Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-04-14 @ 6:17 AM
Study NCT ID:
NCT01024920
Status:
COMPLETED
Last Update Posted:
2021-07-19
First Post:
2009-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C530716', 'term': 'nintedanib'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', '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': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 55, 'seriousNumAtRisk': 64, 'deathsNumAffected': 50, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 27, 'seriousNumAtRisk': 32, 'deathsNumAffected': 25, 'seriousNumAffected': 11}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperthermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Aortic valve sclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Periorbital oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Incisional hernia, obstructive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Metastases to spine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Quadriparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Probability Rates of Progression-free Survival at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.431', 'groupId': 'OG000', 'lowerLimit': '0.306', 'upperLimit': '0.550'}, {'value': '0.452', 'groupId': 'OG001', 'lowerLimit': '0.274', 'upperLimit': '0.614'}]}]}], 'analyses': [{'pValue': '0.8531', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'P-value for comparison of Kaplan-Meier estimates at 9 months using normal approximation test (two-sided).', 'statisticalMethod': 'Normal approximation test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'At 9 months after randomisation.', 'description': 'Progression free survival rate at 9 months is the estimated probability of being alive and not having progressive disease at 9 months after randomisation.\n\nProgression was defined using Response Evaluation Criteria In Solid Tumors Criteria version 1.1 (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.', 'unitOfMeasure': 'Probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'PRIMARY', 'title': 'Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline to Day 15 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-0.7', 'upperLimit': '5.9'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '3.7'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '1.6'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '2.8'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '2.8'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '3.6'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '-1.1', 'upperLimit': '5.5'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '6.4'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '3.4'}]}]}, {'title': 'Time-matched change from baseline to Day 15 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-1.7', 'upperLimit': '4.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': "QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 15 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 15 obtained at time t minus baseline QTcF measurement at time t. 0 h is 5 min prior to dosing on Day 15.\n\nTime-matched change from baseline to Day 15 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h,1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 15 of are reported.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex (Q, R and S wave) to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.44', 'groupId': 'OG000', 'lowerLimit': '5.59', 'upperLimit': '11.10'}, {'value': '8.38', 'groupId': 'OG001', 'lowerLimit': '5.59', 'upperLimit': '13.86'}]}]}], 'analyses': [{'pValue': '0.6395', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.120', 'ciLowerLimit': '0.697', 'ciUpperLimit': '1.800', 'estimateComment': 'Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery.', 'groupDescription': 'A stratified log-rank test (two-sided, 0.05 significance level) was used to test the effect of nintedanib on PFS compared with sunitinib. The test was stratified by Motzer risk score category (low/intermediate or high) and prior nephrectomy surgery for Renal Cell Cancer (yes or no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years.', 'description': 'Progression free survival (PFS) from randomisation to the occurrence of disease progression (by RECIST Version 1.1) or death, whichever occurred first.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.\n\nThe Kaplan-Meier method was used to calculate the estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set: all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Objective Response According to RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Complete Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1213', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.484', 'ciLowerLimit': '0.193', 'ciUpperLimit': '1.212', 'estimateComment': 'Odds ratio \\> 1 favours nintedanib.', 'groupDescription': 'A logistic regression model stratified by Motzer risk score category and prior surgery for renal cell cancer (RCC) was used to compare the objective response rate between the two treatment arms. The corresponding odds ratio and 95% Confidence Intervals was also presented.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years.', 'description': 'Objective response was defined as complete response (CR, the disappearance of all target and non-target lesions and no new lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of the longest diameters and no new lesions) as determined by RECIST Version 1.1. Numbers of participants with objective response are reported.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Objective Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.42', 'comment': 'Upper Interquartile-Range cannot be estimated based on the current limited data in a small sample-sized study.', 'groupId': 'OG000', 'lowerLimit': '8.31', 'upperLimit': 'NA'}, {'value': '11.66', 'groupId': 'OG001', 'lowerLimit': '7.06', 'upperLimit': '28.45'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of first objective response to the time of disease progression or death (whichever comes first), up to 3 years.', 'description': 'Duration (months) of objective response was measured from the time of first objective response to the time of disease progression (by RECIST Version 1.1) or death, whichever occurred first.\n\nObjective response was defined as complete response (CR, the disappearance of all target and non-target lesions and no new lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of the longest diameters and no new lesions) as determined by RECIST Version 1.1.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates.', 'unitOfMeasure': 'Months', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment and showed objective response.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.37', 'groupId': 'OG000', 'lowerLimit': '13.86', 'upperLimit': '29.01'}, {'value': '21.22', 'groupId': 'OG001', 'lowerLimit': '11.01', 'upperLimit': '31.74'}]}]}], 'analyses': [{'pValue': '0.7593', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.920', 'ciLowerLimit': '0.542', 'ciUpperLimit': '1.564', 'pValueComment': 'P-value from log-rank stratified by Motzer risk score and previous surgery.', 'estimateComment': 'Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \\< 1 favours nintedanib.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation to death, up to 3 years.', 'description': 'Overall survival was calculated as the time (months) from randomisation to death. Patients for whom there was no evidence of death at the time of analysis were censored on the date that they were last known to have been alive.\n\nThe Kaplan-Meier method was used to calculate the estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS) : All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.48', 'groupId': 'OG000', 'lowerLimit': '7.56', 'upperLimit': '11.20'}, {'value': '8.54', 'groupId': 'OG001', 'lowerLimit': '5.68', 'upperLimit': '13.90'}]}]}], 'analyses': [{'pValue': '0.5958', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.143', 'ciLowerLimit': '0.697', 'ciUpperLimit': '1.873', 'estimateComment': 'Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \\< 1 favours nintedanib.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value from log-rank stratified by Motzer risk score and previous surgery.'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation up to objective tumour progression, up to 3 years.', 'description': 'Time to progression is defined as the time period from randomisation to objective tumour progression. Patients with no progression (by RECIST Version 1.1) were censored at the date of the last evaluable imaging.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.44', 'groupId': 'OG000', 'lowerLimit': '5.62', 'upperLimit': '10.97'}, {'value': '8.36', 'groupId': 'OG001', 'lowerLimit': '5.55', 'upperLimit': '13.86'}]}]}], 'analyses': [{'pValue': '0.5712', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.142', 'ciLowerLimit': '0.720', 'ciUpperLimit': '1.812', 'estimateComment': 'Hazard ratio from Cox proportional hazards model stratified by Motzer risk score and previous surgery. Hazard ratio \\< 1 favours nintedanib.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'P-value from log-rank stratified by Motzer risk score and previous surgery (two-sided).'}], 'paramType': 'MEDIAN', 'timeFrame': 'From randomisation up to objective tumour progression, up to 3 years.', 'description': 'Time to treatment failure was defined as the time from randomisation to objective tumour progression (by RECIST Version 1.1), death, global deterioration of health status requiring treatment discontinuation, or start of new anticancer treatment, whichever came first. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.The Kaplan-Meier method was used to calculate the estimates.', 'unitOfMeasure': 'Month', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Time-matched Change From Baseline to Day 1 in QTcF (QT Interval Corrected by the Fridericia Formula) at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline to Day 1 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '1.2'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '-0.3'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '0.2'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '0.3'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '1.4'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '0.9'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-4.4', 'upperLimit': '1.3'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.6', 'groupId': 'OG000', 'lowerLimit': '-6.4', 'upperLimit': '-0.7'}]}]}, {'title': 'Time-matched change from baseline to Day 1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '0.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 of treatment Cycle 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': "QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 obtained at time t minus baseline QTcF measurement at time t.\n\nTime-matched change from baseline to Day 1 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 1 are reported.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-matched Change From Baseline in QTcF Interval (QT Interval Corrected by the Fridericia Formula) at the Time of Each Participant's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in QTcF interval at maximum BIBF 1120 concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '-0.6'}]}]}, {'title': 'Time-matched change from baseline in QTcF interval at maximum BIBF 1120 concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '-0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in QTcF Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in QTcF interval at maximum BIBF 1202 concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-4.6', 'upperLimit': '-0.5'}]}]}, {'title': 'Time-matched change from baseline in QTcF interval at maximum BIBF 1202 concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum BIBF 1202 (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in QTcF Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change in QTcF from baseline at maximum BIBF 1202-glucuronide concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '0.0'}]}]}, {'title': 'Time-matched change in QTcF from baseline at maximum BIBF 1202-glucuronide concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '1.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum BIBF 1202-glucuronide (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Average Time-matched Changes From Baseline in QTcF Interval Over 1 h to 12 h After Dosing on Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Averaged time-matched changes from baseline in QTcF interval over 1 h to 12 h after dosing on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-3.5', 'upperLimit': '-0.8'}]}]}, {'title': 'Averaged time-matched changes from baseline in QTcF interval over 1 h to 12 h after dosing on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-1.4', 'upperLimit': '2.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'Average time-matched in QTcF interval (QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula) changes over 1 to 12 hours was evaluated using a t-test for paired observation. The mean differences between post-treatment values (Days 1 and 15) and baseline (Day -1) along with two-sided 90% confidence limits are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time-matched Changes From Baseline to Day 15 in QT Interval at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched QT interval change from baseline to Day 15 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '5.6'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '5.1'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '6.2'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '-0.2', 'upperLimit': '9.0'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.3'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '9.7'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '12.3'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '11.7'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '8.0'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 15 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '-0.4', 'upperLimit': '8.8'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': "QT interval is the electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 15 in QT at time t was defined as the QT measurement following administration of nintedanib on Day 15 obtained at time t minus baseline QT measurement at time t. 0 h is 5 min prior to dosing on Day 15.\n\nTime-matched change from baseline to Day 15 in QT was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 15 of Cycle 1are reported.", 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time-matched Changes From Baseline to Day 1 in QT Interval at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched QT interval change from baseline to Day 1 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-6.3', 'upperLimit': '2.3'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '5.9'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '7.8'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '5.7'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '-2.9', 'upperLimit': '5.7'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '6.1'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '5.0'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000', 'lowerLimit': '-6.0', 'upperLimit': '2.7'}]}]}, {'title': 'Time-matched QT interval change from baseline to Day 1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-6.5', 'upperLimit': '2.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': "QT interval is the electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 obtained at time t minus baseline QT measurement at time t.\n\nTime-matched change from baseline to Day 1 in QT was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 1 are reported.", 'unitOfMeasure': 'millisecond (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in QT interval at maximum BIBF 1120 concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-2.3', 'upperLimit': '4.0'}]}]}, {'title': 'Time-matched change from baseline in QT interval at maximum BIBF 1120 concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-5.0', 'upperLimit': '4.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "QT interval is the (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QT measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QT' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.", 'unitOfMeasure': 'millisecond (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in QT interval at maximum BIBF 1202 concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '4.3'}]}]}, {'title': 'Time-matched change from baseline in QT interval at maximum BIBF 1202 concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-2.7', 'upperLimit': '6.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': "QT interval is the (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QT measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QT' at the time of the participant's maximum BIBF 1202 (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'millisecond (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in QT at maximum BIBF 1202-glucuronide concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '3.1'}]}]}, {'title': 'Time-matched change from baseline in QT at maximum BIBF 1202-glucuronide concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '5.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "QT interval is the (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QT measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QT' at the time of the participant's maximum BIBF 1202-glucuronide (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'millisecond (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Averaged Time-matched Changes From Baseline in QT Interval (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) Over 1 h to 12 h After Dosing on Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Averaged time-matched changes from baseline in QT interval over 1 h to 12 h after dosing on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-1.3', 'upperLimit': '3.0'}]}]}, {'title': 'Averaged time-matched changes from baseline in QT interval over 1 h to 12 h after dosing on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '7.7'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle.', 'description': 'Averaged time-matched QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) changes from baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120) to Day 1 (first drug dose nintedanib (BIBF 1120)) and to Day 15 (steady state) over 1 to 12 hours was evaluated using a t-test for paired observation. The mean differences between post-treatment values (Days 1 and 15) and baseline (Day -1) along with two-sided 90% confidence limits are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.', 'unitOfMeasure': 'millisecond (ms)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time-Matched Heart Rate (HR) Changes From Baseline to Day 15 at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '-1.2', 'upperLimit': '3.0'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '1.9'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '0.1'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'groupId': 'OG000', 'lowerLimit': '-5.4', 'upperLimit': '-1.2'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.4', 'groupId': 'OG000', 'lowerLimit': '-5.5', 'upperLimit': '-1.3'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.1', 'groupId': 'OG000', 'lowerLimit': '-5.2', 'upperLimit': '-1.0'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-5.9', 'upperLimit': '-1.7'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'groupId': 'OG000', 'lowerLimit': '-4.9', 'upperLimit': '-0.7'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-4.5', 'upperLimit': '-0.5'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 15 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '0.5'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib (BIBF 1120) at time t. Time-matched change from baseline to Day 15 in HR at time t was defined as the HR measurement following administration of nintedanib (BIBF 1120) on Day 15 obtained at time t minus baseline HR measurement at time t. 0 h is 5 min prior to dosing on Day 15.\n\nTime-matched change from baseline to Day 15 in HR was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib (BIBF 1120) on Day 15 of Cycle 1 are reported.", 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time-Matched Heart Rate (HR) Changes From Baseline to Day 1 at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-1.9', 'upperLimit': '1.8'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'groupId': 'OG000', 'lowerLimit': '-4.7', 'upperLimit': '-1.0'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.8', 'groupId': 'OG000', 'lowerLimit': '-5.7', 'upperLimit': '-2.0'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '-0.6'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'groupId': 'OG000', 'lowerLimit': '-3.7', 'upperLimit': '0.0'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'groupId': 'OG000', 'lowerLimit': '-4.1', 'upperLimit': '-0.4'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '0.4'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.3', 'groupId': 'OG000', 'lowerLimit': '-3.2', 'upperLimit': '0.6'}]}]}, {'title': 'Time-matched heart rate (HR) change from baseline to Day 1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '-1.8', 'upperLimit': '1.9'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib (BIBF 1120) at time t. Time-matched change from baseline to Day 1 in HR at time t was defined as the HR measurement following administration of nintedanib (BIBF 1120) on Day 1 obtained at time t minus baseline HR measurement at time t.\n\nTime-matched change from baseline to Day 1 in HR was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib (BIBF 1120) on Day 1 are reported.", 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Nintedanib (BIBF 1120) Plasma Concentration, Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in HR at maximum BIBF 1120 concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '-0.7'}]}]}, {'title': 'Time-matched change from baseline in HR at maximum BIBF 1120 concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'groupId': 'OG000', 'lowerLimit': '-4.3', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in HR at time t was defined as the HR measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline HR measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in HR' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in HR at maximum BIBF 1202 concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'groupId': 'OG000', 'lowerLimit': '-3.8', 'upperLimit': '-0.8'}]}]}, {'title': 'Time-matched change from baseline in HR at maximum BIBF 1202 concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'groupId': 'OG000', 'lowerLimit': '-4.2', 'upperLimit': '0.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in HR at time t was defined as the HR measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline HR measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in HR' at the time of the participant's maximum BIBF 1202 (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.", 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': "Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Time-matched change from baseline in HR at maximum BIBF 1202-glucuronide concentration on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000', 'lowerLimit': '-2.6', 'upperLimit': '0.3'}]}]}, {'title': 'Time-matched change from baseline in HR at maximum BIBF 1202-glucuronide concentration on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '0.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of treatment cycle 1. Continues in the description.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in HR at time t was defined as the HR measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline HR measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in HR' at the time of the participant's maximum BIBF 1202-glucuronide (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.", 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Averaged Time-Matched Heart Rate (HR) Change From Baseline Over 1 to 12 Hours, Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Averaged time-matched HR change from baseline over 1 to 12 hours on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'groupId': 'OG000', 'lowerLimit': '-2.8', 'upperLimit': '-1.1'}]}]}, {'title': 'Averaged time-matched HR change from baseline over 1 to 12 hours on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.5', 'groupId': 'OG000', 'lowerLimit': '-4.0', 'upperLimit': '-0.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15.', 'description': 'Averaged time-matched heart rate changes from baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) to Day 1 (first drug dose nintedanib (BIBF 1120)) and to Day 15 (steady state) over 1 to 12 hours was evaluated using a t-test for paired observation. The mean differences between post-treatment values (Days 1 and 15) and baseline (Day -1) along with two-sided 90% confidence limits are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.', 'unitOfMeasure': 'beats per minute (bpm)', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of Patients With Maximum Time-Matched QTcF Interval Change From Baseline Categorized by Magnitude of Change, Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Frequency of patients with maximum time-matched QTcF change from baseline on Day 1, 1-12 hours (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'title': '<= 30 milliseconds (ms)', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': '> 30 to 60 milliseconds (ms)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '> 60 milliseconds (ms)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Frequency of patients with maximum time-matched QTcF change from baseline on Day 15, -0:05-12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': '<= 30 milliseconds (ms)', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': '> 30 to 60 milliseconds (ms)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': '> 60 milliseconds (ms)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of patients with maximum time-matched change from baseline in the QTcF interval observed at each point in time, i.e., 9 time points on Day 1 and 10 timepoints on Day 15 is reported. 3 categories of individual QTcF increases from baseline to maximum value were defined:\n\n\\<= 30 milliseconds (ms)\n\n\\> 30 to 60 milliseconds (ms)\n\n\\> 60 milliseconds (ms) Changes more than 60 ms in the QTcF interval represent notable changes. Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of Patients With Maximum Time-Matched QT Interval (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) Change From Baseline Categorized by Magnitude of Change, Days 1 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Frequency of patients with maximum time-matched QTcF change from baseline on Day 1, 1-12 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'title': '<= 60 milliseconds (ms)', 'measurements': [{'value': '64', 'groupId': 'OG000'}]}, {'title': '> 60 milliseconds (ms)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Frequency of patients with maximum time-matched QTcF change from baseline on Day 15, -0:05-12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': '<= 60 milliseconds (ms)', 'measurements': [{'value': '62', 'groupId': 'OG000'}]}, {'title': '> 60 milliseconds (ms)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'Number of patients with maximum time-matched change from baseline in the QT interval observed at each point in time, i.e., 9 time points on Day 1 and 10 timepoints on Day 15 is reported. 3 categories of individual QTcF increases from baseline to maximum value were defined:\n\n\\<= 30 milliseconds (ms)\n\n\\> 30 to 60 milliseconds (ms)\n\n\\> 60 milliseconds (ms) Changes more than 60 ms in the QT interval represent notable changes. Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF ≤450 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Number of participants with new onset of QTcF ≤450 (ms) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with new onset of QTcF ≤450 (ms) on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset (not present at any time pre-dose) of QTcF ≤450 milliseconds (ms) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF >450 to 470 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Number of participants with new onset of QTcF >450 to 470 ms on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with new onset of QTcF >450 to 470 ms on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset of QTcF \\>450 to 470 milliseconds (ms) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New Onset of QTcF> 470 to 500 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Number of participants with new onset of QTcF> 470 to 500 ms on Day 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with new onset of QTcF> 470 to 500 ms on Day 15', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset of QTcF\\> 470 to 500 milliseconds (ms) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF> 500 Milliseconds (ms) (Notable Prolongation), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Number of participants with new onset of QTcF> 500 (ms) on Day 1, 1-12 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with new onset of QTcF> 500 (ms) (notable prolongation) on Day 15, -0:05-12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset of QTcF\\> 500 milliseconds (ms) (notable prolongation) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QT (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) > 500 ms (Notable Prolongation), Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Number of participants with new onset of QT> 500 (ms) on Day 1, 1-12 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of participants with new onset of QT> 500 (ms) on Day 15, -0:05-12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'Number of participants with new onset of QT (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave)\\> 500 milliseconds (ms) (notable prolongation) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values at Baseline (Day -1) and Day 1 and Changes From Baseline to Day 1 at Each Point in Time in PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Absolute value in PR interval on Day -1 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '164.7', 'spread': '23.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '165.7', 'spread': '24.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.8', 'spread': '24.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.6', 'spread': '24.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.1', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167.2', 'spread': '26.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.1', 'spread': '26.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.9', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.0', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.0', 'spread': '29.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '165.7', 'spread': '25.6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167.4', 'spread': '28.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.4', 'spread': '28.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.0', 'spread': '27.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.0', 'spread': '28.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.4', 'spread': '27.5', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.8', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.9', 'spread': '27.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value n PR interval on Day 1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.8', 'spread': '26.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '171.3', 'spread': '28.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '7.6', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '11.6', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '8.6', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in PR interval at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '9.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': 'The PR interval is an electrocardiogram (ECG) interval and is the time from the onset of the P wave to the start of the QRS complex (combination of the Q wave, R wave and S wave). It reflects conduction through the atrioventricular node (AV) node. The normal PR interval is between 120 - 200 milliseconds (ms) (0.12-0.20s) in duration. Absolute values at baseline (Day-1 prior to the first dosing of nintedanib) and at Day 1 (first drug dose of nintedanib (BIBF 1120)) and changes from baseline to Day 1 at each point in time i.e., 10 time points from 0 to 12 in the PR interval are reported.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values at Baseline (Day -1) and Day 15 and Changes From Baseline to Day 15 at Each Point in Time in PR Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Absolute value in PR interval on Day -1 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '164.7', 'spread': '24.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '165.7', 'spread': '25.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.8', 'spread': '25.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.5', 'spread': '24.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.0', 'spread': '27.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167.2', 'spread': '26.5', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.3', 'spread': '26.6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.9', 'spread': '27.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.1', 'spread': '26.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day -1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.1', 'spread': '29.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '164.5', 'spread': '24.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.1', 'spread': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '166.8', 'spread': '26.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167.4', 'spread': '25.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.7', 'spread': '27.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '167.7', 'spread': '27.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.3', 'spread': '26.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.0', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '169.1', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in PR interval on Day 15 at 12:00 h:min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '168.8', 'spread': '27.9', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '12.5', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.0', 'spread': '12.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '14.6', 'groupId': 'OG000'}]}]}, {'title': 'Time matched - change from Day -1 to Day 15 in PR interval at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '12.2', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '13.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '13.2', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '11.2', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in PR interval at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.5', 'spread': '12.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': 'The PR interval is an electrocardiogram (ECG) interval and is the time from the onset of the P wave to the start of the QRS complex (combination of the Q wave, R wave and S wave). It reflects conduction through the atrioventricular node (AV) node. The normal PR interval is between 120 - 200 milliseconds (ms) (0.12-0.20s) in duration. Absolute values at baseline (Day-1 prior to the first dosing of nintedanib (BIBF 1120) and at Day 15 (steady state) and changes from baseline to Day 15 at each point in time i.e., 10 time points from 0 to 12 in the PR interval are reported.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values at Baseline (Day -1) and Day 1 and Changes From Baseline to Day 1 at Each Point in Time in QRS Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Absolute value in QRS interval on Day -1 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.4', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '10.5', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.6', 'spread': '10.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.7', 'spread': '9.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.6', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.5', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.8', 'spread': '11.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1, 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.5', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.6', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.5', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.4', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.4', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.2', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.3', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.8', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '5.2', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 3h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to day 1 in QRS interval at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '5.6', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '4.9', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 1 in QRS interval at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '4.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': 'QRS interval is an electrocardiogram (ECG) interval and is the time interval from the onset to the end of the QRS complex (combination of the Q wave, R wave and S wave). The normal QRS duration is less than 120 milliseconds (ms). Absolute values and changes from baseline (Day-1 prior to the first dosing of nintedanib) to Day 1 (first drug dose of nintedanib (BIBF 1120)) at each point in time i.e., 10 time points from 0 to 12 in the QRS interval are reported.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Absolute Values at Baseline (Day -1) and Day 15 and Changes From Baseline to Day 15 at Each Point in Time in QRS Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Absolute value in QRS interval on Day -1 at -5 minutes (min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.5', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.8', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.6', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.7', 'spread': '9.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.7', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.7', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.1', 'spread': '10.6', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.8', 'spread': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day -1 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.6', 'spread': '10.4', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.3', 'spread': '11.0', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value Day 15, 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.9', 'spread': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.0', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.9', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.6', 'spread': '11.2', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.6', 'spread': '10.9', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.1', 'spread': '11.1', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.1', 'spread': '11.3', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.8', 'spread': '10.7', 'groupId': 'OG000'}]}]}, {'title': 'Absolute value in QRS interval on Day 15 at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '11.5', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at -5 min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 1 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Time-matched change from Day -1 to Day 15 in QRS interval at 12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '4.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': 'QRS interval is an electrocardiogram (ECG) interval and is the time interval from the onset to the end of the QRS complex (combination of the Q wave, R wave and S wave). The normal QRS duration is less than 120 milliseconds (ms). Absolute values and changes from baseline (Day-1 prior to the first dosing of nintedanib) to Day 15 (steady state) at each point in time i.e., 10 time points from 0 to 12 in the QRS interval are reported.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of Patients by Clinical Electrocardiogram (ECG) Measurement Interpretation, Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'ECG interpretation on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Not normal and not normal at baseline', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Not normal and new onset of finding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'ECG interpretation on Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Normal', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Not normal and not normal at baseline', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Not normal and new onset of finding', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'Based on the interpretation of the electrocardiogram (ECG) patients were classified in 3 categories:\n\n* Normal (a normal ECG reading would be a reading that includes the following normal findings: 1) normal general features; 2) no arrhythmia; 3) no conduction delays; 4) T-wave morphology of normal; and 5) normal U-wave morphology) on Day 1 or on Day 15)\n* Not normal and not normal at baseline (an abnormal ECG reading would be a reading that includes one or more of the following abnormal findings: 1) abnormal general features; 2) arrhythmia; 3) conduction delays; 4) T-wave morphology of flat, inverted or biphasic; and 5) abnormal U-wave morphology) on Day 1 or on Day 15)\n* Not normal and new onset of finding; Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of Adverse Events Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'The number of participants who experienced adverse events graded according to NCI CTCAE version 3.0, is reported below.The maximum grade of adverse event intensity for each type of treatment-related adverse event was recorded for each patient.\n\nGrade 1 - Mild AE Grade 2 - Moderate AE Grade 3 - Severe AE Grade 4 - Life-threatening or disabling AE Grade 5 - Death related to AE', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Leading to Dose Reduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of participants who experienced Adverse Events which led to dose reduction of the trial medication is reported for each treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Leading to Discontinuation of Trial Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of participants with Adverse Events which lead to discontinuation of trial medication drug is reported for each treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated Set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Requiring or Prolonging Hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of participants who experienced Adverse Events which required or prolonged hospitalisation of patients is reported for each treatment arm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Hospital Stays Due to Adverse Events Requiring or Prolonging Hospitalisation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.40', 'spread': '8.56', 'groupId': 'OG000'}, {'value': '13.10', 'spread': '8.32', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Duration of hospitalisation in days for each treatment arm is reported for those patients who experienced adverse events which required or prolonged hospitalisation (of the patients).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment and experienced Adverse Events requiring or prolonging hospitalisation.'}, {'type': 'SECONDARY', 'title': 'Frequency of Patients With Possible Clinically Significant Abnormal Lab Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'OG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'classes': [{'title': 'Alkaline phosphatase', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'APTT (Activated partial thrombopl. time)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Prothrombin time (PT)-international normalized ratio (INR)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Potassium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Sodium', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Platelets', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate amino Transferase (AST)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Alanine aminotransferase (ALT)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin, total', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'White blood cell count', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of patients with possible clinically significant abnormal lab values for the lab parameters alkaline phosphatase, activated partial thromboplastin time (APTT), creatinine, haemoglobin, prothrombin time (PT)-international normalized ratio (INR), potassium, lymphocytes, sodium, neutrophils, platelets, aspartate amino transferase (AST), alanine aminotransferase (ALT), bilirubin and white blood cell count is reported. Only lab values with CTCAE rule for possible clinical significance are displayed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): All patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment. 1 patient in the Sunitinib arm did not have on-treatment lab values.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'FG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Patient refusal to continue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'An open-label, 2:1 randomised, parallel-arm comparison of nintedanib versus sunitinib in patients with advanced renal cell cancer (RCC) who had not received prior systemic therapy.', 'preAssignmentDetails': 'All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nintedanib (BIBF 1120)', 'description': 'Participants received orally (swallowed) soft gelatine capsules of nintedanib (BIBF 1120) twice daily (bid) starting with a dose of 200 milligram (mg) bid given continuously in 4-week cycles. Nintedanib was to be swallowed unchewed with about 200 milliliter (mL) of water after food intake with a dosing interval of approximately 12 hours. In case of Adverse Events, the dose was to be reduced to 150 mg bid and 100 mg bid, respectively. The dose was continued daily until withdrawal criteria were fulfilled.'}, {'id': 'BG001', 'title': 'Sunitinib', 'description': 'Participants received orally (swallowed) hard capsule of sunitinib starting with a dose of 50 milligram (mg) once daily (qd). In case of Adverse Events the dose was to be reduced to 37.5 mg once daily and 25 mg once daily, respectively. The daily dosing was performed in 6-week cycles (4 weeks on and 2 weeks off) until withdrawal criteria were fulfilled.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.4', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '55.5', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '58.8', 'spread': '10.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'QTcF interval baseline values', 'classes': [{'title': '-5 minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '405.2', 'spread': '19.6', 'groupId': 'BG000'}, {'value': '405.2', 'spread': '19.6', 'groupId': 'BG002'}]}]}, {'title': '1 hour (h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '406.0', 'spread': '20.3', 'groupId': 'BG000'}, {'value': '406.0', 'spread': '20.3', 'groupId': 'BG002'}]}]}, {'title': '2 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '405.3', 'spread': '19.4', 'groupId': 'BG000'}, {'value': '405.3', 'spread': '19.4', 'groupId': 'BG002'}]}]}, {'title': '3 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '406.7', 'spread': '19.4', 'groupId': 'BG000'}, {'value': '406.7', 'spread': '19.4', 'groupId': 'BG002'}]}]}, {'title': '4 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '407.0', 'spread': '17.8', 'groupId': 'BG000'}, {'value': '407.0', 'spread': '17.8', 'groupId': 'BG002'}]}]}, {'title': '5 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '407.2', 'spread': '18.0', 'groupId': 'BG000'}, {'value': '407.2', 'spread': '18.0', 'groupId': 'BG002'}]}]}, {'title': '6 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '405.9', 'spread': '18.3', 'groupId': 'BG000'}, {'value': '405.9', 'spread': '18.3', 'groupId': 'BG002'}]}]}, {'title': '7 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '405.4', 'spread': '19.2', 'groupId': 'BG000'}, {'value': '405.4', 'spread': '19.2', 'groupId': 'BG002'}]}]}, {'title': '10 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '406.6', 'spread': '19.2', 'groupId': 'BG000'}, {'value': '406.6', 'spread': '19.2', 'groupId': 'BG002'}]}]}, {'title': '12 h', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '406.0', 'spread': '19.2', 'groupId': 'BG000'}, {'value': '406.0', 'spread': '19.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'QTcF interval (QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex (ECG interval consisting of Q, R and S wave) to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula) baseline values were measured at -5 minutes (min), at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h of Day -1 (prior to the first dosing of nintedanib (BIBF 1120)).', 'unitOfMeasure': 'millisecconds (ms)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set electrocardiogram (FAS-ECG): All patients in the treated set who were treated with nintedanib (BIBF 1120) and had at least 1 time-matched pair of QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex (Q, R and S wave) to the end of the T wave) measurements available from baseline and from either Day 1 or Day 15 of Treatment Cycle 1 (first 4-week cycle). Only participants with non-missing outcomes were included in the analysis.'}], 'populationDescription': 'Treated set: all patients who were dispensed trial medication and were documented to have taken at least 1 dose of investigational treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12-16'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2009-11-24', 'resultsFirstSubmitDate': '2020-03-26', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-16', 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-11-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Probability Rates of Progression-free Survival at 9 Months', 'timeFrame': 'At 9 months after randomisation.', 'description': 'Progression free survival rate at 9 months is the estimated probability of being alive and not having progressive disease at 9 months after randomisation.\n\nProgression was defined using Response Evaluation Criteria In Solid Tumors Criteria version 1.1 (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.'}, {'measure': 'Time-matched Change From Baseline to Day 15 in QTcF (QT Interval Corrected by the Fridericia Formula) at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': "QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 15 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 15 obtained at time t minus baseline QTcF measurement at time t. 0 h is 5 min prior to dosing on Day 15.\n\nTime-matched change from baseline to Day 15 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h,1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 15 of are reported."}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years.', 'description': 'Progression free survival (PFS) from randomisation to the occurrence of disease progression (by RECIST Version 1.1) or death, whichever occurred first.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.\n\nThe Kaplan-Meier method was used to calculate the estimates.'}, {'measure': 'Objective Response According to RECIST Criteria', 'timeFrame': 'From the start of study until the cut-off date for 3 year efficacy analysis, up to 3 years.', 'description': 'Objective response was defined as complete response (CR, the disappearance of all target and non-target lesions and no new lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of the longest diameters and no new lesions) as determined by RECIST Version 1.1. Numbers of participants with objective response are reported.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.'}, {'measure': 'Duration of Objective Response', 'timeFrame': 'From the time of first objective response to the time of disease progression or death (whichever comes first), up to 3 years.', 'description': 'Duration (months) of objective response was measured from the time of first objective response to the time of disease progression (by RECIST Version 1.1) or death, whichever occurred first.\n\nObjective response was defined as complete response (CR, the disappearance of all target and non-target lesions and no new lesions) or partial response (PR, at least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum of the longest diameters and no new lesions) as determined by RECIST Version 1.1.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates.'}, {'measure': 'Overall Survival', 'timeFrame': 'From randomisation to death, up to 3 years.', 'description': 'Overall survival was calculated as the time (months) from randomisation to death. Patients for whom there was no evidence of death at the time of analysis were censored on the date that they were last known to have been alive.\n\nThe Kaplan-Meier method was used to calculate the estimates.'}, {'measure': 'Time to Progression', 'timeFrame': 'From randomisation up to objective tumour progression, up to 3 years.', 'description': 'Time to progression is defined as the time period from randomisation to objective tumour progression. Patients with no progression (by RECIST Version 1.1) were censored at the date of the last evaluable imaging.\n\nProgression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum of the longest diameters recorded since the treatment started together with an absolute increase in the sum of the longest diameters of at least 5 mm, or the appearance of one or more new lesions.\n\nTumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication. The Kaplan-Meier method was used to calculate the estimates.'}, {'measure': 'Time to Treatment Failure', 'timeFrame': 'From randomisation up to objective tumour progression, up to 3 years.', 'description': 'Time to treatment failure was defined as the time from randomisation to objective tumour progression (by RECIST Version 1.1), death, global deterioration of health status requiring treatment discontinuation, or start of new anticancer treatment, whichever came first. Tumour imaging was made by investigators using Computed tomography (CT)/Magnetic Resonance imaging (MRI) every 12 weeks after the first administration of the trial medication.The Kaplan-Meier method was used to calculate the estimates.'}, {'measure': 'Time-matched Change From Baseline to Day 1 in QTcF (QT Interval Corrected by the Fridericia Formula) at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 of treatment Cycle 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': "QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 obtained at time t minus baseline QTcF measurement at time t.\n\nTime-matched change from baseline to Day 1 in QTcF was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 1 are reported."}, {'measure': "Time-matched Change From Baseline in QTcF Interval (QT Interval Corrected by the Fridericia Formula) at the Time of Each Participant's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula. Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15."}, {'measure': "Time-Matched Change From Baseline in QTcF Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum BIBF 1202 (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15."}, {'measure': "Time-Matched Change From Baseline in QTcF Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline QTcF measurement at time t was defined as the QTcF measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QTcF at time t was defined as the QTcF measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QTcF measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QTcF' at the time of the participant's maximum BIBF 1202-glucuronide (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline values were taken at exactly the same time points as on Day 15."}, {'measure': 'Average Time-matched Changes From Baseline in QTcF Interval Over 1 h to 12 h After Dosing on Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'Average time-matched in QTcF interval (QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula) changes over 1 to 12 hours was evaluated using a t-test for paired observation. The mean differences between post-treatment values (Days 1 and 15) and baseline (Day -1) along with two-sided 90% confidence limits are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.'}, {'measure': 'Time-matched Changes From Baseline to Day 15 in QT Interval at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': "QT interval is the electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 15 in QT at time t was defined as the QT measurement following administration of nintedanib on Day 15 obtained at time t minus baseline QT measurement at time t. 0 h is 5 min prior to dosing on Day 15.\n\nTime-matched change from baseline to Day 15 in QT was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 15 of Cycle 1are reported."}, {'measure': 'Time-matched Changes From Baseline to Day 1 in QT Interval at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': "QT interval is the electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 obtained at time t minus baseline QT measurement at time t.\n\nTime-matched change from baseline to Day 1 in QT was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib on Day 1 are reported."}, {'measure': "Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration of Nintedanib (BIBF 1120), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "QT interval is the (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QT measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QT' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15."}, {'measure': "Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': "QT interval is the (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QT measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QT' at the time of the participant's maximum BIBF 1202 (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15."}, {'measure': "Time-Matched Change From Baseline in QT Interval at the Time of Each Patient's Maximum Plasma Concentration BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "QT interval is the (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave. Baseline QT measurement at time t was defined as the QT measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in QT at time t was defined as the QT measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline QT measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in QT' at the time of the participant's maximum BIBF 1202-glucuronide (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15."}, {'measure': 'Averaged Time-matched Changes From Baseline in QT Interval (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) Over 1 h to 12 h After Dosing on Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle.', 'description': 'Averaged time-matched QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) changes from baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120) to Day 1 (first drug dose nintedanib (BIBF 1120)) and to Day 15 (steady state) over 1 to 12 hours was evaluated using a t-test for paired observation. The mean differences between post-treatment values (Days 1 and 15) and baseline (Day -1) along with two-sided 90% confidence limits are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.'}, {'measure': 'Time-Matched Heart Rate (HR) Changes From Baseline to Day 15 at 0 Hour (h), at 1 h, at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib (BIBF 1120) at time t. Time-matched change from baseline to Day 15 in HR at time t was defined as the HR measurement following administration of nintedanib (BIBF 1120) on Day 15 obtained at time t minus baseline HR measurement at time t. 0 h is 5 min prior to dosing on Day 15.\n\nTime-matched change from baseline to Day 15 in HR was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib (BIBF 1120) on Day 15 of Cycle 1 are reported."}, {'measure': 'Time-Matched Heart Rate (HR) Changes From Baseline to Day 1 at 1 Hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h After Dosing of Nintedanib (BIBF 1120)', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib (BIBF 1120) at time t. Time-matched change from baseline to Day 1 in HR at time t was defined as the HR measurement following administration of nintedanib (BIBF 1120) on Day 1 obtained at time t minus baseline HR measurement at time t.\n\nTime-matched change from baseline to Day 1 in HR was modelled using a linear mixed-effects model for repeated measures which included 'time' as repeated measures and the time-matched baseline value as a covariate. Adjusted means with corresponding 2-sided 90% confidence intervals at 0 h, 1 h, 2 h, 3 h, 4 h, 5 h, 6 h, 7 h, 10 h and 12 h after dosing of nintedanib (BIBF 1120) on Day 1 are reported."}, {'measure': "Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Nintedanib (BIBF 1120) Plasma Concentration, Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in HR at time t was defined as the HR measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline HR measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in HR' at the time of the participant's maximum nintedanib plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15."}, {'measure': "Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202 (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in HR at time t was defined as the HR measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline HR measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in HR' at the time of the participant's maximum BIBF 1202 (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15."}, {'measure': "Time-Matched Change From Baseline in Heart Rate (HR) at the Time of Each Patient's Maximum Plasma Concentration of BIBF 1202-glucuronide (a Nintedanib (BIBF 1120) Metabolite), Calculated Separately for Days 1 and 15 of Treatment Cycle 1", 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of treatment cycle 1. Continues in the description.', 'description': "Baseline heart rate (HR) measurement at time t was defined as the HR measurement collected 1 day prior to the day of the first administration of nintedanib at time t. Time-matched change from baseline to Day 1 (Day 15) in HR at time t was defined as the HR measurement following administration of nintedanib on Day 1 (Day 15) obtained at time t minus baseline HR measurement at time t.\n\nFor each participant 'Time-matched change from baseline to Day 1 (Day 15) in HR' at the time of the participant's maximum BIBF 1202-glucuronide (a nintedanib (BIBF 1120) metabolite) plasma concentration was obtained and the mean across all participants calculated. Corresponding two-sided 90% confidence intervals based on the t-distribution are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15."}, {'measure': 'Averaged Time-Matched Heart Rate (HR) Change From Baseline Over 1 to 12 Hours, Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15.', 'description': 'Averaged time-matched heart rate changes from baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) to Day 1 (first drug dose nintedanib (BIBF 1120)) and to Day 15 (steady state) over 1 to 12 hours was evaluated using a t-test for paired observation. The mean differences between post-treatment values (Days 1 and 15) and baseline (Day -1) along with two-sided 90% confidence limits are reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 1 and on Day 15.'}, {'measure': 'Frequency of Patients With Maximum Time-Matched QTcF Interval Change From Baseline Categorized by Magnitude of Change, Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of patients with maximum time-matched change from baseline in the QTcF interval observed at each point in time, i.e., 9 time points on Day 1 and 10 timepoints on Day 15 is reported. 3 categories of individual QTcF increases from baseline to maximum value were defined:\n\n\\<= 30 milliseconds (ms)\n\n\\> 30 to 60 milliseconds (ms)\n\n\\> 60 milliseconds (ms) Changes more than 60 ms in the QTcF interval represent notable changes. Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Frequency of Patients With Maximum Time-Matched QT Interval (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) Change From Baseline Categorized by Magnitude of Change, Days 1 and 15', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'Number of patients with maximum time-matched change from baseline in the QT interval observed at each point in time, i.e., 9 time points on Day 1 and 10 timepoints on Day 15 is reported. 3 categories of individual QTcF increases from baseline to maximum value were defined:\n\n\\<= 30 milliseconds (ms)\n\n\\> 30 to 60 milliseconds (ms)\n\n\\> 60 milliseconds (ms) Changes more than 60 ms in the QT interval represent notable changes. Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF ≤450 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset (not present at any time pre-dose) of QTcF ≤450 milliseconds (ms) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF >450 to 470 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of the first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset of QTcF \\>450 to 470 milliseconds (ms) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Number of Participants With New Onset of QTcF> 470 to 500 Milliseconds (ms), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset of QTcF\\> 470 to 500 milliseconds (ms) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QTcF> 500 Milliseconds (ms) (Notable Prolongation), Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'QTcF interval is the QT interval (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave) corrected for the effects of heart rate (HR) by the Fridericia formula.\n\nNumber of participants with new onset of QTcF\\> 500 milliseconds (ms) (notable prolongation) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Number of Participants With New (Not Present at Any Time Pre-dose) Onset of QT (Electrocardiogram (ECG) Interval From the Beginning of the QRS Complex to the End of the T Wave) > 500 ms (Notable Prolongation), Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'Number of participants with new onset of QT (electrocardiogram (ECG) interval from the beginning of the QRS complex to the end of the T wave)\\> 500 milliseconds (ms) (notable prolongation) on Day 1 (first drug dose nintedanib (BIBF 1120)) and Day 15 (steady state) compared to the baseline (Day -1 prior to the first dosing of nintedanib (BIBF 1120)) is reported.\n\nTime frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Absolute Values at Baseline (Day -1) and Day 1 and Changes From Baseline to Day 1 at Each Point in Time in PR Interval', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': 'The PR interval is an electrocardiogram (ECG) interval and is the time from the onset of the P wave to the start of the QRS complex (combination of the Q wave, R wave and S wave). It reflects conduction through the atrioventricular node (AV) node. The normal PR interval is between 120 - 200 milliseconds (ms) (0.12-0.20s) in duration. Absolute values at baseline (Day-1 prior to the first dosing of nintedanib) and at Day 1 (first drug dose of nintedanib (BIBF 1120)) and changes from baseline to Day 1 at each point in time i.e., 10 time points from 0 to 12 in the PR interval are reported.'}, {'measure': 'Absolute Values at Baseline (Day -1) and Day 15 and Changes From Baseline to Day 15 at Each Point in Time in PR Interval', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': 'The PR interval is an electrocardiogram (ECG) interval and is the time from the onset of the P wave to the start of the QRS complex (combination of the Q wave, R wave and S wave). It reflects conduction through the atrioventricular node (AV) node. The normal PR interval is between 120 - 200 milliseconds (ms) (0.12-0.20s) in duration. Absolute values at baseline (Day-1 prior to the first dosing of nintedanib (BIBF 1120) and at Day 15 (steady state) and changes from baseline to Day 15 at each point in time i.e., 10 time points from 0 to 12 in the PR interval are reported.'}, {'measure': 'Absolute Values at Baseline (Day -1) and Day 1 and Changes From Baseline to Day 1 at Each Point in Time in QRS Interval', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1. Baseline (Day -1) values were taken at exactly the same time points as on Day 1.', 'description': 'QRS interval is an electrocardiogram (ECG) interval and is the time interval from the onset to the end of the QRS complex (combination of the Q wave, R wave and S wave). The normal QRS duration is less than 120 milliseconds (ms). Absolute values and changes from baseline (Day-1 prior to the first dosing of nintedanib) to Day 1 (first drug dose of nintedanib (BIBF 1120)) at each point in time i.e., 10 time points from 0 to 12 in the QRS interval are reported.'}, {'measure': 'Absolute Values at Baseline (Day -1) and Day 15 and Changes From Baseline to Day 15 at Each Point in Time in QRS Interval', 'timeFrame': 'At 5 minutes (min) before the first dose and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 15. Baseline (Day -1) values were taken at exactly the same time points as on Day 15.', 'description': 'QRS interval is an electrocardiogram (ECG) interval and is the time interval from the onset to the end of the QRS complex (combination of the Q wave, R wave and S wave). The normal QRS duration is less than 120 milliseconds (ms). Absolute values and changes from baseline (Day-1 prior to the first dosing of nintedanib) to Day 15 (steady state) at each point in time i.e., 10 time points from 0 to 12 in the QRS interval are reported.'}, {'measure': 'Frequency of Patients by Clinical Electrocardiogram (ECG) Measurement Interpretation, Calculated Separately for Days 1 and 15 of Treatment Cycle 1', 'timeFrame': 'At 5 minutes (min) before the first dose on Day 15 and at 1 hour (h), at 2 h, at 3 h, at 4 h, at 5 h, at 6 h, at 7 h, at 10 h and at 12 h after the first dose of nintedanib on Day 1 and on Day 15 of first treatment cycle. Continues in the description.', 'description': 'Based on the interpretation of the electrocardiogram (ECG) patients were classified in 3 categories:\n\n* Normal (a normal ECG reading would be a reading that includes the following normal findings: 1) normal general features; 2) no arrhythmia; 3) no conduction delays; 4) T-wave morphology of normal; and 5) normal U-wave morphology) on Day 1 or on Day 15)\n* Not normal and not normal at baseline (an abnormal ECG reading would be a reading that includes one or more of the following abnormal findings: 1) abnormal general features; 2) arrhythmia; 3) conduction delays; 4) T-wave morphology of flat, inverted or biphasic; and 5) abnormal U-wave morphology) on Day 1 or on Day 15)\n* Not normal and new onset of finding; Time frame: Baseline (Day -1) values were taken at exactly the same time points as on Day 15.'}, {'measure': 'Frequency of Adverse Events Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'The number of participants who experienced adverse events graded according to NCI CTCAE version 3.0, is reported below.The maximum grade of adverse event intensity for each type of treatment-related adverse event was recorded for each patient.\n\nGrade 1 - Mild AE Grade 2 - Moderate AE Grade 3 - Severe AE Grade 4 - Life-threatening or disabling AE Grade 5 - Death related to AE'}, {'measure': 'Number of Participants With Adverse Events Leading to Dose Reduction', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of participants who experienced Adverse Events which led to dose reduction of the trial medication is reported for each treatment arm.'}, {'measure': 'Number of Participants With Adverse Events Leading to Discontinuation of Trial Drug', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of participants with Adverse Events which lead to discontinuation of trial medication drug is reported for each treatment arm.'}, {'measure': 'Number of Participants With Adverse Events Requiring or Prolonging Hospitalisation', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of participants who experienced Adverse Events which required or prolonged hospitalisation of patients is reported for each treatment arm.'}, {'measure': 'Duration of Hospital Stays Due to Adverse Events Requiring or Prolonging Hospitalisation', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Duration of hospitalisation in days for each treatment arm is reported for those patients who experienced adverse events which required or prolonged hospitalisation (of the patients).'}, {'measure': 'Frequency of Patients With Possible Clinically Significant Abnormal Lab Values', 'timeFrame': 'From first dose of study drug administration up to 28 days after last dose of study drug, up to 121 months.', 'description': 'Number of patients with possible clinically significant abnormal lab values for the lab parameters alkaline phosphatase, activated partial thromboplastin time (APTT), creatinine, haemoglobin, prothrombin time (PT)-international normalized ratio (INR), potassium, lymphocytes, sodium, neutrophils, platelets, aspartate amino transferase (AST), alanine aminotransferase (ALT), bilirubin and white blood cell count is reported. Only lab values with CTCAE rule for possible clinical significance are displayed.'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Renal Cell']}, 'referencesModule': {'references': [{'pmid': '37146227', 'type': 'DERIVED', 'citation': 'Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.'}, {'pmid': '23625328', 'type': 'DERIVED', 'citation': 'Eisen T, Shparyk Y, Macleod N, Jones R, Wallenstein G, Temple G, Khder Y, Dallinger C, Studeny M, Loembe AB, Bondarenko I. Effect of small angiokinase inhibitor nintedanib (BIBF 1120) on QT interval in patients with previously untreated, advanced renal cell cancer in an open-label, phase II study. Invest New Drugs. 2013 Oct;31(5):1283-93. doi: 10.1007/s10637-013-9962-7. Epub 2013 Apr 27.'}], 'seeAlsoLinks': [{'url': 'http://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Compare safety and efficacy of BIBF 1120 versus sunitinib in patients with advanced RCC and to investigate the effects of BIBF 1120 on the heart rate (HR) corrected QT interval (QTcF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. Patients with unresectable or metastatic Renal Cell Cancer, who have received no previous systemic anti-cancer treatment.\n2. Histological-confirmed diagnosis of renal cell cancer with clear cell component.\n3. Acceptable renal,liver,cardiovascular,bone marrow and other functions to allow sunitinib/BIBF 1120 treatment.\n\nExclusion criteria:\n\n1. Patients unable to tolerate Sunitinib/BIBF 1120 treatment\n2. Treatment with other investigational drugs or participation in another clinical study within the past 4 weeks before start of therapy or concomitantly with this study.\n3. Patients unable to comply with the 1199.26 protocol.\n4. Pregnancy or breast feeding.\n5. Active alcohol or drug abuse.\n6. Women of child bearing potential, or men who are able to father a child, unwilling to use a medically acceptable form of contraception during the study period.'}, 'identificationModule': {'nctId': 'NCT01024920', 'briefTitle': 'Compare Safety and Efficacy of BIBF 1120 Versus Sunitinib.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Open Label, Parallel Group Phase II Study Comparing the Efficacy and Tolerability of BIBF 1120 Versus Sunitinib in Previously Untreated Patients With Renal Cell Cancer', 'orgStudyIdInfo': {'id': '1199.26'}, 'secondaryIdInfos': [{'id': '2009-009516-44', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nintedanib (BIBF 1120)', 'description': 'Non-marketed substance: Twice daily oral doses of 200mg BIBF 1120 given continuously.', 'interventionNames': ['Drug: BIBF 1120']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sunitinib', 'description': 'Marketed substance: Once a day oral doses of 50mg sunitinib given in repeated 6 week cycles: 4 weeks active, 2 weeks rest.', 'interventionNames': ['Drug: sunitinib']}], 'interventions': [{'name': 'BIBF 1120', 'type': 'DRUG', 'description': 'VEGF inhibitor', 'armGroupLabels': ['Nintedanib (BIBF 1120)']}, {'name': 'sunitinib', 'type': 'DRUG', 'description': 'VEGF inhibitor', 'armGroupLabels': ['sunitinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pecs Medical School, Dept. of Oncotherapy', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '20-099', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Ziemia Lubelska Oncological Center, Lublin', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '02-781', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Onco.Cent. - Instit. of Maria Sklodowskiej-Curie', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '010825', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Military Central Clinical Emergency Hospital', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '200347', 'city': 'Craiova', 'country': 'Romania', 'facility': 'Sf. Nectarie Oncology Center, Craiova', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '200385', 'city': 'Craiova', 'country': 'Romania', 'facility': 'ONCOLAB SRL, Craiova', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '18009', 'city': 'Cherkasy', 'country': 'Ukraine', 'facility': 'Municipal Establishment Cherkasy Oncology Centre', 'geoPoint': {'lat': 49.44452, 'lon': 32.05738}}, {'zip': '58013', 'city': 'Chernivtsi', 'country': 'Ukraine', 'facility': 'Bukovynsk State Medical University', 'geoPoint': {'lat': 48.29045, 'lon': 25.93241}}, {'zip': '49102', 'city': 'Dnipropetrovks', 'country': 'Ukraine', 'facility': 'Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council'}, {'zip': '79031', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}, {'zip': '88000', 'city': 'Uzhhorod', 'country': 'Ukraine', 'facility': 'Uzhgorod National University, Oncology Centre', 'geoPoint': {'lat': 48.6242, 'lon': 22.2947}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'G12 0YN', 'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'Beatson West of Scotland Cancer Centre', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'GU2 7WG', 'city': 'Guildford', 'country': 'United Kingdom', 'facility': 'Surrey Cancer Research Institute', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': "St James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}