Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-19 @ 2:18 PM
Study NCT ID:
NCT05321069
Status:
COMPLETED
Last Update Posted:
2025-10-20
First Post:
2022-04-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Georgia', 'Serbia'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000727475', 'term': 'BI 1015550'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '018002430127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AE collection and All-cause mortality From first trial drug administration (Placebo or Nerandomilast) up to 22.9 months.', 'description': 'Treated Set (TS): This patient set includes all randomized patients who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.', 'otherNumAtRisk': 393, 'deathsNumAtRisk': 393, 'otherNumAffected': 316, 'seriousNumAtRisk': 393, 'deathsNumAffected': 42, 'seriousNumAffected': 181}, {'id': 'EG001', 'title': 'Nera 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.', 'otherNumAtRisk': 392, 'deathsNumAtRisk': 392, 'otherNumAffected': 319, 'seriousNumAtRisk': 392, 'deathsNumAffected': 36, 'seriousNumAffected': 159}, {'id': 'EG002', 'title': 'Nera 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.', 'otherNumAtRisk': 392, 'deathsNumAtRisk': 392, 'otherNumAffected': 337, 'seriousNumAtRisk': 392, 'deathsNumAffected': 26, 'seriousNumAffected': 165}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 130}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 166}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Condition aggravated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 30}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 59}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 49}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 49}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 56}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 41}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 31}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 44}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 42}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 73}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Acquired factor VIII deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Autoimmune haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Blood loss anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Acute right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cor pulmonale', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cor pulmonale chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Heart failure with preserved ejection fraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 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'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Granulomatosis with polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Iliac artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Microscopic polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 393, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 392, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 392, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-183.48', 'groupId': 'OG000', 'lowerLimit': '-210.86', 'upperLimit': '-156.10'}, {'value': '-138.60', 'groupId': 'OG001', 'lowerLimit': '-165.59', 'upperLimit': '-111.61'}, {'value': '-114.65', 'groupId': 'OG002', 'lowerLimit': '-141.81', 'upperLimit': '-87.50'}]}]}], 'analyses': [{'pValue': '0.0222', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.89', 'ciLowerLimit': '6.44', 'ciUpperLimit': '83.33', 'estimateComment': 'Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 9 mg bid group and the Placebo group.', 'groupDescription': 'Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.'}, {'pValue': '0.0005', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.83', 'ciLowerLimit': '30.26', 'ciUpperLimit': '107.39', 'estimateComment': 'Adjusted mean difference in FVC change from baseline at Week 52 between the Nera 18 mg bid group and the Placebo group.', 'groupDescription': 'Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of baseline forced vital capacity (FVC) in milliliters at each visit. Patients were treated as a random effect. Visit was treated as the repeated measure, and an unstructured covariance structure was used to model the within-patient measurements.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The Kenward-Roger method estimated denominator degrees of freedom and adjusted standard errors; tests used two-sided α per multiple testing strategy.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52', 'description': 'The absolute change from baseline in Forced Vital Capacity (FVC) \\[mL\\] at Week 52 is reported.\n\nThe absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covariance structure for within-patient variability.', 'unitOfMeasure': 'Milliliters (mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. only patients with baseline measurement and at least one post-baseline measurement are included.'}, {'type': 'SECONDARY', 'title': 'Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'title': 'Acute IPF exacerbation as the first event', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Hospitalisation for respiratory cause as the first event', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Death as the first event', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5443', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.22', 'groupDescription': "The hazard ratio (HR) was estimated using a Cox proportional hazards model with treatment group, baseline antifibrotic therapy use, age (continuous), baseline FVC % predicted, and baseline DLCO % predicted (hemoglobin-corrected) as covariates. Breslow's method was applied for tied event times. A two-sided p-value from the Wald test assessed the treatment effect. P-values were not adjusted for multiplicity.", 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9512', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.31', 'groupDescription': 'Based on Cox proportional hazards model including treatment, baseline antifibrotic therapy, age, baseline Forced Vital Capacity (FVC) percent predicted, and baseline Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) percent predicted (corrected for haemoglobin) as covariates. p-values not adjusted for multiplicity.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': "Time to the first occurrence of any component of the composite endpoint-acute IPF exacerbation, hospitalization for a respiratory cause, or death (whichever occurred first)-is reported as the number of participants who experienced one or more of these events during the trial.\n\nAcute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following:\n\nAcute worsening or development of dyspnea, typically of less than 1 month's duration.\n\nComputed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.\n\nDeterioration not fully explained by cardiac failure or fluid overload.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation, hospitalization, death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'title': 'Acute IPF exacerbation', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.5583', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.67', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5896', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.65', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': "The time to first acute IPF exacerbation or death during the trial is reported as the number of participants who experienced either event.\n\nAcute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following:\n\nAcute worsening or development of dyspnea, typically of less than 1 month's duration.\n\nComputed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.\n\nDeterioration not fully explained by cardiac failure or fluid overload.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation followed by death.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'title': 'Hospitalization for respiratory cause', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.36', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4687', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.13', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.56', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'Time to hospitalization for respiratory cause or death over the duration of the trial is reported as the number of participants who experienced either event.\n\nHospitalizations due to respiratory causes were recorded on a specific non-elective hospitalization CRF page. This page captured the hospitalization date, confirmation of a respiratory cause, and the primary admission diagnosis.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: hospitalization for respiratory cause, followed by death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'title': 'Absolute decline in FVC % predicted of > 10%', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.7695', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.74', 'ciUpperLimit': '1.25', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2068', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.10', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'The time to absolute decline of more than 10% from baseline in forced vital capacity (FVC) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy; Absolute decline in FVC % predicted of \\> 10% followed by death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'title': 'Absolute decline in DLCO % predicted of > 15%', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9251', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.41', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4988', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.26', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'The time to absolute decline of more than 15% from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.\n\nPredicted DLCO value was corrected for hemoglobin (Hb).\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: Absolute decline in DLCO % predicted of \\> 15%, followed by Death.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Death Over the Duration of the Trial', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '392', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9084', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.60', 'ciUpperLimit': '1.76', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4682', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.81', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.43', 'groupDescription': 'Analysis was performed using a Cox proportional hazards regression model that included baseline use of antifibrotic therapy (antifibrotic group vs non-antifibrotic group), age, baseline forced vital capacity (FVC) percentage predicted, baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted (corrected for hemoglobin levels), and treatment group as covariates.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'Time to death over the duration of the trial is reported as the number of participants who died.\n\nTime to death will be based either on the date of death on the AE report for patients with AEs leading to death or will be based on the information from the vital status assessment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.26', 'groupId': 'OG000', 'lowerLimit': '5.70', 'upperLimit': '8.82'}, {'value': '6.26', 'groupId': 'OG001', 'lowerLimit': '4.71', 'upperLimit': '7.80'}, {'value': '6.63', 'groupId': 'OG002', 'lowerLimit': '5.09', 'upperLimit': '8.17'}]}]}], 'analyses': [{'pValue': '0.3697', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.00', 'ciLowerLimit': '-3.20', 'ciUpperLimit': '1.19', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 9mg BID group and the Placebo group at Week 52.', 'groupDescription': 'The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5734', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-2.83', 'ciUpperLimit': '1.57', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Dyspnea score) between the Nera 18mg BID group and the Placebo group at Week 52.', 'groupDescription': 'The analysis used a Mixed Model for Repeated Measures (MMRM) with fixed categorical effects for treatment group and baseline antifibrotic therapy at each visit, and fixed continuous effects of baseline Living with Pulmonary Fibrosis (L-PF) Dyspnea domain score. An unstructured covariance structure accounted for within-patient correlations. Baseline antifibrotic use, as recorded in the concomitant medication case report form (CRF), was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline use of antifibrotic therapy, and baseline dyspnea score at each visit, with an unstructured covariance structure to model repeated measures.\n\nThe Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:\n\nSymptoms (23 items) and\n\nImpacts (21 items).\n\nThe Symptoms module yields three domain scores:\n\nDyspnea,\n\nCough, and\n\nFatigue,\n\nas well as a Total Symptoms score.\n\nScoring is based on the mean of item ratings within each domain, multiplied by 100.\n\nScores range from 0 to 100, with higher scores indicating greater impairment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '379', 'groupId': 'OG000'}, {'value': '373', 'groupId': 'OG001'}, {'value': '385', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.54', 'groupId': 'OG000', 'lowerLimit': '2.49', 'upperLimit': '6.59'}, {'value': '4.44', 'groupId': 'OG001', 'lowerLimit': '2.42', 'upperLimit': '6.46'}, {'value': '3.95', 'groupId': 'OG002', 'lowerLimit': '1.93', 'upperLimit': '5.97'}]}]}], 'analyses': [{'pValue': '0.9442', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-2.98', 'ciUpperLimit': '2.77', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 9 mg BID group and the Placebo group at Week 52.', 'groupDescription': 'The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6862', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '2.28', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Cough score) between the Nera 18 mg BID group and the Placebo group at Week 52.', 'groupDescription': 'The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Cough domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline L-PF Cough score at each visit, with an unstructured covariance matrix for repeated measures.\n\nThe Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:\n\nSymptoms (23 items) and\n\nImpacts (21 items).\n\nThe Symptoms module yields three domain scores:\n\nDyspnea,\n\nCough, and\n\nFatigue,\n\nas well as a Total Symptoms score.\n\nScoring is based on the mean of item ratings within each domain, multiplied by 100.\n\nScores range from 0 to 100, with higher scores indicating greater impairment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '375', 'groupId': 'OG001'}, {'value': '386', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.40', 'groupId': 'OG000', 'lowerLimit': '3.66', 'upperLimit': '7.14'}, {'value': '5.59', 'groupId': 'OG001', 'lowerLimit': '3.88', 'upperLimit': '7.30'}, {'value': '5.82', 'groupId': 'OG002', 'lowerLimit': '4.11', 'upperLimit': '7.54'}]}]}], 'analyses': [{'pValue': '0.8759', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.19', 'ciLowerLimit': '-2.25', 'ciUpperLimit': '2.63', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 9 mg BID group and the Placebo group at Week 52.', 'groupDescription': 'The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7320', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.43', 'ciLowerLimit': '-2.02', 'ciUpperLimit': '2.87', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in symptom change (L-PF Fatigue score) between the Nera 18 mg BID group and the Placebo group at Week 52.', 'groupDescription': 'The analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed categorical effects for treatment group at each visit, baseline use of antifibrotic therapy at each visit, and fixed continuous effects of the baseline Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at each visit. An unstructured covariance structure modeled repeated measures. Baseline antifibrotic use, recorded in the concomitant medication case report form (CRF), was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at Week 52 is reported.\n\nThe analysis used a mixed model for repeated measures (MMRM) with fixed categorical effects for treatment, baseline antifibrotic (AF) therapy, and the fixed continuous effect of baseline L-PF score. Covariance was unstructured. Baseline AF therapy was a covariate.\n\nThe Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:\n\nSymptoms (23 items) and\n\nImpacts (21 items).\n\nThe Symptoms module yields three domain scores:\n\nDyspnea,\n\nCough, and\n\nFatigue,\n\nas well as a Total Symptoms score.\n\nScoring is based on the mean of item ratings within each domain, multiplied by 100.\n\nScores range from 0 to 100, with higher scores indicating greater impairment.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Forced Vital Capacity Percent Predicted at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '391', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}, {'value': '392', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.92', 'groupId': 'OG000', 'lowerLimit': '-5.67', 'upperLimit': '-4.18'}, {'value': '-3.75', 'groupId': 'OG001', 'lowerLimit': '-4.48', 'upperLimit': '-3.01'}, {'value': '-3.19', 'groupId': 'OG002', 'lowerLimit': '-3.93', 'upperLimit': '-2.45'}]}]}], 'analyses': [{'pValue': '0.0280', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.13', 'ciUpperLimit': '2.22', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 9 mg BID group and the placebo group at Week 52.', 'groupDescription': 'Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0013', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.73', 'ciLowerLimit': '0.68', 'ciUpperLimit': '2.78', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in percent predicted Forced Vital Capacity between the Nera 18 mg BID group and the placebo group at Week 52.', 'groupDescription': 'Analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in Forced Vital Capacity percent predicted at Week 52 is reported.\n\nAnalysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.', 'unitOfMeasure': 'FVC percent predicted', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '378', 'groupId': 'OG001'}, {'value': '384', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'OG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'OG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.14', 'groupId': 'OG000', 'lowerLimit': '-7.35', 'upperLimit': '-4.94'}, {'value': '-3.66', 'groupId': 'OG001', 'lowerLimit': '-4.85', 'upperLimit': '-2.46'}, {'value': '-4.47', 'groupId': 'OG002', 'lowerLimit': '-5.66', 'upperLimit': '-3.27'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.49', 'ciLowerLimit': '0.79', 'ciUpperLimit': '4.19', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 9 mg BID group and the placebo group at Week 52.', 'groupDescription': 'Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0530', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '3.37', 'estimateComment': 'The adjusted mean difference represents the model-estimated difference in percent predicted DLCO between the Nera 18 mg BID group and the placebo group at Week 52.', 'groupDescription': 'Based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment, baseline use of antifibrotic therapy, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication CRF page, was included as a covariate.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated DLCO measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in Diffusing Capacity of the Lungs for Carbon Monoxide percent predicted at Week 52 is reported.\n\nThe analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.', 'unitOfMeasure': 'DLCO percent predicted', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug. Only patients with baseline measurement and at least one post-baseline measurement are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film coated tablet orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'FG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'FG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Started Trial Medication', 'achievements': [{'groupId': 'FG000', 'numSubjects': '393'}, {'groupId': 'FG001', 'numSubjects': '392'}, {'groupId': 'FG002', 'numSubjects': '392'}]}, {'type': 'Completed Treatment Period A (52 Weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '324'}, {'groupId': 'FG002', 'numSubjects': '318'}]}, {'type': 'COMPLETED', 'comment': 'Completed planned trial treatment period over the whole trial', 'achievements': [{'groupId': 'FG000', 'numSubjects': '292'}, {'groupId': 'FG001', 'numSubjects': '298'}, {'groupId': 'FG002', 'numSubjects': '299'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '94'}, {'groupId': 'FG002', 'numSubjects': '93'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '52'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '64'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No reason stated by the participants', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '16'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This was a randomized, double-blind, placebo-controlled, multi-centre, Phase III trial evaluating the efficacy, safety, and tolerability of nerandomilast (BI 1015550) 9 mg and 18 mg bid versus placebo in patients with IPF. The trial included two parts: Treatment Period A lasted up to 52 weeks post-randomisation, followed by Treatment Period B with continued blinded treatment for a variable duration beyond 52 weeks.', 'preAssignmentDetails': 'All participants were screened for eligibility prior to participation in the trial. Participants attended a specialist site which ensured that they (the participants) strictly met all inclusion and none of the exclusion criteria. Participants were not to be allocated to a treatment sequence if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '392', 'groupId': 'BG002'}, {'value': '1177', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.'}, {'id': 'BG001', 'title': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'BG002', 'title': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '70.5', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '70.2', 'spread': '7.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Full Analysis Set (FAS):\n\nThis patient set includes all randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '200', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '317', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}, {'value': '977', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '95', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '365', 'groupId': 'BG000'}, {'value': '369', 'groupId': 'BG001'}, {'value': '348', 'groupId': 'BG002'}, {'value': '1082', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '367', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '273', 'groupId': 'BG000'}, {'value': '266', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}, {'value': '797', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'Participants'}, {'title': 'Forced Vital Capacity (FVC) at baseline', 'classes': [{'categories': [{'measurements': [{'value': '2863.9', 'spread': '804.6', 'groupId': 'BG000'}, {'value': '2837.2', 'spread': '781.4', 'groupId': 'BG001'}, {'value': '2827.3', 'spread': '758.0', 'groupId': 'BG002'}, {'value': '2842.8', 'spread': '781.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'Milliliters (mL)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set (FAS): This patient set includes all randomized patients who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-09-20', 'size': 4223096, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-08-05T03:52', 'hasProtocol': True}, {'date': '2024-08-19', 'size': 839338, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-08-05T03:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1177}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-15', 'studyFirstSubmitDate': '2022-04-04', 'resultsFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2022-04-04', 'lastUpdatePostDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-11', 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-08-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absolute Change From Baseline in Forced Vital Capacity (FVC) [mL] at Week 52', 'timeFrame': 'The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52', 'description': 'The absolute change from baseline in Forced Vital Capacity (FVC) \\[mL\\] at Week 52 is reported.\n\nThe absolute change from baseline in forced vital capacity (FVC) at Week 52 was analyzed using a restricted maximum likelihood (REML)-based mixed model with repeated measures (MMRM). The model included fixed categorical effects of treatment and baseline antifibrotic use at each visit, as well as the continuous effect of baseline FVC. Visit was treated as a repeated measure, with an unstructured covariance structure for within-patient variability.'}], 'secondaryOutcomes': [{'measure': 'Key Secondary Endpoint: Time to the First Occurrence of Any of the Components of the Composite Endpoint: Time to First Acute IPF Exacerbation, First Hospitalization for Respiratory Cause, or Death (Whichever Occurs First) Over the Duration of the Trial', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': "Time to the first occurrence of any component of the composite endpoint-acute IPF exacerbation, hospitalization for a respiratory cause, or death (whichever occurred first)-is reported as the number of participants who experienced one or more of these events during the trial.\n\nAcute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following:\n\nAcute worsening or development of dyspnea, typically of less than 1 month's duration.\n\nComputed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.\n\nDeterioration not fully explained by cardiac failure or fluid overload.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation, hospitalization, death."}, {'measure': 'Time to First Acute IPF Exacerbation or Death Over the Duration of the Trial', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': "The time to first acute IPF exacerbation or death during the trial is reported as the number of participants who experienced either event.\n\nAcute IPF is defined as an acute, clinically significant respiratory deterioration characterized by evidence of new, widespread alveolar abnormality, with all of the following:\n\nAcute worsening or development of dyspnea, typically of less than 1 month's duration.\n\nComputed tomography showing new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with IPF.\n\nDeterioration not fully explained by cardiac failure or fluid overload.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the following hierarchy: acute IPF exacerbation followed by death."}, {'measure': 'Time to Hospitalization for Respiratory Cause or Death Over the Duration of the Trial', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'Time to hospitalization for respiratory cause or death over the duration of the trial is reported as the number of participants who experienced either event.\n\nHospitalizations due to respiratory causes were recorded on a specific non-elective hospitalization CRF page. This page captured the hospitalization date, confirmation of a respiratory cause, and the primary admission diagnosis.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: hospitalization for respiratory cause, followed by death.'}, {'measure': 'Time to Absolute Decline in Forced Vital Capacity (FVC) % Predicted of >10% From Baseline or Death Over the Duration of the Trial', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'The time to absolute decline of more than 10% from baseline in forced vital capacity (FVC) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy; Absolute decline in FVC % predicted of \\> 10% followed by death.'}, {'measure': 'Time to Absolute Decline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percentage Predicted by More Than 15% From Baseline or Death, Measured Over the Duration of the Trial', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'The time to absolute decline of more than 15% from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted, or death, over the duration of the trial is reported as the number of participants who experienced either event.\n\nPredicted DLCO value was corrected for hemoglobin (Hb).\n\nIf more than one component occurred on the same day, the patient was counted under the first event according to the hierarchy: Absolute decline in DLCO % predicted of \\> 15%, followed by Death.'}, {'measure': 'Time to Death Over the Duration of the Trial', 'timeFrame': 'From first administration of any trial drug (Nerandomilast or Placebo) up to 22.9 months.', 'description': 'Time to death over the duration of the trial is reported as the number of participants who died.\n\nTime to death will be based either on the date of death on the AE report for patients with AEs leading to death or will be based on the information from the vital status assessment.'}, {'measure': 'Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Dyspnea Domain Score at Week 52', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Symptoms Dyspnea domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline use of antifibrotic therapy, and baseline dyspnea score at each visit, with an unstructured covariance structure to model repeated measures.\n\nThe Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:\n\nSymptoms (23 items) and\n\nImpacts (21 items).\n\nThe Symptoms module yields three domain scores:\n\nDyspnea,\n\nCough, and\n\nFatigue,\n\nas well as a Total Symptoms score.\n\nScoring is based on the mean of item ratings within each domain, multiplied by 100.\n\nScores range from 0 to 100, with higher scores indicating greater impairment.'}, {'measure': 'Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score at Week 52', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in the L-PF Cough domain score at Week 52 is reported. This endpoint was analyzed using a Mixed Model for Repeated Measures (MMRM). The model included fixed effects for treatment, baseline antifibrotic therapy, and baseline L-PF Cough score at each visit, with an unstructured covariance matrix for repeated measures.\n\nThe Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:\n\nSymptoms (23 items) and\n\nImpacts (21 items).\n\nThe Symptoms module yields three domain scores:\n\nDyspnea,\n\nCough, and\n\nFatigue,\n\nas well as a Total Symptoms score.\n\nScoring is based on the mean of item ratings within each domain, multiplied by 100.\n\nScores range from 0 to 100, with higher scores indicating greater impairment.'}, {'measure': 'Absolute Change From Baseline in Living With Pulmonary Fibrosis (L-PF) Symptoms Fatigue Domain Score at Week 52', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated L-PF measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in the Living with Pulmonary Fibrosis (L-PF) Fatigue domain score at Week 52 is reported.\n\nThe analysis used a mixed model for repeated measures (MMRM) with fixed categorical effects for treatment, baseline antifibrotic (AF) therapy, and the fixed continuous effect of baseline L-PF score. Covariance was unstructured. Baseline AF therapy was a covariate.\n\nThe Living with Pulmonary Fibrosis (L-PF) questionnaire is a 44-item tool consisting of two modules:\n\nSymptoms (23 items) and\n\nImpacts (21 items).\n\nThe Symptoms module yields three domain scores:\n\nDyspnea,\n\nCough, and\n\nFatigue,\n\nas well as a Total Symptoms score.\n\nScoring is based on the mean of item ratings within each domain, multiplied by 100.\n\nScores range from 0 to 100, with higher scores indicating greater impairment.'}, {'measure': 'Absolute Change From Baseline in Forced Vital Capacity Percent Predicted at Week 52', 'timeFrame': 'The MMRM model is a longitudinal analysis, and it incorporated FVC measurements from baseline (Week -8 to Week -1) and Week 1, Week 2, Week 6, Week 12, Week 18, Week 26, Week 36, Week 44 and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in Forced Vital Capacity percent predicted at Week 52 is reported.\n\nAnalysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline forced vital capacity (FVC) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.'}, {'measure': 'Absolute Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide Percent Predicted at Week 52', 'timeFrame': 'The MMRM model is a longitudinal analysis and it incorporated DLCO measurements from baseline (Week -8 to Week -1) and Week 12, Week 26, and Week 52. The data represent the Least Squares Mean at Week 52.', 'description': 'The absolute change from baseline in Diffusing Capacity of the Lungs for Carbon Monoxide percent predicted at Week 52 is reported.\n\nThe analysis was based on a Mixed Model for Repeated Measures (MMRM), which included fixed, categorical effects of treatment at each visit, baseline use of antifibrotic therapy at each visit, and the fixed continuous effects of baseline diffusing capacity of the lungs for carbon monoxide (DLCO) percentage predicted at each visit. An unstructured covariance structure was used to model repeated measures within patients.\n\nBaseline use of antifibrotic therapy, as recorded in the concomitant medication case report form (CRF) page, was included as a covariate.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Idiopathic Pulmonary Fibrosis']}, 'referencesModule': {'references': [{'pmid': '41345848', 'type': 'DERIVED', 'citation': 'Wuyts WA, Richeldi L, Assassi S, Azuma A, Cottin V, Hoffmann-Vold AM, Kreuter M, Oldham JM, Martinez FJ, Valenzuela C, Wijsenbeek MS, Kanakapura M, James A, Weimann G, Drzewuski C, Coeck C, Maher TM. Design of an open-label extension trial of nerandomilast (BI 1015550) in patients with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis (FIBRONEER-ON). BMC Pulm Med. 2025 Dec 4. doi: 10.1186/s12890-025-03973-7. Online ahead of print.'}, {'pmid': '40387033', 'type': 'DERIVED', 'citation': 'Richeldi L, Azuma A, Cottin V, Kreuter M, Maher TM, Martinez FJ, Oldham JM, Valenzuela C, Clerisme-Beaty E, Gordat M, Wachtlin D, Liu Y, Schlecker C, Stowasser S, Zoz DF, Wijsenbeek MS; FIBRONEER-IPF Trial Investigators. Nerandomilast in Patients with Idiopathic Pulmonary Fibrosis. N Engl J Med. 2025 Jun 12;392(22):2193-2202. doi: 10.1056/NEJMoa2414108. Epub 2025 May 18.'}, {'pmid': '37597969', 'type': 'DERIVED', 'citation': 'Richeldi L, Azuma A, Cottin V, Kreuter M, Maher TM, Martinez FJ, Oldham JM, Valenzuela C, Gordat M, Liu Y, Stowasser S, Zoz DF, Wijsenbeek MS. Design of a phase III, double-blind, randomised, placebo-controlled trial of BI 1015550 in patients with idiopathic pulmonary fibrosis (FIBRONEER-IPF). BMJ Open Respir Res. 2023 Aug;10(1):e001563. doi: 10.1136/bmjresp-2022-001563.'}], 'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "This study is open to adults with a lung disease called Idiopathic Pulmonary Fibrosis (IPF). People can join the study if they are 40 years or older. If they already take nintedanib or pirfenidone for their IPF, they can continue treatment throughout the study. The purpose of this study is to find out whether a medicine called BI 1015550 helps people with IPF.\n\nParticipants are put into 3 groups randomly, which means by chance. Participants in 2 groups take different doses of BI 1015550 as tablets twice a day. Participants in the placebo group take placebo tablets twice a day. Placebo tablets look like BI 1015550 tablets but do not contain any medicine.\n\nParticipants are in the study for up to two and a half years. During the first year, they visit the study site 10 times. Afterwards, they visit the study site every 3 months. The doctors regularly test participants' lung function. The results of the lung function tests are compared between the groups. The doctors also regularly check participants' health and take note of any unwanted effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n1. Patients ≥40 years old at the time of signed informed consent.\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.\n3. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).\n4. Patients may be either:\n\n * on a stable therapy\\* with nintedanib or pirfenidone for at least 12 weeks prior to Visit 1 and during screening and are planning to stay on this background treatment after randomization. Combination of nintedanib plus pirfenidone is not allowed. (\\*stable therapy is defined as the individually and general tolerated regimen of either nintedanib or pirfenidone (no dose changes) for at least 12 weeks).\n * not on a treatment with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and during the screening period (e.g. either Antifibrotic (AF)-treatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic treatment.\n5. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1.\n6. Diffusing Capacity (of Lung) for Carbon Monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1.\n7. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OCs) also have to use one barrier method.\n\nExclusion criteria\n\n1. Prebronchodilator Forced Expiratory Volume in 1 second (FEV1)/Forced vital capacity (FVC) \\<0.7 at Visit 1.\n2. In the opinion of the Investigator, other clinically significant pulmonary abnormalities.\n3. Acute Idiopathic Pulmonary Fibrosis (IPF) exacerbation within 3 months prior to Visit 1 and/or during the screening period (investigator-determined).\n4. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and viral hepatitis.\n5. Confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) not fully recovered according to investigator judgement within the 4 weeks prior to randomization (Visit 2).\n6. Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to Visit 2 or planned during the trial period, e.g. hip replacement. Registration on lung transplantation list would not be considered as planned major surgery.\n7. Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix.\n8. Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) \\>2.5 x Upper limit of normal (ULN) or total Bilirubin \\>1.5 x ULN at Visit 1.\n\nFurther exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT05321069', 'briefTitle': 'A Study to Find Out Whether BI 1015550 Improves Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Double Blind, Randomized, Placebo-controlled Trial Evaluating the Efficacy and Safety of BI 1015550 Over at Least 52 Weeks in Patients With Idiopathic Pulmonary Fibrosis (IPF)', 'orgStudyIdInfo': {'id': '1305-0014'}, 'secondaryIdInfos': [{'id': '2022-001091-34', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nerandomilast 9 mg BID', 'description': 'Participants received 9 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.', 'interventionNames': ['Drug: BI 1015550']}, {'type': 'EXPERIMENTAL', 'label': 'Nerandomilast 18 mg BID', 'description': 'Participants received 18 mg film-coated nerandomilast tablets orally twice daily, with doses administered at least 12 hours apart, each taken with 250 mL of water.', 'interventionNames': ['Drug: BI 1015550']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BI 1015550', 'type': 'DRUG', 'otherNames': ['Nerandomilast, JASCAYD®'], 'description': 'Participants received film-coated nerandomilast tablets orally twice daily at doses of either 9 mg or 18 mg, with each dose administered at least 12 hours apart and taken with 250 mL of water.', 'armGroupLabels': ['Nerandomilast 18 mg BID', 'Nerandomilast 9 mg BID']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants received placebo matching 9 mg or 18 mg nerandomilast film-coated tablets orally twice daily, with doses given at least 12 hours apart and each taken with 250 mL of water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 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'ipdSharingStatementModule': {'url': 'https://www.mystudywindow.com/msw/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.', 'ipdSharing': 'YES', 'description': 'Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".\n\nFurthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.', 'accessCriteria': "For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}