Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-02-19 @ 1:08 AM
Study NCT ID:
NCT00544557
Status:
COMPLETED
Last Update Posted:
2015-05-12
First Post:
2007-10-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013167', 'term': 'Spondylitis, Ankylosing'}], 'ancestors': [{'id': 'D000089183', 'term': 'Axial Spondyloarthritis'}, {'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': 'D000844', 'term': 'Ankylosis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}]}, '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': '1--800--718--1021', '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': {'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.', 'eventGroups': [{'id': 'EG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.', 'otherNumAtRisk': 1685, 'otherNumAffected': 588, 'seriousNumAtRisk': 1685, 'seriousNumAffected': 128}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Furuncle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Acute tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Infection susceptibility increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rash pustular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tracheobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Acarodermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cellulitis of male external genital organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Erythrasma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastrointestinal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Genital candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hepatitis B', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Oophoritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Paronychia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Perirectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Peritonsillar abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pseudofolliculitis barbae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Vaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Viral tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Local swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Drug ineffective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Drug intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site macule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Application site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 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'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin exfoliation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Muscle disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Osteitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sacroiliitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Breath odour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Chapped lips', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Epiploic appendagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Radicular cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cervical root pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cervicobrachial syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sensory disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Areflexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hyperaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Intercostal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Meralgia paraesthetica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Restless legs syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Syncope vasovagal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Arthroscopy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Investigation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Antinuclear antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bacterial test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Biopsy prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'DNA antibody positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Diagnostic procedure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'ECG signs of myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Laboratory test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Red blood cell sedimentation rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Blood pressure diastolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pharyngolaryngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rhonchi', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sneezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sputum discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Nasal dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Painful respiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Visual disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abnormal sensation in eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Iridocyclitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Carpal tunnel decompression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Synoviorthesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abortion induced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Angioplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ankle operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Arterial stent insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': "Baker's cyst excision", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Catheterisation cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dental operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dental treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hip arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Infiltration anaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ligament operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Neurolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Osteotomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Spinal deformity correction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tendon operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tendon sheath incision', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tonsillectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Drug exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Joint sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skeletal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 8}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Depressed mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Alcohol abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Libido decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Mood swings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Somatoform disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tobacco abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cardiac discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Mitral valve prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 6}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Delivery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'First trimester pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': "Cow's milk intolerance", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Obesity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Type 2 diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ear pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Inner ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sudden hearing loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Melanocytic naevus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Superficial spreading melanoma stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Calculus urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Erectile dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Genital erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Menstruation irregular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Androgen deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': "Cushing's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hepatic steatosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}], 'seriousEvents': [{'term': 'Ankylosing spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Fibromyalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Spondylitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': "Dupuytren's contracture", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Joint ankylosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Joint instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Osteochondrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Rheumatoid arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Adenoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Glioblastoma multiforme', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Intracranial haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Metastasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Oropharyngeal neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pilonidal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Drug exposure during pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Joint dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cervical vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ligament rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Lymphatic duct rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Meniscus lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 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'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Mitral valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 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'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Injection site hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Implantable defibrillator insertion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 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'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Iritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bone marrow disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Skull malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Cervical polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Bursitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1685, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v17.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Partial Remission at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1305', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '21.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 26', 'description': 'Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants greater than or equal to (\\>=) 18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Partial Remission at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1111', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '25.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, who received etanercept therapy for the first time and had post-baseline documentation. Here 'N' signifies participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1685', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '25.6'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': '38.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants with available post-baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1685', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed due to low number of participants.', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '25.6'}]}]}, {'title': 'AEs', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not analyzed due to low number of participants.', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants with available post--baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1635)', 'categories': [{'measurements': [{'value': '5.327', 'spread': '2.029', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1128)', 'categories': [{'measurements': [{'value': '-2.199', 'spread': '2.163', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1626)', 'categories': [{'measurements': [{'value': '4.9', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1129)', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': "BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Occiput-to-Wall Distance at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1347)', 'categories': [{'measurements': [{'value': '6.7', 'spread': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=788)', 'categories': [{'measurements': [{'value': '-0.7', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lateral Lumbar Flexion at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1123)', 'categories': [{'measurements': [{'value': '11.8', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=656)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '8.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': "Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1630)', 'categories': [{'measurements': [{'value': '6.5', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1117)', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1602)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1094)', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1655)', 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1171)', 'categories': [{'measurements': [{'value': '-4.2', 'spread': '2.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Duration of Morning Stiffness at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1641)', 'categories': [{'measurements': [{'value': '58.6', 'spread': '59.2', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1165)', 'categories': [{'measurements': [{'value': '-37.0', 'spread': '54.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Significant Reduction of Morning Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Week 2 (n=1405)', 'categories': [{'measurements': [{'value': '51.6', 'spread': '59.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (n=1452)', 'categories': [{'measurements': [{'value': '62.1', 'spread': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=1480)', 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n=1395)', 'categories': [{'measurements': [{'value': '68.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 38 (n=1235)', 'categories': [{'measurements': [{'value': '69.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (n=1186)', 'categories': [{'measurements': [{'value': '70.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 2, 6, 12, 26, 38, 52', 'description': "Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Presence of Peripheral Arthritis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1663)', 'categories': [{'measurements': [{'value': '36.8', 'spread': '59.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 (n=1405)', 'categories': [{'measurements': [{'value': '26.0', 'spread': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (n=1452)', 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=1480)', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n=1395)', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 38 (n=1235)', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (n=1186)', 'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 6, 12, 26, 38, 52', 'description': 'Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1652)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '5.5', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1174)', 'categories': [{'measurements': [{'value': '-1.3', 'spread': '5.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.', 'unitOfMeasure': 'joints', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Presence of Enthesitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1663)', 'categories': [{'measurements': [{'value': '20.6', 'spread': '59.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 2 (n=1405)', 'categories': [{'measurements': [{'value': '14.7', 'spread': '31.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 6 (n=1452)', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 12 (n=1480)', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 26 (n=1395)', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 38 (n=1235)', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 52 (n=1186)', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Week 2, 6, 12, 26, 38, 52', 'description': 'Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1658)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=1174)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.', 'unitOfMeasure': 'body parts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in C-Reactive Protein (CRP) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1497)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=873)', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1422)', 'categories': [{'measurements': [{'value': '26.9', 'spread': '21.7', 'groupId': 'OG000'}]}]}, {'title': 'Change at Week 52 (n=812)', 'categories': [{'measurements': [{'value': '-14.2', 'spread': '21.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.', 'unitOfMeasure': 'mm/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Week 12 (n=1480)', 'categories': [{'measurements': [{'value': '60.6', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '63.3'}]}]}, {'title': 'Week 26 (n=1395)', 'categories': [{'measurements': [{'value': '61.6', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '64.3'}]}]}, {'title': 'Week 38 (n=1235)', 'categories': [{'measurements': [{'value': '63.1', 'groupId': 'OG000', 'lowerLimit': '60.3', 'upperLimit': '66.0'}]}]}, {'title': 'Week 52 (n=1186)', 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000', 'lowerLimit': '60.7', 'upperLimit': '66.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, 26, 38, 52', 'description': "ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least \\>= 20 percent improvement from baseline and an absolute change \\>=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Week 12 (n=1480)', 'categories': [{'measurements': [{'value': '44.1', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '46.8'}]}]}, {'title': 'Week 26 (n=1395)', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '49.5'}]}]}, {'title': 'Week 38 (n=1235)', 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '45.6', 'upperLimit': '51.5'}]}]}, {'title': 'Week 52 (n=1186)', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '54.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12, 26, 38, 52', 'description': "ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (\\>=) 40 percent improvement from baseline and an absolute change \\>=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1623)', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.30', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '46.8'}]}]}, {'title': 'Week 26 (n=1343)', 'categories': [{'measurements': [{'value': '0.80', 'spread': '0.22', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '49.5'}]}]}, {'title': 'Week 52 (n=1143)', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.20', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '54.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, 52', 'description': 'EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline (n=1623)', 'categories': [{'measurements': [{'value': '54.3', 'spread': '20.7', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '46.8'}]}]}, {'title': 'Week 26 (n=1343)', 'categories': [{'measurements': [{'value': '71.9', 'spread': '19.2', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '49.5'}]}]}, {'title': 'Week 52 (n=1143)', 'categories': [{'measurements': [{'value': '74.2', 'spread': '18.9', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '54.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, 52', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline: Work Time Missed (n=776)', 'categories': [{'measurements': [{'value': '21.9', 'spread': '36.3', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '46.8'}]}]}, {'title': 'Baseline: Impairment While Working (n=890)', 'categories': [{'measurements': [{'value': '48.3', 'spread': '26.9', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '49.5'}]}]}, {'title': 'Baseline: Overall work impairment (n=716)', 'categories': [{'measurements': [{'value': '52.9', 'spread': '29.8', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '54.0'}]}]}, {'title': 'Baseline: Activity impairment (n = 1624)', 'categories': [{'measurements': [{'value': '58.1', 'spread': '24.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Work Time Missed (n = 666)', 'categories': [{'measurements': [{'value': '6.6', 'spread': '20.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Impairment While Working (n = 799)', 'categories': [{'measurements': [{'value': '27.3', 'spread': '23.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Overall work impairment (n = 657)', 'categories': [{'measurements': [{'value': '29.8', 'spread': '25.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Activity impairment (n = 1331)', 'categories': [{'measurements': [{'value': '34.6', 'spread': '24.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Work Time Missed (n = 588)', 'categories': [{'measurements': [{'value': '6.3', 'spread': '19.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Impairment While Working (n = 706)', 'categories': [{'measurements': [{'value': '24.6', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Overall work impairment (n = 578)', 'categories': [{'measurements': [{'value': '26.3', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Activity impairment (n = 1137)', 'categories': [{'measurements': [{'value': '32.3', 'spread': '24.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, 52', 'description': 'WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.', 'unitOfMeasure': 'percentage of impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Healthcare Resource Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline: General Practitioner Visit (n=1654)', 'categories': [{'measurements': [{'value': '4.7', 'spread': '8.3', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '46.8'}]}]}, {'title': 'Baseline: Rheumatologist Visit (n=1657)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.3', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '49.5'}]}]}, {'title': 'Baseline: Other Specialist Visit (n=1659)', 'categories': [{'measurements': [{'value': '1.6', 'spread': '3.1', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '54.0'}]}]}, {'title': 'Baseline: In-patient Hospitalization (n = 1658)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: In-patient Rehabilitation (n = 1657)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Follow-up Treatment (n = 1662)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Out-patient Rehabilitation (n = 1661)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Physiotherapy (n = 1659)', 'categories': [{'measurements': [{'value': '9.1', 'spread': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Out-patient Hospitalization (n = 1663)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Ergotherapy (n = 1663)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Other Health Care Resources (n = 1662)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '7.4', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Sum Over All Care Resources (n = 1663)', 'categories': [{'measurements': [{'value': '20.3', 'spread': '29.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: General Practitioner Visit (n = 1389)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Rheumatologist Visit (n = 1392)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Other Specialist Visit (n = 1393)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: In-patient Hospitalization (n = 1395)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: In-patient Rehabilitation (n = 1392)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Follow-up Treatment (n = 1395)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Out-patient Rehabilitation (n = 1395)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Physiotherapy (n = 1395)', 'categories': [{'measurements': [{'value': '5.0', 'spread': '14.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Out-patient Hospitalization (n = 1394)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Ergotherapy (n = 1395)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Other Health Care Resources (n = 1390)', 'categories': [{'measurements': [{'value': '0.5', 'spread': '4.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Sum Over All Care Resources (n = 1395)', 'categories': [{'measurements': [{'value': '11.5', 'spread': '16.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: General Practitioner Visit (n = 1184)', 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Rheumatologist Visit (n = 1184)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Other Specialist Visit (n = 1183)', 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: In-patient Hospitalization (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: In-patient Rehabilitation (n = 1186)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Follow-up Treatment (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Out-patient Rehabilitation (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Physiotherapy (n = 1186)', 'categories': [{'measurements': [{'value': '4.3', 'spread': '13.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Out-patient Hospitalization (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Ergotherapy (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Other Health Care Resources (n = 1185)', 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Sum Over All Care Resources (n = 1186)', 'categories': [{'measurements': [{'value': '9.6', 'spread': '15.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, 52', 'description': "Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation.", 'unitOfMeasure': 'events', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'N' signifies participants evaluable for this outcome measure and 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Duration of Healthcare Resources Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1663', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Baseline: General Practitioner Visit (n=986)', 'categories': [{'measurements': [{'value': '3.7', 'spread': '10.5', 'groupId': 'OG000', 'lowerLimit': '41.4', 'upperLimit': '46.8'}]}]}, {'title': 'Baseline: Rheumatologist Visit (n=928)', 'categories': [{'measurements': [{'value': '3.1', 'spread': '5.7', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '49.5'}]}]}, {'title': 'Baseline: Other Specialist Visit (n=1242)', 'categories': [{'measurements': [{'value': '0.9', 'spread': '2.5', 'groupId': 'OG000', 'lowerLimit': '47.9', 'upperLimit': '54.0'}]}]}, {'title': 'Baseline: In-patient Hospitalization (n = 1633)', 'categories': [{'measurements': [{'value': '2.0', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: In-patient Rehabilitation (n = 1648)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Follow-up Treatment (n = 1661)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Out-patient Rehabilitation (n = 1654)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Physiotherapy (n = 1551)', 'categories': [{'measurements': [{'value': '6.2', 'spread': '20.2', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Out-patient Hospitalization (n = 1661)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Ergotherapy (n = 1663)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.1', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Other Health Care Resources (n = 1641)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'Baseline: Sum Over All Care Resources (n = 1663)', 'categories': [{'measurements': [{'value': '14.5', 'spread': '28.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: General Practitioner Visit (n = 917)', 'categories': [{'measurements': [{'value': '1.2', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Rheumatologist Visit (n = 834)', 'categories': [{'measurements': [{'value': '2.2', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Other Specialist Visit (n = 1190)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: In-patient Hospitalization (n = 1390)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: In-patient Rehabilitation (n = 1391)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Follow-up Treatment (n = 1395)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Out-patient Rehabilitation (n = 1394)', 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Physiotherapy (n = 1350)', 'categories': [{'measurements': [{'value': '3.0', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Out-patient Hospitalization (n = 1395)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Ergotherapy (n = 1393)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Other Health Care Resources (n = 1376)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 26: Sum Over All Care Resources (n = 1395)', 'categories': [{'measurements': [{'value': '7.0', 'spread': '14.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: General Practitioner Visit (n = 762)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Rheumatologist Visit (n = 716)', 'categories': [{'measurements': [{'value': '1.5', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Other Specialist Visit (n = 1009)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: In-patient Hospitalization (n = 1177)', 'categories': [{'measurements': [{'value': '0.3', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: In-patient Rehabilitation (n = 1185)', 'categories': [{'measurements': [{'value': '0.4', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Follow-up Treatment (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Out-patient Rehabilitation (n = 1186)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Physiotherapy (n = 1151)', 'categories': [{'measurements': [{'value': '2.6', 'spread': '9.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Out-patient Hospitalization (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Ergotherapy (n = 1186)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Other Health Care Resources (n = 1162)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '2.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 52: Sum Over All Care Resources (n = 1186)', 'categories': [{'measurements': [{'value': '5.4', 'spread': '13.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 26, 52', 'description': "Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation.", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Effectiveness population: all treated participants \\>=18 years of age, with confirmed diagnosis of ankylosing spondylitis, received etanercept therapy for first time and had post-baseline documentation. Here 'n' signifies participants evaluable for this measure at given time points."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1685', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'title': 'Concomitant Medication', 'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '58.0', 'upperLimit': '63.3'}]}]}, {'title': 'Prior Therapy', 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '60.7', 'upperLimit': '66.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants with available post-baseline safety data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Discontinuation of Treatment Due to Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1685', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 52', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all treated participants with available post--baseline safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1685'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1251'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '434'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '140'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '196'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '98'}]}]}], 'preAssignmentDetails': 'A total of 1715 participants were enrolled for documentation. Of these 1715 participants enrolled, only 1685 participants were included in analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1685', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Etanercept', 'description': 'Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '12.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1067', 'groupId': 'BG000'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '615', 'groupId': 'BG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population included all treated participants with available post-baseline safety data.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1715}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-23', 'studyFirstSubmitDate': '2007-10-15', 'resultsFirstSubmitDate': '2015-04-23', 'studyFirstSubmitQcDate': '2007-10-15', 'lastUpdatePostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-23', 'studyFirstPostDateStruct': {'date': '2007-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Partial Remission at Week 26', 'timeFrame': 'Week 26', 'description': 'Percentage of participants achieving partial remission was determined by assessment of spondyloarthritis international society (ASAS) criteria. Partial remission was defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.'}, {'measure': 'Percentage of Participants Achieving Partial Remission at Week 52', 'timeFrame': 'Week 52', 'description': 'Percentage of participants achieving partial remission was determined by ASAS criteria. Partial remission defined as a score of less than 2 units (on a scale of 0-10, where 0= no disease activity and 10= high disease activity) in each of the 4 assessment in ASAS domains: participant global assessment of disease activity, pain, function, and inflammation.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs)', 'timeFrame': 'Baseline up to Week 52', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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 or incapacity; congenital anomaly. Percentage of participants with AEs included participants affected with both SAEs and non--SAEs.'}, {'measure': 'Percentage of Participants With Serious Adverse Events (SAEs) or Adverse Events (AEs) by Co-morbidity', 'timeFrame': 'Baseline up to Week 52'}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "BASDAI is a validated self-assessment tool used to determine disease activity in participant with AS. Utilizing a 11-point Likert-scale (0= none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. The index was computed by adding questions 1 to 4 plus the mean of questions 5 and 6. The resulting 0 to 50 score was divided by 5 to give a final 0-10 BASDAI score (0 being no problem and 10 being the worst problem)."}, {'measure': 'Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': "BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10)."}, {'measure': 'Change From Baseline in Occiput-to-Wall Distance at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Occiput-to-wall distance is the distance between the occiput (posterior or back portion of the head) and the wall when the participant stood with heels and shoulder against the wall and the back straight.'}, {'measure': 'Change From Baseline in Lateral Lumbar Flexion at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Lateral lumbar flexion was determined by the difference of the finger-floor-distance in normal position and in lateral bending position.'}, {'measure': "Change From Baseline in Patient's Global Assessment (PtGA) of Pain at Week 52", 'timeFrame': 'Baseline, Week 52', 'description': 'Participants were asked to assess their global pain intensity within the past 7 days. Pain was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).'}, {'measure': 'Change From Baseline in Patient Global Assessment (PtGA) of Disease Activity at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Participants were asked to assess their disease activity within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).'}, {'measure': 'Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Physicians were asked to assess the disease activity of participants within the past 7 days. Disease activity was evaluated on an 11-point Likert scale: min = 0 (best), max = 10 (worst).'}, {'measure': 'Change From Baseline in Duration of Morning Stiffness at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes.'}, {'measure': 'Percentage of Participants With Significant Reduction of Morning Stiffness', 'timeFrame': 'Week 2, 6, 12, 26, 38, 52', 'description': "Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. A significant reduction of duration of morning stiffness is defined as a reduction of the duration in minutes by at least 20 percent or reduction to 'no morning stiffness' (absence of morning stiffness)."}, {'measure': 'Percentage of Participants With Presence of Peripheral Arthritis', 'timeFrame': 'Baseline, Week 2, 6, 12, 26, 38, 52', 'description': 'Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis.'}, {'measure': 'Change From Baseline in Number of Affected Joints by Peripheral Arthritis at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Peripheral arthritis is the inflammation of joints that involved asymmetrically. It involved the hips, shoulder girdle (glenohumeral, acromioclavicular, and sternoclavicular joints), joints of the chest wall (costovertebral joints, costosternal junctions) and symphysis pubis. In case of no presence of peripheral arthritis the number of affected joints was set to 0.'}, {'measure': 'Percentage of Participants With Presence of Enthesitis', 'timeFrame': 'Baseline, Week 2, 6, 12, 26, 38, 52', 'description': 'Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort.'}, {'measure': 'Change From Baseline in Number of Affected Body Parts by Enthesitis at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Enthesitis is the inflammation of the enthesis, where the joint capsules, ligaments or tendons attach to the bone. This inflammation can lead to severe pain and discomfort. In case of no presence of enthesitis the number of affected body parts was set to 0.'}, {'measure': 'Change From Baseline in C-Reactive Protein (CRP) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.'}, {'measure': 'Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeter/hour (mm/hr). A higher rate is consistent with inflammation.'}, {'measure': 'Percentage of Participants With Assessment in Ankylosing Spondylitis 20 (ASAS-20) Response', 'timeFrame': 'Week 12, 26, 38, 52', 'description': "ASAS measures symptomatic improvement in AS participants. ASAS = 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20= at least \\>= 20 percent improvement from baseline and an absolute change \\>=1 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain."}, {'measure': 'Percentage of Participants With Assessment in Ankylosing Spondylitis 40 (ASAS-40) Response', 'timeFrame': 'Week 12, 26, 38, 52', 'description': "ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants. ASAS =4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 40= at least (\\>=) 40 percent improvement from baseline and an absolute change \\>=2 unit on a 0-10 numeric scale (0=no disease activity; 10=high disease activity) in at least 3 of the domains (on a 0-10 numerical scale): Global assessment of disease activity by participant, participant's global pain intensity, function measured by BASFI and inflammation measured by the average of the last two Likert-scales in BASDAI concerning morning stiffness intensity and duration and no worsening in the remaining domain."}, {'measure': 'Euro Quality of Life-5 Dimensions (EQ-5D) Time Trade Off (TTO)', 'timeFrame': 'Baseline, Week 26, 52', 'description': 'EQ 5D: participant rated questionnaire to assess health-related quality of life. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (extreme problems). Score of each domain is transformed into a single TTO value using formula developed by Greiner et al and results in a total score range -0.205 to 0.999, higher score indicates a better health state.'}, {'measure': 'Euro Quality of Life (EQ--5D)- Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, Week 26, 52', 'description': 'EQ-5D: participant rated questionnaire to assess health-related quality of life. Health. State Profile component assesses level of current health for 5 domains: mobility, self care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicate worst health state. Score of each domain is transformed into a single VAS score using formula developed by Greiner et al and results in a total score range of 0 to 100, where higher score indicates a better health state.'}, {'measure': 'Work Productivity and Activity Impairment - Special Health Problems (WPAI:SHP)', 'timeFrame': 'Baseline, Week 26, 52', 'description': 'WPAI:SHP is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to rheumatoid arthritis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.'}, {'measure': 'Healthcare Resource Utilization', 'timeFrame': 'Baseline, Week 26, 52', 'description': "Participants utilization of healthcare resources was evaluated as number of events for healthcare resources utilization including: number of visits to general practitioners, visits to rheumatologist, visits to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of events for participants' healthcare resources utilization during last 12 months before enrollment into the study were documented. After enrollment, number of events for participants' healthcare resources utilization were documented for last 6 months after previous documentation."}, {'measure': 'Duration of Healthcare Resources Utilization', 'timeFrame': 'Baseline, Week 26, 52', 'description': "Participants duration of healthcare resources utilization was evaluated as number of days for healthcare resources utilization including: duration of visits to general practitioners, to rheumatologist, to other medical specialists, inpatient hospitalizations, inpatient rehabilitations, inpatient follow-up treatment, outpatient rehabilitations, physiotherapy, and other healthcare utilizations. At baseline, number of days for participants' healthcare resources utilizations during last 12 months before enrollment into the study were documented. After enrollment, number of days for participants' healthcare resources utilization were documented for last 6 months after previous documentation."}, {'measure': 'Percentage of Participants With Prior or Concomitant Medication Use for Treatment of Ankylosing Spondylitis', 'timeFrame': 'Baseline up to Week 52', 'description': 'Participants taking any non-study medications which were administered either prior to or during the study treatment for AS were reported.'}, {'measure': 'Percentage of Participants With Discontinuation of Treatment Due to Adverse Events', 'timeFrame': 'Baseline up to Week 52', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ankylosing Spondylitis']}, 'referencesModule': {'references': [{'pmid': '29843776', 'type': 'DERIVED', 'citation': 'Druce KL, Aikman L, Dilleen M, Burden A, Szczypa P, Basu N. Fatigue independently predicts different work disability dimensions in etanercept-treated rheumatoid arthritis and ankylosing spondylitis patients. Arthritis Res Ther. 2018 May 29;20(1):96. doi: 10.1186/s13075-018-1598-8.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881X1-4463&StudyName=Study%20Evaluating%20The%20Use%20Of%20Etanercept%20In%20Patients%20With%20Ankylosing%20Spondylitis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to provide a holistic assessment of patients receiving etanercept in a real-world setting.', 'detailedDescription': 'Non-interventional study: subjects to be selected according to the usual clinical practice of their physician'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with an established diagnosis of Ankylosing Spondylitis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ankylosing spondylitis (AS)\n\nExclusion Criteria:\n\n* Hypersensitivity to etanercept\n* Active infection including chronic or localised infection\n* Sepsis or risk of sepsis'}, 'identificationModule': {'nctId': 'NCT00544557', 'briefTitle': 'Study Evaluating The Use Of Etanercept In Patients With Ankylosing Spondylitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Observational Study Of The Use Of Enbrel (Registered) (Etanercept) In Routine Clinical Practice To Treat Ankylosing Spondylitis (as) Patients: An Effectiveness, Safety, And Health Economic Evaluation', 'orgStudyIdInfo': {'id': '0881X1-4463'}, 'secondaryIdInfos': [{'id': 'B1801087', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Ankylosing Spondylitis', 'interventionNames': ['Drug: Etanercept']}], 'interventions': [{'name': 'Etanercept', 'type': 'DRUG', 'otherNames': ['Enbrel'], 'description': "The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.", 'armGroupLabels': ['Patients with Ankylosing Spondylitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Klinikum Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}