Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04396756
Status:
COMPLETED
Last Update Posted:
2024-06-03
First Post:
2020-05-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GCosgrove@pliantrx.com', 'phone': '1-650-481-6770', 'title': 'Gregory P. Cosgrove, MD, Vice President, Clinical Development', 'organization': 'Pliant Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'Per protocol, the data generated in this clinical study are the exclusive property of the Sponsor and are confidential. Any publication of the results of this study must be authorized by the Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All cause mortality: randomization up to 190.1 days plus 14 days. Adverse events: First dose date up to 29 days plus 14 days (Part A PLN-74809 40 mg), up to 83.6 days plus 14 days (Part B PLN-74809 40 mg), up to 86.0 days plus 14 days (Part C PLN-74809 80 mg), up to 82.7 days plus 14 days (Part C PLN-74809 160 mg), up to 190.1 days plus 14 days (Part D PLN-74809 320 mg) and up to 107.6 days plus 14 days (Parts B, C, D placebo).', 'description': 'All-cause mortality: All Randomized population included all participants who were randomized in the study.\n\nAdverse Events: Safety population included all participants who took at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'PLN-74809 (Part A) - 40 mg', 'description': 'PLN-74809 (Part A) - 40 mg PLN-74809', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - 40 mg PLN-74809', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 8, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - 80 mg PLN-74809', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 8, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PLN-74809 (Part C) -160 mg', 'description': 'PLN-74809 (Part C) -160 mg PLN-74809', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 10, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - 320 mg PLN-74809', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 18, 'seriousNumAtRisk': 22, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 14, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Idiopathic pulmonary fibrosis/Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bladder dilatation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Idiopathic pulmonary fibrosis/Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhagic arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperlactacidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part A - Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part A) - 40 mg', 'description': 'PLN-74809 (Part A) - up to 4 weeks\n\n40 mg PLN-74809'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - up to 12 weeks\n\n40 mg PLN-74809'}, {'id': 'OG001', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n80 mg PLN-74809'}, {'id': 'OG002', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n160 mg PLN-74809'}, {'id': 'OG003', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG004', 'title': 'Placebo (Part B, C, D)', 'description': 'Placebo (Part B, C) - up to 12 weeks\n\nPlacebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part D - Number of Participants With Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG001', 'title': 'Placebo (Part D)', 'description': 'Placebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part A - Number of Participants With Serious Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part A) - 40 mg', 'description': 'PLN-74809 (Part A) - up to 4 weeks\n\n40 mg PLN-74809'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - up to 12 weeks\n\n40 mg PLN-74809'}, {'id': 'OG001', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n80 mg PLN-74809'}, {'id': 'OG002', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n160 mg PLN-74809'}, {'id': 'OG003', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG004', 'title': 'Placebo (Part B, C, D)', 'description': 'Placebo (Part B, C) - up to 12 weeks\n\nPlacebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 weeks', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Part D - Number of Participants With Serious Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG001', 'title': 'Placebo (Part D)', 'description': 'Placebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 weeks', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Part A - Assessment of PLN-74809 Total Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part A) - 40 mg', 'description': 'PLN-74809 (Part A) - up to 4 weeks\n\n40 mg PLN-74809'}], 'classes': [{'categories': [{'measurements': [{'value': '829', 'spread': 'NA', 'comment': 'SD is NA due to only 1 data point available', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4, 1 Hour Post Dose', 'description': 'Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.'}, {'type': 'SECONDARY', 'title': 'Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - up to 12 weeks\n\n40 mg PLN-74809'}, {'id': 'OG001', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n80 mg PLN-74809'}, {'id': 'OG002', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n160 mg PLN-74809'}, {'id': 'OG003', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}], 'classes': [{'categories': [{'measurements': [{'value': '921.45', 'spread': '549.103', 'groupId': 'OG000'}, {'value': '1731.70', 'spread': '875.776', 'groupId': 'OG001'}, {'value': '2733.71', 'spread': '1038.402', 'groupId': 'OG002'}, {'value': '3742.78', 'spread': '1383.345', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12, 2 Hours Post Dose', 'description': 'Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.'}, {'type': 'SECONDARY', 'title': 'Part D - Assessment of PLN-74809 Total Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}], 'classes': [{'categories': [{'measurements': [{'value': '4120.63', 'spread': '1866.606', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 24, 2 Hours Post Dose', 'description': 'Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population included all participants who took at least 1 dose of study drug with at least one post baseline evaluable PLN-74809 concentration.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - up to 12 weeks\n\n40 mg PLN-74809'}, {'id': 'OG001', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n80 mg PLN-74809'}, {'id': 'OG002', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n160 mg PLN-74809'}, {'id': 'OG003', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN - 74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG004', 'title': 'Placebo (Part B, C, D)', 'description': 'Placebo (Part B, C) - up to 12 weeks\n\nPlacebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.1', 'spread': '39.64', 'groupId': 'OG000'}, {'value': '25.6', 'spread': '38.57', 'groupId': 'OG001'}, {'value': '-25.6', 'spread': '40.49', 'groupId': 'OG002'}, {'value': '29.4', 'spread': '43.35', 'groupId': 'OG003'}, {'value': '-110.5', 'spread': '36.38', 'groupId': 'OG004'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG001', 'title': 'Placebo (Part D)', 'description': 'Placebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.9', 'spread': '50.57', 'groupId': 'OG000'}, {'value': '-109.3', 'spread': '74.93', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy modified Intent-to-Treat (mITT) Population includes all randomized participants who do not have FVC values that meet outlier criteria.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - up to 12 weeks\n\n40 mg PLN-74809'}, {'id': 'OG001', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n80 mg PLN-74809'}, {'id': 'OG002', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n160 mg PLN-74809'}, {'id': 'OG003', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG004', 'title': 'Placebo (Part B, C, D)', 'description': 'Placebo (Part B, C) - up to 12 weeks\n\nPlacebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'spread': '4.796', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '4.194', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '3.960', 'groupId': 'OG002'}, {'value': '0.20', 'spread': '2.817', 'groupId': 'OG003'}, {'value': '1.46', 'spread': '4.951', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG001', 'title': 'Placebo (Part D)', 'description': 'Placebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.31', 'spread': '2.650', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '4.381', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per computed tomography (CT) population includes all randomized participants with evaluable CT scans per the imaging charter.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - up to 12 weeks\n\n40 mg PLN-74809'}, {'id': 'OG001', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n80 mg PLN-74809'}, {'id': 'OG002', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - up to 12 weeks\n\n160 mg PLN-74809'}, {'id': 'OG003', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG004', 'title': 'Placebo (Part B, C, D)', 'description': 'Placebo (Part B, C) - up to 12 weeks\n\nPlacebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.2', 'spread': '20.92', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '13.85', 'groupId': 'OG001'}, {'value': '3.8', 'spread': '26.46', 'groupId': 'OG002'}, {'value': '-2.9', 'spread': '31.19', 'groupId': 'OG003'}, {'value': '-0.3', 'spread': '16.43', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 12 weeks', 'description': 'Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.', 'unitOfMeasure': 'Point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D) - at least 24 weeks and up to 48 weeks\n\n320 mg PLN-74809'}, {'id': 'OG001', 'title': 'Placebo (Part D)', 'description': 'Placebo (Part D) - at least 24 weeks and up to 48 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '17.70', 'groupId': 'OG000'}, {'value': '16.8', 'spread': '33.78', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 24 weeks', 'description': 'Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.', 'unitOfMeasure': 'Point', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy Intent-to-Treat (ITT) Population includes all randomized participants with evaluable cough scores.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PLN-74809 (Part A) - 40 mg', 'description': 'PLN-74809 (Part A): Consists of an up to 28-day screening period, a 4-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.\n\nPLN-74809 tablet administered orally.\n\nParticipants took either PLN-74809 40mg or a matching placebo with 100ml water after fasting.'}, {'id': 'FG001', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B): Consists of an up to 28-day screening period, a 12-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.\n\nPLN-74809 tablet administered orally.\n\nParticipants took either PLN-74809 40mg or a matching placebo with 240ml water after fasting.'}, {'id': 'FG002', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C): Consists of an up to 28-day screening period, a 12-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.\n\nPLN-74809 tablet administered orally.\n\nParticipants took either PLN-74809 80mg or a matching placebo with 240ml water after fasting.'}, {'id': 'FG003', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C): Consists of an up to 28-day screening period, a 12-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.\n\nPLN-74809 tablets administered orally.\n\nParticipants took either PLN-74809 160mg or a matching placebo with 240ml water after fasting.'}, {'id': 'FG004', 'title': 'PLN-74809 (Part D) -320 mg', 'description': 'PLN-74809 (Part D): Consists of an up to 28-day screening period, at least 24-week treatment period, and a 2-week (+/- 3 days) post-treatment follow-up period.\n\nPLN-74809 tablets administered orally.\n\nParticipants took either PLN-74809 320 mg or a matching placebo with 240ml water after fasting.'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Matching placebo tablets administered orally.\n\nParticipants took a matching placebo with water after fasting.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '22'}, {'groupId': 'FG004', 'numSubjects': '21'}, {'groupId': 'FG005', 'numSubjects': '31'}]}, {'type': 'Received Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '120', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'PLN-74809 (Part A) - 40 mg', 'description': 'PLN-74809 (Part A) - 40 mg PLN-74809'}, {'id': 'BG001', 'title': 'PLN-74809 (Part B) - 40 mg', 'description': 'PLN-74809 (Part B) - 40 mg PLN-74809'}, {'id': 'BG002', 'title': 'PLN-74809 (Part C) - 80 mg', 'description': 'PLN-74809 (Part C) - 80 mg PLN-74809'}, {'id': 'BG003', 'title': 'PLN-74809 (Part C) - 160 mg', 'description': 'PLN-74809 (Part C) - 160 mg PLN-74809'}, {'id': 'BG004', 'title': 'PLN-74809 (Part D) - 320 mg', 'description': 'PLN-74809 (Part D) - 320 mg PLN-74809'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Placebo (Part B, C, D)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'spread': 'NA', 'comment': 'No SD due to only 1 data point available', 'groupId': 'BG000'}, {'value': '69.2', 'spread': '7.11', 'groupId': 'BG001'}, {'value': '74.2', 'spread': '4.70', 'groupId': 'BG002'}, {'value': '71.5', 'spread': '6.63', 'groupId': 'BG003'}, {'value': '70.6', 'spread': '7.31', 'groupId': 'BG004'}, {'value': '72.1', 'spread': '6.20', 'groupId': 'BG005'}, {'value': '71.4', 'spread': '6.61', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '19', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '27', 'groupId': 'BG005'}, {'value': '101', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '116', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population included all participants who took at least 1 dose of study drug.\n\nOverall Number of Participants is 120 not 121. One participant received both placebo and PLN-74809 320 mg due to incorrect study drug dispensation and is counted in the denominator of both treatment groups for demographic and safety reporting.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-19', 'size': 1269745, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-05-10T13:08', 'hasProtocol': True}, {'date': '2023-05-09', 'size': 2286876, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-13T22:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-16', 'studyFirstSubmitDate': '2020-05-06', 'resultsFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2020-05-15', 'lastUpdatePostDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-02', 'studyFirstPostDateStruct': {'date': '2020-05-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Part B, C, D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Up to 12 weeks', 'description': 'Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 12.'}, {'measure': 'Part D - Assessment of Change From Baseline in Forced Vital Capacity (FVC)', 'timeFrame': 'Up to 24 weeks', 'description': 'Change from Baseline by Visit, Mixed Model for Repeated Measures through Week 24.'}, {'measure': 'Part B, C, D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 12', 'timeFrame': 'Up to 12 weeks', 'description': 'Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.'}, {'measure': 'Part D - Change in Pulmonary Fibrosis Score by Quantitative HRCT at Week 24', 'timeFrame': 'Up to 24 weeks', 'description': 'Quantitative Lung Fibrosis extent (%) measures the percentage of lung tissue that is assessed as fibrotic.'}, {'measure': 'Part B,C, D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough', 'timeFrame': 'Up to 12 weeks', 'description': 'Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.'}, {'measure': 'Part D - Assessment of Change From Baseline in a Visual Analog Scale (VAS) Scale for Cough', 'timeFrame': 'Up to 24 weeks', 'description': 'Visual Analog Scale for Cough measures participant reported cough severity on a scale of 0 to 100 with higher scores representative of more severe cough. A negative change from baseline nominally represents reduced cough severity and a positive change from baseline nominally represents increased cough severity.'}], 'primaryOutcomes': [{'measure': 'Part A - Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 4 weeks', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.'}, {'measure': 'Part B, C, D - Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 12 weeks', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.'}, {'measure': 'Part D - Number of Participants With Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 48 weeks', 'description': 'An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 14 days after permanent discontinuation of study drug.'}, {'measure': 'Part A - Number of Participants With Serious Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 4 weeks', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.'}, {'measure': 'Part B, C, D - Number of Participants With Serious Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 12 weeks', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.'}, {'measure': 'Part D - Number of Participants With Serious Treatment-Emergent Adverse Events', 'timeFrame': 'Up to 48 weeks', 'description': 'An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.'}], 'secondaryOutcomes': [{'measure': 'Part A - Assessment of PLN-74809 Total Plasma Concentrations', 'timeFrame': 'Week 4, 1 Hour Post Dose', 'description': 'Part A - Assessment of PLN-74809 Total Plasma Concentrations Week 4, 1 Hour Post Dose'}, {'measure': 'Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations', 'timeFrame': 'Week 12, 2 Hours Post Dose', 'description': 'Part B, C, D - Assessment of PLN-74809 Total Plasma Concentrations Week 12, 2 Hours Post Dose'}, {'measure': 'Part D - Assessment of PLN-74809 Total Plasma Concentrations', 'timeFrame': 'Week 24, 2 Hours Post Dose', 'description': 'Part D - Assessment of PLN-74809 Total Plasma Concentrations Week 24, 2 Hours Post Dose'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '38843105', 'type': 'DERIVED', 'citation': 'Lancaster L, Cottin V, Ramaswamy M, Wuyts WA, Jenkins RG, Scholand MB, Kreuter M, Valenzuela C, Ryerson CJ, Goldin J, Kim GHJ, Jurek M, Decaris M, Clark A, Turner S, Barnes CN, Achneck HE, Cosgrove GP, Lefebvre EA, Flaherty KR; PLN-74809-IPF-202 Trial Investigators. Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Clinical Trial. Am J Respir Crit Care Med. 2024 Aug 15;210(4):424-434. doi: 10.1164/rccm.202403-0636OC.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and PK of once-daily treatment with PLN-74809 in participants with idiopathic pulmonary fibrosis.', 'detailedDescription': 'Four part study:\n\nPart A - 4 week treatment period evaluating PLN-74809 or matching placebo\n\nPart B - 12 week treatment period evaluating PLN-74809 or matching placebo\n\nPart C - 12 week treatment period evaluating up to two intermediatery PLN-74809 doses or matching placebo\n\nPart D - ≥ 24 week treatment period evaluating higher PLN-74809 dose or matching placebo'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of IPF based upon the Fleischner Society guidelines within 3 years from Screening (Part A) or based on ATS/ERS/JRS/ALAT 2018 guidelines within 5 years from Screening (Part B, C \\& D)\n* FVC % of predicted ≥45%\n* DLco (hemoglobin-adjusted) ≥30%\n* Participants receiving treatment for IPF with nintedanib or pirfenidone are allowed, if on a stable dose for at least 3 months\n\nExclusion Criteria:\n\n* Currently receiving or planning to initiate treatment for IPF (fibrosis) with agents not approved for that indication by the FDA\n* Forced expiratory volume during the first seconds of the forced breath (FEV1)/FVC ratio \\<0.7 at Screening\n* Clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect FVC measurement or IPF progression\n* Known acute IPF exacerbation or suspicion by the Investigator of such, within 6 months of Screening\n* Smoking of any kind within 3 months of Screening'}, 'identificationModule': {'nctId': 'NCT04396756', 'briefTitle': 'Evaluation of Efficacy and Safety of PLN-74809 in Patients With Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pliant Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Dose-ranging, Placebo Controlled Phase 2a Evaluation of the Safety, Tolerability and Pharmacokinetics of PLN-74809 in Participants With Idiopathic Pulmonary Fibrosis (INTEGRIS-IPF)', 'orgStudyIdInfo': {'id': 'PLN-74809-IPF-202'}, 'secondaryIdInfos': [{'id': 'INTEGRIS-IPF', 'type': 'OTHER', 'domain': 'Pliant Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'PLN-74809 Dose Level 1 (Part A)', 'description': 'PLN-74809 Dose Level 1 (Part A) - 4 weeks', 'interventionNames': ['Drug: PLN-74809']}, {'type': 'EXPERIMENTAL', 'label': 'PLN-74809 Dose Level 2 (Part A)', 'description': 'PLN-74809 Dose Level 2 (Part A) - 4 weeks', 'interventionNames': ['Drug: PLN-74809']}, {'type': 'EXPERIMENTAL', 'label': 'PLN-74809 Dose Level 2 (Part B)', 'description': 'PLN-74809 Dose Level 2 (Part B) - 12 weeks', 'interventionNames': ['Drug: PLN-74809']}, {'type': 'EXPERIMENTAL', 'label': 'PLN-74809 - Dose Level 3 (Part C)', 'description': 'PLN-74809 Dose Level 3 (Part C) - 12 weeks', 'interventionNames': ['Drug: PLN-74809']}, {'type': 'EXPERIMENTAL', 'label': 'PLN-74809 - Dose Level 4 (Part C)', 'description': 'PLN-74809 Dose Level 4 (Part C) - 12 weeks', 'interventionNames': ['Drug: PLN-74809']}, {'type': 'EXPERIMENTAL', 'label': 'PLN-74809 - Dose Level 5 (Part D)', 'description': 'PLN-74809 Dose Level 5 (Part D) - ≥ 24 weeks', 'interventionNames': ['Drug: PLN-74809']}], 'interventions': [{'name': 'PLN-74809', 'type': 'DRUG', 'description': 'PLN-74809', 'armGroupLabels': ['PLN-74809 - Dose Level 3 (Part C)', 'PLN-74809 - Dose Level 4 (Part C)', 'PLN-74809 - Dose Level 5 (Part D)', 'PLN-74809 Dose Level 1 (Part A)', 'PLN-74809 Dose Level 2 (Part A)', 'PLN-74809 Dose Level 2 (Part B)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates, PA', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center, Interstitial Lung Disease Program, Pulmonary and Critical Care Medicine', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University Scool of Medicine/ Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63017-3625', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': "Cardio-Pulmonary Associates of St. Luke's Hospital - Chesterfield", 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '27403', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'PulmonIx', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Lung Institute at One Hundred Oaks', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2050', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Royal Prince Alfred Hospital', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'N8X 5A6', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Anil Dhar Medicine Professional Corporation', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS de la Montérégie Centre', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': '20123', 'city': 'Milan', 'country': 'Italy', 'facility': 'San Giuseppe Hospital, Multimedica S.p.a.', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '5623', 'city': 'Eindhoven', 'state': 'EJ', 'country': 'Netherlands', 'facility': 'Catharina Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '6532', 'city': 'Nijmegen', 'state': 'SZ', 'country': 'Netherlands', 'facility': 'Canisius-Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '1051', 'city': 'Greenlane', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'New Zealand Respiratory and Sleep Institute', 'geoPoint': {'lat': -36.89055, 'lon': 174.79426}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'University of Otago Christchurch', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}], 'overallOfficials': [{'name': 'Pliant Therapeutics Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pliant Therapeutics, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pliant Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}