Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT02956967
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2016-11-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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': {'timeFrame': 'Baseline up to 6 months', 'description': 'Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days.", 'otherNumAtRisk': 171, 'deathsNumAtRisk': 171, 'otherNumAffected': 74, 'seriousNumAtRisk': 171, 'deathsNumAffected': 0, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Gingival bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 14}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pain in jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Mucosal Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Mucosal toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Peripheral swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Cytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Nail disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dermatitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dysaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Oral Candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Vulvovaginal mycotic infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Platelet count increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Cardiovascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Axillary vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Blepharospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Athralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 171, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Any Significant Comorbidities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1)', 'description': 'Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Different Types of Haematological Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': "Hodgkin's lymphoma", 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Leukemia', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': "Non-Hodgkin's lymphoma", 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Other stem cell transformations', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1)', 'description': "Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Different Types of Solid Tumour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Digestive organ: Colon/Rectum Tumour', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Digestive organ: Oesophageal Tumour', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Digestive organ: Pancreatic Tumour', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Digestive organ: Stomach Tumour', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Gynaecological: Breast Tumour', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Gynaecological: Endometrial Tumour', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Gynaecological: Ovarian Tumour', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: Non-small cell lung cancer', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Lungs: Small cell lung cancer', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'Urological: Bladder Tumour', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Urological: Prostate Gland Tumour', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}]}]}, {'title': 'Urological: Testicles Tumour', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Other organ Tumour', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1)', 'description': 'Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'PRIMARY', 'title': 'Duration of Solid Tumour in Participants Prior to Enrolment in Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '2.86', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N (Number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Received Chemotherapy Prior to Enrolment in Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'PRIMARY', 'title': 'Duration of Different Types of Chemotherapies Received by Participants During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'timeFrame': 'Baseline up to 6 months', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Response to Study Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'timeFrame': 'Baseline up to 6 months', 'reportingStatus': 'POSTED', 'populationDescription': 'The data for this outcome measure was not collected as it was not planned to be analyzed as prespecified in protocol.'}, {'type': 'SECONDARY', 'title': "Participants' Overall Satisfaction Scores in Response to the Study Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'spread': '0.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Participant's Assessment for Nivestim Packaging", 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Easy', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}]}]}, {'title': 'Complicated', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Participant's Assessment of Injection Site Pain and Tolerability", 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Injection Site Pain: Did not feel anything', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}]}]}, {'title': 'Injection Site Pain: Did not feel much', 'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}]}]}, {'title': 'Injection Site Pain: Light stitch', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}]}]}, {'title': 'Injection Site Pain: Painful', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Injection Site Pain: Very painful', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability: Very good', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability: Good', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability: Satisfactory', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability: Did not tolerate well', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Tolerability: Did not tolerate at all', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Participant's Assessment of Overall Tolerability of Subcutaneous Injection", 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Very good', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Did not tolerate well', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Did not tolerate at all', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, N signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Percentage of participants with absolute neutrophil count (greater than)\\>0.5\\*10\\^9 Neutrophils per Liter were reported in this outcome measure.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Infection and Serious Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Infection', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000'}]}]}, {'title': 'Serious Infection', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.36', 'spread': '3.005', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.528', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.76', 'spread': '5.304', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.35', 'spread': '4.787', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.49', 'spread': '1.924', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.50', 'spread': '4.107', 'groupId': 'OG000'}]}]}, {'title': 'Change at Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.556', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Cycle 1, 2, 3, 4, 5, 6', 'unitOfMeasure': '10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, number analyzed (n) signifies those participants who were evaluable at specified time points only.'}, {'type': 'SECONDARY', 'title': 'Minimum Value of Absolute Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.49', 'spread': '3.271', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.12', 'spread': '3.485', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.95', 'spread': '3.015', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.90', 'spread': '1.941', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.20', 'spread': 'NA', 'comment': 'As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.15', 'spread': '0.354', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6', 'unitOfMeasure': '10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.'}, {'type': 'SECONDARY', 'title': 'Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.22', 'spread': '9.874', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.50', 'spread': '6.297', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.52', 'spread': '7.570', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.78', 'spread': '0.873', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': 'NA', 'comment': 'As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.15', 'spread': '51.831', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)', 'unitOfMeasure': '10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.'}, {'type': 'SECONDARY', 'title': 'Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.18', 'spread': '9.548', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.26', 'spread': '5.872', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.70', 'spread': '7.450', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.13', 'spread': '2.653', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.50', 'spread': 'NA', 'comment': 'As only 1 participant was analyzed at Cycle 5, standard deviation could not be calculated.', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.00', 'spread': '52.184', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6', 'unitOfMeasure': '10^9 Neutrophils per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.'}, {'type': 'SECONDARY', 'title': 'Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '28'}]}]}, {'title': 'Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '41'}]}]}, {'title': 'Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '18'}]}]}, {'title': 'Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '7'}]}]}, {'title': 'Cycle 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '9.0'}]}]}, {'title': 'Cycle 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF. Here, n signifies those participants who were evaluable at specified time points only.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Febrile Neutropenia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (\\>=) 38.0 degree Celsius and absolute neutrophil count of less than (\\<) 1.0 × 10\\^9 Neutrophils per Liter.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 6 months', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in eCRF.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 microgram per day (mcg/day) as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Reason non-related to neutropenia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Termination of Nivestim administration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nivestim', 'description': "Participants with an ongoing malignant solid or haematological tumour undergoing cytotoxic chemotherapy and treated prophylactically with subcutaneous Nivestim up to a maximum dose of 48 mcg/day as per the physician's decision were observed for up to a maximum duration of 6 months in this study. The median duration of treatment cycles was 21 days."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.3', 'spread': '11.36', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set included all participants with at least one dose of Nivestim documented in electronic case report form (eCRF).'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 171}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-18', 'studyFirstSubmitDate': '2016-11-03', 'resultsFirstSubmitDate': '2017-12-11', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-18', 'studyFirstPostDateStruct': {'date': '2016-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 6 months', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. 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; cancer; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 months that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious.'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Any Significant Comorbidities', 'timeFrame': 'Baseline (Day 1)', 'description': 'Comorbidities included ongoing cardiovascular diseases, liver failure, psychological disorders, respiratory disease, viral infections and other infections (respiratory tract, systemic, uro-genital). Percentage of participants with any ongoing comorbidities were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With Different Types of Haematological Malignancies', 'timeFrame': 'Baseline (Day 1)', 'description': "Different types of Haematological malignancies included Hodgkin's lymphoma, leukemia (chronic lymphocytic leukemia), non-Hodgkin's lymphoma and other stem cell transformations. Percentage of participants with different type of ongoing haematological malignancies were reported in this outcome measure."}, {'measure': 'Percentage of Participants With Different Types of Solid Tumour', 'timeFrame': 'Baseline (Day 1)', 'description': 'Different types of solid tumour included tumour of a) Digestive organs such as colon, oesophagus, pancreas, stomach tumour b) Gynaecological organs such as breast, endometrium, ovaries tumour c) Lung organs such as non-small cell lung cancer and small cell lung cancer d) Urological organs such as bladder, prostate gland, testicles tumour e) other organ tumours. Percentage of participants with different types of ongoing solid tumour were reported in this outcome measure.'}, {'measure': 'Duration of Solid Tumour in Participants Prior to Enrolment in Study', 'timeFrame': 'Baseline (Day 1)', 'description': 'Time from diagnosis of any previous solid tumour in participants up to the enrolment in the study was recorded at baseline and reported in this outcome measure.'}, {'measure': 'Number of Participants Who Received Chemotherapy Prior to Enrolment in Study', 'timeFrame': 'Baseline (Day 1)'}, {'measure': 'Duration of Different Types of Chemotherapies Received by Participants During Study', 'timeFrame': 'Baseline up to 6 months'}, {'measure': 'Percentage of Participants With Response to Study Treatment', 'timeFrame': 'Baseline up to 6 months'}], 'secondaryOutcomes': [{'measure': "Participants' Overall Satisfaction Scores in Response to the Study Treatment", 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants rated the overall satisfaction with Nivestim as part of a questionnaire. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. The satisfaction was rated on a scale ranging from 1 (minimum score) to 6 (maximum score), where higher scores indicated dissatisfaction with the treatment. For this outcome measure, the within-participant average scores are summarized.'}, {'measure': "Participant's Assessment for Nivestim Packaging", 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants evaluated the packaging of Nivestim as part of a questionnaire. The packaging was rated under the 2 available categories as either easy or complicated. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.'}, {'measure': "Participant's Assessment of Injection Site Pain and Tolerability", 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants evaluated the injection site pain and the injection site tolerability of the treatment as part of a questionnaire. The injection site pain was rated under the 5 available categories as: Did not feel anything, did not feel much, light stitch, painful and very painful. Injection site tolerability was also rated under the 5 available categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all.The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For both the injection site pain and tolerability, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category for each of them.'}, {'measure': "Participant's Assessment of Overall Tolerability of Subcutaneous Injection", 'timeFrame': 'Baseline up to 6 months', 'description': 'Participants evaluated the overall tolerability of subcutaneous injection of treatment as part of a questionnaire. The tolerability was rated under the 5 categories as: Very good, good, satisfactory, did not tolerate well, did not tolerate at all. The participants were asked to complete the questionnaire at three time points (any 3 time points during the study duration of 6 months). The data from all the three time points was summarized and reported collectively in this outcome measure. For this outcome measure, the total number of participants in each answer category at at least one of the time points is displayed, that is participants who provided different ratings at the individual time points are included in more than one answer category in this summary.'}, {'measure': 'Percentage of Participants With Neutropenia', 'timeFrame': 'Baseline up to 6 months', 'description': 'Percentage of participants with absolute neutrophil count (greater than)\\>0.5\\*10\\^9 Neutrophils per Liter were reported in this outcome measure.'}, {'measure': 'Percentage of Participants With at Least One Infection and Serious Infection', 'timeFrame': 'Baseline up to 6 months', 'description': 'Infections included bronchitis, upper respiratory tract infection, cystitis, herpes virus infection, influenza, lung infection, oral candidiasis, skin infection and vulvovaginal mycotic infection. Serious Infections included serious adverse events resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}, {'measure': 'Change From Baseline in Absolute Neutrophil Count at Cycle 1, 2, 3, 4, 5 and 6', 'timeFrame': 'Baseline, Cycle 1, 2, 3, 4, 5, 6'}, {'measure': 'Minimum Value of Absolute Neutrophil Count', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6'}, {'measure': 'Absolute Neutrophil Count at the Last Visit During Each Treatment Cycle', 'timeFrame': 'End of study visit of Cycle 1, 2, 3, 4, 5, 6 (maximum up to Month 6)'}, {'measure': 'Difference Between Minimum Value of Absolute Neutrophil Count and Absolute Neutrophil Count', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6'}, {'measure': 'Duration From Minimum Value of Absolute Neutrophil Count to the Absolute Neutrophil Count', 'timeFrame': 'Cycle 1, 2, 3, 4, 5, 6'}, {'measure': 'Percentage of Participants With Febrile Neutropenia', 'timeFrame': 'Baseline up to 6 months', 'description': 'Grade 3/4 febrile neutropenia is defined as a temperature of greater than or equal to (\\>=) 38.0 degree Celsius and absolute neutrophil count of less than (\\<) 1.0 × 10\\^9 Neutrophils per Liter.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-Interventional Study'], 'conditions': ['Non-Interventional Study']}, 'referencesModule': {'references': [{'pmid': '30410313', 'type': 'DERIVED', 'citation': 'Otremba B, Hielscher C, Petersen V, Petrik C. Home administration of filgrastim (Nivestim) in primary prophylaxis of chemotherapy-induced febrile neutropenia. Patient Prefer Adherence. 2018 Oct 16;12:2179-2186. doi: 10.2147/PPA.S168029. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'Non-interventional, non-comparative, national, multi-site, single-arm prospective observational study to investigate home administration of Nivestim in the primary prophylaxis of chemotherapy-Induced febrile neutropenia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing cytotoxic chemotherapy treated prophylactically with NivestimTM in order to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients ≥ 18 years\n* Declaration of informed consent signed by patient\n* Patients with a solid tumour or with a malignant haematological tumour\n* Patients who have been prescribed cytotoxic chemotherapy, irrespective of current cycle\n* GCSF-naïve patients or patients pre-treated with GCSF who received no GCSF in the last three months before enrolment\n* Patients starting primary prophylactic treatment using NivestimTM either to shorten the duration of a neutropenia or to prevent the occurrence of chemotherapy-induced FN\n\nExclusion Criteria:\n\n* Patients with chronic myeloid leukaemia (CML) or with myelodysplastic syndrome (MDS)\n* Patients who are hypersensitive to one of the excipients of NivestimTM\n* Patients not undergoing chemotherapy\n* Patients being treated curatively or as secondary prophylaxis with G-CSF'}, 'identificationModule': {'nctId': 'NCT02956967', 'briefTitle': 'Home Administration of NivestimTM in the Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Home Administration Of Nivestim(tm) In The Primary Prophylaxis Of Chemotherapy- Induced Febrile Neutropenia Non-interventional, Observational, Prospective Study Short Name: Home Short Name: Home', 'orgStudyIdInfo': {'id': 'ZOB-NIV-1504'}, 'secondaryIdInfos': [{'id': 'C1121004', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients receiving Nivestim', 'interventionNames': ['Other: Overall satisfaction questionnaires of home use of Nivestim']}], 'interventions': [{'name': 'Overall satisfaction questionnaires of home use of Nivestim', 'type': 'OTHER', 'armGroupLabels': ['Patients receiving Nivestim']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Office of Manfred Welslau', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '63739', 'city': 'Aschaffenburg', 'country': 'Germany', 'facility': 'Office of Martine Klausmann', 'geoPoint': {'lat': 49.97704, 'lon': 9.15214}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Office of Bernhard Heinrich', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Campus Charite Mitte, Med. 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