Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-01 @ 5:54 PM
Study NCT ID:
NCT03173560
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2017-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C531958', 'term': 'lenvatinib'}, {'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esi_oncmedinfo@eisai.com', 'phone': '1-888-274-2378', 'title': 'Eisai Medical Information', 'organization': 'Eisai Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)', 'description': 'Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. If there were no intolerable Grade 2 or any \\>= Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), lenvatinib dose was escalated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length = 28 days) during randomization phase.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 172, 'seriousNumAtRisk': 173, 'deathsNumAffected': 71, 'seriousNumAffected': 92}, {'id': 'EG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 166, 'seriousNumAtRisk': 168, 'deathsNumAffected': 60, 'seriousNumAffected': 87}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 56, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 74, 'numAffected': 29}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 13, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 29, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 38, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 42, 'numAffected': 35}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 46, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 40, 'numAffected': 28}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 20, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 32, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 352, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 394, 'numAffected': 123}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 21, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 23, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 104, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 103, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 120, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 92, 'numAffected': 49}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 85, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 85, 'numAffected': 43}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 104, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 100, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 93, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 104, 'numAffected': 50}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 31, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 44, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 21, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 14, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 21, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 21, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 15, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 17, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 19, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 37, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 30, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 42, 'numAffected': 25}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood thyroid stimulating hormone increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 19, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 36, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 33, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 16}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 22, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 20, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 63, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 73, 'numAffected': 41}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 130, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 137, 'numAffected': 57}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 64, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 49, 'numAffected': 26}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 20, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 36, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 112, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 136, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 11, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 21, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 31, 'numAffected': 19}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 23, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 18, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 24, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 19, 'numAffected': 11}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 29, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 31, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 23, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 16, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 20, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 19, 'numAffected': 13}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 34, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 28, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 19, 'numAffected': 16}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 133, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 186, 'numAffected': 66}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 47, 'numAffected': 30}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 28, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 23, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 33, 'numAffected': 25}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 36, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 28, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Palmar-plantar erythrodysaesthesia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 36, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 41, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 43, 'numAffected': 29}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 113, 'numAffected': 54}, {'groupId': 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unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oncologic complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Livedo reticularis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Objective Response Rate at Week 24 (ORR24W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '39.4'}, {'value': '34.8', 'groupId': 'OG001', 'lowerLimit': '27.3', 'upperLimit': '42.3'}]}]}], 'analyses': [{'pValue': '0.2676', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.88', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.32', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Odd ratio for ORR24W was analyzed along with 90% CI for each treatment arm using Cochran-Mantel-Haenszel (CMH) method, stratified by Memorial Sloan-Kettering Cancer Center (MSKCC) prognostic group and prior programmed cell death protein 1/ programmed cell death protein ligand 1 (PD-1/PD-L1) treatment from IxRS data. Non-inferiority would be claimed if 1-sided P value is \\<=0.045 at the final analysis for the non-inferiority test with the non-inferiority margin of the odd ratio =0.76.'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 24', 'description': 'ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\<) 10 millimeters (mm). PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol analysis set 1 (PPAS1) included all randomized participants minus the 32 participants who had received \\>=2 incorrect lenvatinib doses due to interactive voice and web response system (IxRS) issues.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '88.7'}, {'value': '79.6', 'groupId': 'OG001', 'lowerLimit': '73.2', 'upperLimit': '86.0'}]}]}], 'analyses': [{'pValue': '0.4763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.2', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '11.9', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Percentage of participants with intolerable Grade 2 or any Grade \\>=Grade 3 TEAEs within 24 weeks was tested using CMH method at 2-sided α=0.05, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment from IxRS data. The treatment difference and 95% CI were also calculated based on asymptotic normal approximation.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 24', 'description': 'TEAE was defined as an adverse event (AE) with an onset that had occurred after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol safety analysis set included all randomized and treated participants minus 32 participants who had received \\>=2 incorrect lenvatinib doses due to IxRS issues according to actual treatment received.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '12.9'}, {'value': '14.7', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '20.3'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.42', 'ciLowerLimit': '1.08', 'ciUpperLimit': '1.86', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "The hazard ratio and the corresponding 90% CIs were estimated using the Cox regression model with Efron's method for ties, stratified by MSKCC prognostic group and prior PD-1/PD-L1 treatment."}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to date of data cutoff for the primary analysis (up to 29 months)', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documentation of PD by investigator assessment or date of death, whichever occurred first according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 millimeter \\[mm\\]) in the sum of diameter (SOD) of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% confidence interval (CI). As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS1 included all randomized participants minus the 32 participants who had received \\>=2 incorrect lenvatinib doses due to IxRS issues.'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'groupId': 'OG000', 'lowerLimit': '27.1', 'upperLimit': '42.1'}, {'value': '40.6', 'groupId': 'OG001', 'lowerLimit': '32.9', 'upperLimit': '48.4'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.77', 'ciLowerLimit': '0.52', 'ciUpperLimit': '1.14', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Odd ratio for ORR was analyzed along with 90% CI for each treatment arm using CMH method stratified by MSKCC prognostic group and PD-1/PD-L1 treatment from IxRS data.'}], 'paramType': 'NUMBER', 'timeFrame': 'From date of randomization up to first documentation of PD or date of death, whichever occurred first or up to the date of data cut off for the primary analysis (up to 29 months)', 'description': 'ORR was defined as the percentage of participants with a BOR of CR or PR at the at the end of treatment based on investigator assessment according to RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \\<10 mm. PR: defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS1 included all randomized participants minus the 32 participants who had received \\>=2 incorrect lenvatinib doses due to IxRS issues.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With TEAEs and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'title': 'Participants With TEAEs', 'categories': [{'measurements': [{'value': '173', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}, {'title': 'Participants With Serious TEAEs', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)', 'description': 'TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAS) included all participants who were randomized and received at least 1 dose of study drug according to the treatment starting dose actually received.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Discontinued Treatment Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '25.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)', 'description': 'Percentage of participants who discontinued treatment due to toxicity, defined as the percentage of participants who discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to NCI-CTCAE v4.03.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment Failure Due to Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.15', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '12.7'}, {'value': '5.70', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '24.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization to the date of discontinuation of study treatment due to TEAEs, or date of data cut off for the primary analysis (up to 29 months)', 'description': 'Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to CTCAE v4.03. As planned, data for this secondary outcome measure was collected and analyzed till the primary analysis only.', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Plasma Concentration of Lenvatinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'title': 'Cycle 1 Day 1: 0.5-4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.9', 'spread': '96.54', 'groupId': 'OG000'}, {'value': '82.3', 'spread': '119.89', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 1: 6-10 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '136.3', 'spread': '66.53', 'groupId': 'OG000'}, {'value': '193.7', 'spread': '93.08', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.7', 'spread': '62.31', 'groupId': 'OG000'}, {'value': '64.0', 'spread': '59.71', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: 0.5-4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'spread': '102.54', 'groupId': 'OG000'}, {'value': '133.4', 'spread': '125.65', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: 6-10 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '177.8', 'spread': '89.42', 'groupId': 'OG000'}, {'value': '236.2', 'spread': '135.21', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.8', 'spread': '42.84', 'groupId': 'OG000'}, {'value': '50.6', 'spread': '46.06', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: 2-12 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '172.8', 'spread': '130.90', 'groupId': 'OG000'}, {'value': '190.3', 'spread': '114.85', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'PK sparse sampling was performed. As planned, the post-dose plasma sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma or everolimus whole blood concentration data. Here, "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable for this outcome measure at given time points.'}, {'type': 'SECONDARY', 'title': 'Whole Blood Concentration of Everolimus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'title': 'Cycle 1 Day 1: 0.5-4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '15.89', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '16.39', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 1: 6-10 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '5.64', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'spread': '4.84', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '5.51', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: 0.5-4 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': '15.41', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '16.96', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 1 Day 15: 6-10 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'spread': '5.83', 'groupId': 'OG000'}, {'value': '14.3', 'spread': '9.22', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '5.44', 'groupId': 'OG000'}, {'value': '5.9', 'spread': '4.02', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1: 2-12 hours post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.9', 'spread': '12.67', 'groupId': 'OG000'}, {'value': '19.5', 'spread': '9.74', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'PK sparse sampling was performed. As planned, the post-dose whole blood sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma or everolimus whole blood concentration data. Here, "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points.'}, {'type': 'SECONDARY', 'title': 'Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 18 mg', 'description': 'Participants with RCC received lenvatinib 18 mg, capsule, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and in this current study E7080-G000-218 (NCT03173560).'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants with RCC received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and in this current study E7080-G000-218 (NCT03173560).'}], 'classes': [{'categories': [{'measurements': [{'value': '6.37', 'spread': '2.01', 'groupId': 'OG000'}, {'value': '5.77', 'spread': '2.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib CL/F value was derived from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.', 'unitOfMeasure': 'liter per hour (L/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 18 mg', 'description': 'Participants with RCC received lenvatinib 18 mg, capsule, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and in this current study E7080-G000-218 (NCT03173560).'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants with RCC received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and in this current study E7080-G000-218 (NCT03173560).'}], 'classes': [{'categories': [{'measurements': [{'value': '3693', 'spread': '1295', 'groupId': 'OG000'}, {'value': '4350', 'spread': '2934', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*h/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg', 'description': 'Participants with RCC received everolimus 10 mg, capsule, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or in this current study E7080-G000-218 (NCT03173560).'}, {'id': 'OG001', 'title': 'Lenvatinib + Everolimus 5 mg', 'description': 'Participants with RCC received lenvatinib 12 to 24 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or in this current study E7080-G000-218 (NCT03173560).'}], 'classes': [{'categories': [{'measurements': [{'value': '22.3', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '7.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus CL/F value was derived from the final PK model.', 'unitOfMeasure': 'liter per hour (L/h)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable everolimus whole blood concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '345', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Everolimus 10 mg', 'description': 'Participants with RCC received everolimus 10 mg, capsule, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or in this current study E7080-G000-218 (NCT03173560).'}, {'id': 'OG001', 'title': 'Lenvatinib + Everolimus 5 mg', 'description': 'Participants with RCC received lenvatinib 12 to 24 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up or until the end of the study, whichever occurred first in studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or in this current study E7080-G000-218 (NCT03173560).'}], 'classes': [{'categories': [{'measurements': [{'value': '507.4', 'spread': '176.6', 'groupId': 'OG000'}, {'value': '305.5', 'spread': '174.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model.', 'unitOfMeasure': 'ng*hour/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable everolimus whole blood concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.0', 'comment': 'Upper limit of 95% CI was not estimable because insufficient number of participants had events.', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and upper limit of 95% CI was not estimable because insufficient number of participants had events.', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)', 'description': 'OS was defined as the time from the date of randomization until the date of death from any cause. In the absence of confirmation of death, participants will be censored either at the date that the participant was last known to be alive or the date of data cutoff for the primary analysis, whichever comes earlier. Median OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS1 included all randomized participants minus the 32 participants who had received \\>=2 incorrect lenvatinib doses due to IxRS issues.'}, {'type': 'SECONDARY', 'title': 'Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.69', 'spread': '4.819', 'groupId': 'OG000'}, {'value': '29', 'spread': '5.886', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.43', 'spread': '5.269', 'groupId': 'OG000'}, {'value': '28.31', 'spread': '5.162', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.26', 'spread': '5.344', 'groupId': 'OG000'}, {'value': '28.80', 'spread': '5.455', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.97', 'spread': '5.524', 'groupId': 'OG000'}, {'value': '29.11', 'spread': '5.183', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28', 'spread': '5.680', 'groupId': 'OG000'}, {'value': '29.14', 'spread': '5.081', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.63', 'spread': '5.185', 'groupId': 'OG000'}, {'value': '29.46', 'spread': '5.107', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.31', 'spread': '5.486', 'groupId': 'OG000'}, {'value': '29.58', 'spread': '4.803', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.36', 'spread': '6.204', 'groupId': 'OG000'}, {'value': '29.85', 'spread': '4.610', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.58', 'spread': '5.562', 'groupId': 'OG000'}, {'value': '29.84', 'spread': '5.005', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.10', 'spread': '5.294', 'groupId': 'OG000'}, {'value': '30.70', 'spread': '4.297', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.56', 'spread': '5.035', 'groupId': 'OG000'}, {'value': '30.09', 'spread': '5.316', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.34', 'spread': '5.149', 'groupId': 'OG000'}, {'value': '30.75', 'spread': '5.127', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.26', 'spread': '4.851', 'groupId': 'OG000'}, {'value': '30.93', 'spread': '4.201', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.81', 'spread': '4.752', 'groupId': 'OG000'}, {'value': '31.06', 'spread': '4.830', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.09', 'spread': '5.121', 'groupId': 'OG000'}, {'value': '30.52', 'spread': '4.417', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.93', 'spread': '5.293', 'groupId': 'OG000'}, {'value': '30.91', 'spread': '4.704', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.36', 'spread': '5.233', 'groupId': 'OG000'}, {'value': '31.52', 'spread': '4.875', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.81', 'spread': '4.293', 'groupId': 'OG000'}, {'value': '31.41', 'spread': '4.639', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.48', 'spread': '6.216', 'groupId': 'OG000'}, {'value': '30.82', 'spread': '4.469', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.77', 'spread': '6.058', 'groupId': 'OG000'}, {'value': '30.69', 'spread': '4.575', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.35', 'spread': '4.707', 'groupId': 'OG000'}, {'value': '32', 'spread': '3.243', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.32', 'spread': '4.978', 'groupId': 'OG000'}, {'value': '30.59', 'spread': '5.168', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.53', 'spread': '3.998', 'groupId': 'OG000'}, {'value': '30.29', 'spread': '5.544', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.47', 'spread': '5.041', 'groupId': 'OG000'}, {'value': '31.58', 'spread': '3.977', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.92', 'spread': '6.388', 'groupId': 'OG000'}, {'value': '31.69', 'spread': '4.270', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.75', 'spread': '4.862', 'groupId': 'OG000'}, {'value': '29.82', 'spread': '6.422', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.83', 'spread': '5.345', 'groupId': 'OG000'}, {'value': '32.86', 'spread': '2.854', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.50', 'spread': '4.435', 'groupId': 'OG000'}, {'value': '33.67', 'spread': '1.862', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.50', 'spread': '4.359', 'groupId': 'OG000'}, {'value': '33.40', 'spread': '1.342', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.75', 'spread': '4.031', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.42', 'spread': '5.953', 'groupId': 'OG000'}, {'value': '27.86', 'spread': '6.500', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)', 'description': 'The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Quality of Life (QoL) analysis set consisted of all participants who had any QoL data. Here "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points.'}, {'type': 'SECONDARY', 'title': 'HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'title': 'Global Health Status/QoL Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.35', 'spread': '22.020', 'groupId': 'OG000'}, {'value': '63.58', 'spread': '21.340', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.60', 'spread': '21.234', 'groupId': 'OG000'}, {'value': '60.93', 'spread': '20.280', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.43', 'spread': '24.065', 'groupId': 'OG000'}, {'value': '61.85', 'spread': '20.202', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.71', 'spread': '19.754', 'groupId': 'OG000'}, {'value': '62.62', 'spread': '19.641', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.38', 'spread': '21.670', 'groupId': 'OG000'}, {'value': '63.76', 'spread': '20.339', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.75', 'spread': '21.028', 'groupId': 'OG000'}, {'value': '63.73', 'spread': '19.756', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.72', 'spread': '20.134', 'groupId': 'OG000'}, {'value': '62.54', 'spread': '20.153', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.68', 'spread': '20.409', 'groupId': 'OG000'}, {'value': '62.11', 'spread': '20.271', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.97', 'spread': '18.726', 'groupId': 'OG000'}, {'value': '63.77', 'spread': '20.429', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.13', 'spread': '19.612', 'groupId': 'OG000'}, {'value': '66.44', 'spread': '19.012', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.87', 'spread': '18.705', 'groupId': 'OG000'}, {'value': '65.86', 'spread': '21.173', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.81', 'spread': '18.891', 'groupId': 'OG000'}, {'value': '66.94', 'spread': '18.409', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.39', 'spread': '19.047', 'groupId': 'OG000'}, {'value': '68.94', 'spread': '18.388', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.56', 'spread': '17.498', 'groupId': 'OG000'}, {'value': '70.35', 'spread': '15.605', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.98', 'spread': '16.795', 'groupId': 'OG000'}, {'value': '66.83', 'spread': '16.955', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.59', 'spread': '17.567', 'groupId': 'OG000'}, {'value': '64.54', 'spread': '19.386', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.88', 'spread': '16.882', 'groupId': 'OG000'}, {'value': '67.71', 'spread': '18.794', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.68', 'spread': '16.258', 'groupId': 'OG000'}, {'value': '68.38', 'spread': '17.859', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'spread': '19.747', 'groupId': 'OG000'}, {'value': '66.67', 'spread': '15.215', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.95', 'spread': '18.479', 'groupId': 'OG000'}, {'value': '66.40', 'spread': '15.736', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '57.05', 'spread': '18.362', 'groupId': 'OG000'}, {'value': '71.13', 'spread': '15.463', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.72', 'spread': '14.532', 'groupId': 'OG000'}, {'value': '66.05', 'spread': '17.438', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '15.494', 'groupId': 'OG000'}, {'value': '66.67', 'spread': '14.948', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.44', 'spread': '17.385', 'groupId': 'OG000'}, {'value': '65.79', 'spread': '18.818', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '69.79', 'spread': '14.868', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.38', 'spread': '15.064', 'groupId': 'OG000'}, {'value': '60.90', 'spread': '18.442', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.72', 'spread': '18.572', 'groupId': 'OG000'}, {'value': '71.43', 'spread': '18.545', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.33', 'spread': '21.517', 'groupId': 'OG000'}, {'value': '77.78', 'spread': '13.608', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.25', 'spread': '18.478', 'groupId': 'OG000'}, {'value': '75', 'spread': '16.667', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.17', 'spread': '15.957', 'groupId': 'OG000'}, {'value': '66.67', 'groupId': 'OG001'}]}]}, {'title': 'Global Health Status/QoL Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}]}]}, {'title': 'Global Health Status/QoL Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.04', 'spread': '23.133', 'groupId': 'OG000'}, {'value': '56.05', 'spread': '22.363', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.36', 'spread': '19.282', 'groupId': 'OG000'}, {'value': '76.60', 'spread': '21.855', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.54', 'spread': '19.857', 'groupId': 'OG000'}, {'value': '75.38', 'spread': '19.706', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.74', 'spread': '21.227', 'groupId': 'OG000'}, {'value': '76.15', 'spread': '19.160', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.90', 'spread': '20.873', 'groupId': 'OG000'}, {'value': '75.40', 'spread': '20.155', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.80', 'spread': '19.284', 'groupId': 'OG000'}, {'value': '77.85', 'spread': '18.342', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.17', 'spread': '21.694', 'groupId': 'OG000'}, {'value': '77.76', 'spread': '18.562', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.02', 'spread': '20.769', 'groupId': 'OG000'}, {'value': '78.41', 'spread': '18.034', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.77', 'spread': '20.422', 'groupId': 'OG000'}, {'value': '79.11', 'spread': '17.707', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.54', 'spread': '19.389', 'groupId': 'OG000'}, {'value': '80.60', 'spread': '16.041', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.06', 'spread': '18.908', 'groupId': 'OG000'}, {'value': '81.20', 'spread': '16.271', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.72', 'spread': '18.073', 'groupId': 'OG000'}, {'value': '81.13', 'spread': '16.638', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.52', 'spread': '17.080', 'groupId': 'OG000'}, {'value': '83.01', 'spread': '15.254', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.55', 'spread': '17.874', 'groupId': 'OG000'}, {'value': '80.24', 'spread': '16.873', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.78', 'spread': '16.925', 'groupId': 'OG000'}, {'value': '82.39', 'spread': '16.387', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.45', 'spread': '16.629', 'groupId': 'OG000'}, {'value': '80.92', 'spread': '17.283', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.46', 'spread': '17.129', 'groupId': 'OG000'}, {'value': '81.74', 'spread': '15.982', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.85', 'spread': '17.896', 'groupId': 'OG000'}, {'value': '82.33', 'spread': '15.657', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.48', 'spread': '17.838', 'groupId': 'OG000'}, {'value': '81.52', 'spread': '16.135', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.67', 'spread': '15.771', 'groupId': 'OG000'}, {'value': '81.57', 'spread': '16.002', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.09', 'spread': '22.071', 'groupId': 'OG000'}, {'value': '82.80', 'spread': '13.854', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.62', 'spread': '18.668', 'groupId': 'OG000'}, {'value': '84.29', 'spread': '12.335', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.35', 'spread': '14.483', 'groupId': 'OG000'}, {'value': '82.72', 'spread': '15.164', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.56', 'spread': '14.357', 'groupId': 'OG000'}, {'value': '81.39', 'spread': '17.248', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.33', 'spread': '16.676', 'groupId': 'OG000'}, {'value': '83.86', 'spread': '13.755', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.78', 'spread': '15.688', 'groupId': 'OG000'}, {'value': '84.17', 'spread': '15.753', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.67', 'spread': '6.172', 'groupId': 'OG000'}, {'value': '71.79', 'spread': '29.833', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.67', 'spread': '6.992', 'groupId': 'OG000'}, {'value': '85.71', 'spread': '16.523', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.33', 'spread': '3.333', 'groupId': 'OG000'}, {'value': '90', 'spread': '15.635', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.33', 'spread': '3.333', 'groupId': 'OG000'}, {'value': '86.67', 'spread': '16.330', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.67', 'spread': '3.849', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.50', 'spread': '25.891', 'groupId': 'OG000'}, {'value': '70.41', 'spread': '25.139', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.78', 'spread': '27.471', 'groupId': 'OG000'}, {'value': '75.72', 'spread': '27.932', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.25', 'spread': '27.951', 'groupId': 'OG000'}, {'value': '69.33', 'spread': '27.449', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'spread': '28.136', 'groupId': 'OG000'}, {'value': '72.18', 'spread': '25.630', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.67', 'spread': '27.993', 'groupId': 'OG000'}, {'value': '73.60', 'spread': '26.169', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.32', 'spread': '28.479', 'groupId': 'OG000'}, {'value': '72.44', 'spread': '25.143', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.16', 'spread': '27.245', 'groupId': 'OG000'}, {'value': '73.75', 'spread': '27.557', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.51', 'spread': '27.424', 'groupId': 'OG000'}, {'value': '73.97', 'spread': '25.205', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.20', 'spread': '27.712', 'groupId': 'OG000'}, {'value': '75.60', 'spread': '26.139', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.58', 'spread': '26.101', 'groupId': 'OG000'}, {'value': '75.91', 'spread': '25.242', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.52', 'spread': '27.131', 'groupId': 'OG000'}, {'value': '76.89', 'spread': '24.027', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.57', 'spread': '25.237', 'groupId': 'OG000'}, {'value': '79.11', 'spread': '23.691', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.51', 'spread': '24.785', 'groupId': 'OG000'}, {'value': '80.91', 'spread': '22.953', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.64', 'spread': '24.434', 'groupId': 'OG000'}, {'value': '80', 'spread': '24.721', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.09', 'spread': '24.242', 'groupId': 'OG000'}, {'value': '81.13', 'spread': '23.121', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.73', 'spread': '22.184', 'groupId': 'OG000'}, {'value': '74.84', 'spread': '25.685', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.33', 'spread': '23.426', 'groupId': 'OG000'}, {'value': '79.08', 'spread': '21.272', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.74', 'spread': '22.868', 'groupId': 'OG000'}, {'value': '83.75', 'spread': '18.292', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.74', 'spread': '20.609', 'groupId': 'OG000'}, {'value': '82.35', 'spread': '22.073', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.28', 'spread': '28.300', 'groupId': 'OG000'}, {'value': '77.45', 'spread': '23.883', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.37', 'spread': '23.266', 'groupId': 'OG000'}, {'value': '79.57', 'spread': '24.612', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.23', 'spread': '21.956', 'groupId': 'OG000'}, {'value': '81.55', 'spread': '19.948', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.44', 'spread': '20.313', 'groupId': 'OG000'}, {'value': '77.78', 'spread': '22.169', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '73.33', 'spread': '25.040', 'groupId': 'OG000'}, {'value': '79.86', 'spread': '23.560', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.89', 'spread': '16.019', 'groupId': 'OG000'}, {'value': '83.33', 'spread': '19.245', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.78', 'spread': '17.885', 'groupId': 'OG000'}, {'value': '82.29', 'spread': '23.936', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'spread': '12.599', 'groupId': 'OG000'}, {'value': '69.23', 'spread': '31.066', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '77.78', 'spread': '13.608', 'groupId': 'OG000'}, {'value': '90.48', 'spread': '16.265', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.17', 'spread': '15.957', 'groupId': 'OG000'}, {'value': '97.22', 'spread': '6.804', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75', 'spread': '9.623', 'groupId': 'OG000'}, {'value': '96.67', 'spread': '7.454', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.50', 'spread': '15.957', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Role Functioning Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.67', 'groupId': 'OG000'}]}]}, {'title': 'Role Functioning Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.97', 'spread': '31.790', 'groupId': 'OG000'}, {'value': '63.51', 'spread': '31.656', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.35', 'spread': '19.704', 'groupId': 'OG000'}, {'value': '80.06', 'spread': '19.729', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.41', 'spread': '19.465', 'groupId': 'OG000'}, {'value': '82.06', 'spread': '19.167', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.47', 'spread': '21.642', 'groupId': 'OG000'}, {'value': '82.90', 'spread': '19.314', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Functioning Score; 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Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.94', 'spread': '20.832', 'groupId': 'OG000'}, {'value': '16', 'spread': '23.561', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.33', 'spread': '20.921', 'groupId': 'OG000'}, {'value': '14.89', 'spread': '21.768', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.59', 'spread': '16.877', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '21.082', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.96', 'spread': '25.958', 'groupId': 'OG000'}, {'value': '11.76', 'spread': '19.903', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; 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Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.67', 'spread': '22.537', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '23.399', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.44', 'spread': '26.627', 'groupId': 'OG000'}, {'value': '12.28', 'spread': '19.909', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '17.408', 'groupId': 'OG000'}, {'value': '12.50', 'spread': '20.638', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '17.817', 'groupId': 'OG000'}, {'value': '20.51', 'spread': '32.026', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.22', 'spread': '17.213', 'groupId': 'OG000'}, {'value': '9.52', 'spread': '16.265', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '17.213', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '13.33', 'spread': '18.257', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Insomnia Score; 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Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.67', 'spread': '13.801', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '21.234', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.44', 'spread': '17.213', 'groupId': 'OG000'}, {'value': '8.77', 'spread': '21.779', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '12.975', 'groupId': 'OG000'}, {'value': '18.75', 'spread': '29.736', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '15.430', 'groupId': 'OG000'}, {'value': '15.38', 'spread': '25.875', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '27.889', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '31.914', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '31.914', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '33.333', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Constipation Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}]}]}, {'title': 'Constipation Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.33', 'spread': '23.481', 'groupId': 'OG000'}, {'value': '12.61', 'spread': '21.863', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.43', 'spread': '15.045', 'groupId': 'OG000'}, {'value': '6.79', 'spread': '15.823', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.29', 'spread': '29.572', 'groupId': 'OG000'}, {'value': '17.66', 'spread': '26.333', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.21', 'spread': '30.858', 'groupId': 'OG000'}, {'value': '27.19', 'spread': '32.023', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.59', 'spread': '33.634', 'groupId': 'OG000'}, {'value': '29.41', 'spread': '28.991', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.61', 'spread': '28.085', 'groupId': 'OG000'}, {'value': '29.33', 'spread': '29.207', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.96', 'spread': '30.550', 'groupId': 'OG000'}, {'value': '26.89', 'spread': '27.541', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.64', 'spread': '31.885', 'groupId': 'OG000'}, {'value': '31.75', 'spread': '27.881', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.55', 'spread': '28.818', 'groupId': 'OG000'}, {'value': '31.27', 'spread': '28.793', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.43', 'spread': '33.129', 'groupId': 'OG000'}, {'value': '28.62', 'spread': '28.637', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.22', 'spread': '29.992', 'groupId': 'OG000'}, {'value': '29.33', 'spread': '25.088', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.02', 'spread': '28.367', 'groupId': 'OG000'}, {'value': '26.85', 'spread': '26.619', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.49', 'spread': '31.273', 'groupId': 'OG000'}, {'value': '22.78', 'spread': '23.363', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.19', 'spread': '28.223', 'groupId': 'OG000'}, {'value': '23.03', 'spread': '25.558', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.53', 'spread': '25.440', 'groupId': 'OG000'}, {'value': '24.36', 'spread': '22.008', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.55', 'spread': '29.828', 'groupId': 'OG000'}, {'value': '30.07', 'spread': '26.038', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.33', 'spread': '27.767', 'groupId': 'OG000'}, {'value': '23.40', 'spread': '21.886', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.30', 'spread': '24.107', 'groupId': 'OG000'}, {'value': '29.17', 'spread': '28.432', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.51', 'spread': '25.164', 'groupId': 'OG000'}, {'value': '25.49', 'spread': '23.296', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.46', 'spread': '28.963', 'groupId': 'OG000'}, {'value': '21.57', 'spread': '21.528', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.75', 'spread': '23.130', 'groupId': 'OG000'}, {'value': '22.58', 'spread': '23.392', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.51', 'spread': '26.795', 'groupId': 'OG000'}, {'value': '21.43', 'spread': '18.624', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.54', 'spread': '20.393', 'groupId': 'OG000'}, {'value': '24.69', 'spread': '19.812', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.56', 'spread': '17.213', 'groupId': 'OG000'}, {'value': '22.22', 'spread': '16.051', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': '16.265', 'groupId': 'OG000'}, {'value': '19.30', 'spread': '16.909', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.44', 'spread': '22.285', 'groupId': 'OG000'}, {'value': '18.75', 'spread': '17.078', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '29.547', 'groupId': 'OG000'}, {'value': '17.95', 'spread': '17.296', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'spread': '21.082', 'groupId': 'OG000'}, {'value': '33.33', 'spread': '19.245', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '19.245', 'groupId': 'OG000'}, {'value': '22.22', 'spread': '17.213', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.33', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '20.00', 'spread': '18.257', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '19.245', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Diarrhea Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}]}]}, {'title': 'Diarrhea Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.33', 'spread': '25.380', 'groupId': 'OG000'}, {'value': '12.16', 'spread': '19.565', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.76', 'spread': '28.382', 'groupId': 'OG000'}, {'value': '20.37', 'spread': '29.076', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.08', 'spread': '28.177', 'groupId': 'OG000'}, {'value': '15.01', 'spread': '24.852', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.13', 'spread': '27.201', 'groupId': 'OG000'}, {'value': '18.20', 'spread': '27.451', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.90', 'spread': '27.761', 'groupId': 'OG000'}, {'value': '16.42', 'spread': '25.113', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.93', 'spread': '28.213', 'groupId': 'OG000'}, {'value': '18.78', 'spread': '29.058', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '27.416', 'groupId': 'OG000'}, {'value': '17.80', 'spread': '25.666', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.16', 'spread': '31.866', 'groupId': 'OG000'}, {'value': '15.87', 'spread': '24.062', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.43', 'spread': '29.176', 'groupId': 'OG000'}, {'value': '17.53', 'spread': '24.576', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.56', 'spread': '30.002', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '23.440', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '80', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.50', 'spread': '27.952', 'groupId': 'OG000'}, {'value': '17.35', 'spread': '24.913', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.26', 'spread': '30.108', 'groupId': 'OG000'}, {'value': '16.20', 'spread': '24.382', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.87', 'spread': '28.061', 'groupId': 'OG000'}, {'value': '16.11', 'spread': '24.156', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.03', 'spread': '26.351', 'groupId': 'OG000'}, {'value': '19.14', 'spread': '25.577', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.83', 'spread': '22.413', 'groupId': 'OG000'}, {'value': '17.31', 'spread': '25.127', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.71', 'spread': '27.103', 'groupId': 'OG000'}, {'value': '19.61', 'spread': '26.813', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.67', 'spread': '25.654', 'groupId': 'OG000'}, {'value': '17.02', 'spread': '24.937', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.81', 'spread': '27.501', 'groupId': 'OG000'}, {'value': '19.17', 'spread': '27.099', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.20', 'spread': '18.995', 'groupId': 'OG000'}, {'value': '19.61', 'spread': '28.566', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.52', 'spread': '19.245', 'groupId': 'OG000'}, {'value': '20.59', 'spread': '28.444', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.05', 'spread': '21.424', 'groupId': 'OG000'}, {'value': '20.43', 'spread': '30.644', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.23', 'spread': '21.444', 'groupId': 'OG000'}, {'value': '20.24', 'spread': '27.725', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.56', 'spread': '24.450', 'groupId': 'OG000'}, {'value': '20.99', 'spread': '29.451', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.78', 'spread': '17.213', 'groupId': 'OG000'}, {'value': '23.61', 'spread': '31.819', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.78', 'spread': '21.331', 'groupId': 'OG000'}, {'value': '19.30', 'spread': '25.618', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '22.473', 'groupId': 'OG000'}, {'value': '16.67', 'spread': '24.343', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.83', 'spread': '24.801', 'groupId': 'OG000'}, {'value': '20.51', 'spread': '32.026', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.67', 'spread': '18.257', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.00', 'spread': '16.667', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Financial Difficulties Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Financial Difficulties Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.65', 'spread': '32.423', 'groupId': 'OG000'}, {'value': '25.11', 'spread': '30.318', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)', 'description': 'The EORT QLQ-C30 consisted of 30 questions comprising 9 multiple-item scales and 6 single items. Multiple-item scales of QLQ-C30 consisted of 5 functional scales (physical, role, emotional, cognitive, and social) and 3 symptom scales (fatigue, nausea and vomiting, pain) and a global health status/QOL score. Six single-item scales of QLQ-C30 involved dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. First 28 questions used a 4-point scale (1 = Not at all to 4 = Very much); and last 2 questions used a 7-point scale (1 = Very poor to 7 = Excellent). Scores for all scales range from 0 to 100. For the overall HRQoL and functioning scales, a higher score was correlated with better HRQoL, whereas a higher score for symptom scales represented worse HRQoL. As pre-specified in protocol, data for secondary outcome measure was collected and analyzed till primary analysis only.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QoL analysis set consisted of all participants who had any QoL data. Here, overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points.'}, {'type': 'SECONDARY', 'title': 'HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'title': 'EQ-5D Index Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.216', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.232', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.178', 'groupId': 'OG000'}, {'value': '0.76', 'spread': '0.230', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.232', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.239', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '131', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.213', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.236', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.212', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.199', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '0.77', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.71', 'spread': '0.219', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.196', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.187', 'groupId': 'OG000'}, {'value': '0.80', 'spread': '0.187', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.192', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.177', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.185', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.82', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.173', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.161', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.179', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.163', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.165', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.179', 'groupId': 'OG000'}, {'value': '0.81', 'spread': '0.212', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.211', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.158', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.76', 'spread': '0.148', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.177', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.69', 'spread': '0.266', 'groupId': 'OG000'}, {'value': '0.79', 'spread': '0.205', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.167', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.180', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '0.173', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.149', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.242', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.172', 'groupId': 'OG000'}, {'value': '0.84', 'spread': '0.156', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.70', 'spread': '0.245', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.175', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.72', 'spread': '0.170', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.438', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.77', 'spread': '0.135', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.117', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.73', 'spread': '0.112', 'groupId': 'OG000'}, {'value': '0.97', 'spread': '0.067', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.74', 'spread': '0.120', 'groupId': 'OG000'}, {'value': '0.96', 'spread': '0.075', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.391', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'EQ-5D Index Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000'}]}]}, {'title': 'EQ-5D Index Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.61', 'spread': '0.331', 'groupId': 'OG000'}, {'value': '0.68', 'spread': '0.314', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.57', 'spread': '18.348', 'groupId': 'OG000'}, {'value': '70.01', 'spread': '20.552', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.05', 'spread': '18.531', 'groupId': 'OG000'}, {'value': '69.52', 'spread': '19.155', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.22', 'spread': '17.804', 'groupId': 'OG000'}, {'value': '70.71', 'spread': '17.648', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.69', 'spread': '18.265', 'groupId': 'OG000'}, {'value': '69.66', 'spread': '17.784', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 5 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.86', 'spread': '18.908', 'groupId': 'OG000'}, {'value': '70.30', 'spread': '19.492', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 6 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.53', 'spread': '20.027', 'groupId': 'OG000'}, {'value': '71.73', 'spread': '17.366', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 7 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.74', 'spread': '18.063', 'groupId': 'OG000'}, {'value': '70.39', 'spread': '19.387', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.16', 'spread': '18.969', 'groupId': 'OG000'}, {'value': '70.40', 'spread': '20.130', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 9 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.51', 'spread': '17.670', 'groupId': 'OG000'}, {'value': '69.92', 'spread': '19.452', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 10 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.92', 'spread': '17.747', 'groupId': 'OG000'}, {'value': '73.18', 'spread': '20.167', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 11 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.74', 'spread': '16.850', 'groupId': 'OG000'}, {'value': '73.21', 'spread': '19.310', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 12 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.46', 'spread': '18.680', 'groupId': 'OG000'}, {'value': '74.46', 'spread': '17.139', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 13 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.64', 'spread': '19.690', 'groupId': 'OG000'}, {'value': '74.35', 'spread': '17.766', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 14 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.41', 'spread': '17.839', 'groupId': 'OG000'}, {'value': '74.40', 'spread': '17.678', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 15 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.05', 'spread': '17.847', 'groupId': 'OG000'}, {'value': '72.58', 'spread': '19.060', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.54', 'spread': '18.118', 'groupId': 'OG000'}, {'value': '72.80', 'spread': '17.733', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 17 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.78', 'spread': '17.755', 'groupId': 'OG000'}, {'value': '73.80', 'spread': '17.593', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 18 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.70', 'spread': '18.170', 'groupId': 'OG000'}, {'value': '73.71', 'spread': '16.665', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 19 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.15', 'spread': '20.676', 'groupId': 'OG000'}, {'value': '71.76', 'spread': '19.272', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 20 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.70', 'spread': '19.779', 'groupId': 'OG000'}, {'value': '72.07', 'spread': '19.293', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 21 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.12', 'spread': '17.974', 'groupId': 'OG000'}, {'value': '76.46', 'spread': '16.836', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 22 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.21', 'spread': '14.722', 'groupId': 'OG000'}, {'value': '74.44', 'spread': '16.860', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 23 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.73', 'spread': '15.650', 'groupId': 'OG000'}, {'value': '73.67', 'spread': '17.704', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 24 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.27', 'spread': '19.381', 'groupId': 'OG000'}, {'value': '71.21', 'spread': '21.212', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 25 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.58', 'spread': '19.313', 'groupId': 'OG000'}, {'value': '72.81', 'spread': '16.897', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 26 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.13', 'spread': '16.313', 'groupId': 'OG000'}, {'value': '65.23', 'spread': '25.652', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 27 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.83', 'spread': '18.357', 'groupId': 'OG000'}, {'value': '77.43', 'spread': '16.762', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 28 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54.25', 'spread': '8.694', 'groupId': 'OG000'}, {'value': '77.50', 'spread': '20.907', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 29 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.75', 'spread': '12.093', 'groupId': 'OG000'}, {'value': '74', 'spread': '21.036', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 30 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.75', 'spread': '11.295', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'EQ-VAS Score; Cycle 31 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'EQ-VAS Score; Off-treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.48', 'spread': '23.516', 'groupId': 'OG000'}, {'value': '62.66', 'spread': '22.252', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)', 'description': 'The EQ-5D-3L is a health profile questionnaire assessing quality of life along 5 dimensions. Participants rate 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 5-15 with "5" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. The EQ-5D index was calculated by applying preference-based weights (tariffs) to the scores of the five health state dimensions. Index values can range from -1 to 1, with 0 representing a health state equivalent to death and 1 representing perfect health. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'QoL analysis set consisted of all participants who had any QoL data. Here "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points. . As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till primary analysis only.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival After Next Line of Therapy (PFS2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '156', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'OG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '22.5'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '23.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time of randomization to the date of PD after next line of therapy or death from any cause or the date of data cutoff for the primary analysis, whichever occurs first (up to 29 months)', 'description': 'PFS2, defined as the time from randomization to the date of PD after next line of therapy or death from any cause, whichever occurred first based on investigator assessment according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS2 was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% CI. As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PPAS1 included all randomized participants minus the 32 participants who had received \\>=2 incorrect lenvatinib doses due to IxRS issues.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any greater than or equal to (\\>=) Grade 3 treatment-emergent adverse events (TEAEs) that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length equals to (=) 28 days) during randomization phase.'}, {'id': 'FG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '171'}]}, {'type': 'Treated Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '169'}]}, {'type': 'Safety Set', 'comment': 'One participant was randomized to lenvatinib 18 mg arm but received lenvatinib 14 mg as the starting dose and therefore was included in lenvatinib 14 mg arm in safety population.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '101'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '70'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 82 investigative sites in Australia, Korea, Taiwan, Czech, Poland, Romania, Russia, Finland, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom, Canada and the United States from 17 August 2017 to 20 June 2024.', 'preAssignmentDetails': 'A total of 489 participants were screened, of which 146 were screen failures and 343 were enrolled and randomized, out of which 341 participants were treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Lenvatinib 14 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \\>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.'}, {'id': 'BG001', 'title': 'Lenvatinib 18 mg + Everolimus 5 mg', 'description': 'Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '9.59', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '9.90', 'groupId': 'BG001'}, {'value': '61.0', 'spread': '9.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '277', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-09-11', 'size': 2556057, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-28T02:15', 'hasProtocol': True}, {'date': '2020-04-29', 'size': 721893, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-28T02:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Study was initially double-blind.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2017-05-22', 'resultsFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2017-05-31', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-12', 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate at Week 24 (ORR24W)', 'timeFrame': 'At Week 24', 'description': 'ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\\<) 10 millimeters (mm). PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response.'}, {'measure': 'Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks', 'timeFrame': 'Up to Week 24', 'description': 'TEAE was defined as an adverse event (AE) with an onset that had occurred after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.'}], 'secondaryOutcomes': [{'measure': 'Progression-free Survival (PFS)', 'timeFrame': 'From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to date of data cutoff for the primary analysis (up to 29 months)', 'description': 'PFS was defined as the time from the date of randomization to the date of the first documentation of PD by investigator assessment or date of death, whichever occurred first according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 millimeter \\[mm\\]) in the sum of diameter (SOD) of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% confidence interval (CI). As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'From date of randomization up to first documentation of PD or date of death, whichever occurred first or up to the date of data cut off for the primary analysis (up to 29 months)', 'description': 'ORR was defined as the percentage of participants with a BOR of CR or PR at the at the end of treatment based on investigator assessment according to RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to \\<10 mm. PR: defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.'}, {'measure': 'Number of Participants With TEAEs and Serious TEAEs', 'timeFrame': 'From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)', 'description': 'TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.'}, {'measure': 'Percentage of Participants Who Discontinued Treatment Due to Toxicity', 'timeFrame': 'From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)', 'description': 'Percentage of participants who discontinued treatment due to toxicity, defined as the percentage of participants who discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to NCI-CTCAE v4.03.'}, {'measure': 'Time to Treatment Failure Due to Toxicity', 'timeFrame': 'From the date of randomization to the date of discontinuation of study treatment due to TEAEs, or date of data cut off for the primary analysis (up to 29 months)', 'description': 'Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to CTCAE v4.03. As planned, data for this secondary outcome measure was collected and analyzed till the primary analysis only.'}, {'measure': 'Plasma Concentration of Lenvatinib', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'PK sparse sampling was performed. As planned, the post-dose plasma sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.'}, {'measure': 'Whole Blood Concentration of Everolimus', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'PK sparse sampling was performed. As planned, the post-dose whole blood sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.'}, {'measure': 'Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib CL/F value was derived from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.'}, {'measure': 'Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.'}, {'measure': 'Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus CL/F value was derived from the final PK model.'}, {'measure': 'Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction', 'timeFrame': 'Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)', 'description': 'Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model.'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)', 'description': 'OS was defined as the time from the date of randomization until the date of death from any cause. In the absence of confirmation of death, participants will be censored either at the date that the participant was last known to be alive or the date of data cutoff for the primary analysis, whichever comes earlier. Median OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.'}, {'measure': 'Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores', 'timeFrame': 'At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)', 'description': 'The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.'}, {'measure': 'HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores', 'timeFrame': 'At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)', 'description': 'The EORT QLQ-C30 consisted of 30 questions comprising 9 multiple-item scales and 6 single items. Multiple-item scales of QLQ-C30 consisted of 5 functional scales (physical, role, emotional, cognitive, and social) and 3 symptom scales (fatigue, nausea and vomiting, pain) and a global health status/QOL score. Six single-item scales of QLQ-C30 involved dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. First 28 questions used a 4-point scale (1 = Not at all to 4 = Very much); and last 2 questions used a 7-point scale (1 = Very poor to 7 = Excellent). Scores for all scales range from 0 to 100. For the overall HRQoL and functioning scales, a higher score was correlated with better HRQoL, whereas a higher score for symptom scales represented worse HRQoL. As pre-specified in protocol, data for secondary outcome measure was collected and analyzed till primary analysis only.'}, {'measure': 'HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS)', 'timeFrame': 'At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)', 'description': 'The EQ-5D-3L is a health profile questionnaire assessing quality of life along 5 dimensions. Participants rate 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 5-15 with "5" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. The EQ-5D index was calculated by applying preference-based weights (tariffs) to the scores of the five health state dimensions. Index values can range from -1 to 1, with 0 representing a health state equivalent to death and 1 representing perfect health. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best).'}, {'measure': 'Progression-free Survival After Next Line of Therapy (PFS2)', 'timeFrame': 'From the time of randomization to the date of PD after next line of therapy or death from any cause or the date of data cutoff for the primary analysis, whichever occurs first (up to 29 months)', 'description': 'PFS2, defined as the time from randomization to the date of PD after next line of therapy or death from any cause, whichever occurred first based on investigator assessment according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS2 was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% CI. As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renal Cell Carcinoma', 'lenvatinib', 'everolimus', 'E7080', 'VEGF-targeted treatment'], 'conditions': ['Renal Cell Carcinoma']}, 'referencesModule': {'references': [{'pmid': '35881028', 'type': 'DERIVED', 'citation': "Bergerot C, Young Rha S, Pal S, Koralewski P, Stroyakovskiy D, Alekseev B, Parnis F, Castellano D, Lyun Lee J, Sunela K, Ciuleanu T, Heng D, Glen H, Wang J, Bennett L, Pan J, O'Hara K, Puente J. Health-Related Quality of Life Outcomes With Two Different Starting Doses of Lenvatinib in Combination With Everolimus for Previously Treated Renal Cell Carcinoma. Oncologist. 2023 Jan 18;28(1):59-71. doi: 10.1093/oncolo/oyac142."}]}, 'descriptionModule': {'briefSummary': 'Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \\[ORR\\] at 24 weeks \\[ORR24W\\]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (\\>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological or cytological confirmation of predominant clear cell renal cell carcinoma (RCC) (original tissue diagnosis of RCC is acceptable)\n* Documented evidence of advanced RCC\n* One prior disease progression episode on or after vascular endothelial growth factor (VEGF)-targeted treatment (for example, but not limited to, sunitinib, sorafenib, pazopanib, cabozantinib, bevacizumab, axitinib, vatalanib, AV951/tivozanib) administered for the treatment of RCC. Prior programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) treatment in addition to 1 prior VEGF-targeted treatment is allowed.\n* At least 1 measurable target lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) meeting the following criteria:\n\n * Lymph node (LN) lesion that measures at least 1 dimension as \\>=1.5 centimeter (cm) in the short axis;\n * Non-nodal lesion that measures \\>=1.0 cm in the longest diameter;\n * The lesion is suitable for repeat measurement using computerized tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.\n* Male or female participants age \\>=18 years (or any age \\>=18 years if that age is considered to be an adult per the local jurisdiction) at the time of informed consent\n* Karnofsky Performance Status (KPS) of \\>=70\n* Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP less than or equal to (\\<=) 150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive medications within 1 week before Cycle 1/Day 1\n* Adequate renal function defined as calculated creatinine clearance \\>=30 milliliters per minute (mL/min) per the Cockcroft and Gault formula\n* Adequate bone marrow function defined by:\n\n * Absolute neutrophil count (ANC) \\>=1500/millimeters cubed (mm\\^3) (\\>=1.5\\*10\\^9/Liters \\[L\\]);\n * Platelets \\>=100,000/mm\\^3 (\\>=100\\*10\\^9/L);\n * Hemoglobin \\>=9 grams per deciliter (g/dL)\n* Adequate blood coagulation function defined by International Normalized Ratio (INR) \\<=1.5 (except for participants on warfarin therapy where INR must be \\<=3.0 prior to randomization)\n* Adequate liver function defined by:\n\n * Total bilirubin \\<=1.5 times the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome;\n * Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) \\<=3\\* the ULN (in the case of liver metastases \\<=5\\* the ULN). Participants with bone metastases with ALP values greater than 3 times can be included.\n* Participant must voluntarily agree to provide written informed consent\n* Participant must be willing and able to comply with all aspects of the protocol\n\nExclusion Criteria:\n\n* More than 1 prior VEGF-targeted treatment for advanced RCC\n* Participants with Central Nervous System (CNS) metastases are not eligible, unless they have completed local therapy for at least 4 weeks and have discontinued the use of corticosteroids for this indication or are on a tapering regimen of corticosteroids (defined as \\<=10 mg prednisolone equivalent) before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment.\n* Active malignancy (except for RCC or definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past 24 months\n* Any anti-cancer treatment (except for radiation therapy) within 21 days, or any investigational agent within 30 days prior to the first dose of study drug; participants should have recovered from any toxicity related to previous anti-cancer treatment to Common Toxicity Criteria (CTC) grade 0 or 1.\n* Prior radiation therapy within 21 days prior to the start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start\n* Known intolerance to study drug (or any of the excipients) and/or known hypersensitivity to rapamycins (example, sirolimus, everolimus, temsirolimus) or any of the excipients\n* Participants with proteinuria greater than (\\>) 1+ on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein \\>=1 g/24 hour will be ineligible.\n* Fasting total cholesterol ˃300 mg/dL (or ˃7.75 millimoles \\[mmol\\]/L) and/or fasting triglycerides level ˃2.5\\* the ULN. Note: these participants can be included after initiation or adjustment of lipid-lowering medication.\n* Uncontrolled diabetes as defined by fasting glucose \\>1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication.\n* Prolongation of QT corrected (QTc) interval to \\>480 milliseconds (ms)\n* Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy\n* Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib or everolimus\n* Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (example, carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.\n* Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug\n* Significant cardiovascular impairment within 6 months prior to the first dose of study drug; history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke, or cardiac arrhythmia associated with significant cardiovascular impairment or left ventricular ejection fraction (LVEF) below the institutional normal range as determined by screening multigated acquisition (MUGA) scan or echocardiogram.\n* Active infection (any infection requiring systemic treatment)\n* Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in a clinical study\n* Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin \\[β-hCG\\] (or human chorionic gonadotropin \\[hCG\\]) test with a minimum sensitivity of 25 International Units per Liter \\[IU/L\\] or equivalent units of β-hCG \\[or hCG\\]). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.\n* Females of childbearing potential who (Note: all females will be considered to be of childbearing potential unless they are postmenopausal \\[amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause\\] or have been sterilized surgically \\[that is, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing\\].):\n\n * do not agree to use a highly effective method of contraception for the entire study period and for up to 8 weeks after study drug discontinuation, that is:\n\n * total abstinence (if it is their preferred and usual lifestyle)\n * an intrauterine device (IUD) or hormone releasing system (IUS)\n * a contraceptive implant\n * an oral contraceptive (with additional barrier method) (Note: Participants must be on a stable dose of the same oral hormonal contraceptive product for at least 4 weeks before dosing with study drug and for the duration of the study.) OR\n * do not have a vasectomized partner with confirmed azoospermia\n\nFor sites outside of the European Union, it is permissible that if a highly effective method of contraception is not appropriate or acceptable to the participant, then the participant must agree to use a medically acceptable method of contraception, that is, double barrier methods of contraception, such as condom plus diaphragm or cervical/vault cap with spermicide."}, 'identificationModule': {'nctId': 'NCT03173560', 'briefTitle': 'Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment', 'orgStudyIdInfo': {'id': 'E7080-G000-218'}, 'secondaryIdInfos': [{'id': '2016-002778-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lenvatinib 14 mg plus everolimus 5 mg', 'description': 'Participants will receive oral lenvatinib 14 mg once daily (QD) plus oral everolimus 5 mg QD as the starting dose for Cycle 1. If there are no intolerable Grade 2 or any \\>= Grade 3 treatment-emergent adverse events (TEAEs) that require dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), the lenvatinib dose will be escalated to 18 mg QD (plus everolimus 5 mg) beginning in Cycle 2 or later (cycle length equal to \\[=\\] 28 days) during randomization phase. After the data cutoff for the primary analysis, participants will receive study treatment as continuous 56-day cycles.', 'interventionNames': ['Drug: lenvatinib', 'Drug: everolimus']}, {'type': 'EXPERIMENTAL', 'label': 'Lenvatinib 18 mg plus everolimus 5 mg', 'description': 'Participants will receive oral lenvatinib 18 mg QD plus oral everolimus 5 mg QD as the starting dose in Cycle 1 or later (cycle length =28 days) during randomization phase. After the data cutoff for the primary analysis, participants will receive study treatment as continuous 56-day cycles.', 'interventionNames': ['Drug: lenvatinib', 'Drug: everolimus']}], 'interventions': [{'name': 'lenvatinib', 'type': 'DRUG', 'description': 'lenvatinib capsules.', 'armGroupLabels': ['Lenvatinib 14 mg plus everolimus 5 mg', 'Lenvatinib 18 mg plus everolimus 5 mg']}, {'name': 'everolimus', 'type': 'DRUG', 'description': 'everolimus tablets.', 'armGroupLabels': ['Lenvatinib 14 mg plus everolimus 5 mg', 'Lenvatinib 18 mg plus everolimus 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Innovative Clinical Research Institute, LLC', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'zip': '33143', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Baptist Health Medical Group Oncology, LLC - 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