '2.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.58', 'spread': '1.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.42', 'spread': '1.43', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.60', 'spread': '0.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.63', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.33', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.93', 'spread': '2.31', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.79', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.13', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.18', 'spread': '2.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.38', 'spread': '2.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.20', 'spread': '2.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.05', 'spread': '2.85', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.37', 'spread': '2.29', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.74', 'spread': '2.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.45', 'spread': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.54', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.62', 'spread': '1.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.57', 'spread': '1.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.72', 'spread': '2.08', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.85', 'spread': '2.11', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.38', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.97', 'spread': '2.88', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.04', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'spread': '2.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.60', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.63', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.07', 'spread': '2.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.14', 'spread': '2.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.83', 'spread': '2.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.25', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '3.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '4.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '5.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.25', 'spread': '5.30', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.81', 'spread': '1.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.73', 'spread': '2.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.83', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.86', 'spread': '3.03', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.81', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.44', 'spread': '2.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.83', 'spread': '2.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.93', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.17', 'spread': '2.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.33', 'spread': '1.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.30', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.72', 'spread': '0.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.59', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.57', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.86', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.97', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '0.81', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.48', 'spread': '0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.40', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.41', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '1.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.04', 'spread': '0.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.04', 'spread': '1.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.16', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.65', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.66', 'spread': '0.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.80', 'spread': '0.78', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '0.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'spread': '0.85', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.94', 'spread': '1.11', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '0.23', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.25', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.18', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.31', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.22', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.25', 'spread': '0.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \\> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.07', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \\> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.42', 'spread': '0.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \\> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.00', 'spread': '5.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.94', 'spread': '5.59', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.82', 'spread': '5.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.48', 'spread': '4.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.43', 'spread': '4.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.82', 'spread': '4.46', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.98', 'spread': '4.78', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.27', 'spread': '4.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.71', 'spread': '4.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.74', 'spread': '4.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.56', 'spread': '4.35', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.56', 'spread': '4.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.40', 'spread': '3.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.14', 'spread': '3.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.37', 'spread': '3.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.17', 'spread': '3.58', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.96', 'spread': '5.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.53', 'spread': '5.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.50', 'spread': '4.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.73', 'spread': '4.96', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.70', 'spread': '5.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.40', 'spread': '5.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.38', 'spread': '4.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.00', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.86', 'spread': '3.02', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.17', 'spread': '2.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.75', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 53 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.00', 'spread': '3.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.50', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.50', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.31', 'spread': '4.31', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.46', 'spread': '4.29', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.17', 'spread': '4.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.18', 'spread': '4.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.60', 'spread': '4.97', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.63', 'spread': '2.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.33', 'spread': '2.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.67', 'spread': '2.35', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.86', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.33', 'spread': '1.97', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.33', 'spread': '1.97', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.60', 'spread': '0.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.75', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.33', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.80', 'spread': '5.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.51', 'spread': '5.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.32', 'spread': '5.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.12', 'spread': '4.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.03', 'spread': '4.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.23', 'spread': '4.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.63', 'spread': '4.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.90', 'spread': '4.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '4.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.38', 'spread': '4.02', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.64', 'spread': '3.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.71', 'spread': '4.11', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.90', 'spread': '4.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.45', 'spread': '4.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.63', 'spread': '3.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '3.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.38', 'spread': '4.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.60', 'spread': '5.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.67', 'spread': '3.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.36', 'spread': '3.70', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.40', 'spread': '4.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.10', 'spread': '3.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.75', 'spread': '3.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.71', 'spread': '3.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.71', 'spread': '3.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.83', 'spread': '3.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.25', 'spread': '4.03', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.67', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.15', 'spread': '4.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.46', 'spread': '4.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.75', 'spread': '5.59', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.45', 'spread': '5.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.60', 'spread': '5.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.88', 'spread': '4.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.78', 'spread': '4.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.44', 'spread': '3.97', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.71', 'spread': '4.39', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.83', 'spread': '3.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.83', 'spread': '3.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.80', 'spread': '2.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '2.94', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.', 'unitOfMeasure': 'Joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.71', 'spread': '12.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.37', 'spread': '13.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.82', 'spread': '15.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '13.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.89', 'spread': '12.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.52', 'spread': '14.91', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.96', 'spread': '22.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.01', 'spread': '14.61', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.79', 'spread': '15.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.25', 'spread': '13.28', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.39', 'spread': '13.61', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.64', 'spread': '13.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.31', 'spread': '11.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.52', 'spread': '15.32', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.37', 'spread': '15.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.59', 'spread': '22.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligram/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.99', 'spread': '14.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.47', 'spread': '6.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.01', 'spread': '6.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.07', 'spread': '2.07', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '1.61', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '2.48', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.15', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.68', 'spread': '10.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.26', 'spread': '4.35', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.06', 'spread': '0.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '1.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligram/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.50', 'spread': '11.59', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.99', 'spread': '9.03', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.42', 'spread': '9.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.91', 'spread': '9.46', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.68', 'spread': '8.88', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.79', 'spread': '10.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.13', 'spread': '11.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.18', 'spread': '11.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.76', 'spread': '28.99', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '18.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '19.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.44', 'spread': '46.78', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.57', 'spread': '2.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.30', 'spread': '8.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligram/Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.43', 'spread': '2.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.02', 'spread': '2.52', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.24', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.40', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.26', 'spread': '2.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.03', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.82', 'spread': '3.21', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.15', 'spread': '2.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.51', 'spread': '2.65', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.36', 'spread': '2.44', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.26', 'spread': '2.67', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.19', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.25', 'spread': '2.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.09', 'spread': '2.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.20', 'spread': '2.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.39', 'spread': '2.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.75', 'spread': '2.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.03', 'spread': '2.97', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.00', 'spread': '2.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.36', 'spread': '2.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.70', 'spread': '2.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '2.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.81', 'spread': '2.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.36', 'spread': '3.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.00', 'spread': '2.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.67', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.50', 'spread': '3.54', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.67', 'spread': '3.25', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.50', 'spread': '3.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': '4.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.75', 'spread': '4.60', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.64', 'spread': '2.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.65', 'spread': '3.20', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.68', 'spread': '2.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.05', 'spread': '3.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.25', 'spread': '3.23', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.25', 'spread': '3.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.13', 'spread': '3.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.29', 'spread': '3.44', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.57', 'spread': '3.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '1.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.75', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.83', 'spread': '0.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-52.11', 'spread': '56.63', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-73.33', 'spread': '110.91', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.24', 'spread': '108.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-72.19', 'spread': '105.84', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-66.36', 'spread': '110.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-75.04', 'spread': '112.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-73.75', 'spread': '111.59', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-76.22', 'spread': '118.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-82.21', 'spread': '124.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-89.10', 'spread': '126.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-95.56', 'spread': '134.35', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-89.26', 'spread': '148.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.17', 'spread': '141.86', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-91.83', 'spread': '143.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-101.85', 'spread': '140.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-99.78', 'spread': '152.26', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day = 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-83.96', 'spread': '119.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-71.43', 'spread': '98.85', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-56.67', 'spread': '62.32', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.09', 'spread': '26.72', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.00', 'spread': '26.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.00', 'spread': '26.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.63', 'spread': '29.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.71', 'spread': '31.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.71', 'spread': '31.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.83', 'spread': '31.69', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.25', 'spread': '37.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-41.67', 'spread': '38.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-41.67', 'spread': '38.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.00', 'spread': '35.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-25.00', 'spread': '35.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-116.15', 'spread': '138.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-107.69', 'spread': '147.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-126.67', 'spread': '144.23', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-130.00', 'spread': '151.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-111.00', 'spread': '142.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-85.63', 'spread': '137.98', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-72.22', 'spread': '142.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-89.38', 'spread': '135.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-101.43', 'spread': '140.88', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-60.00', 'spread': '94.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-60.00', 'spread': '94.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.00', 'spread': '37.82', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.50', 'spread': '9.57', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.00', 'spread': '10.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '21.9'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '37.6'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '25.0', 'upperLimit': '48.7'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '36.7'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '43.9'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '46.0'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '19.9', 'upperLimit': '46.3'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '43.3'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '49.5'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '17.0', 'upperLimit': '47.6'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '42.2'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '28.2'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '42.3'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.6', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '47.2'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.9', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '46.3'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '48.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of less than or equal to (\\<=) 15 minutes.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '75.6'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '88.2'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '34.9', 'upperLimit': '90.1'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000', 'lowerLimit': '48.2', 'upperLimit': '97.7'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.0', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '97.5'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '99.7'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000', 'lowerLimit': '29.0', 'upperLimit': '96.3'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '99.6'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '88.2'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '99.2'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '100'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '84.2'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '97.5'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of \\<=15 minutes.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '53.8'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '74.9'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '65.1'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '76.6'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '81.3'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '91.5'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '70.1'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '86.3'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '71.0'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '64.1'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '77.7'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '85.3'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '93.2'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '90.6'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '98.7'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of \\<=15 minutes.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.00', 'spread': '8.08', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.09', 'spread': '8.01', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.83', 'spread': '9.11', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.73', 'spread': '7.84', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.54', 'spread': '7.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.89', 'spread': '7.40', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.23', 'spread': '8.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.65', 'spread': '7.70', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.68', 'spread': '8.15', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.26', 'spread': '6.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.19', 'spread': '6.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.48', 'spread': '6.77', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.13', 'spread': '4.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.68', 'spread': '4.81', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.18', 'spread': '4.51', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.92', 'spread': '4.75', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.66', 'spread': '8.96', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.90', 'spread': '9.04', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.41', 'spread': '8.34', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.25', 'spread': '9.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.19', 'spread': '9.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.44', 'spread': '9.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.42', 'spread': '9.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.60', 'spread': '6.32', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.50', 'spread': '7.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.10', 'spread': '6.58', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.83', 'spread': '7.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.25', 'spread': '9.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.50', 'spread': '9.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.59', 'spread': '6.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.80', 'spread': '6.68', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.39', 'spread': '7.98', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.26', 'spread': '9.31', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.51', 'spread': '8.78', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.68', 'spread': '8.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.04', 'spread': '7.89', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.90', 'spread': '7.47', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.45', 'spread': '9.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.85', 'spread': '6.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.85', 'spread': '5.96', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.82', 'spread': '4.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.50', 'spread': '2.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.17', 'spread': '2.25', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.88', 'spread': '27.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.66', 'spread': '28.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.34', 'spread': '30.98', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.08', 'spread': '31.57', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.50', 'spread': '28.70', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.69', 'spread': '31.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.37', 'spread': '34.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.98', 'spread': '34.18', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.14', 'spread': '25.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.15', 'spread': '26.87', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.52', 'spread': '24.80', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.07', 'spread': '27.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.07', 'spread': '28.19', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.57', 'spread': '29.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-20.84', 'spread': '30.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.", 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.13', 'spread': '26.75', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-27.48', 'spread': '33.22', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-35.21', 'spread': '33.07', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-30.50', 'spread': '51.62', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-32.00', 'spread': '49.50', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.50', 'spread': '47.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.50', 'spread': '47.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.00', 'spread': '74.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.00', 'spread': '53.74', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-34.00', 'spread': '46.67', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study', 'description': "Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.", 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.00', 'spread': '7.07', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-29.00', 'spread': '18.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-24.50', 'spread': '12.02', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.50', 'spread': '10.61', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-31.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 46 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-21.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-26.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "Overall back pain assessed by participant's parent using a 100 mm VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain.", 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.41', 'spread': '29.79', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-14.99', 'spread': '28.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.90', 'spread': '29.53', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.09', 'spread': '31.21', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.31', 'spread': '29.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.23', 'spread': '30.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.16', 'spread': '31.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-23.78', 'spread': '33.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.83', 'spread': '30.43', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-19.99', 'spread': '29.90', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.45', 'spread': '29.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.89', 'spread': '30.10', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.49', 'spread': '34.10', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-17.39', 'spread': '37.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-22.49', 'spread': '37.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.", 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 1 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '3.45', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.03', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '1.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '0.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.50', 'spread': '16.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.", 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'WAS included participants who entered the withdrawal period. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 3 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.00', 'spread': '8.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.00', 'spread': '4.24', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 9 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.50', 'spread': '12.02', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '12.73', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.00', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain.", 'unitOfMeasure': 'millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'RTAS included those participants who entered the re-treatment period. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.64', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.53', 'groupId': 'OG000'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.68', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'spread': '0.66', 'groupId': 'OG000'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.51', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.67', 'groupId': 'OG000'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.58', 'groupId': 'OG000'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.30', 'groupId': 'OG000'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored on a 3-point scale ranged from 0 to 2 (0=normal mobility, 2=severe reduction, where higher scores indicated more reduction). The total BASMI score range from 0 to 10, where higher scores indicated more reduction in spinal mobility.", 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "Number of Participants Analyzed", signifies participants with ERA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.45', 'spread': '10.36', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.07', 'spread': '13.96', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.82', 'spread': '12.55', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.85', 'spread': '13.71', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.95', 'spread': '14.42', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.38', 'spread': '15.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.18', 'spread': '14.21', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.81', 'spread': '14.06', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.45', 'spread': '14.34', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.09', 'spread': '13.66', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.88', 'spread': '13.38', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.88', 'spread': '19.95', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.39', 'spread': '14.64', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-13.50', 'spread': '14.93', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-16.83', 'spread': '15.83', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-15.80', 'spread': '17.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage (Head and neck= 10% \\[10 palms\\], upper extremities= 20% \\[20 palms\\], Trunk \\[axillae and groin\\]= 30% \\[30 palms\\], lower extremities \\[buttocks\\]= 40% \\[40 palms\\]). The total BSA affected was the summation of individual regions affected.", 'unitOfMeasure': 'Percentage of body surface area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "Number of Participants Analyzed", signifies participants with PsA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': "Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Change at Month 6 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 12 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.23', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 18 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '1.26', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.54', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 30 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '1.49', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '1.12', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 42 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.42', 'spread': '1.08', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 54 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 60 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.18', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 66 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.20', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.11', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 78 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.13', 'spread': '1.13', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '1.07', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 90 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.50', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96 of extension study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.80', 'spread': '1.10', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5, where 0= no psoriasis to 5= severe disease, where higher scores indicated more severity. \'Clear\' and "Almost clear\' includes all participants who were scored as a 0 or 1.', 'unitOfMeasure': 'Units on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "Number of Participants Analyzed", signifies participants with PsA and "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'All Cause Mortality: All Periods of Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'The considered event was death due to any cause from baseline to the end of the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants enrolled in the extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Prior Non-study Medication: All Periods of Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Anti-infective', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Oral Corticosteroids', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Parenteral Corticosteroid', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disease-modifying Antirheumatic Drugs', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}]}]}, {'title': 'Oral Non-steroidal Anti-inflammatory Medication', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs and oral non-steroidal anti-inflammatory medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants enrolled in the extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Anti-infective Medications', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Oral Corticosteroids', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Parenteral Corticosteroid', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Disease-modifying Antirheumatic Drugs', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}]}]}, {'title': 'Non-steroidal Anti-inflammatory Drugs', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Oral Non-steroidal Anti-inflammatory Drugs', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'Concomitant non-study medications were defined as any non-study medications taken during the treatment period. These included anti-infective medications, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants enrolled in the extension study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With After Non-study Medication: All Periods of Extension Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Anti-infectives', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Oral Corticosteroids', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Parenteral Corticosteroid', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Disease-modifying Antirheumatic Drugs', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Non-steroidal Anti-inflammatory Drugs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Oral Non-steroidal Anti-inflammatory Drugs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Extension study: Last dose of study medication up to 30 days (maximum up to 97 months)', 'description': 'After non-study medications referred to any non-study medications taken after the last dose of the investigational product. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory medication and non-steroidal anti-inflammatory medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants enrolled in the extension study.'}, {'type': 'SECONDARY', 'title': 'Exposure Time: Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'categories': [{'measurements': [{'value': '244.79', 'spread': '147.71', 'groupId': 'OG000', 'lowerLimit': '147.71'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'The exposure time (in years) to etanercept was calculated for each participant using the following formula: (the last dose date minus the first dose date plus 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. Exposure time in year was converted into weeks and reported here.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '57.4', 'upperLimit': '78.7'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.0', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '82.6'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000', 'lowerLimit': '66.8', 'upperLimit': '88.3'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '89.1'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.5', 'groupId': 'OG000', 'lowerLimit': '71.2', 'upperLimit': '95.5'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '98.0'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '70.8', 'upperLimit': '98.9'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '99.9'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '69.8', 'upperLimit': '99.8'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '69.2', 'upperLimit': '100.0'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '63.1', 'upperLimit': '100.0'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '59.0', 'upperLimit': '100.0'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '54.1', 'upperLimit': '100.0'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '100.0'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100.0'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '39.8', 'upperLimit': '100.0'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ.", 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study. Here, "number analyzed" signifies participants evaluable at specified time points.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'classes': [{'title': 'Pulse (low)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Systolic blood pressure (high)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (low)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Diastolic blood pressure (high)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Temperature', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 96 active treatment period of extension study', 'description': "Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all participants in the parent study who received at least 1 dose of investigational product regardless of whether they received any investigational product during the extension study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'periods': [{'title': 'Parent Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '119'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'drug ineffective+prohibited drug taken', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Failed to return', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Overall Period for Extension Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}, {'type': 'Enrolled Into Active Treatment Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'Enrolled Into Observational Period', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '27 participants completed study in Active Treatment period, 45 completed study in Observational Period, 5 completed study in Re-treatment Period, and 7 completed study in Withdrawal Period.', 'groupId': 'FG000', 'numSubjects': '84'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Medication error without associated adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No longer willing to participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Active Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '99'}]}, {'type': 'ERA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'PsA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No longer willing to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Insufficient clinical response', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Medication error without associated adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Enrolled in withdrawal period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'Enrolled in observational period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}]}, {'title': '2a. Withdrawal Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period.', 'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'ERA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'PsA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'No longer willing to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Enrolled in observational period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Enrolled in re-treatment period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}]}]}, {'title': '2b. Retreatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': "Participants requiring re-treatment per investigator's judgment entered re-treatment period.", 'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'ERA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'PsA', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Enrolled in observational period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Observational Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '10 participants entered directly from Parent study B1801014 (NCT00962741)', 'groupId': 'FG000', 'numSubjects': '53'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'No longer willing to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'This was an extension study in pediatric participants diagnosed with one of three subtypes of juvenile idiopathic arthritis (JIA): extended oligoarticular JIA, enthesitis related arthritis (ERA), or psoriatic arthritis (PsA) and had received at least one dose of Etanercept and completed approximately 96 weeks of participation in study B1801014 (NCT00962741).', 'preAssignmentDetails': 'Total 127 participants were enrolled and treated in parent study, B1801014 (NCT00962741) and included in analysis of this extension study. Total 109 participants from the Parent study were enrolled in this extension study, B1801023. Out of which 10 participants directly entered into observational phase and did not receive treatment in this extension study. The extension study has 3 periods: active treatment period, withdrawal/re-treatment period and observational period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': "Participants who completed 96 weeks of Etanercept treatment in study B1801014 and eligible to continue Etanercept in study B1801023, entered directly into active treatment period to receive Etanercept subcutaneous dose of 0.8 milligram/kilogram once a week, for maximum of 96 months. Eligible participants from active treatment, who either met Wallace definition for clinically inactive disease for at least 6 months or had good clinical response and would benefit from treatment withdrawal entered withdrawal period. Eligible participants requiring re-treatment per investigator's judgment entered re-treatment period. Participants who discontinued treatment prior to 96 weeks in study B1801014 or not eligible to continue treatment in B1801023 entered directly into observational period. Participants who discontinued treatment/study period, prior to completion also entered into observational period. In observational period, all participants were followed up for maximum of 96 months from time of initial entry into this study."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.28', 'spread': '4.49', 'groupId': 'BG000', 'lowerLimit': '4.49'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '61', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '101', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all enrolled participants from parent study B1801014 (NCT00962741) who received at least 1 dose of investigational product in parent study, regardless of whether they received any investigational product during the extension study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-03-09', 'size': 2788016, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-01-13T17:50', 'hasProtocol': True}, {'date': '2017-03-22', 'size': 2166267, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-01-13T17:50', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 109}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2011-08-18', 'resultsFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2011-08-18', 'lastUpdatePostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-06', 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Malignancy: All Periods of Parent and Extension Study', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Number of participants who had adverse event (AE) of malignancy were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious Adverse Events: All Periods of Parent and Extension Study', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}, {'measure': 'Number of Participants With Serious Infections: All Periods of Parent and Extension Study', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Serious infections were defined as any infections those were life threatening or resulted in disability, infections requiring intravenous antibiotic treatment and hospitalization.'}, {'measure': 'Number of Participants With Medically Important Infections: All Periods of Parent and Extension Study', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Medically important infections were defined as an infection requiring parenteral (intravenous \\[IV\\], intramuscular \\[IM\\]) anti-infective agent(s) and/or hospitalization.'}, {'measure': 'Number of Participants With Infections: All Periods of Parent and Extension Study', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Number of participants who had infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}, {'measure': 'Number of Participants With Treatment Emergent Infections and Injection Site Reactions: All Periods of Extension Study', 'timeFrame': 'Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)', 'description': 'Number of participants who had treatment emergent infections and injection site reactions as adverse events were reported. Treatment emergent infections were infections occurring in a participant who received study medication without regard to possibility of causal relationship to it. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}, {'measure': 'Number of Participants With Infections: Extension Study: Withdrawal Period', 'timeFrame': 'Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)', 'description': 'Number of participants who had treatment emergent infections as AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}, {'measure': 'Number of Participants Withdrawn Due to Adverse Events: All Periods of Parent and Extension Study', 'timeFrame': 'First dose of study medication in parent study up to 96 months in the extension study, for a maximum duration of 118 months (22 months of parent study and 96 months of extension study)', 'description': 'Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}, {'measure': 'Number of Participants Withdrawn Due to Adverse Events: Extension Study: Withdrawal Period', 'timeFrame': 'Extension study: Day of study treatment withdrawal up to entering re-treatment period or observational period (for a maximum of 96 months)', 'description': 'Participants withdrew from the study due to AEs were reported. An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it.'}, {'measure': 'Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities Based on National Cancer Institute Criteria Version 4.03: All Periods of Extension Study', 'timeFrame': 'Extension study: Baseline (Day 1) up to 30 days after the last dose of investigational product (maximum up to 97 months)', 'description': 'Abnormality of laboratory parameters was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.'}, {'measure': 'Change From Baseline of Parent Study in Z-Score at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study', 'description': 'Growth parameters including weight, height and body-mass index (BMI) were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, greater than (\\>) 0 a greater mean, and less than (\\<0) a lesser mean than the standard.'}, {'measure': 'Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 withdrawal period of extension study', 'description': 'Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, \\>0 a greater mean, and \\<0 a lesser mean than the standard.'}, {'measure': 'Change From Baseline in Z-Score at Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 42, 48, 60, 72, 84 and 96 re-treatment period of extension study', 'description': 'Growth parameters including weight, height and BMI were compared to the standard growth data by using Z-Score. Z-Score is a statistical measure to evaluate how a single data point or mean compares to a standard. A Z-Score describes whether a mean is above or below the standard and how unusual the measurement is. Z-scores range from -3 to +3. A Z-score of 0 indicates the same mean, \\>0 a greater mean, and \\<0 a lesser mean than the standard.'}, {'measure': 'Change From Baseline (of Parent Study) in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study', 'description': 'Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.'}, {'measure': 'Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 withdrawal period of extension study', 'description': 'Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.'}, {'measure': 'Change From Baseline in Tanner Assessment Score for Participants Aged <18 Years at Month 12, 24, 36, 48, 60, 72, 84 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the extension study; Month 12, 24, 36, 48, 60, 72, 84 and 96 re-treatment period of extension study', 'description': 'Tanner assessment score: used to document the stage of development of secondary sexual characteristics. Female pubertal development staged by pubic hair development and breast size; male pubertal development staged by size of the genitalia and development of pubic hair. Tanner assessment score ranged from 1 (no development) to 5 (adult-like development in quantity and size), higher scores indicated more development.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR30PR: \\>=30% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR30PR: \\>=30% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 30% (ACR30) Pediatric Response (ACR30PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period:', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': "ACR30PR: \\>=30% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR50PR: \\>=50% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR50PR: \\>=50% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Pediatric Response (ACR50PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': 'ACR50PR:\\>=50% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria:1)PGA of disease activity(DA),2)PtGA of arthritis pain,3) CHAQ 4)number(no.) of active joints5)no. of joints with limited range of motion 6)C-reactive protein.PGA of DA: 21-circle VAS ranging 0-10, with 0=\\&10=maximumDA,higher score=more severe disease.PGA:21-circle VAS ranging 0-10,0=very well,10=very poor,higher scores=worsening condition.CHAQ: assessment of functional disability,discomfort. Ability to perform activities:dressing,arising,eating,walking,hygiene,reach,grip, common activities distributed in total of 30 items. Ranging 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do.Highest score for each domain:score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered.Ranged 0=no difficulty to 3=extreme difficulty;higher scores indicated more functional disability and discomfort. Participants \\>18 years assessed using CHAQ.'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR70PR: \\>=70% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR70PR: \\>=70% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Pediatric Response (ACR70PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': "ACR70PR: \\>=70% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR90PR: \\>=90% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 withdrawal period of extension study', 'description': "ACR90PR: \\>=90% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 90% (ACR90) Pediatric Response (ACR90PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84 and 96 re-treatment period of extension study', 'description': "ACR90PR: \\>=90% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 100% (ACR100) Pediatric Response (ACR100PR) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "ACR100PR: 100% improvement from baseline in 3 of 6 criteria with worsening \\>30% in no more than 1 of 6 criteria: physician's global assessment (on 21-circle VAS ranging 0 \\[no disease activity\\] to 10 \\[maximum disease activity\\],higher score=more severe disease), patient global assessment (on 21-circle VAS ranging 0 \\[very well\\] to 10 \\[very poor\\],higher score=higher pain), childhood health assessment questionnaire (\\[CHAQ\\] Participants \\>18 years assessed for functional disability, discomfort. Ability to dressing, arising, eat, walk, hygiene, reach, grip, common activities were distributed in 30 items. Each item scored from 0 \\[no difficulty\\] to 3 \\[unable to do\\]. Highest score for each domain was score for that domain. Overall CHAQ score=sum of domain scores/number of domains answered and ranged from 0 \\[no difficulty\\] to 3 \\[extreme difficulty\\], where higher scores=more functional disability and discomfort), number of active joints and joints with limited range of motion, C-reactive protein."}, {'measure': "Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period", 'timeFrame': 'Baseline of the parent study; Month 12, 24, 36, 48, 60, 72, 84 and 96 active treatment period of extension study', 'description': 'PGA of disease activity was measured on a 21-circle Visual Analog Scale (VAS) ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.'}, {'measure': "Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period", 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.'}, {'measure': "Change From Baseline (of Parent Study) in Physician's Global Assessment of Disease Activity Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period", 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'PGA of disease activity was measured on a 21-circle VAS ranging from 0 to 10, with 0 = no disease activity and 10= maximum disease activity, where higher score indicated more severe disease.'}, {'measure': 'Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition."}, {'measure': 'Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition."}, {'measure': 'Change From Baseline (of Parent Study) in Patient/Parent Global Assessment Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "Patient/Parent Global Assessment was assessed by the participant's parent using a 21-circle VAS ranging from 0 to 10, with 0 = very well and 10 = very poor, where higher scores indicated worsening of condition."}, {'measure': 'Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ."}, {'measure': 'Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ."}, {'measure': 'Change From Baseline (of Parent Study) in Childhood Health Assessment Questionnaire (CHAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ."}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants Years at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \\> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \\> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.'}, {'measure': 'Change From Baseline in Health Assessment Questionnaire (HAQ) Score for Participants at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'HAQ is a self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ total score range from 0 to 3, where 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=unable to do. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25=normal functioning; 0.25-0.5=mild functional limitation; 0.5-1=moderate functional limitation; \\> 1=significant functional limitation. Participants aged 18 years or above were assessed using HAQ scores.'}, {'measure': 'Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.'}, {'measure': 'Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.'}, {'measure': 'Change From Baseline (of Parent Study) in Number of Joints With Active Arthritis at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Joints with active arthritis were defined as joints that were swollen or, in the absence of swelling, joints with limited range of motion accompanied by pain and/or tenderness.'}, {'measure': 'Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. Joint replacement (JR) and not evaluable (NE) were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.'}, {'measure': 'Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.'}, {'measure': 'Change From Baseline (of Parent Study) in Number of Joints With Limited Motion at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Total number of joints with limited range of motion was the number of joints with limited range of motion. It was defined as 69\\*(total number of joints with score of limited range of motion greater than zero)/number of non-missing limited range of motions. JR and NE were treated as missing. If more than 34 scores of limited range of motion were missing, then the total number of joints with limited range of motion was defined as missing.'}, {'measure': 'Change From Baseline (of Parent Study) in C-reactive Protein at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': 'Change From Baseline (of Parent Study) in C-reactive Protein at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': 'Change From Baseline (of Parent Study) in C-reactive Protein at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 and 96 re-treatment period of extension study', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': 'Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.'}, {'measure': 'Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.'}, {'measure': 'Change From Baseline (of Parent Study) in Visual Analogue Scale (VAS) Pain Score at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'VAS: 10-point pain intensity ordinal rating system: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-9 = severe pain, 10 = worst possible pain. A higher score indicates greater pain intensity.'}, {'measure': 'Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day = 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).'}, {'measure': 'Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).'}, {'measure': 'Change From Baseline (of Parent Study) in Duration of Morning Stiffness at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes (if none was present = 0; if stiffness persisted the entire day, 1440 minutes was recorded; if morning stiffness was continuing at the time of assessment or was unusual compared to the recent past, average of duration of stiffness over the past 3 days was reported).'}, {'measure': 'Percentage of Participants With Clinically Inactive Disease at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of less than or equal to (\\<=) 15 minutes.'}, {'measure': 'Percentage of Participants With Clinically Inactive Disease at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of \\<=15 minutes.'}, {'measure': 'Percentage of Participants With Clinically Inactive Disease at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': 'Clinically inactive disease was defined as no joints with active arthritis; no fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA; no active uveitis; normal range of CRP; PGA of disease activity of 0 on a 21-circle VAS and duration of morning stiffness of \\<=15 minutes.'}, {'measure': 'Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.'}, {'measure': 'Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.'}, {'measure': 'Change From Baseline (of Parent Study) in Juvenile Arthritis Disease Activity Score 73 Joints (JADAS-73) at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period', 'timeFrame': 'Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': 'JADAS-73 is a validated composite disease activity measure for JIA. It was derived from four components; 1) Physician global assessment of disease activity (assessed on 10 cm VAS, where 0= no activity and 10=maximum activity, higher scores indicated more disease activity). 2) Parent/participant global assessment of overall well-being (assessed on a VAS, where 0= very well and 10=very poor, higher scores indicated worse condition). 3) Number of joints with active disease (defined as joint with swelling or, in absence of swelling, limited range of motion accompanied by either pain on motion or tenderness). 4) An inflammatory marker, CRP that was measured in mg/L and its value normalized to 0 to 10 scale, where higher scores indicated more disease activity. JADAS total score was calculated as the sum of its four components and ranged from 0-103. A higher score indicates more disease activity.'}, {'measure': 'Change From Baseline (of Parent Study) in Overall Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain."}, {'measure': 'Change From Baseline (of Parent Study) in Overall Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of Extension study', 'description': "Overall back pain assessed by participant's parent using a 100 millimeter (mm) VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain."}, {'measure': 'Change From Baseline (of Parent Study) in Overall Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "Overall back pain assessed by participant's parent using a 100 mm VAS with 0 mm= no pain and 100 mm= most severe pain, higher scores indicated more pain."}, {'measure': 'Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Baseline of the parent study; Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain."}, {'measure': 'Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Withdrawal Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Baseline of the parent study; Month 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 withdrawal period of extension study', 'description': "Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain."}, {'measure': 'Change From Baseline (of Parent Study) in Nocturnal Back Pain at Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Re-treatment Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Baseline of the parent study; Month 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 re-treatment period of extension study', 'description': "Nocturnal back pain assessed by participant's parent using a 100 mm VAS with 0 mm = no pain and 100 mm = most severe pain, higher scores indicated more pain."}, {'measure': 'Bath Ankylosing Spondylitis Metrology Index (BASMI) Score at Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Enthesitis-Related Arthritis (ERA)', 'timeFrame': 'Month 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored on a 3-point scale ranged from 0 to 2 (0=normal mobility, 2=severe reduction, where higher scores indicated more reduction). The total BASMI score range from 0 to 10, where higher scores indicated more reduction in spinal mobility."}, {'measure': 'Change From Baseline (of Parent Study) in Percentage Body Surface Area (BSA) at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)', 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "Percentage of body surface area affected by psoriasis was estimated using the palm method: one of the participant's palm to proximal interphalangeal and thumb= 1% of BSA. Regions of the body were assigned specific number of palms with percentage (Head and neck= 10% \\[10 palms\\], upper extremities= 20% \\[20 palms\\], Trunk \\[axillae and groin\\]= 30% \\[30 palms\\], lower extremities \\[buttocks\\]= 40% \\[40 palms\\]). The total BSA affected was the summation of individual regions affected."}, {'measure': "Change From Baseline (of Parent Study) in Physician's Global Assessment (PGA) of Psoriasis Score at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period: Psoriatic Arthritis (PsA)", 'timeFrame': 'Baseline of the parent study; Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': 'PGA of Psoriasis assessed the amount of induration, erythema, and scaling averaged over all psoriatic lesions on a scale of 0 to 5, where 0= no psoriasis to 5= severe disease, where higher scores indicated more severity. \'Clear\' and "Almost clear\' includes all participants who were scored as a 0 or 1.'}, {'measure': 'All Cause Mortality: All Periods of Extension Study', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'The considered event was death due to any cause from baseline to the end of the study.'}, {'measure': 'Number of Participants With Prior Non-study Medication: All Periods of Extension Study', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'Prior non-study medications were defined as any non-study medications taken before the first dose of investigational product taken at the start of the study. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs and oral non-steroidal anti-inflammatory medication.'}, {'measure': 'Number of Participants With Concomitant Non-study Medication: All Periods of Extension Study', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'Concomitant non-study medications were defined as any non-study medications taken during the treatment period. These included anti-infective medications, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory drugs and non-steroidal anti-inflammatory drugs.'}, {'measure': 'Number of Participants With After Non-study Medication: All Periods of Extension Study', 'timeFrame': 'Extension study: Last dose of study medication up to 30 days (maximum up to 97 months)', 'description': 'After non-study medications referred to any non-study medications taken after the last dose of the investigational product. These included anti-infective, corticosteroids, oral corticosteroids, Parenteral corticosteroids, disease-modifying antirheumatic drugs, oral non-steroidal anti-inflammatory medication and non-steroidal anti-inflammatory medication.'}, {'measure': 'Exposure Time: Extension Study: Active Treatment Period', 'timeFrame': 'Extension study: First dose of study medication up to 30 days after last dose of study drug (maximum up to 97 months)', 'description': 'The exposure time (in years) to etanercept was calculated for each participant using the following formula: (the last dose date minus the first dose date plus 1)/365.25. If the gap was less than 28 days between two etanercept treatment periods, the cumulative exposure included the gap. Else, the gap was excluded from the cumulative exposure. Exposure time in year was converted into weeks and reported here.'}, {'measure': 'Percentage of Participants With Total Childhood Health Assessment Questionnaire (CHAQ) Score Improvement of >0.188 at Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 of Extension Study: Active Treatment Period', 'timeFrame': 'Month 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90 and 96 active treatment period of extension study', 'description': "CHAQ: parent-administered, valid assessment of functional disability, discomfort in pediatrics with rheumatic diseases. Parents report participant's ability to perform activities in 8 domains: dressing, arising, eating, walking, hygiene, reach, grip, common activities distributed in total of 30 items. Each item is scored on 4-point Likert scale: 0=no difficulty;1=some difficulty;2=much difficulty;3=unable to do. Highest score reported for each domain is score for that domain. Overall CHAQ score was calculated as sum of domain scores divided by number of domains answered and ranged from 0=no difficulty to 3=extreme difficulty, where higher scores indicated more functional disability and discomfort in pediatrics with rheumatic disease. Participants below 18 years of age were assessed using CHAQ."}, {'measure': 'Number of Participants With Vital Signs Abnormalities: Extension Study: Active Treatment Period', 'timeFrame': 'Month 96 active treatment period of extension study', 'description': "Vital signs assessment included temperature, pulse, systolic and diastolic blood pressure. Pulse rate was obtained with participant in the seated position, after having sat calmly for at least 5 minutes. Clinical significance of vital signs was determined at the investigator's discretion."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Use of etanercept to treat pediatric subjects with extended oligoarticular JIA', 'enthestitis related arthritis (ERA)', 'or psoriatic arthritis (PsA).'], 'conditions': ['Juvenile Idiopahtic Arthritis']}, 'referencesModule': {'references': [{'pmid': '37140539', 'type': 'DERIVED', 'citation': 'Vojinovic J, Foeldvari I, Dehoorne J, Panaviene V, Susic G, Horneff G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Akikusa J, Avcin T, Borlenghi C, Arthur E, Tatulych SY, Zang C, Tsekouras V, Vlahos B, Martini A, Ruperto N. Ten-year safety and clinical benefit from open-label etanercept treatment in children and young adults with juvenile idiopathic arthritis. Rheumatology (Oxford). 2024 Jan 4;63(1):140-148. doi: 10.1093/rheumatology/kead183.'}, {'pmid': '31122296', 'type': 'DERIVED', 'citation': 'Foeldvari I, Constantin T, Vojinovic J, Horneff G, Chasnyk V, Dehoorne J, Panaviene V, Susic G, Stanevicha V, Kobusinska K, Zuber Z, Dobrzyniecka B, Nikishina I, Bader-Meunier B, Breda L, Dolezalova P, Job-Deslandre C, Rumba-Rozenfelde I, Wulffraat N, Pedersen RD, Bukowski JF, Vlahos B, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO). Etanercept treatment for extended oligoarticular juvenile idiopathic arthritis, enthesitis-related arthritis, or psoriatic arthritis: 6-year efficacy and safety data from an open-label trial. Arthritis Res Ther. 2019 May 23;21(1):125. doi: 10.1186/s13075-019-1916-9.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801023&StudyName=Extension%20Study%20Evaluating%20Etanercept%20in%203%20Subtypes%20of%20Childhood%20Arthritis%0A', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a 8-year extension study in pediatric subjects who have been diagnosed with one of 3 subtypes of Juvenile Idiopathic Arthritis (JIA) \\[extended oligoarticular JIA, enthestitis related arthritis (ERA), or psoriatic arthritis (PsA)\\] who have completed approximately 96 weeks of participation in study 0881A1-3338 (B1801014). The study contains an active treatment period, withdrawal/re-treatment period and a observational period (non-treatment).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nReceipt of at least 1 dose of investigational product (etanercept) and participation for approximately 96 weeks in study 0881A1-3338 (B1801014)\n\nPersonally signed and dated informed consent document (and assent document, as applicable) indicating the subject (or legally representative/guardian) has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\nExclusion criteria for subject planning to continue investigational product:\n\nwithdrawal from investigational product in study 0881A1-3338 for any reason (safety or non-safety).\n\nHistory of maliginancy other than squamous cell, basal cell carcinoma or cervical carcinoma in situ.'}, 'identificationModule': {'nctId': 'NCT01421069', 'acronym': 'CLIPPER2', 'briefTitle': 'Extension Study Evaluating Etanercept in 3 Subtypes of Childhood Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'AN OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY AND CLINICAL BENEFIT OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS-RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1-3338-WW(B1801014)', 'orgStudyIdInfo': {'id': 'B1801023'}, 'secondaryIdInfos': [{'id': '0881A1-3342', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2010-023802-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: etanercept']}], 'interventions': [{'name': 'etanercept', 'type': 'DRUG', 'description': 'Subjects aged \\<18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).\n\nSubjects aged greater than or equal to 18 years or \\>62 kg will receive etanercept SC at a dose of 50 mg QW.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Westmead, Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': "The Children's Hospital at Westmead"}, {'zip': '3052', 'city': 'Parkville, Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': "Royal Children's Hospital"}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '680003', 'city': 'Bucaramanga', 'state': 'Santander Department', 'country': 'Colombia', 'facility': 'Servimed S.A.S', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'zip': '61300', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Brno - Detska nemocnice, Ambulance detske revmatologie', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '121 00', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Klinika detskeho a dorostoveho lekarstvi 1. LF UK a VFN v Praze', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '128 50', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Revmatologicky ustav', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital NECKER-Enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'HELIOS Klinikum Berlin-Buch', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '28177', 'city': 'Bremen', 'country': 'Germany', 'facility': 'Klinikum Bremen-Mitte', 'geoPoint': {'lat': 53.07582, 'lon': 8.80717}}, {'zip': '22081', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Schön Klinik Hamburg Eilbek', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '53757', 'city': 'Saint Augustin', 'country': 'Germany', 'facility': 'Asklepios Klinik Sankt Augustin GmbH, Zentrum fuer Kinder- und Jugendrheumatologie'}, {'zip': '1094', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Semmelweis Egyetem', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '66013', 'city': 'Chieti Scalo', 'country': 'Italy', 'facility': 'Centro di Ricerca Clinica - Fondazione dell\'Universita\' degli Studi "G. 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