{"description":"Safety analysis set included all participants who received at least one dose of study drug/s and had at least one postbaseline safety evaluation. AE severity was assessed using Common Terminology for Adverse Events (CTCAE). Serious AEs were followed until the event resolved or the event or sequelae stabilized.","eventGroups":[{"deathsNumAffected":6,"deathsNumAtRisk":7,"description":"Oral lenvatinib (12 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in a fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no dose-limiting toxicity (DLT) occurred, then enrollment proceeded to Cohort 2. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 1. If 1 or none of the 6 participants had a DLT, then enrollment proceeded to Cohort 2.\n\nIf 2 or more participants had a DLT during Cycle 1, the dose escalation committee (DEC) decided if they were lenvatinib-related and if enrollment could proceed, lenvatinib was reduced to 6 mg daily (everolimus dose was not reduced). If it could not be determined that the DLTs were lenvatinib-related, enrollment stopped.","id":"EG000","otherNumAffected":7,"otherNumAtRisk":7,"seriousNumAffected":6,"seriousNumAtRisk":7,"title":"Phase 1b (Cohort 1): 12 mg Lenvatinib Plus 5 mg Everolimus"},{"deathsNumAffected":9,"deathsNumAtRisk":11,"description":"Oral lenvatinib (18 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment would proceed to Cohort 3. If 1 participant had a DLT, 3 more participants were enrolled in Cohort 2. If 1 or none of the 6 participants exhibited a DLT, enrollment proceeded to Cohort 3.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.","id":"EG001","otherNumAffected":11,"otherNumAtRisk":11,"seriousNumAffected":8,"seriousNumAtRisk":11,"title":"Phase 1b (Cohort 2): 18 mg Lenvatinib Plus 5 mg Everolimus"},{"deathsNumAffected":0,"deathsNumAtRisk":2,"description":"Oral lenvatinib (24 mg) and everolimus (5 mg) were taken once daily in continuous 28-day cycles. Dose Escalation Cohort-Cycle 1: both study drugs were taken at the same time of day in the fasting state with water. Cycles 2, 3, etc. and Expansion Cohort: both study drugs were taken at the same time of day with water, either after a meal or in a fasting state. Dose escalation began with 3 participants in Cohort 1. If no DLT occurred, then enrollment proceeded to Cohort 4. If 1 participant had a DLT, 3 more participants were enrolled Cohort 3. If 1 or none of the 6 participants exhibited a DLT, then enrollment proceeded to Cohort 4.\n\nIf 2 or more participants had a DLT during Cycle 1, dose escalation ceased and additional participants were enrolled to the next lower dose to achieve a total of 6 participants in that cohort.","id":"EG002","otherNumAffected":2,"otherNumAtRisk":2,"seriousNumAffected":0,"seriousNumAtRisk":2,"title":"Phase 1b (Cohort 3): 24 mg Lenvatinib Plus 5 mg Everolimus"},{"deathsNumAffected":0,"deathsNumAtRisk":0,"description":"The DLT was achieved and no participants were enrolled into this cohort.","id":"EG003","otherNumAffected":0,"otherNumAtRisk":0,"seriousNumAffected":0,"seriousNumAtRisk":0,"title":"Phase 1b (Cohort 4): 24 mg Lenvatinib Plus 10 mg Everolimus"},{"deathsNumAffected":43,"deathsNumAtRisk":51,"description":"Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.","id":"EG004","otherNumAffected":51,"otherNumAtRisk":51,"seriousNumAffected":30,"seriousNumAtRisk":51,"title":"Phase 2 (Arm A): 18 mg Lenvatinib Plus 5 mg Everolimus"},{"deathsNumAffected":40,"deathsNumAtRisk":52,"description":"Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.","id":"EG005","otherNumAffected":51,"otherNumAtRisk":52,"seriousNumAffected":28,"seriousNumAtRisk":52,"title":"Phase 2 (Arm B): 24 mg Lenvatinib"},{"deathsNumAffected":45,"deathsNumAtRisk":50,"description":"Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4 week) cycles.","id":"EG006","otherNumAffected":50,"otherNumAtRisk":50,"seriousNumAffected":21,"seriousNumAtRisk":50,"title":"Phase 2 (Arm C): 10 mg Everolimus"}],"frequencyThreshold":"5","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":7,"numAtRisk":51},{"groupId":"EG005","numAffected":3,"numAtRisk":52},{"groupId":"EG006","numAffected":11,"numAtRisk":50}],"term":"Anaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Haemorrhagic Disorder"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Lymphadenopathy"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Neutropenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":2,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":5,"numAtRisk":51},{"groupId":"EG005","numAffected":1,"numAtRisk":52},{"groupId":"EG006","numAffected":4,"numAtRisk":50}],"term":"Thrombocytopenia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Angina Pectoris"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Aortic Valve Incompetence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Coronary Artery Disease"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":1,"numAtRisk":50}],"term":"Coronary Artery Occlusion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Mitral Valve Incompetence"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":2,"numAtRisk":50}],"term":"Palpitations"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":2,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Tachycardia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Ventricular Hypokinesia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Ear Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":12,"numAtRisk":51},{"groupId":"EG005","numAffected":19,"numAtRisk":52},{"groupId":"EG006","numAffected":1,"numAtRisk":50}],"term":"Hypothyroidism"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Inappropriate Antidiuretic Hormone Secretion"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":1,"numAtRisk":50}],"term":"Diplopia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":1,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Eye Swelling"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":0,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":1,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Ocular Hyperaemia"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":1,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Vision Blurred"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":7},{"groupId":"EG001","numAffected":3,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":12,"numAtRisk":51},{"groupId":"EG005","numAffected":11,"numAtRisk":52},{"groupId":"EG006","numAffected":1,"numAtRisk":50}],"term":"Abdominal Pain"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":8,"numAtRisk":51},{"groupId":"EG005","numAffected":7,"numAtRisk":52},{"groupId":"EG006","numAffected":3,"numAtRisk":50}],"term":"Abdominal Pain Upper"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 19.1","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":7},{"groupId":"EG001","numAffected":1,"numAtRisk":11},{"groupId":"EG002","numAffected":0,"numAtRisk":2},{"groupId":"EG003","numAffected":0,"numAtRisk":0},{"groupId":"EG004","numAffected":0,"numAtRisk":51},{"groupId":"EG005","numAffected":0,"numAtRisk":52},{"groupId":"EG006","numAffected":0,"numAtRisk":50}],"term":"Anal Pruritus"},{"assessmentType":"SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA 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