Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-30 @ 8:23 AM
Study NCT ID:
NCT01933334
Status:
COMPLETED
Last Update Posted:
2016-08-04
First Post:
2013-08-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D045743', 'term': 'Scleroderma, Diffuse'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093844', 'term': 'pirfenidone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800-821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-LaRoche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline up to 28 days after the last dose of study drug (last dose = Week 16)', 'eventGroups': [{'id': 'EG000', 'title': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).', 'otherNumAtRisk': 32, 'otherNumAffected': 31, 'seriousNumAtRisk': 32, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).', 'otherNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Photosensitivity reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'seriousEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).'}, {'id': 'OG001', 'title': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).'}], 'classes': [{'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000'}, {'value': '96.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 28 days after the last dose of study drug (last dose = Week 16)', 'description': 'Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).'}, {'id': 'OG001', 'title': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline up to 28 days after the last dose of study drug (last dose = Week 16)', 'description': '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/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all randomized participants who provided written informed consent and received at least one dose of study treatment.'}, {'type': 'SECONDARY', 'title': 'University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).'}, {'id': 'OG001', 'title': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).'}], 'classes': [{'title': 'Reflux: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.3398', 'spread': '0.34083', 'groupId': 'OG000'}, {'value': '0.3347', 'spread': '0.29117', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.4727', 'spread': '0.43270', 'groupId': 'OG000'}, {'value': '0.3548', 'spread': '0.36529', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: CFB Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1328', 'spread': '0.36469', 'groupId': 'OG000'}, {'value': '0.0202', 'spread': '0.26437', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.4660', 'spread': '0.39881', 'groupId': 'OG000'}, {'value': '0.4389', 'spread': '0.46573', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1261', 'spread': '0.36875', 'groupId': 'OG000'}, {'value': '0.1043', 'spread': '0.41664', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.4306', 'spread': '0.41069', 'groupId': 'OG000'}, {'value': '0.3417', 'spread': '0.33142', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0880', 'spread': '0.35494', 'groupId': 'OG000'}, {'value': '0.0042', 'spread': '0.26155', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.3950', 'spread': '0.37270', 'groupId': 'OG000'}, {'value': '0.3348', 'spread': '0.39682', 'groupId': 'OG001'}]}]}, {'title': 'Reflux: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0750', 'spread': '0.25259', 'groupId': 'OG000'}, {'value': '-0.0045', 'spread': '0.31820', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.3984', 'spread': '0.57100', 'groupId': 'OG000'}, {'value': '0.5968', 'spread': '0.58693', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.6406', 'spread': '0.65049', 'groupId': 'OG000'}, {'value': '0.4919', 'spread': '0.65346', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: CFB Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2422', 'spread': '0.41874', 'groupId': 'OG000'}, {'value': '-0.1048', 'spread': '0.50734', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: Week 8 (n=32,31)', 'categories': [{'measurements': [{'value': '0.5703', 'spread': '0.60985', 'groupId': 'OG000'}, {'value': '0.4247', 'spread': '0.57188', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1719', 'spread': '0.47280', 'groupId': 'OG000'}, {'value': '-0.1720', 'spread': '0.43245', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.5370', 'spread': '0.70610', 'groupId': 'OG000'}, {'value': '0.4250', 'spread': '0.56152', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.2130', 'spread': '0.59929', 'groupId': 'OG000'}, {'value': '-0.1833', 'spread': '0.47766', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.4800', 'spread': '0.61627', 'groupId': 'OG000'}, {'value': '0.4286', 'spread': '0.48523', 'groupId': 'OG001'}]}]}, {'title': 'Distention/Bloating: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.1200', 'spread': '0.45139', 'groupId': 'OG000'}, {'value': '-0.1518', 'spread': '0.45307', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.3281', 'spread': '0.48542', 'groupId': 'OG000'}, {'value': '0.2742', 'spread': '0.48026', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.3125', 'spread': '0.48775', 'groupId': 'OG000'}, {'value': '0.2258', 'spread': '0.48026', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: CFB Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '-0.0156', 'spread': '0.57480', 'groupId': 'OG000'}, {'value': '-0.0484', 'spread': '0.43503', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2813', 'spread': '0.37968', 'groupId': 'OG000'}, {'value': '0.3226', 'spread': '0.55600', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '-0.0469', 'spread': '0.46419', 'groupId': 'OG000'}, {'value': '0.0484', 'spread': '0.58245', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.2778', 'spread': '0.46685', 'groupId': 'OG000'}, {'value': '0.2000', 'spread': '0.48423', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '-0.0556', 'spread': '0.56045', 'groupId': 'OG000'}, {'value': '-0.0667', 'spread': '0.58329', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.3400', 'spread': '0.51478', 'groupId': 'OG000'}, {'value': '0.2500', 'spread': '0.51819', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0400', 'spread': '0.57591', 'groupId': 'OG000'}, {'value': '-0.0179', 'spread': '0.61587', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1250', 'spread': '0.28078', 'groupId': 'OG000'}, {'value': '0.1893', 'spread': '0.43585', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1563', 'spread': '0.26072', 'groupId': 'OG000'}, {'value': '0.1775', 'spread': '0.27199', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: CFB Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0313', 'spread': '0.25893', 'groupId': 'OG000'}, {'value': '-0.0118', 'spread': '0.28143', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1886', 'spread': '0.31322', 'groupId': 'OG000'}, {'value': '0.1936', 'spread': '0.33647', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0635', 'spread': '0.29233', 'groupId': 'OG000'}, {'value': '0.0044', 'spread': '0.37997', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.1173', 'spread': '0.23488', 'groupId': 'OG000'}, {'value': '0.1944', 'spread': '0.30028', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0432', 'spread': '0.25154', 'groupId': 'OG000'}, {'value': '-0.0011', 'spread': '0.35730', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0600', 'spread': '0.13502', 'groupId': 'OG000'}, {'value': '0.1667', 'spread': '0.27596', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0133', 'spread': '0.16607', 'groupId': 'OG000'}, {'value': '-0.0131', 'spread': '0.40515', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0937', 'spread': '0.26033', 'groupId': 'OG000'}, {'value': '0.1326', 'spread': '0.41910', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: Week 4 (n=32, 30)', 'categories': [{'measurements': [{'value': '0.0937', 'spread': '0.21697', 'groupId': 'OG000'}, {'value': '0.0778', 'spread': '0.32516', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: CFB Week 4 (n=32, 30)', 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.17831', 'groupId': 'OG000'}, {'value': '-0.0593', 'spread': '0.14808', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.1181', 'spread': '0.33273', 'groupId': 'OG000'}, {'value': '0.0825', 'spread': '0.29680', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0243', 'spread': '0.11887', 'groupId': 'OG000'}, {'value': '-0.0502', 'spread': '0.19846', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0493', 'spread': '0.13182', 'groupId': 'OG000'}, {'value': '0.0852', 'spread': '0.30979', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0123', 'spread': '0.12055', 'groupId': 'OG000'}, {'value': '-0.0482', 'spread': '0.14786', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0266', 'spread': '0.08030', 'groupId': 'OG000'}, {'value': '0.0833', 'spread': '0.39959', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.10627', 'groupId': 'OG000'}, {'value': '-0.0357', 'spread': '0.12851', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0313', 'spread': '0.17678', 'groupId': 'OG000'}, {'value': '0.1290', 'spread': '0.42755', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0313', 'spread': '0.17678', 'groupId': 'OG000'}, {'value': '0.1290', 'spread': '0.42755', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: CFB Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.00000', 'groupId': 'OG000'}, {'value': '0.0000', 'spread': '0.00000', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0313', 'spread': '0.17678', 'groupId': 'OG000'}, {'value': '0.1613', 'spread': '0.45437', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0000', 'spread': '0.00000', 'groupId': 'OG000'}, {'value': '0.0323', 'spread': '0.17961', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0370', 'spread': '0.19245', 'groupId': 'OG000'}, {'value': '0.1333', 'spread': '0.43417', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0370', 'spread': '0.19245', 'groupId': 'OG000'}, {'value': '0.0000', 'spread': '0.00000', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0400', 'spread': '0.20000', 'groupId': 'OG000'}, {'value': '0.1071', 'spread': '0.41627', 'groupId': 'OG001'}]}]}, {'title': 'Fecal Soilage: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0400', 'spread': '0.20000', 'groupId': 'OG000'}, {'value': '0.0000', 'spread': '0.00000', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2422', 'spread': '0.40899', 'groupId': 'OG000'}, {'value': '0.1694', 'spread': '0.26130', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Week 4 (n=32, 30)', 'categories': [{'measurements': [{'value': '0.2656', 'spread': '0.34159', 'groupId': 'OG000'}, {'value': '0.1500', 'spread': '0.29066', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: CFB Week 4 (n=32, 30)', 'categories': [{'measurements': [{'value': '0.0234', 'spread': '0.42293', 'groupId': 'OG000'}, {'value': '-0.0250', 'spread': '0.30336', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2578', 'spread': '0.39901', 'groupId': 'OG000'}, {'value': '0.1613', 'spread': '0.46345', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0156', 'spread': '0.25350', 'groupId': 'OG000'}, {'value': '-0.0081', 'spread': '0.38989', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.2407', 'spread': '0.38904', 'groupId': 'OG000'}, {'value': '0.2111', 'spread': '0.36075', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0370', 'spread': '0.37148', 'groupId': 'OG000'}, {'value': '0.0528', 'spread': '0.49008', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.1800', 'spread': '0.29333', 'groupId': 'OG000'}, {'value': '0.1518', 'spread': '0.27504', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0200', 'spread': '0.37444', 'groupId': 'OG000'}, {'value': '-0.0179', 'spread': '0.42453', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: Baseline (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2194', 'spread': '0.24262', 'groupId': 'OG000'}, {'value': '0.2761', 'spread': '0.32679', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2845', 'spread': '0.28528', 'groupId': 'OG000'}, {'value': '0.2432', 'spread': '0.31264', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: CFB Week 4 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0651', 'spread': '0.20058', 'groupId': 'OG000'}, {'value': '-0.0330', 'spread': '0.13591', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.2759', 'spread': '0.26133', 'groupId': 'OG000'}, {'value': '0.2706', 'spread': '0.29132', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: CFB Week 8 (n=32, 31)', 'categories': [{'measurements': [{'value': '0.0564', 'spread': '0.15749', 'groupId': 'OG000'}, {'value': '-0.0055', 'spread': '0.20053', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.2416', 'spread': '0.25329', 'groupId': 'OG000'}, {'value': '0.2299', 'spread': '0.27136', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: CFB Week 12 (n=27, 30)', 'categories': [{'measurements': [{'value': '0.0564', 'spread': '0.16790', 'groupId': 'OG000'}, {'value': '-0.0492', 'spread': '0.17709', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.2237', 'spread': '0.19767', 'groupId': 'OG000'}, {'value': '0.2284', 'spread': '0.26906', 'groupId': 'OG001'}]}]}, {'title': 'Total Score: CFB Week 16 (n=25, 28)', 'categories': [{'measurements': [{'value': '0.0481', 'spread': '0.14444', 'groupId': 'OG000'}, {'value': '-0.0372', 'spread': '0.20737', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 4, 8, 12, and 16', 'description': "UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. n = number of participants analyzed at specified time.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day \\[mg/day\\]) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).'}, {'id': 'FG001', 'title': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).'}, {'id': 'BG001', 'title': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.3', 'spread': '12.08', 'groupId': 'BG000'}, {'value': '51.9', 'spread': '12.52', 'groupId': 'BG001'}, {'value': '50.6', 'spread': '12.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all randomized participants who provided written informed consent and received at least one dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-06', 'studyFirstSubmitDate': '2013-08-23', 'resultsFirstSubmitDate': '2015-08-25', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-25', 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (AEs)', 'timeFrame': 'From baseline up to 28 days after the last dose of study drug (last dose = Week 16)', 'description': 'Percentage of participants who had treatment-emergent AEs, defined as newly occurring or worsening after first dose. Relatedness to (study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Serious Adverse Events (SAEs)', 'timeFrame': 'From baseline up to 28 days after the last dose of study drug (last dose = Week 16)', 'description': '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/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}], 'secondaryOutcomes': [{'measure': 'University of California at Los Angeles (UCLA) Scleroderma Clinical Trial Consortium (SCTC) Gastrointestinal Trial (GIT) Questionnaire Scale Scores', 'timeFrame': 'Baseline, Weeks 4, 8, 12, and 16', 'description': "UCLA SCTC GIT Scale 2.0 is a 34-item self-administered questionnaire to obtain participant's assessment of the frequency of GI symptoms in preceding 7 days and how symptoms affected his/her life. All but 2 items were scored on a 0 to 3 scale (0=better health, 3=worse health); remaining 2 items were scored as 0 (better health) and 1 (worse health). The 34 items are divided into seven scales (reflux, distention/bloating, fecal soilage, diarrhea, social functioning, emotional well-being, and constipation). Individual scale score was calculated as the average of the items in the scale. Individual scale score ranged from 0 to 3 for reflux, distention/bloating, fecal soilage, social functioning, and emotional well-being; 0 to 2 for diarrhea; and 0 to 2.5 for constipation. A total score was also calculated as the average of 6 of the 7 scales (omitting constipation) and ranged from 0 to 2.83. For individual and total scores 0 indicated better health and higher score indicates worse health."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pirfenidone', 'SSc-ILD', 'scleroderma', 'systemic sclerosis', 'interstitial lung disease'], 'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '7378088', 'type': 'BACKGROUND', 'citation': 'Preliminary criteria for the classification of systemic sclerosis (scleroderma). Subcommittee for scleroderma criteria of the American Rheumatism Association Diagnostic and Therapeutic Criteria Committee. Arthritis Rheum. 1980 May;23(5):581-90. doi: 10.1002/art.1780230510.'}, {'pmid': '27370878', 'type': 'DERIVED', 'citation': 'Khanna D, Albera C, Fischer A, Khalidi N, Raghu G, Chung L, Chen D, Schiopu E, Tagliaferri M, Seibold JR, Gorina E. An Open-label, Phase II Study of the Safety and Tolerability of Pirfenidone in Patients with Scleroderma-associated Interstitial Lung Disease: the LOTUSS Trial. J Rheumatol. 2016 Sep;43(9):1672-9. doi: 10.3899/jrheum.151322. Epub 2016 Jul 1.'}]}, 'descriptionModule': {'briefSummary': 'PSSc-001 (LOTUSS)\n\nThis study is a Phase 2, multinational, open-label, randomized, parallel-group, safety and tolerability study of pirfenidone in participants with systemic sclerosis-related interstitial lung disease (SSc-ILD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of systemic sclerosis-related (SSc) confirmed by the American College of Rheumatology classification criteria of systemic sclerosis (Masi 1980); duration of diagnosis less than (\\<) 7 years\n2. Diagnosis of SSc-ILD based on an high-resolution computed tomography (HRCT) scan\n3. Screening forced vital capacity (FVC) greater than equal to (\\>=) 50 percent (%) of the predicted value, and screening carbon monoxide diffusing capacity (DLCO) \\>=40% of the predicted value\n4. At study entry, the participant either was not taking SSc-ILD medication or was taking cyclophosphamide or mycophenolate\n\nExclusion Criteria:\n\n1. Clinically significant pulmonary hypertension\n2. Known underlying liver disease\n3. Clinical evidence of significant aspiration or uncontrolled gastroesophageal reflux\n4. History of clinically significant asthma or chronic obstructive pulmonary disease\n5. Active infection\n6. Diagnosis of another connective tissue disorder\n7. Evidence of a malignancy that is likely to result in significant disability or require significant medical or surgical intervention\n8. History of unstable or deteriorating cardiac or pulmonary disease (other than SSc-ILD)\n9. Pregnancy or lactation\n10. Creatinine clearance \\<40 milliliters per minute (mL/min)\n11. Prior use of pirfenidone\n12. Unsuitable for enrollment or unlikely to comply with study requirements'}, 'identificationModule': {'nctId': 'NCT01933334', 'acronym': 'LOTUSS', 'briefTitle': 'Safety and Tolerability of Pirfenidone in Participants With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'The LOTUSS Trial: An Open-Label, Randomized, Phase 2 Study of the Safety and Tolerability of Pirfenidone When Administered to Patients With Systemic Sclerosis-Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)', 'orgStudyIdInfo': {'id': 'PSSc-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pirfenidone: 4-Week Titration Group', 'description': 'Participants will receive one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day \\[mg/day\\]) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks maintenance period).', 'interventionNames': ['Drug: Pirfenidone']}, {'type': 'EXPERIMENTAL', 'label': 'Pirfenidone: 2-Week Titration Group', 'description': 'Participants will receive one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).', 'interventionNames': ['Drug: Pirfenidone']}], 'interventions': [{'name': 'Pirfenidone', 'type': 'DRUG', 'description': 'Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).', 'armGroupLabels': ['Pirfenidone: 2-Week Titration Group', 'Pirfenidone: 4-Week Titration Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic, Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94063', 'city': 'Redwood City', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Medical and Research Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University, Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02118', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Boston University Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43614', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '15261', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': 'L8N 142', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M5T 3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '10043', 'city': 'Orbassano', 'state': 'Turin', 'country': 'Italy', 'facility': 'Università di Torino', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '50139', 'city': 'Florence', 'country': 'Italy', 'facility': 'University of Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}], 'overallOfficials': [{'name': 'For additional information, call InterMune Medical Information Telephone: 1-888-486-6411', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Cincinnati'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}