Viewing Study NCT00219557

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 6:41 PM

Ignite Modification Date: 2025-12-25 @ 4:12 PM

Study NCT ID: NCT00219557

Status: COMPLETED

Last Update Posted: 2019-05-14

First Post: 2005-09-13

Is NOT Gene Therapy: False

Has Adverse Events: True

Brief Title: AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000077784', 'term': 'Axitinib'}], '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'}, {'id': 'D001549', 'term': 'Benzamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Population pharmacokinetics was not presented, as the data was not available for the single study and data of other axitinib (AG-013736) Phase 2 studies would be pooled together in a separate report.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.', 'otherNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m\\^2 30-minute infusion on Day 1, 8 and 15 of each cycle.', 'otherNumAtRisk': 68, 'otherNumAffected': 67, 'seriousNumAtRisk': 68, 'seriousNumAffected': 35}, {'id': 'EG002', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.', 'otherNumAtRisk': 31, 'otherNumAffected': 26, 'seriousNumAtRisk': 31, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Granulocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Eyelid oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Aphthous stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gingival pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gingival swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lip ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Mesenteric artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oral pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Peptic ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Small intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Gallbladder obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Jaundice cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Enterobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lung abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Neuromyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Post thrombotic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v13.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '210', 'groupId': 'OG000', 'lowerLimit': '162', 'upperLimit': '308'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '125', 'upperLimit': '267'}]}]}], 'analyses': [{'pValue': '0.1026', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.758', 'ciLowerLimit': '0.490', 'ciUpperLimit': '1.170', 'pValueComment': 'One-sided log-rank test at alpha = 0.1 significance level was used.', 'groupDescription': 'Differences in OS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are Eastern Cooperative Oncology Group (ECOG) performance status (less than or equal to 1 or 2) and extent of disease (locally advanced or metastatic).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant', 'description': 'Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 intent to treat (ITT) population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Phase 1 baseline up to Week 4', 'description': 'Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (\\>=) Gr 3 anemia or non hematological toxicities for \\>= 7 days (except alopecia) or \\>= Gr 1 hemoptysis or \\>=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Phase 1 Baseline up to Week 4', 'description': 'Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (\\>=) Gr 3 anemia or non hematological toxicities for \\>= 7 days (except alopecia) or \\>= Gr 1 hemoptysis or \\>=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 safety population included all participants who received at least 1 dose of study drug with treatment assignments designated according to actual study treatment received. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.08', 'spread': '34.32', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1', 'unitOfMeasure': 'nanogram/milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 Pharmacokinetic (PK) evaluable population included all ITT participants who completed PK blood sampling on at least 1 day.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '282.34', 'spread': '135.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.52', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '2.20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1', 'description': 'Tmax was based on the actual time points when the samples were collected.', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.97', 'spread': '1.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of Gemcitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '27280.0', 'spread': '12599.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13656.00', 'spread': '4142.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Plasma Decay Half-life (t1/2) of Gemcitabine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.310', 'spread': '0.028', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 1 PK evaluable population included all participants who completed PK blood sampling on at least 1 day. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2', 'timeFrame': 'Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks', 'description': 'Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '16.1'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '15.3'}]}]}], 'analyses': [{'pValue': '0.661', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.3', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '12.7', 'groupDescription': 'Difference in percent of participants with overall response expressed as response rate, was used for calculation of 95% confidence interval (CI).', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks', 'description': 'Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non-target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Duration of Response (DR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '379', 'groupId': 'OG000', 'lowerLimit': '136', 'upperLimit': '379'}, {'value': '155', 'comment': '95% CI was not estimable because only one participant was evaluable.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks', 'description': 'Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subgroup of participants from Phase 2 ITT population, with a confirmed objective tumor response (CR or PR).'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '109', 'upperLimit': '160'}, {'value': '113', 'groupId': 'OG001', 'lowerLimit': '68', 'upperLimit': '205'}]}]}], 'analyses': [{'pValue': '0.4466', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9648', 'ciLowerLimit': '0.5400', 'ciUpperLimit': '1.7300', 'pValueComment': 'One-sided log-rank test at alpha = 0.1 significance level was used.', 'groupDescription': 'Differences in PFS between treatment arms was analyzed by the stratified log-rank test where the stratification factors are ECOG performance status (less than equal to 1 or 2) and extent of disease (locally advanced or metastatic).', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks', 'description': 'Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was "Death").', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'One Year Survival Probability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.81', 'groupId': 'OG000', 'lowerLimit': '25.71', 'upperLimit': '47.93'}, {'value': '23.53', 'groupId': 'OG001', 'lowerLimit': '11.48', 'upperLimit': '38.01'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant', 'description': 'One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.', 'unitOfMeasure': 'Percent chance of survival', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 ITT population included all participants randomized with study drug assignment designated according to initial randomization, regardless of whether participants received study drug or a drug different from that to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'title': 'Global QoL: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.60', 'spread': '27.18', 'groupId': 'OG000'}, {'value': '54.32', 'spread': '21.10', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.90', 'spread': '24.73', 'groupId': 'OG000'}, {'value': '82.22', 'spread': '14.44', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.56', 'spread': '33.21', 'groupId': 'OG000'}, {'value': '60.26', 'spread': '35.30', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.22', 'spread': '26.17', 'groupId': 'OG000'}, {'value': '66.98', 'spread': '23.96', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.82', 'spread': '23.93', 'groupId': 'OG000'}, {'value': '82.10', 'spread': '19.57', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.44', 'spread': '33.00', 'groupId': 'OG000'}, {'value': '70.51', 'spread': '29.56', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.50', 'spread': '29.78', 'groupId': 'OG000'}, {'value': '42.80', 'spread': '25.73', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and Vomiting: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.74', 'spread': '28.24', 'groupId': 'OG000'}, {'value': '13.58', 'spread': '20.17', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.00', 'spread': '33.31', 'groupId': 'OG000'}, {'value': '37.04', 'spread': '31.80', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '21.82', 'groupId': 'OG000'}, {'value': '16.05', 'spread': '26.75', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.28', 'spread': '31.66', 'groupId': 'OG000'}, {'value': '39.51', 'spread': '39.26', 'groupId': 'OG001'}]}]}, {'title': 'Appetite loss: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 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'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '33.03', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Appetite loss: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '63.62', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '38.83', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '43.42', 'groupId': 'OG000'}, {'value': '-66.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.17', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Global QoL: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '21.52', 'groupId': 'OG000'}, {'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-19.05', 'spread': '13.01', 'groupId': 'OG000'}, {'value': '-46.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-23.81', 'spread': '21.21', 'groupId': 'OG000'}, {'value': '-50.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-20.24', 'spread': '23.00', 'groupId': 'OG000'}, {'value': '-16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.52', 'spread': '21.21', 'groupId': 'OG000'}, {'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was 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'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '25.46', 'groupId': 'OG000'}, {'value': '16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.90', 'spread': '35.63', 'groupId': 'OG000'}, {'value': '16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea: Change at C10 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.22', 'spread': '27.22', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 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'spread': '23.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Global QoL: Change at C11 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-38.89', 'spread': '53.58', 'groupId': 'OG000'}, {'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at C11 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-24.44', 'spread': '36.72', 'groupId': 'OG000'}, {'value': '-40.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was 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{'title': 'Role Functioning: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.11', 'spread': '19.25', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.78', 'spread': '20.97', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Functioning: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '16.67', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': 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[{'value': '-8.33', 'spread': '35.36', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '47.14', 'groupId': 'OG000'}]}]}, {'title': 'Nausea and Vomiting: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': '35.36', 'groupId': 'OG000'}]}]}, {'title': 'Pain: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.67', 'spread': '58.93', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnea: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Insomnia: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Appetite loss: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '47.14', 'groupId': 'OG000'}]}]}, {'title': 'Constipation: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Financial Difficulties: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Global QoL: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Role Functioning: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Emotional Functioning: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive Functioning: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Social Functioning: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Fatigue: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.22', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Nausea and Vomiting: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Pain: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Dyspnea: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Insomnia: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Appetite loss: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Constipation: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Financial Difficulties: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Global QoL: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-54.17', 'spread': '29.46', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-70.00', 'spread': '4.71', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.67', 'spread': '35.36', 'groupId': 'OG000'}, {'value': '-25.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive Functioning: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-66.67', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-83.33', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.56', 'spread': '15.71', 'groupId': 'OG000'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Nausea and Vomiting: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.67', 'spread': '82.50', 'groupId': 'OG000'}, {'value': '16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Dyspnea: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.67', 'spread': '47.14', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Appetite loss: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.00', 'spread': '70.71', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Constipation: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '117.85', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '47.14', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.44', 'ciLowerLimit': '-19.06', 'ciUpperLimit': '2.19', 'groupDescription': 'For change in global QoL at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.02', 'ciLowerLimit': '-15.4', 'ciUpperLimit': '3.36', 'groupDescription': 'For change in physical functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.32', 'ciLowerLimit': '-23.77', 'ciUpperLimit': '5.12', 'groupDescription': 'For change in role functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.73', 'ciLowerLimit': '-15.25', 'ciUpperLimit': '5.79', 'groupDescription': 'For change in emotional functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.11', 'ciLowerLimit': '-15.83', 'ciUpperLimit': '5.61', 'groupDescription': 'For change in cognitive functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-18.72', 'ciUpperLimit': '12.06', 'groupDescription': 'For change in social functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.41', 'ciLowerLimit': '-1.62', 'ciUpperLimit': '22.44', 'groupDescription': 'For change in fatigue at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.30', 'ciLowerLimit': '-16.55', 'ciUpperLimit': '7.96', 'groupDescription': 'For change in nausea and vomiting at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.37', 'ciLowerLimit': '-7.57', 'ciUpperLimit': '22.32', 'groupDescription': 'For change in pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.51', 'ciLowerLimit': '-1.28', 'ciUpperLimit': '26.30', 'groupDescription': 'For change in dyspnea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.90', 'ciLowerLimit': '-5.70', 'ciUpperLimit': '25.49', 'groupDescription': 'For change in insomnia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.63', 'ciLowerLimit': '-4.81', 'ciUpperLimit': '32.07', 'groupDescription': 'For change in appetite loss at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.67', 'ciLowerLimit': '-11.62', 'ciUpperLimit': '20.96', 'groupDescription': 'For change in constipation at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.28', 'ciLowerLimit': '-15.1', 'ciUpperLimit': '12.54', 'groupDescription': 'For change in diarrhea at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.43', 'ciLowerLimit': '-4.67', 'ciUpperLimit': '15.53', 'groupDescription': 'For change in financial difficulties at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.83', 'ciLowerLimit': '-32.34', 'ciUpperLimit': '0.67', 'groupDescription': 'For change in global QoL at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.58', 'ciLowerLimit': '-24.12', 'ciUpperLimit': '0.96', 'groupDescription': 'For change in physical functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.65', 'ciLowerLimit': '-35.47', 'ciUpperLimit': '-1.83', 'groupDescription': 'For change in role functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.92', 'ciLowerLimit': '-29.16', 'ciUpperLimit': '1.32', 'groupDescription': 'For change in emotional functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.10', 'ciLowerLimit': '-20.97', 'ciUpperLimit': '6.77', 'groupDescription': 'For change in cognitive functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.62', 'ciLowerLimit': '-28.28', 'ciUpperLimit': '9.04', 'groupDescription': 'For change in social functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.14', 'ciLowerLimit': '-1.27', 'ciUpperLimit': '33.54', 'groupDescription': 'For change in fatigue at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.80', 'ciLowerLimit': '-18.78', 'ciUpperLimit': '15.18', 'groupDescription': 'For change in nausea and vomiting at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.59', 'ciLowerLimit': '-3.22', 'ciUpperLimit': '36.39', 'groupDescription': 'For change in pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.39', 'ciLowerLimit': '-5.68', 'ciUpperLimit': '26.47', 'groupDescription': 'For change in dyspnea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '-20.19', 'ciUpperLimit': '23.36', 'groupDescription': 'For change in insomnia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.24', 'ciLowerLimit': '-7.62', 'ciUpperLimit': '40.1', 'groupDescription': 'For change in appetite loss at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.76', 'ciLowerLimit': '-17.49', 'ciUpperLimit': '23.02', 'groupDescription': 'For change in constipation at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.87', 'ciLowerLimit': '-16.29', 'ciUpperLimit': '22.03', 'groupDescription': 'For change in diarrhea at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.56', 'ciLowerLimit': '-9.81', 'ciUpperLimit': '20.92', 'groupDescription': 'For change in financial difficulties at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.97', 'ciLowerLimit': '-19.52', 'ciUpperLimit': '7.57', 'groupDescription': 'For change in global QoL at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.64', 'ciLowerLimit': '-19.75', 'ciUpperLimit': '8.46', 'groupDescription': 'For change in physical functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.53', 'ciLowerLimit': '-39.11', 'ciUpperLimit': '4.05', 'groupDescription': 'For change in role functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.25', 'ciLowerLimit': '-26.5', 'ciUpperLimit': '2.00', 'groupDescription': 'For change in emotional functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.99', 'ciLowerLimit': '-23.13', 'ciUpperLimit': '9.15', 'groupDescription': 'For change in cognitive functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.09', 'ciLowerLimit': '-30.48', 'ciUpperLimit': '16.31', 'groupDescription': 'For change in social functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.88', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '27.63', 'groupDescription': 'For change in fatigue at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.10', 'ciLowerLimit': '-24.11', 'ciUpperLimit': '1.91', 'groupDescription': 'For change in nausea and vomiting at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.13', 'ciLowerLimit': '-24.26', 'ciUpperLimit': '14.00', 'groupDescription': 'For change in pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.13', 'ciLowerLimit': '-14.18', 'ciUpperLimit': '24.44', 'groupDescription': 'For change in dyspnea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.33', 'ciLowerLimit': '-26.25', 'ciUpperLimit': '13.59', 'groupDescription': 'For change in insomnia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.03', 'ciLowerLimit': '-15.26', 'ciUpperLimit': '33.32', 'groupDescription': 'For change in appetite loss at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-25.71', 'ciUpperLimit': '26.82', 'groupDescription': 'For change in constipation at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '-24.07', 'ciUpperLimit': '28.01', 'groupDescription': 'For change in diarrhea at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.48', 'ciLowerLimit': '-5.89', 'ciUpperLimit': '24.86', 'groupDescription': 'For change in financial difficulties at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.01', 'ciLowerLimit': '-43.19', 'ciUpperLimit': '3.17', 'groupDescription': 'For change in global QoL at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.57', 'ciLowerLimit': '-27.24', 'ciUpperLimit': '10.10', 'groupDescription': 'For change in physical functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.07', 'ciLowerLimit': '-41.10', 'ciUpperLimit': '8.96', 'groupDescription': 'For change in role functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-24.11', 'ciLowerLimit': '-42.72', 'ciUpperLimit': '-5.50', 'groupDescription': 'For change in emotional functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.52', 'ciLowerLimit': '-29.66', 'ciUpperLimit': '10.61', 'groupDescription': 'For change in cognitive functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.24', 'ciLowerLimit': '-47.93', 'ciUpperLimit': '7.46', 'groupDescription': 'For change in social functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '3.23', 'ciUpperLimit': '46.77', 'groupDescription': 'For change in fatigue at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.25', 'ciLowerLimit': '-13.49', 'ciUpperLimit': '25.99', 'groupDescription': 'For change in nausea and vomiting at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.64', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '46.41', 'groupDescription': 'For change in pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.02', 'ciLowerLimit': '0.38', 'ciUpperLimit': '43.66', 'groupDescription': 'For change in dyspnea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.12', 'ciLowerLimit': '-18.49', 'ciUpperLimit': '38.73', 'groupDescription': 'For change in insomnia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.83', 'ciLowerLimit': '-13.98', 'ciUpperLimit': '55.65', 'groupDescription': 'For change in appetite loss at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.90', 'ciLowerLimit': '-19.02', 'ciUpperLimit': '42.83', 'groupDescription': 'For change in constipation at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.90', 'ciLowerLimit': '-16.13', 'ciUpperLimit': '39.94', 'groupDescription': 'For change in diarrhea at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-23.38', 'ciUpperLimit': '23.38', 'groupDescription': 'For change in financial difficulties at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.66', 'ciLowerLimit': '-34.53', 'ciUpperLimit': '17.21', 'groupDescription': 'For change in global QoL at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.98', 'ciLowerLimit': '-52.01', 'ciUpperLimit': '26.04', 'groupDescription': 'For change in physical functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-26.32', 'ciLowerLimit': '-71.87', 'ciUpperLimit': '19.24', 'groupDescription': 'For change in role functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.14', 'ciLowerLimit': '-26.59', 'ciUpperLimit': '14.31', 'groupDescription': 'For change in emotional functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.99', 'ciLowerLimit': '-35.46', 'ciUpperLimit': '11.48', 'groupDescription': 'For change in cognitive functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.04', 'ciLowerLimit': '-20.97', 'ciUpperLimit': '49.04', 'groupDescription': 'For change in social functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.39', 'ciLowerLimit': '-15.83', 'ciUpperLimit': '62.61', 'groupDescription': 'For change in fatigue at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.95', 'ciLowerLimit': '-30.84', 'ciUpperLimit': '38.73', 'groupDescription': 'For change in nausea and vomiting at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.56', 'ciLowerLimit': '-13.08', 'ciUpperLimit': '62.20', 'groupDescription': 'For change in pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.85', 'ciLowerLimit': '-38.65', 'ciUpperLimit': '34.94', 'groupDescription': 'For change in dyspnea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.65', 'ciLowerLimit': '-37.43', 'ciUpperLimit': '56.73', 'groupDescription': 'For change in insomnia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.16', 'ciLowerLimit': '-71.22', 'ciUpperLimit': '97.54', 'groupDescription': 'For change in appetite loss at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.81', 'ciLowerLimit': '-22.61', 'ciUpperLimit': '68.22', 'groupDescription': 'For change in constipation at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.75', 'ciLowerLimit': '-39.10', 'ciUpperLimit': '35.59', 'groupDescription': 'For change in diarrhea at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.98', 'ciLowerLimit': '1.09', 'ciUpperLimit': '46.86', 'groupDescription': 'For change in financial difficulties at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.04', 'ciLowerLimit': '-39.03', 'ciUpperLimit': '63.11', 'groupDescription': 'For change in global QoL at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.89', 'ciLowerLimit': '-20.74', 'ciUpperLimit': '58.52', 'groupDescription': 'For change in physical functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-48.33', 'ciLowerLimit': '-111.94', 'ciUpperLimit': '15.28', 'groupDescription': 'For change in role functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.93', 'ciLowerLimit': '-22.59', 'ciUpperLimit': '20.74', 'groupDescription': 'For change in emotional functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.22', 'ciLowerLimit': '-24.98', 'ciUpperLimit': '39.43', 'groupDescription': 'For change in cognitive functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.00', 'ciLowerLimit': '-57.71', 'ciUpperLimit': '77.71', 'groupDescription': 'For change in social functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.04', 'ciLowerLimit': '-58.87', 'ciUpperLimit': '24.79', 'groupDescription': 'For change in fatigue at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.00', 'ciLowerLimit': '-43.10', 'ciUpperLimit': '13.10', 'groupDescription': 'For change in nausea and vomiting at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.78', 'ciLowerLimit': '-41.75', 'ciUpperLimit': '57.30', 'groupDescription': 'For change in pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-53.79', 'ciUpperLimit': '20.46', 'groupDescription': 'For change in dyspnea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.11', 'ciLowerLimit': '-73.14', 'ciUpperLimit': '30.92', 'groupDescription': 'For change in insomnia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-32.22', 'ciLowerLimit': '-115.58', 'ciUpperLimit': '51.13', 'groupDescription': 'For change in appetite loss at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '53.33', 'ciLowerLimit': '-18.60', 'ciUpperLimit': '125.26', 'groupDescription': 'For change in constipation at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.33', 'ciLowerLimit': '-34.92', 'ciUpperLimit': '41.58', 'groupDescription': 'For change in diarrhea at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.67', 'ciLowerLimit': '-34.3', 'ciUpperLimit': '20.96', 'groupDescription': 'For change in financial difficulties at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.83', 'ciLowerLimit': '-58.94', 'ciUpperLimit': '100.60', 'groupDescription': 'For change in global QoL at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.33', 'ciLowerLimit': '-44.54', 'ciUpperLimit': '63.20', 'groupDescription': 'For change in physical functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.00', 'ciLowerLimit': '-35.30', 'ciUpperLimit': '75.30', 'groupDescription': 'For change in role functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.50', 'ciLowerLimit': '-51.66', 'ciUpperLimit': '36.66', 'groupDescription': 'For change in emotional functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.67', 'ciLowerLimit': '-36.06', 'ciUpperLimit': '69.39', 'groupDescription': 'For change in cognitive functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.00', 'ciLowerLimit': '-76.36', 'ciUpperLimit': '86.36', 'groupDescription': 'For change in social functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-17.78', 'ciLowerLimit': '-77.63', 'ciUpperLimit': '42.08', 'groupDescription': 'For change in fatigue at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-62.33', 'ciUpperLimit': '28.99', 'groupDescription': 'For change in nausea and vomiting at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.33', 'ciLowerLimit': '-79.59', 'ciUpperLimit': '96.26', 'groupDescription': 'For change in pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.52', 'ciLowerLimit': '-89.98', 'ciUpperLimit': '52.94', 'groupDescription': 'For change in dyspnea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-20.00', 'ciLowerLimit': '-133.08', 'ciUpperLimit': '93.08', 'groupDescription': 'For change in insomnia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-36.67', 'ciLowerLimit': '-151.27', 'ciUpperLimit': '77.94', 'groupDescription': 'For change in appetite loss at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-72.58', 'ciUpperLimit': '65.91', 'groupDescription': 'For change in constipation at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.33', 'ciLowerLimit': '-16.45', 'ciUpperLimit': '163.12', 'groupDescription': 'For change in diarrhea at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.33', 'ciLowerLimit': '-48.23', 'ciUpperLimit': '41.56', 'groupDescription': 'For change in financial difficulties at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.62', 'ciLowerLimit': '-74.75', 'ciUpperLimit': '106.00', 'groupDescription': 'For change in global QoL at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.33', 'ciLowerLimit': '-17.22', 'ciUpperLimit': '83.89', 'groupDescription': 'For change in physical functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.17', 'ciLowerLimit': '-58.04', 'ciUpperLimit': '66.37', 'groupDescription': 'For change in role functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.21', 'ciLowerLimit': '-28.19', 'ciUpperLimit': '38.61', 'groupDescription': 'For change in emotional functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.25', 'ciLowerLimit': '-40.94', 'ciUpperLimit': '103.44', 'groupDescription': 'For change in cognitive functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.08', 'ciLowerLimit': '-91.02', 'ciUpperLimit': '145.18', 'groupDescription': 'For change in social functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.28', 'ciLowerLimit': '-99.46', 'ciUpperLimit': '68.90', 'groupDescription': 'For change in fatigue at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.00', 'ciLowerLimit': '-69.69', 'ciUpperLimit': '19.69', 'groupDescription': 'For change in nausea and vomiting at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-77.40', 'ciUpperLimit': '77.40', 'groupDescription': 'For change in pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.29', 'ciLowerLimit': '-82.89', 'ciUpperLimit': '54.32', 'groupDescription': 'For change in dyspnea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.17', 'ciLowerLimit': '-87.02', 'ciUpperLimit': '78.69', 'groupDescription': 'For change in insomnia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.00', 'ciLowerLimit': '-184.57', 'ciUpperLimit': '134.57', 'groupDescription': 'For change in appetite loss at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.33', 'ciLowerLimit': '-105.73', 'ciUpperLimit': '89.06', 'groupDescription': 'For change in constipation at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '79.17', 'ciLowerLimit': '-29.72', 'ciUpperLimit': '188.06', 'groupDescription': 'For change in diarrhea at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.17', 'ciLowerLimit': '-57.74', 'ciUpperLimit': '49.41', 'groupDescription': 'For change in financial difficulties at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.67', 'ciLowerLimit': '-39.62', 'ciUpperLimit': '72.95', 'groupDescription': 'For change in global QoL at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.62', 'ciLowerLimit': '-6.42', 'ciUpperLimit': '61.66', 'groupDescription': 'For change in physical functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.19', 'ciLowerLimit': '-29.28', 'ciUpperLimit': '81.66', 'groupDescription': 'For change in role functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.57', 'ciLowerLimit': '-63.74', 'ciUpperLimit': '56.6', 'groupDescription': 'For change in emotional functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.81', 'ciLowerLimit': '-31.66', 'ciUpperLimit': '79.28', 'groupDescription': 'For change in cognitive functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.57', 'ciLowerLimit': '-53.82', 'ciUpperLimit': '110.96', 'groupDescription': 'For change in social functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-30.16', 'ciLowerLimit': '-94.53', 'ciUpperLimit': '34.21', 'groupDescription': 'For change in fatigue at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-83.26', 'ciUpperLimit': '49.93', 'groupDescription': 'For change in nausea and vomiting at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.76', 'ciLowerLimit': '-97.98', 'ciUpperLimit': '88.45', 'groupDescription': 'For change in pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.11', 'ciLowerLimit': '-86.68', 'ciUpperLimit': '64.46', 'groupDescription': 'For change in dyspnea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.76', 'ciLowerLimit': '-55.41', 'ciUpperLimit': '64.93', 'groupDescription': 'For change in insomnia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.52', 'ciLowerLimit': '-129.86', 'ciUpperLimit': '110.82', 'groupDescription': 'For change in appetite loss at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.05', 'ciLowerLimit': '-117.92', 'ciUpperLimit': '79.82', 'groupDescription': 'For change in constipation at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.19', 'ciLowerLimit': '-6.75', 'ciUpperLimit': '159.13', 'groupDescription': 'For change in diarrhea at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.76', 'ciLowerLimit': '-64.93', 'ciUpperLimit': '55.41', 'groupDescription': 'For change in financial difficulties at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.56', 'ciLowerLimit': '-271.74', 'ciUpperLimit': '260.62', 'groupDescription': 'For change in global QoL at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.56', 'ciLowerLimit': '-166.87', 'ciUpperLimit': '197.98', 'groupDescription': 'For change in physical functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.78', 'ciLowerLimit': '-238.4', 'ciUpperLimit': '293.96', 'groupDescription': 'For change in role functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-275.22', 'ciUpperLimit': '241.89', 'groupDescription': 'For change in emotional functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.56', 'ciLowerLimit': '-307.94', 'ciUpperLimit': '319.05', 'groupDescription': 'For change in cognitive functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.78', 'ciLowerLimit': '-238.40', 'ciUpperLimit': '293.96', 'groupDescription': 'For change in social functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.81', 'ciLowerLimit': '-215.01', 'ciUpperLimit': '244.64', 'groupDescription': 'For change in fatigue at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.11', 'ciLowerLimit': '-302.38', 'ciUpperLimit': '324.60', 'groupDescription': 'For change in nausea and vomiting at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.89', 'ciLowerLimit': '-305.85', 'ciUpperLimit': '383.63', 'groupDescription': 'For change in pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.11', 'ciLowerLimit': '-355.85', 'ciUpperLimit': '333.63', 'groupDescription': 'For change in dyspnea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.22', 'ciLowerLimit': '-322.52', 'ciUpperLimit': '366.97', 'groupDescription': 'For change in insomnia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.44', 'ciLowerLimit': '-208.53', 'ciUpperLimit': '297.42', 'groupDescription': 'For change in appetite loss at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-165.61', 'ciUpperLimit': '165.61', 'groupDescription': 'For change in constipation at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.78', 'ciLowerLimit': '-17.84', 'ciUpperLimit': '173.39', 'groupDescription': 'For change in diarrhea at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.11', 'ciLowerLimit': '-106.73', 'ciUpperLimit': '84.5', 'groupDescription': 'For change in financial difficulties at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-54.17', 'ciLowerLimit': '-512.66', 'ciUpperLimit': '404.33', 'groupDescription': 'For change in global QoL at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-70.00', 'ciLowerLimit': '-143.36', 'ciUpperLimit': '3.36', 'groupDescription': 'For change in physical functioning at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.33', 'ciLowerLimit': '-400.13', 'ciUpperLimit': '333.46', 'groupDescription': 'For change in role functioning at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-41.67', 'ciLowerLimit': '-591.86', 'ciUpperLimit': '508.53', 'groupDescription': 'For change in emotional functioning at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-66.67', 'ciLowerLimit': '-66.67', 'ciUpperLimit': '-66.67', 'groupDescription': 'For change in cognitive functioning at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-83.33', 'ciLowerLimit': '-450.13', 'ciUpperLimit': '283.46', 'groupDescription': 'For change in social functioning at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.67', 'ciLowerLimit': '-177.86', 'ciUpperLimit': '311.2', 'groupDescription': 'For change in fatigue at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.33', 'ciLowerLimit': '-333.46', 'ciUpperLimit': '400.13', 'groupDescription': 'For change in nausea and vomiting at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '-1258.79', 'ciUpperLimit': '1308.79', 'groupDescription': 'For change in pain at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '83.33', 'ciLowerLimit': '-283.46', 'ciUpperLimit': '450.13', 'groupDescription': 'For change in dyspnea at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.33', 'ciLowerLimit': '-700.26', 'ciUpperLimit': '766.93', 'groupDescription': 'For change in insomnia at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '50.00', 'ciLowerLimit': '-1050.39', 'ciUpperLimit': '1150.39', 'groupDescription': 'For change in appetite loss at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-1850.65', 'ciUpperLimit': '1817.32', 'groupDescription': 'For change in constipation at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.33', 'ciLowerLimit': '-700.26', 'ciUpperLimit': '766.93', 'groupDescription': 'For change in diarrhea at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-16.67', 'ciLowerLimit': '-383.46', 'ciUpperLimit': '350.13', 'groupDescription': 'For change in financial difficulties at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).', 'description': "EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. ''n'' signifies the number of participants evaluable for the respective scale at the respective time point."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'OG001', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'classes': [{'title': 'Pancreatic Pain: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.52', 'spread': '27.88', 'groupId': 'OG000'}, {'value': '38.89', 'spread': '21.18', 'groupId': 'OG001'}]}]}, {'title': 'Eating Related Items: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.40', 'spread': '35.18', 'groupId': 'OG000'}, {'value': '33.95', 'spread': '27.92', 'groupId': 'OG001'}]}]}, {'title': 'Altered Bowel Habits: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.32', 'spread': '26.19', 'groupId': 'OG000'}, {'value': '25.31', 'spread': '28.26', 'groupId': 'OG001'}]}]}, {'title': 'Jaundice: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.89', 'spread': '18.34', 'groupId': 'OG000'}, {'value': '15.38', 'spread': '23.06', 'groupId': 'OG001'}]}]}, {'title': 'Body Image: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.64', 'spread': '29.80', 'groupId': 'OG000'}, {'value': '26.54', 'spread': '25.84', 'groupId': 'OG001'}]}]}, {'title': 'Health Care Satisfaction: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.38', 'spread': '27.57', 'groupId': 'OG000'}, {'value': '69.75', 'spread': '25.33', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Functioning: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.35', 'spread': '34.42', 'groupId': 'OG000'}, {'value': '57.97', 'spread': '37.56', 'groupId': 'OG001'}]}]}, {'title': 'Ascites: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.29', 'spread': '31.00', 'groupId': 'OG000'}, {'value': '25.93', 'spread': '25.04', 'groupId': 'OG001'}]}]}, {'title': 'Indigestion: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.86', 'spread': '28.09', 'groupId': 'OG000'}, {'value': '30.86', 'spread': '34.50', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.59', 'spread': '32.67', 'groupId': 'OG000'}, {'value': '39.51', 'spread': '29.29', 'groupId': 'OG001'}]}]}, {'title': 'Cachexia: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.62', 'spread': '25.43', 'groupId': 'OG000'}, {'value': '31.48', 'spread': '23.72', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.78', 'spread': '24.80', 'groupId': 'OG000'}, {'value': '27.35', 'spread': '21.77', 'groupId': 'OG001'}]}]}, {'title': 'Fear of Future Health: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.22', 'spread': '31.03', 'groupId': 'OG000'}, {'value': '59.26', 'spread': '33.76', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Plan Future: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.55', 'spread': '35.27', 'groupId': 'OG000'}, {'value': '41.98', 'spread': '36.51', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic Pain: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-11.05', 'spread': '25.39', 'groupId': 'OG000'}, {'value': '-13.64', 'spread': '22.05', 'groupId': 'OG001'}]}]}, {'title': 'Eating Related Items: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.38', 'spread': '34.19', 'groupId': 'OG000'}, {'value': '-3.79', 'spread': '27.67', 'groupId': 'OG001'}]}]}, {'title': 'Altered Bowel Habits: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '28.19', 'groupId': 'OG000'}, {'value': '-11.36', 'spread': '22.05', 'groupId': 'OG001'}]}]}, {'title': 'Jaundice: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '20.65', 'groupId': 'OG000'}, {'value': '-12.70', 'spread': '25.22', 'groupId': 'OG001'}]}]}, {'title': 'Body Image: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.95', 'spread': '26.53', 'groupId': 'OG000'}, {'value': '-7.14', 'spread': '25.04', 'groupId': 'OG001'}]}]}, {'title': 'Health Care Satisfaction: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.39', 'spread': '34.60', 'groupId': 'OG000'}, {'value': '-3.97', 'spread': '37.60', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Functioning: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.56', 'spread': '22.14', 'groupId': 'OG000'}, {'value': '18.63', 'spread': '38.59', 'groupId': 'OG001'}]}]}, {'title': 'Ascites: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-10.85', 'spread': '36.89', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '22.79', 'groupId': 'OG001'}]}]}, {'title': 'Indigestion: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.65', 'spread': '24.75', 'groupId': 'OG000'}, {'value': '-10.61', 'spread': '37.64', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.30', 'spread': '34.43', 'groupId': 'OG000'}, {'value': '-9.09', 'spread': '21.04', 'groupId': 'OG001'}]}]}, {'title': 'Cachexia: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.47', 'spread': '19.15', 'groupId': 'OG000'}, {'value': '-3.03', 'spread': '17.55', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.70', 'spread': '16.39', 'groupId': 'OG000'}, {'value': '-3.17', 'spread': '20.90', 'groupId': 'OG001'}]}]}, {'title': 'Fear of Future Health: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.33', 'spread': '23.45', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '31.62', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Plan Future: Change at C2 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.55', 'spread': '35.65', 'groupId': 'OG000'}, {'value': '-1.67', 'spread': '27.52', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic Pain: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.92', 'spread': '24.62', 'groupId': 'OG000'}, {'value': '-23.78', 'spread': '20.61', 'groupId': 'OG001'}]}]}, {'title': 'Eating Related Items: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.07', 'spread': '37.34', 'groupId': 'OG000'}, {'value': '-10.42', 'spread': '28.46', 'groupId': 'OG001'}]}]}, {'title': 'Altered Bowel Habits: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.53', 'spread': '31.34', 'groupId': 'OG000'}, {'value': '-8.33', 'spread': '31.03', 'groupId': 'OG001'}]}]}, {'title': 'Jaundice: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.19', 'spread': '13.52', 'groupId': 'OG000'}, {'value': '-9.38', 'spread': '26.51', 'groupId': 'OG001'}]}]}, {'title': 'Body Image: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.51', 'spread': '30.89', 'groupId': 'OG000'}, {'value': '-5.21', 'spread': '29.01', 'groupId': 'OG001'}]}]}, {'title': 'Health Care Satisfaction: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.41', 'spread': '40.07', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '24.88', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Functioning: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.13', 'spread': '21.77', 'groupId': 'OG000'}, {'value': '-4.44', 'spread': '31.79', 'groupId': 'OG001'}]}]}, {'title': 'Ascites: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.63', 'spread': '28.35', 'groupId': 'OG000'}, {'value': '-4.17', 'spread': '23.96', 'groupId': 'OG001'}]}]}, {'title': 'Indigestion: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.50', 'spread': '34.39', 'groupId': 'OG000'}, {'value': '-15.56', 'spread': '37.52', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.65', 'spread': '37.09', 'groupId': 'OG000'}, {'value': '6.25', 'spread': '27.81', 'groupId': 'OG001'}]}]}, {'title': 'Cachexia: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.47', 'spread': '24.56', 'groupId': 'OG000'}, {'value': '5.21', 'spread': '17.97', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.55', 'spread': '27.41', 'groupId': 'OG000'}, {'value': '-7.64', 'spread': '26.28', 'groupId': 'OG001'}]}]}, {'title': 'Fear of Future Health: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.86', 'spread': '34.65', 'groupId': 'OG000'}, {'value': '-2.22', 'spread': '42.66', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Plan Future: Change at C3 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.01', 'spread': '43.50', 'groupId': 'OG000'}, {'value': '-12.50', 'spread': '34.16', 'groupId': 'OG001'}]}]}, {'title': 'Pancreatic Pain: Change at C4 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-18.30', 'spread': '26.90', 'groupId': 'OG000'}, {'value': '-14.10', 'spread': '22.92', 'groupId': 'OG001'}]}]}, {'title': 'Eating Related Items: Change at C4 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.47', 'spread': '26.57', 'groupId': 'OG000'}, {'value': '5.13', 'spread': '36.88', 'groupId': 'OG001'}]}]}, {'title': 'Altered Bowel Habits: Change at C4 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.09', 'spread': '35.21', 'groupId': 'OG000'}, {'value': '3.85', 'spread': '28.99', 'groupId': 'OG001'}]}]}, {'title': 'Jaundice: Change at C4 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 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'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Ascites: Change at C8 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.70', 'spread': '26.06', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Indigestion: Change at C8 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-7.41', 'spread': '40.06', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Change at C8 D1', 'denoms': [{'units': 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'groupId': 'OG001'}]}]}, {'title': 'Pancreatic Pain: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '30.43', 'groupId': 'OG000'}, {'value': '-16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Eating Related Items: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.29', 'spread': '39.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Altered Bowel Habits: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, 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'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Health Care Satisfaction: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.38', 'spread': '24.40', 'groupId': 'OG000'}, {'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Functioning: Change at C9 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-13.33', 'spread': '29.81', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Ascites: Change at C9 D1', 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'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '16.67', 'groupId': 'OG000'}]}]}, {'title': 'Altered Bowel Habits: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.78', 'spread': '34.69', 'groupId': 'OG000'}]}]}, {'title': 'Jaundice: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Body Image: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '16.67', 'groupId': 'OG000'}]}]}, {'title': 'Health Care Satisfaction: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.56', 'spread': '41.94', 'groupId': 'OG000'}]}]}, {'title': 'Sexual Functioning: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '66.67', 'groupId': 'OG000'}]}]}, {'title': 'Ascites: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-22.22', 'spread': '19.25', 'groupId': 'OG000'}]}]}, {'title': 'Indigestion: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Flatulence: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Cachexia: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '28.87', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Change at C12 D1(n=3,0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '40.06', 'groupId': 'OG000'}]}]}, {'title': 'Fear of Future Health: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Ability to Plan Future: Change at C12 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic Pain: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.83', 'spread': '5.89', 'groupId': 'OG000'}]}]}, {'title': 'Eating Related Items: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'spread': '58.93', 'groupId': 'OG000'}]}]}, {'title': 'Altered Bowel Habits: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '11.79', 'groupId': 'OG000'}]}]}, {'title': 'Jaundice: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '35.36', 'groupId': 'OG000'}]}]}, {'title': 'Body Image: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.67', 'spread': '58.93', 'groupId': 'OG000'}]}]}, {'title': 'Health Care Satisfaction: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Sexual Functioning: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-50.00', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Ascites: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Indigestion: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Flatulence: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Cachexia: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '47.14', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '7.86', 'groupId': 'OG000'}]}]}, {'title': 'Fear of Future Health: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Ability to Plan Future: Change at C13 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '23.57', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic Pain: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-8.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Eating Related Items: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Altered Bowel Habits: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Jaundice: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Body Image: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Health Care Satisfaction: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Sexual Functioning: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Ascites: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Indigestion: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Flatulence: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Cachexia: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Side Effects: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Fear of Future Health: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Ability to Plan Future: Change at C14 D1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}]}]}, {'title': 'Pancreatic Pain: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'spread': '35.36', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Eating Related Items: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '82.50', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Altered Bowel Habits: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Jaundice: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '11.79', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Body Image: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.67', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '-16.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Health Care Satisfaction: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Sexual Functioning: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Ascites: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '47.14', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Indigestion: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '47.14', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.33', 'spread': '23.57', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Cachexia: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.67', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Side Effects: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.44', 'spread': '90.35', 'groupId': 'OG000'}, {'value': '-11.11', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Fear of Future Health: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '-33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}, {'title': 'Ability to Plan Future: Change at EoS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.67', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG000'}, {'value': '33.33', 'spread': 'NA', 'comment': 'Standard deviation was not calculated because only one participant was evaluable.', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.59', 'ciLowerLimit': '-10.11', 'ciUpperLimit': '15.29', 'groupDescription': 'For change in pancreatic pain at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.41', 'ciLowerLimit': '-13.39', 'ciUpperLimit': '20.20', 'groupDescription': 'For change in eating related items at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.70', 'ciLowerLimit': '5.96', 'ciUpperLimit': '33.43', 'groupDescription': 'For change in altered bowel habits at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.70', 'ciLowerLimit': '0.93', 'ciUpperLimit': '24.47', 'groupDescription': 'For change in jaundice at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.10', 'ciLowerLimit': '1.28', 'ciUpperLimit': '28.91', 'groupDescription': 'For change in body image at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.36', 'ciLowerLimit': '-14.59', 'ciUpperLimit': '23.30', 'groupDescription': 'For change in health care satisfaction at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.19', 'ciLowerLimit': '-37.53', 'ciUpperLimit': '-4.85', 'groupDescription': 'For change in sexual functioning at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.82', 'ciLowerLimit': '-25.04', 'ciUpperLimit': '9.40', 'groupDescription': 'For change in ascites at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.95', 'ciLowerLimit': '-9.59', 'ciUpperLimit': '21.50', 'groupDescription': 'For change in indigestion at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.39', 'ciLowerLimit': '-1.61', 'ciUpperLimit': '30.40', 'groupDescription': 'For change in flatulence at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.50', 'ciLowerLimit': '2.78', 'ciUpperLimit': '22.22', 'groupDescription': 'For change in cachexia at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.88', 'ciLowerLimit': '1.36', 'ciUpperLimit': '20.39', 'groupDescription': 'For change in side effects at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.33', 'ciLowerLimit': '-16.36', 'ciUpperLimit': '11.71', 'groupDescription': 'For change in fear of future health at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.21', 'ciLowerLimit': '-11.78', 'ciUpperLimit': '24.20', 'groupDescription': 'For change in ability to plan future at Cycle 2 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.87', 'ciLowerLimit': '0.79', 'ciUpperLimit': '28.94', 'groupDescription': 'For change in pancreatic pain at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.49', 'ciLowerLimit': '-7.45', 'ciUpperLimit': '34.42', 'groupDescription': 'For change in eating related items at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.86', 'ciLowerLimit': '0.17', 'ciUpperLimit': '37.55', 'groupDescription': 'For change in altered bowel habits at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.57', 'ciLowerLimit': '0.66', 'ciUpperLimit': '22.48', 'groupDescription': 'For change in jaundice at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.72', 'ciLowerLimit': '0.49', 'ciUpperLimit': '36.95', 'groupDescription': 'For change in body image at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.61', 'ciLowerLimit': '-32.40', 'ciUpperLimit': '11.17', 'groupDescription': 'For change in health care satisfaction at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.32', 'ciLowerLimit': '-14.63', 'ciUpperLimit': '17.27', 'groupDescription': 'For change in sexual functioning at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.54', 'ciLowerLimit': '-14.70', 'ciUpperLimit': '17.78', 'groupDescription': 'For change in ascites at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.05', 'ciLowerLimit': '-10.65', 'ciUpperLimit': '32.75', 'groupDescription': 'For change in indigestion at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.40', 'ciLowerLimit': '-17.33', 'ciUpperLimit': '24.13', 'groupDescription': 'For change in flatulence at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.27', 'ciLowerLimit': '-4.40', 'ciUpperLimit': '22.93', 'groupDescription': 'For change in cachexia at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.19', 'ciLowerLimit': '2.99', 'ciUpperLimit': '35.39', 'groupDescription': 'For change in side effects at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.63', 'ciLowerLimit': '-23.70', 'ciUpperLimit': '22.43', 'groupDescription': 'For change in fear of future health at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.51', 'ciLowerLimit': '-3.10', 'ciUpperLimit': '46.12', 'groupDescription': 'For change in ability to plan future at Cycle 3 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.19', 'ciLowerLimit': '-21.57', 'ciUpperLimit': '13.19', 'groupDescription': 'For change in pancreatic pain at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.60', 'ciLowerLimit': '-32.86', 'ciUpperLimit': '7.66', 'groupDescription': 'For change in eating related items at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.25', 'ciLowerLimit': '-10.33', 'ciUpperLimit': '34.82', 'groupDescription': 'For change in altered bowel habits at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.84', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '25.85', 'groupDescription': 'For change in jaundice at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.85', 'ciLowerLimit': '-16.45', 'ciUpperLimit': '24.14', 'groupDescription': 'For change in body image at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.05', 'ciLowerLimit': '-23.23', 'ciUpperLimit': '37.34', 'groupDescription': 'For change in health care satisfaction at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.53', 'ciLowerLimit': '-26.55', 'ciUpperLimit': '21.50', 'groupDescription': 'For change in sexual functioning at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.46', 'ciLowerLimit': '-27.48', 'ciUpperLimit': '8.56', 'groupDescription': 'For change in ascites at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.96', 'ciLowerLimit': '-30.62', 'ciUpperLimit': '16.70', 'groupDescription': 'For change in indigestion at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.71', 'ciLowerLimit': '-20.37', 'ciUpperLimit': '27.80', 'groupDescription': 'For change in flatulence at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.04', 'ciLowerLimit': '-5.73', 'ciUpperLimit': '31.81', 'groupDescription': 'For change in cachexia at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.12', 'ciLowerLimit': '-3.23', 'ciUpperLimit': '33.46', 'groupDescription': 'For change in side effects at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.91', 'ciLowerLimit': '-36.18', 'ciUpperLimit': '20.37', 'groupDescription': 'For change in fear of future health at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.38', 'ciLowerLimit': '-20.24', 'ciUpperLimit': '51.01', 'groupDescription': 'For change in ability to plan future at Cycle 4 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.25', 'ciLowerLimit': '-10.09', 'ciUpperLimit': '32.59', 'groupDescription': 'For change in pancreatic pain at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.41', 'ciLowerLimit': '-25.22', 'ciUpperLimit': '40.03', 'groupDescription': 'For change in eating related items at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.28', 'ciLowerLimit': '4.23', 'ciUpperLimit': '52.32', 'groupDescription': 'For change in altered bowel habits at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.22', 'ciLowerLimit': '5.09', 'ciUpperLimit': '43.34', 'groupDescription': 'For change in jaundice at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.11', 'ciLowerLimit': '-0.16', 'ciUpperLimit': '50.38', 'groupDescription': 'For change in body image at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.07', 'ciLowerLimit': '-47.95', 'ciUpperLimit': '27.80', 'groupDescription': 'For change in health care satisfaction at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.61', 'ciLowerLimit': '-21.78', 'ciUpperLimit': '14.57', 'groupDescription': 'For change in sexual functioning at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.98', 'ciLowerLimit': '-17.02', 'ciUpperLimit': '28.99', 'groupDescription': 'For change in ascites at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.08', 'ciLowerLimit': '-5.39', 'ciUpperLimit': '49.55', 'groupDescription': 'For change in indigestion at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.78', 'ciLowerLimit': '-15.33', 'ciUpperLimit': '34.89', 'groupDescription': 'For change in flatulence at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.81', 'ciLowerLimit': '-10.43', 'ciUpperLimit': '42.06', 'groupDescription': 'For change in cachexia at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.77', 'ciLowerLimit': '1.11', 'ciUpperLimit': '42.43', 'groupDescription': 'For change in side effects at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.81', 'ciLowerLimit': '-41.91', 'ciUpperLimit': '12.28', 'groupDescription': 'For change in fear of future health at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.11', 'ciLowerLimit': '1.60', 'ciUpperLimit': '60.62', 'groupDescription': 'For change in ability to plan future at Cycle 5 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.74', 'ciLowerLimit': '-20.62', 'ciUpperLimit': '38.10', 'groupDescription': 'For change in pancreatic pain at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.24', 'ciLowerLimit': '-68.52', 'ciUpperLimit': '42.05', 'groupDescription': 'For change in eating related items at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.06', 'ciLowerLimit': '-7.93', 'ciUpperLimit': '52.05', 'groupDescription': 'For change in altered bowel habits at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.63', 'ciLowerLimit': '-5.64', 'ciUpperLimit': '42.89', 'groupDescription': 'For change in jaundice at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.96', 'ciLowerLimit': '-9.93', 'ciUpperLimit': '57.84', 'groupDescription': 'For change in body image at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.54', 'ciLowerLimit': '-32.70', 'ciUpperLimit': '59.78', 'groupDescription': 'For change in health care satisfaction at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.14', 'ciLowerLimit': '-29.46', 'ciUpperLimit': '55.74', 'groupDescription': 'For change in sexual functioning at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.37', 'ciLowerLimit': '-24.04', 'ciUpperLimit': '36.79', 'groupDescription': 'For change in ascites at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.59', 'ciLowerLimit': '-17.94', 'ciUpperLimit': '59.12', 'groupDescription': 'For change in indigestion at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.29', 'ciLowerLimit': '-20.12', 'ciUpperLimit': '40.71', 'groupDescription': 'For change in flatulence at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.74', 'ciLowerLimit': '-8.22', 'ciUpperLimit': '59.69', 'groupDescription': 'For change in cachexia at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.56', 'ciLowerLimit': '5.32', 'ciUpperLimit': '71.81', 'groupDescription': 'For change in side effects at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.44', 'ciLowerLimit': '-53.14', 'ciUpperLimit': '44.25', 'groupDescription': 'For change in fear of future health at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.17', 'ciLowerLimit': '-69.90', 'ciUpperLimit': '61.57', 'groupDescription': 'For change in ability to plan future at Cycle 6 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.96', 'ciLowerLimit': '-24.52', 'ciUpperLimit': '50.45', 'groupDescription': 'For change in pancreatic pain at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-23.15', 'ciLowerLimit': '-76.41', 'ciUpperLimit': '30.11', 'groupDescription': 'For change in eating related items at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-19.44', 'ciLowerLimit': '-71.89', 'ciUpperLimit': '33.00', 'groupDescription': 'For change in altered bowel habits at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.22', 'ciLowerLimit': '7.31', 'ciUpperLimit': '87.13', 'groupDescription': 'For change in jaundice at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.67', 'ciLowerLimit': '-36.00', 'ciUpperLimit': '119.34', 'groupDescription': 'For change in body image at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.89', 'ciLowerLimit': '-5.05', 'ciUpperLimit': '82.83', 'groupDescription': 'For change in health care satisfaction at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.14', 'ciLowerLimit': '-2.09', 'ciUpperLimit': '66.37', 'groupDescription': 'For change in sexual functioning at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.41', 'ciLowerLimit': '-44.46', 'ciUpperLimit': '29.64', 'groupDescription': 'For change in indigestion at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.96', 'ciLowerLimit': '-40.45', 'ciUpperLimit': '66.37', 'groupDescription': 'For change in flatulence at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.89', 'ciLowerLimit': '-32.71', 'ciUpperLimit': '60.49', 'groupDescription': 'For change in cachexia at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.86', 'ciLowerLimit': '-16.16', 'ciUpperLimit': '77.89', 'groupDescription': 'For change in side effects at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.83', 'ciLowerLimit': '-44.95', 'ciUpperLimit': '86.62', 'groupDescription': 'For change in fear of future health at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-18.52', 'ciLowerLimit': '-115.22', 'ciUpperLimit': '78.19', 'groupDescription': 'For change in ability to plan future at Cycle 7 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.46', 'ciLowerLimit': '-39.71', 'ciUpperLimit': '86.63', 'groupDescription': 'For change in pancreatic pain at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.96', 'ciLowerLimit': '-130.69', 'ciUpperLimit': '104.76', 'groupDescription': 'For change in eating related items at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.15', 'ciLowerLimit': '-7.12', 'ciUpperLimit': '103.42', 'groupDescription': 'For change in altered bowel habits at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '92.59', 'ciLowerLimit': '63.16', 'ciUpperLimit': '122.02', 'groupDescription': 'For change in jaundice at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.56', 'ciLowerLimit': '-85.03', 'ciUpperLimit': '96.14', 'groupDescription': 'For change in body image at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.04', 'ciLowerLimit': '-29.46', 'ciUpperLimit': '103.54', 'groupDescription': 'For change in health care satisfaction at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.14', 'ciLowerLimit': '-41.45', 'ciUpperLimit': '27.16', 'groupDescription': 'For change in sexual functioning at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.70', 'ciLowerLimit': '-67.04', 'ciUpperLimit': '59.64', 'groupDescription': 'For change in ascites at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-7.41', 'ciLowerLimit': '-104.79', 'ciUpperLimit': '89.97', 'groupDescription': 'For change in indigestion at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '22.22', 'ciLowerLimit': '-58.80', 'ciUpperLimit': '103.25', 'groupDescription': 'For change in flatulence at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.78', 'ciLowerLimit': '-36.28', 'ciUpperLimit': '91.83', 'groupDescription': 'For change in cachexia at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.11', 'ciLowerLimit': '-74.30', 'ciUpperLimit': '96.52', 'groupDescription': 'For change in side effects at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-29.17', 'ciLowerLimit': '-142.55', 'ciUpperLimit': '84.21', 'groupDescription': 'For change in fear of future health at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-55.56', 'ciLowerLimit': '-212.46', 'ciUpperLimit': '101.35', 'groupDescription': 'For change in ability to plan future at Cycle 8 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.67', 'ciLowerLimit': '-62.93', 'ciUpperLimit': '96.26', 'groupDescription': 'For change in pancreatic pain at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.29', 'ciLowerLimit': '-87.74', 'ciUpperLimit': '116.31', 'groupDescription': 'For change in eating related items at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '73.81', 'ciLowerLimit': '7.90', 'ciUpperLimit': '139.72', 'groupDescription': 'For change in altered bowel habits at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '76.19', 'ciLowerLimit': '33.64', 'ciUpperLimit': '118.74', 'groupDescription': 'For change in jaundice at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '28.57', 'ciLowerLimit': '-64.64', 'ciUpperLimit': '121.79', 'groupDescription': 'For change in body image at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.71', 'ciLowerLimit': '-28.11', 'ciUpperLimit': '99.53', 'groupDescription': 'For change in health care satisfaction at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.33', 'ciLowerLimit': '-104.01', 'ciUpperLimit': '77.34', 'groupDescription': 'For change in sexual functioning at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-44.44', 'ciLowerLimit': '-140.03', 'ciUpperLimit': '51.14', 'groupDescription': 'For change in ascites at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.76', 'ciLowerLimit': '-88.45', 'ciUpperLimit': '97.98', 'groupDescription': 'For change in indigestion at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.29', 'ciLowerLimit': '-54.32', 'ciUpperLimit': '82.89', 'groupDescription': 'For change in flatulence at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.81', 'ciLowerLimit': '-66.45', 'ciUpperLimit': '114.07', 'groupDescription': 'For change in cachexia at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.75', 'ciLowerLimit': '-56.14', 'ciUpperLimit': '119.63', 'groupDescription': 'For change in side effects at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-50.00', 'ciLowerLimit': '-163.35', 'ciUpperLimit': '63.35', 'groupDescription': 'For change in fear of future health at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.29', 'ciLowerLimit': '-125.23', 'ciUpperLimit': '96.66', 'groupDescription': 'For change in ability to plan future at Cycle 9 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '-45.18', 'ciUpperLimit': '95.18', 'groupDescription': 'For change in pancreatic pain at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '-45.18', 'ciUpperLimit': '95.18', 'groupDescription': 'For change in eating related items at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.78', 'ciLowerLimit': '14.55', 'ciUpperLimit': '141.00', 'groupDescription': 'For change in altered bowel habits at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '86.11', 'ciLowerLimit': '40.61', 'ciUpperLimit': '131.61', 'groupDescription': 'For change in jaundice at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '-56.48', 'ciUpperLimit': '106.48', 'groupDescription': 'For change in body image at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.22', 'ciLowerLimit': '-37.69', 'ciUpperLimit': '132.13', 'groupDescription': 'For change in health care satisfaction at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.00', 'ciLowerLimit': '-70.68', 'ciUpperLimit': '110.68', 'groupDescription': 'For change in sexual functioning at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-33.33', 'ciLowerLimit': '-91.87', 'ciUpperLimit': '25.20', 'groupDescription': 'For change in ascites at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.78', 'ciLowerLimit': '-41.89', 'ciUpperLimit': '97.45', 'groupDescription': 'For change in indigestion at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.67', 'ciLowerLimit': '-34.03', 'ciUpperLimit': '67.36', 'groupDescription': 'For change in flatulence at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.33', 'ciLowerLimit': '-100.19', 'ciUpperLimit': '116.86', 'groupDescription': 'For change in cachexia at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.93', 'ciLowerLimit': '-53.73', 'ciUpperLimit': '105.58', 'groupDescription': 'For change in side effects at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-117.07', 'ciUpperLimit': '117.07', 'groupDescription': 'For change in ability to plan future at Cycle 10 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.89', 'ciLowerLimit': '-221.53', 'ciUpperLimit': '249.31', 'groupDescription': 'For change in pancreatic pain at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.56', 'ciLowerLimit': '-260.62', 'ciUpperLimit': '271.74', 'groupDescription': 'For change in eating related items at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '66.67', 'ciLowerLimit': '-152.41', 'ciUpperLimit': '285.75', 'groupDescription': 'For change in altered bowel habits at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '-119.08', 'ciUpperLimit': '319.08', 'groupDescription': 'For change in jaundice at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.33', 'ciLowerLimit': '-185.75', 'ciUpperLimit': '252.41', 'groupDescription': 'For change in body image at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.44', 'ciLowerLimit': '-82.04', 'ciUpperLimit': '170.93', 'groupDescription': 'For change in health care satisfaction at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-733.59', 'ciUpperLimit': '733.59', 'groupDescription': 'For change in sexual functioning at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.11', 'ciLowerLimit': '-202.34', 'ciUpperLimit': '180.12', 'groupDescription': 'For change in ascites at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.11', 'ciLowerLimit': '-84.50', 'ciUpperLimit': '106.73', 'groupDescription': 'For change in indigestion at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.11', 'ciLowerLimit': '-84.50', 'ciUpperLimit': '106.73', 'groupDescription': 'For change in flatulence at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.89', 'ciLowerLimit': '-87.60', 'ciUpperLimit': '165.37', 'groupDescription': 'For change in cachexia at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.44', 'ciLowerLimit': '-208.53', 'ciUpperLimit': '297.42', 'groupDescription': 'For change in side effects at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-22.22', 'ciLowerLimit': '-275.19', 'ciUpperLimit': '230.75', 'groupDescription': 'For change in ability to plan future at Cycle 11 Day 1, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.33', 'ciLowerLimit': '-491.86', 'ciUpperLimit': '608.53', 'groupDescription': 'For change in pancreatic pain at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.00', 'ciLowerLimit': '-1258.79', 'ciUpperLimit': '1308.79', 'groupDescription': 'For change in eating related items at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '83.33', 'ciLowerLimit': '-283.46', 'ciUpperLimit': '450.13', 'groupDescription': 'For change in altered bowel habits at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.33', 'ciLowerLimit': '-175.06', 'ciUpperLimit': '191.73', 'groupDescription': 'For change in jaundice at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-733.59', 'ciUpperLimit': '733.59', 'groupDescription': 'For change in ascites at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.00', 'ciLowerLimit': '-733.59', 'ciUpperLimit': '733.59', 'groupDescription': 'For change in indigestion at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '83.33', 'ciLowerLimit': '-283.46', 'ciUpperLimit': '450.13', 'groupDescription': 'For change in flatulence at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.56', 'ciLowerLimit': '-1375.5', 'ciUpperLimit': '1436.61', 'groupDescription': 'For change in side effects at EoS, mean change difference was used to compare the two treatment groups.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).', 'description': "QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Phase 2 ITT population was the primary analysis population. N (number of participants analyzed) signifies those participants who were evaluable for this outcome measure. n signifies the number of participants evaluable for the respective scale at the respective time point.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'FG001', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'FG002', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}], 'periods': [{'title': 'Phase 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Started chemotherapy at other institute', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Phase 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '68'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '69'}, {'groupId': 'FG002', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Treatment not received', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '111', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Axitinib + Gemcitabine (Phase 1 Lead-In)', 'description': 'Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m\\^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'BG001', 'title': 'Axitinib + Gemcitabine', 'description': 'Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'BG002', 'title': 'Gemcitabine', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '18 years to 44 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': '45 years to 64 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}]}, {'title': 'Greater than or equal to 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'dispFirstSubmitDate': '2009-03-20', 'completionDateStruct': {'date': '2008-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-22', 'studyFirstSubmitDate': '2005-09-13', 'dispFirstSubmitQcDate': '2009-09-24', 'resultsFirstSubmitDate': '2012-02-25', 'studyFirstSubmitQcDate': '2005-09-13', 'dispFirstPostDateStruct': {'date': '2009-09-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-05-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-07-23', 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Baseline of Phase 2 to death or until at least 1 year after the randomization of the last participant', 'description': 'Time in days from randomization to date of death due to any cause. OS was calculated as the death date minus the date of randomization plus 1. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).'}], 'secondaryOutcomes': [{'measure': 'Dose Confirmation of Axitinib (AG-013736) on Basis of Number of Participants With Dose Limiting Toxicity (DLT)', 'timeFrame': 'Phase 1 baseline up to Week 4', 'description': 'Dose of axitinib (AG-013736) was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (\\>=) Gr 3 anemia or non hematological toxicities for \\>= 7 days (except alopecia) or \\>= Gr 1 hemoptysis or \\>=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.'}, {'measure': 'Dose Confirmation of Gemcitabine on Basis of Number of Participants With Dose Limiting Toxicity (DLT)', 'timeFrame': 'Phase 1 Baseline up to Week 4', 'description': 'Dose of gemcitabine was confirmed if not more than 1 out of 6 participants experienced a DLT during first cycle. DLT included grade (Gr) 4 neutropenia or thrombocytopenia, greater than or equal to (\\>=) Gr 3 anemia or non hematological toxicities for \\>= 7 days (except alopecia) or \\>= Gr 1 hemoptysis or \\>=2 gram /24 hours proteinuria or inability to resume background chemotherapy or axitinib (AG-013736) dosing within 14 days of stopping due to treatment related toxicity.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) for Axitinib (AG-013736)', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hours (hr) post-dose on Day 15 of Phase 1 Cycle 1'}, {'measure': 'Area Under the Curve From Time Zero to 24 Hours [AUC (0-24)] of Axitinib (AG-013736)', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1', 'description': 'AUC (0-24) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to 24 hours (0-24).'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of Axitinib (AG-013736)', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1', 'description': 'Tmax was based on the actual time points when the samples were collected.'}, {'measure': 'Plasma Decay Half-life (t1/2) of Axitinib (AG-013736)', 'timeFrame': '0 (pre-dose), 0.5, 1, 1.5, 2, 3.5, 4.5, 9.5, and 12.5 hr post-dose on Day 15 of Phase 1 Cycle 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of Gemcitabine', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Gemcitabine', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1', 'description': 'AUC (0 - ∞) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞).'}, {'measure': 'Plasma Decay Half-life (t1/2) of Gemcitabine', 'timeFrame': '0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 9 and 12 hr after start of infusion on Day 15 of Phase 1 Cycle 1', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Population Pharmacokinetics of Axitinib (AG-013736) in Phase 2', 'timeFrame': 'Phase 2 Day 1 (Pre-dose), Day 29, Day 57 and then every 8 weeks until disease progression or discontinuation from study or up to 80 weeks', 'description': 'Data for this outcome measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.'}, {'measure': 'Percentage of Participants With Overall Response (OR)', 'timeFrame': 'Phase 2 baseline to disease progression or discontinuation from study, assessed every 8 weeks up to 80 weeks', 'description': 'Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as the disappearance of all lesions (target and/or non-target). PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum of longest dimensions.'}, {'measure': 'Duration of Response (DR)', 'timeFrame': 'Phase 2 baseline to disease progression or discontinuation from study due to any cause, assessed every 8 weeks up to 80 weeks', 'description': 'Time in days from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1. DR was calculated for the subgroup of participants with a confirmed objective tumor response.'}, {'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'Phase 2 baseline until the date of first documented progression or death due to any cause, assessed every 8 weeks up to 80 weeks', 'description': 'Time in days from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as first event date minus the date of randomization plus 1. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease \\[PD\\]), or from adverse event (AE) data (where the outcome was "Death").'}, {'measure': 'One Year Survival Probability', 'timeFrame': 'Phase 2 baseline to disease progression or death due to any cause or at least 1 year after the first dose for the last participant', 'description': 'One year survival probability was defined as the probability of survival at one year after the date of randomization based on the Kaplan Meier estimate.'}, {'measure': 'Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Score at Day 1 of Every Cycle and End of Study', 'timeFrame': 'Phase 2 baseline [Day (D)1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).', 'description': "EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0-100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score."}, {'measure': 'Change From Baseline in 26-item Pancreatic Cancer-specific Quality of Life Questionnaire (QLQ-PAN26) Score at Day 1 of Every Cycle and End of Study', 'timeFrame': 'Phase 2 baseline [Day (D) 1 of Cycle (C)1], Day 1 of all subsequent cycles up to Cycle 14 and end of study (EoS).', 'description': "QLQ-PAN26 consists of 26 questions (Qs) relating to disease symptoms, treatment (Tx) side effects and emotional issues specific to pancreatic cancer (PC). Questions include on altered bowel habits, pain, dietary changes, disease and Tx-related symptoms and issues related to the emotional and social well-being of participants with PC. All 26 Qs are answered on 4-point Likert scale ranging from '1=not at all' to 4='very much' and subsequently transformed into scales that range from 0-100. Higher scores on functioning scales=better functioning; higher scores on the symptom scales=more symptoms."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer'], 'conditions': ['Pancreatic Neoplasms']}, 'referencesModule': {'references': [{'pmid': '18514303', 'type': 'DERIVED', 'citation': 'Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Letourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4061016&StudyName=AG-013736%20In%20Combination%20With%20Gemcitabine%20Versus%20Gemcitabine%20Alone%20For%20Patients%20With%20Metastatic%20Pancreatic%20Cancer', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \\[AG-013736\\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas\n* no prior therapy for metastatic disease\n\nExclusion Criteria:\n\n* patients with locally advanced disease who are candidates for radiation therapy.\n* uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)'}, 'identificationModule': {'nctId': 'NCT00219557', 'briefTitle': 'AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A RANDOMIZED PHASE 2 STUDY OF THE ANTI-ANGIOGENESIS AGENT AG-013736 IN COMBINATION WITH GEMCITABINE IN PATIENTS WITH CHEMOTHERAPY-NAIVE ADVANCED PANCREATIC CANCER PRECEDED BY A PHASE 1 PORTION', 'orgStudyIdInfo': {'id': 'A4061016'}, 'secondaryIdInfos': [{'id': '2005-000053-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Gemcitabine', 'interventionNames': ['Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Axitinib [AG-013736] plus gemcitabine', 'interventionNames': ['Drug: AG-013736', 'Drug: Gemcitabine']}], 'interventions': [{'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 1000 mg/m\\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks', 'armGroupLabels': ['Gemcitabine']}, {'name': 'AG-013736', 'type': 'DRUG', 'description': 'Axitinib (AG-013736) 5 mg 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