Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-03-16 @ 6:12 AM
Study NCT ID:
NCT03086369
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2017-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589393', 'term': 'olaratumab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline to Follow-up (Up To 29 Months)', 'description': 'All participants in phase 1b/2 who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants At Risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 2, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 7, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 12, 'seriousNumAtRisk': 12, 'deathsNumAffected': 12, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'otherNumAtRisk': 81, 'deathsNumAtRisk': 81, 'otherNumAffected': 79, 'seriousNumAtRisk': 81, 'deathsNumAffected': 60, 'seriousNumAffected': 50}, {'id': 'EG004', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'otherNumAtRisk': 78, 'deathsNumAtRisk': 78, 'otherNumAffected': 78, 'seriousNumAtRisk': 78, 'deathsNumAffected': 63, 'seriousNumAffected': 41}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 186, 'numAffected': 46}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 165, 'numAffected': 45}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 13, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 53, 'numAffected': 20}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 70, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 93, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eye haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Eye swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 12, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 21, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 31, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 72, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 58, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 15, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 46, 'numAffected': 33}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 62, 'numAffected': 39}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 4, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 26, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 74, 'numAffected': 53}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 84, 'numAffected': 44}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Subarachnoid haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Abdominal cavity drainage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 81, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 78, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Cycle 1 (Up to 28 days)', 'description': 'A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:\n\n1. Any febrile neutropenia\n2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage\n3. Grade 4 neutropenia lasting 7 days or longer\n4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.\n5. Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in phase 1b who received at least one dose of Olaratumab.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.10', 'groupId': 'OG000', 'lowerLimit': '7.49', 'upperLimit': '14.09'}, {'value': '10.81', 'groupId': 'OG001', 'lowerLimit': '8.51', 'upperLimit': '14.75'}]}]}], 'analyses': [{'pValue': '0.7902', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.054', 'ciLowerLimit': '0.728', 'ciUpperLimit': '1.527', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Date of Death from Any Cause (Up To 29 Months)', 'description': 'OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=26, Placebo+Nab-paclitaxel+Gemcitabine=21.'}, {'type': 'SECONDARY', 'title': 'Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG003', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'title': 'Cycle 1 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '128', 'spread': '36', 'groupId': 'OG000'}, {'value': '86.3', 'spread': '90', 'groupId': 'OG001'}, {'value': '87.8', 'spread': '91', 'groupId': 'OG002'}, {'value': '112', 'spread': '40', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 1 (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '66', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.7', 'spread': '42', 'groupId': 'OG000'}, {'value': '172', 'spread': '76', 'groupId': 'OG001'}, {'value': '101', 'spread': '36', 'groupId': 'OG002'}, {'value': '94.7', 'spread': '62', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 3 (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '204', 'spread': '13', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 184 μg/mL", 'groupId': 'OG001'}, {'value': '173', 'spread': '33', 'groupId': 'OG002'}, {'value': '147', 'spread': '38', 'groupId': 'OG003'}]}]}, {'title': 'Cycle 3 (Day 15)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '159', 'spread': '17', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': "Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 99.7 μg/mL", 'groupId': 'OG001'}, {'value': '101', 'spread': '37', 'groupId': 'OG002'}, {'value': '106', 'spread': '68', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15', 'description': 'PK: Cmin of olaratumab', 'unitOfMeasure': 'micrograms per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in phase 1b/2 who received at least one dose of Olaratumab and had evaluable PK data.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline through Follow-up (Up To 29 Months)', 'description': 'Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in phase 2 who received at least one dose of Olaratumab and had evaluable immunogenicity data.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'timeFrame': 'Baseline to Date of Death from Any Cause (Approximately 9 Months)', 'description': 'OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1b: Zero participants analysed as data was not collected. OS was not measured in phase 1b.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Progression-Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '7.0'}, {'value': '6.41', 'groupId': 'OG001', 'lowerLimit': '5.42', 'upperLimit': '7.98'}]}]}], 'analyses': [{'pValue': '0.3771', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.192', 'ciLowerLimit': '0.806', 'ciUpperLimit': '1.764', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Disease Progression or Death (Up To 26 Months)', 'description': 'PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 \\[RECIST v.1.1\\]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in phase 2 (including the censored participants). Number of participants censored in Olaratumab+Nab-paclitaxel+Gemcitabine=24, Placebo+Nab-paclitaxel+Gemcitabine=26.'}, {'type': 'SECONDARY', 'title': 'Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '82', 'groupId': 'OG003'}, {'value': '80', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG003', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG004', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '30.5', 'groupId': 'OG003'}, {'value': '33.8', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline through Disease Progression or Death (Up To 26 Months)', 'description': 'ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in phase 1b/2.'}, {'type': 'SECONDARY', 'title': 'Phase 1b/2: Duration of Response (DoR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG003', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG004', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': "Median and 95% Confidence Interval couldn't be calculated as there was only one participant. Individual value reported: 6.24 months.", 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': "Median and 95% Confidence Interval couldn't be calculated as there was only one participant. Individual value reported: 3.68 months.", 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.55', 'groupId': 'OG003', 'lowerLimit': '2.63', 'upperLimit': '9.23'}, {'value': '5.55', 'groupId': 'OG004', 'lowerLimit': '3.84', 'upperLimit': '7.26'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)', 'description': 'DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in phase 1b/2 who had CR or PR responses. For phase 1b cohort expansion arm, there were no participants with CR or PR responses to evaluate DoR, hence, zero participants analysed.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.13', 'comment': 'There were not enough events to estimate the upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '5.19', 'upperLimit': 'NA'}, {'value': '6.11', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': '9.95'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.390', 'ciLowerLimit': '0.175', 'ciUpperLimit': '0.872', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Follow-up (Up To 21 Months)', 'description': 'The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in phase 2 who had baseline and at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'title': 'Appetite loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.79', 'upperLimit': 'NA'}, {'value': '2.86', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': 'NA'}]}]}, {'title': 'Constipation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '1.94', 'upperLimit': 'NA'}]}]}, {'title': 'Diarrhoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.79', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '1.87', 'upperLimit': 'NA'}, {'value': '1.97', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '1.91', 'upperLimit': 'NA'}]}]}, {'title': 'Dyspnoea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.79', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': 'NA'}, {'value': '3.12', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': 'NA'}]}]}, {'title': 'Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.87', 'groupId': 'OG000', 'lowerLimit': '1.05', 'upperLimit': '2.33'}, {'value': '1.87', 'groupId': 'OG001', 'lowerLimit': '1.12', 'upperLimit': '2.07'}]}]}, {'title': 'Financial difficulties', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.37', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '2.79', 'upperLimit': 'NA'}]}]}, {'title': 'Insomnia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.19', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '2.83', 'upperLimit': 'NA'}]}]}, {'title': 'Nausea and vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.19', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.10', 'upperLimit': 'NA'}, {'value': '2.86', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': 'NA'}]}]}, {'title': 'Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'There were not enough events to estimate median, upper confidence limit.', 'groupId': 'OG000', 'lowerLimit': '2.76', 'upperLimit': 'NA'}, {'value': '3.25', 'comment': 'There were not enough events to estimate upper confidence limit.', 'groupId': 'OG001', 'lowerLimit': '2.04', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.288', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.718', 'ciLowerLimit': '0.392', 'ciUpperLimit': '1.317', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Appetite loss', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.442', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.788', 'ciLowerLimit': '0.423', 'ciUpperLimit': '1.468', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Constipation', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.883', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.037', 'ciLowerLimit': '0.612', 'ciUpperLimit': '1.755', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Diarrhoea', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.803', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.933', 'ciLowerLimit': '0.532', 'ciUpperLimit': '1.636', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Dyspnoea', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.805', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.053', 'ciLowerLimit': '0.675', 'ciUpperLimit': '1.645', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Fatigue', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.784', 'ciLowerLimit': '0.420', 'ciUpperLimit': '1.464', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Financial difficulties', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.231', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.457', 'ciLowerLimit': '0.787', 'ciUpperLimit': '2.698', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Insomnia', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.748', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.914', 'ciLowerLimit': '0.532', 'ciUpperLimit': '1.570', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Nausea and vomiting', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}, {'pValue': '0.875', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.947', 'ciLowerLimit': '0.491', 'ciUpperLimit': '1.827', 'estimateComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).', 'groupDescription': 'Pain', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by age group (\\<70 years versus ≥70 years) and prior adjuvant/neo-adjuvant gemcitabine use (yes vs no).'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through Follow-up (Up To 21 Months)', 'description': 'The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in phase 2 who had baseline and at least one post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'classes': [{'title': 'Index Value [Cycle 1 (Day1)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Index Value [Cycle 7 (Day1)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score [Cycle 1 (Day1)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.1', 'spread': '21.7', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '20.4', 'groupId': 'OG001'}]}]}, {'title': 'VAS Score [Cycle 7 (Day1)]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.7', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '73.2', 'spread': '22.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1, Cycle 7 Day 1', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants in phase 2 who completed EQ-5D-5L.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m\\^2) and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'FG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'FG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'FG003', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'FG004', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '82'}, {'groupId': 'FG004', 'numSubjects': '80'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '81'}, {'groupId': 'FG004', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '73'}, {'groupId': 'FG004', 'numSubjects': '73'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Completers included participants who died from any cause.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '184', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 15 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'BG001', 'title': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'BG002', 'title': 'Phase1b (Cohort Expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'BG003', 'title': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'BG004', 'title': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '32', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '76', 'groupId': 'BG005'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}, {'value': '108', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '35', 'groupId': 'BG004'}, {'value': '72', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '45', 'groupId': 'BG004'}, {'value': '112', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '74', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '165', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '167', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '162', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants in phase 1b/2.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-20', 'size': 920167, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-10-05T02:44', 'hasProtocol': True}, {'date': '2020-04-03', 'size': 3521732, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-10-05T02:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2017-03-13', 'resultsFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2017-03-20', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-14', 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Cycle 1 (Up to 28 days)', 'description': 'A DLT is defined as an adverse event that is likely related to the study medication or combination, and fulfils any one of the following criteria, graded according to the NCI-CTCAE version 4.03:\n\n1. Any febrile neutropenia\n2. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia complicated by clinically significant hemorrhage\n3. Grade 4 neutropenia lasting 7 days or longer\n4. Nonhematologic Grade ≥3 toxicity, except for toxicities such as nausea, vomiting, transient electrolyte abnormalities, diarrhea which can be controlled with optimal medical management within 48 hours; non-clinically significant, treatable, or reversible laboratory abnormalities including liver function tests, uric acid, electrolytes, etc.\n5. Any other significant toxicity deemed to be dose-limiting (e.g., any toxicity that is possibly related to the study medication that requires the withdrawal of the participant from the study during Cycle 1).'}, {'measure': 'Phase 2: Overall Survival (OS)', 'timeFrame': 'Baseline to Date of Death from Any Cause (Up To 29 Months)', 'description': 'OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.'}], 'secondaryOutcomes': [{'measure': 'Phase 1b/2: Pharmacokinetics (PK): Minimum Concentration (Cmin) of Olaratumab', 'timeFrame': 'Pre-dose, 5 min, 1, 4, 4.5, 24, 96, 168, 336 h post-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15', 'description': 'PK: Cmin of olaratumab'}, {'measure': 'Phase 2: Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies', 'timeFrame': 'Baseline through Follow-up (Up To 29 Months)', 'description': 'Number of Participants With Treatment Emergent Anti-Olaratumab Antibodies'}, {'measure': 'Phase 1b: Overall Survival (OS)', 'timeFrame': 'Baseline to Date of Death from Any Cause (Approximately 9 Months)', 'description': 'OS is defined as the time from the date of randomization to the date of death from any cause. If the participant is alive or lost to follow-up at the time of data analysis, OS data will be censored on the last date the participant is known to be alive. For any participant who has withdrawn consent for further follow-up of survival data, OS will be censored at the last date for which the participant consented to be followed for the study.'}, {'measure': 'Phase 2: Progression-Free Survival (PFS)', 'timeFrame': 'Baseline to Disease Progression or Death (Up To 26 Months)', 'description': 'PFS is defined as the time from randomization to the first date of radiologic disease progression (as defined by Response Evaluation Criteria In Solid Tumors, Version 1.1 \\[RECIST v.1.1\\]) or death due to any cause in the absence of progressive disease (PD). PD is defined as at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. Participants who did not progress or are lost to follow-up were censored at the day of their last radiographic tumor assessment, if available, or date of randomization if no post-baseline radiographic assessment is available. If death or PD occurs after 2 or more consecutive missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the missed visits.'}, {'measure': 'Phase 1b/2: Objective Response Rate (ORR): Percentage of Participants Who Achieve Complete Response (CR) or Partial Response (PR)', 'timeFrame': 'Baseline through Disease Progression or Death (Up To 26 Months)', 'description': 'ORR is the best overall tumor response of CR or PR as classified by the investigator according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). CR is a disappearance of all target and non-target lesions and normalization of tumor marker level. PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of non-target lesions or appearance of new lesions.'}, {'measure': 'Phase 1b/2: Duration of Response (DoR)', 'timeFrame': 'From Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Up To 19 Months)', 'description': 'DoR is defined as the time from the date measurement criteria for CR or PR (whichever is first recorded) are first met until the first date that disease is recurrent or objective progression is observed, per RECIST 1.1 criteria, or the date of death from any cause in the absence of objectively determined disease progression or recurrence.'}, {'measure': 'Phase 2: Time to First Worsening of the Brief Pain Inventory Short Form Modified (mBPI-sf) "Worst Pain Score"', 'timeFrame': 'Baseline through Follow-up (Up To 21 Months)', 'description': 'The mBPI-sf is a 11-item instrument used as a multiple-item measure of cancer pain intensity ranging from 0 (no pain or does not interfere) and ranged through 10 (pain as bad as you can imagine or completely interferes). Time to first worsening of the mBPI-sf "worst pain score" (TWP) was defined as the time from the date of randomization to the first date of either a "worst pain" score increase of greater than or equal to (≥) 2 points from baseline or an analgesic drug class increase of ≥1 level. If the participant has not worsened by either of these criteria, TWP was censored for analysis on the last date the mBPI-sf was administered.'}, {'measure': 'Phase 2: Time to First Worsening of Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Symptom Scales.', 'timeFrame': 'Baseline through Follow-up (Up To 21 Months)', 'description': 'The EORTC QLQ-C30 is a self-reported general cancer instrument consisting of 30 items covered by 1 of 3 dimensions: global health status/quality of life (2 items), functional scales (15 total items addressing either physical, role, emotional, cognitive, or social functioning), symptom scales (13 total items addressing either fatigue, nausea/vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, or financial impact). Time to first worsening of Symptom Burden was defined as the time from randomization to the first observation of worsening on symptom scales (i.e.,) increase of at least 10 points from baseline. For symptom scales, a linear transformation was used to obtain total score ranging from 0 to 100, a high score represents a high level of symptomatology or problems.'}, {'measure': 'Phase 2: Health Status on the EuroQol 5-Dimension 5 Level (EQ-5D-5L)', 'timeFrame': 'Cycle 1 Day 1, Cycle 7 Day 1', 'description': 'The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) of health status are each assessed with 5 response options (1=no problem, 2=slight, 3=moderate, 4=severe, and 5=extreme problem) and scored as a composite index which were anchored on a scale of 0 to 1 with a higher score representing better health status. Additionally, current health status was assessed on a visual analogue scale (VAS) ranging from 0 to 100 with a higher score representing better health status.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Pancreatic Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/13wSI7GbbMae4kSSGsoWOw', 'label': 'A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of nab-paclitaxel and gemcitabine with or without olaratumab in the treatment of first-line metastatic pancreatic cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological or cytological diagnosis of adenocarcinoma of the exocrine pancreas that is metastatic (Stage IV) and not amenable to resection with curative intent.\n* If present, clinically significant or symptomatic amounts of ascites should be drained prior to Day 1.\n* Have had no prior systemic treatment for metastatic disease. Prior adjuvant or neo-adjuvant chemotherapy or radiochemotherapy (other than nab-paclitaxel) is allowed if completed ≥3 months prior to enrollment and no lingering toxicities are present.\n* Prior radiation therapy for treatment of cancer is allowed to \\<25% of the bone marrow.\n* Phase 2: archival tumor tissue or be willing to provide a pre-treatment biopsy.\n* Measurable or nonmeasurable but evaluable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Discontinued all previous treatments for cancer ≥4 weeks prior.\n* Adequate organ function.\n* Life expectancy of at least 3 months.\n\nExclusion Criteria:\n\n* Serious concomitant systemic disorder.\n* Have received first line treatment for metastatic pancreatic cancer.\n* Received prior treatment with nab-paclitaxel.\n* Have known central nervous system malignancy or metastasis.\n* Current hematologic malignancies.\n* Participated within the last 30 days in a clinical trial involving an investigational product.\n* Women with a positive pregnancy test or lactating.\n* Have endocrine pancreatic tumors or ampullary cancer.\n* Currently enrolled in another clinical trial.\n* Have a known additional malignancy that is progressing or required active treatment within the past 1 year.\n* Known allergy to nab-paclitaxel or gemcitabine or any ingredient of study drug formulations.\n* Are taking certain anti-coagulant medications such as warfarin and are unable to be switched to other similar medicines.'}, 'identificationModule': {'nctId': 'NCT03086369', 'briefTitle': 'A Study of Nab-Paclitaxel and Gemcitabine With or Without Olaratumab (LY3012207) in Participants With Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1b (Open-Label) / Phase 2 (Randomized, Double-Blinded) Study Evaluating Nab-Paclitaxel and Gemcitabine With or Without Olaratumab in the Treatment of First-Line Metastatic Pancreatic Cancer', 'orgStudyIdInfo': {'id': '15844'}, 'secondaryIdInfos': [{'id': 'I5B-MC-JGDP', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-001099-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous (IV) infusions of olaratumab 15 milligrams per kilogram (mg/kg), nab-paclitaxel 125 milligrams per meter square (mg/m\\^2) and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'interventionNames': ['Drug: Olaratumab', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'interventionNames': ['Drug: Olaratumab', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'description': 'Following a protocol amendment, "cohort expansion" arm was added in phase 1b with new participants enrolled to confirm the safety of the olaratumab 20 mg/kg dose prior to opening the Phase 2. Participants received intravenous infusions of olaratumab 20 mg/kg, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'interventionNames': ['Drug: Olaratumab', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of olaratumab 20 mg/kg loading dose on days 1, 8, 15 of cycle 1 followed by 15 mg/kg on days 1, 8, 15 of all subsequent cycles, in combination with nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'interventionNames': ['Drug: Olaratumab', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'description': 'Participants received intravenous infusions of placebo, nab-paclitaxel 125 mg/m\\^2 and gemcitabine 1000 mg/m\\^2 on days 1, 8, 15 of a 28-day cycle until disease progression or a criterion for discontinuation were met.', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Placebo']}], 'interventions': [{'name': 'Olaratumab', 'type': 'DRUG', 'otherNames': ['LY3012207'], 'description': 'Administered IV', 'armGroupLabels': ['Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'Phase1b: Olaratumab 15 mg/kg + Nab-paclitaxel + Gemcitabine', 'Phase1b: Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Phase 2: Olaratumab + Nab-paclitaxel + Gemcitabine', 'Phase 2: Placebo + Nab-paclitaxel + Gemcitabine', 'Phase1b (cohort expansion): Olaratumab 20 mg/kg + Nab-paclitaxel + Gemcitabine', 'Phase1b: 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'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263-0002', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Monter Cancer Center', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232-1305', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '57104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Sanford Research/USD', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Chattanooga Oncology Hematology Associates', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute SCRI', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Oncology PLLC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232-6307', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Univ of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah School of Medicine', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53792-4108', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin-Madison Hospital and Health Clinic', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Campus Virchow-Klinikum', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.', 'ipdSharing': 'YES', 'description': 'Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.', 'accessCriteria': 'A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}