Trial Outcomes & Findings for Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors (NCT NCT03245151)

Last Updated: 2023-08-30

Results Overview

MTD was defined as the highest dose level at which no more than 1/6 participants experienced a dose limiting toxicity (DLTs), with the next higher dose having at least 0 of 3 or 1 of 6 participants experiencing DLTs. DLT was graded according to common terminology criteria for adverse events (CTCAE) version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

64 participants

Primary outcome timeframe

Cycle 1 (Each cycle was of 28 days)

Results posted on

2023-08-30

Participant Flow

Participants took part in the study at 24 investigative sites in the United States and Canada from 16 November 2017 to 30 September 2022.

A total of 86 participants were screened, out of which 64 were enrolled and 9 participants completed the study.

Participant milestones

Participant milestones
Measure	Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 8 milligram per square meter (mg/m\^2), capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of disease progression (PD), clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 1, Ewing Sarcoma Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 2, Rhabdomyosarcoma Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory high grade glioma (HGG) received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Overall Study STARTED	5	18	10	20	11
Overall Study COMPLETED	0	3	1	2	3
Overall Study NOT COMPLETED	5	15	9	18	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 8 milligram per square meter (mg/m\^2), capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of disease progression (PD), clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 1, Ewing Sarcoma Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 2, Rhabdomyosarcoma Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory high grade glioma (HGG) received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Overall Study Withdrawal by Subject	2	0	0	2	1
Overall Study Death	3	14	9	16	7
Overall Study Sponsor's decision	0	1	0	0	0

Baseline Characteristics

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 1, Ewing Sarcoma n=10 Participants Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 2, Rhabdomyosarcoma n=20 Participants Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 3, HGG n=11 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Total n=64 Participants Total of all reporting groups
Age, Customized 2-11 years	0 Participants n=5 Participants	16 Participants n=7 Participants	3 Participants n=5 Participants	9 Participants n=4 Participants	3 Participants n=21 Participants	31 Participants n=8 Participants
Age, Customized 12-17 years	4 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	21 Participants n=8 Participants
Age, Customized 18-64 years	1 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	12 Participants n=8 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	10 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	31 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	12 Participants n=4 Participants	3 Participants n=21 Participants	33 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	11 Participants n=7 Participants	8 Participants n=5 Participants	18 Participants n=4 Participants	11 Participants n=21 Participants	52 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=8 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	16 Participants n=4 Participants	6 Participants n=21 Participants	45 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	10 Participants n=8 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Each cycle was of 28 days)

Population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=23 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Maximum Tolerated Dose (MTD) of Lenvatinib in Combination With Everolimus	11 milligram per square meter (mg/m^2)	—	—

PRIMARY outcome

Timeframe: Cycle 1 (Each cycle was of 28 days)

Population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

The RP2D of lenvatinib in combination with everolimus was determined by Dose Escalation Committee (DEC) based on safety (including DLTs), pharmacokinetic and clinical data. DLT was graded according to CTCAE v4.03.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=23 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Recommended Phase 2 Dose (RP2D) of Lenvatinib in Combination With Everolimus	11 mg/m^2	—	—

PRIMARY outcome

Timeframe: From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months)

Population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

A TEAE was defined as an adverse event that emerged during treatment, having been absent at pretreatment or reemerged during treatment, having been present at pretreatment but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the adverse event is continuous. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	5 Participants	18 Participants	—

PRIMARY outcome

Timeframe: From date of first dose up to 28 days after the last dose of study treatment (Up to 17.5 months)

Population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

A TESAE was any untoward medical occurrence that at any dose: resulted in death; life threatening condition; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or was medically important due to other reasons than the above mentioned criteria. An adverse event was defined as any untoward medical occurrence in a participant administered an investigational product.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)	2 Participants	12 Participants	—

PRIMARY outcome

Timeframe: Week 16

Population: Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to the first efficacy assessment due to progressive disease.

ORR at Week 16 was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at Week 16 based on investigator assessment according to response evaluation criteria in solid tumors (RECIST) version 1.1 for non-HGG cohorts and response assessment in neuro-oncology (RANO) for HGG cohort. CR was defined as 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 less than (\<) 10 millimeter (mm). PR was defined as at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=10 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=20 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG n=10 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Objective Response Rate (ORR) at Week 16	0.0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 30.8	10.0 percentage of participants 95% Confidence Interval 1.2 • Interval 1.2 to 31.7	0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: From the date of the first dose of study drug to the date of first documentation of disease progression or death, whichever occurred first (up to 16.5 months)

Population: SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus). Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.

ORR was defined as the percentage of participants with BOR of CR or PR based on investigator assessment according to RECIST version 1.1 for non-HGG cohorts and RANO for HGG cohort. CR was defined as 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 \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=3 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=15 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Objective Response Rate (ORR)	0.0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 70.8	0.0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 21.8	—

SECONDARY outcome

Timeframe: From the date of the first dose of study drug to the date of first documentation of disease progression or death, which ever occurred first (up to 6.5 months)

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=10 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=20 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG n=10 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Objective Response Rate (ORR)	0.0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 30.8	10.0 percentage of participants 95% Confidence Interval 1.2 • Interval 1.2 to 31.7	0.0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months)

Population: SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).

DCR was defined as percentage of participants with a confirmed CR, PR, or stable disease (SD) (SD duration \>=7 weeks since the first dose of study treatment) divided by number of participants in analysis set. DCR was assessed by an investigator based on RECIST v1.1 for non-HGG participants or RANO for HGG participants. CR: 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 \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. 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.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Disease Control Rate (DCR)	20.0 percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 71.6	50.0 percentage of participants 95% Confidence Interval 26.0 • Interval 26.0 to 74.0	—

SECONDARY outcome

Timeframe: From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months)

DCR was defined as percentage of participants with confirmed CR, PR, or SD (SD duration greater than or equal to \[\>=\] 7 weeks since first dose of study treatment) divided by number of participants in analysis set. DCR was assessed by investigator based on RECIST v1.1 for non-HGG cohorts or RANO for HGG cohort. CR: 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 \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. 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.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=10 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=20 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG n=10 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Disease Control Rate (DCR)	40.0 percentage of participants 95% Confidence Interval 12.2 • Interval 12.2 to 73.8	40.0 percentage of participants 95% Confidence Interval 19.1 • Interval 19.1 to 63.9	30.0 percentage of participants 95% Confidence Interval 6.7 • Interval 6.7 to 65.2

SECONDARY outcome

Timeframe: From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months)

Population: SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).

CBR was defined as percentage of participants who had BOR of CR, PR, or durable SD (SD duration \>=23 weeks since the first dose of study treatment) divided by number of participants in analysis set. CBR was assessed by an investigator based on RECIST v1.1 for non-HGG participants or RANO for HGG participants. CR: 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 \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. 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.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Clinical Benefit Rate (CBR)	20.0 percentage of participants 95% Confidence Interval 0.5 • Interval 0.5 to 71.6	22.2 percentage of participants 95% Confidence Interval 6.4 • Interval 6.4 to 47.6	—

SECONDARY outcome

Timeframe: From first dose of study drug until PD or death, whichever occurred first (up to 6.5 months)

CBR was defined as percentage of participants who had BOR of CR, PR, or durable SD (SD duration \>=23 weeks since the first dose of study treatment) divided by number of participants in analysis set. CBR was assessed by an investigator based on RECIST v1.1 for non-HGG cohorts or RANO for HGG cohort. CR: 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 \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. 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.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=10 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=20 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG n=10 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Clinical Benefit Rate (CBR)	20.0 percentage of participants 95% Confidence Interval 2.5 • Interval 2.5 to 55.6	10.0 percentage of participants 95% Confidence Interval 1.2 • Interval 1.2 to 31.7	0.0 percentage of participants 95% Confidence Interval 0.0 • Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: From date of the first observation of CR or PR until the date of first observation of progression or date of death (up to 16.5 months)

DOR was defined as the time (in months) from the date of first observation of confirmed response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1 for non-HGG cohorts and RANO for HGG cohorts, or date of death, whatever the cause. CR: 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 \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From date of the first observation of CR or PR until the date of first observation of progression or date of death (up to 6.5 months)

Population: Evaluable analysis set included all evaluable participants who have measurable disease present at baseline, and at least one postbaseline efficacy assessment, unless they have discontinued prior to first efficacy assessment due to progressive disease. Here, 'overall number of participants analyzed' signifies participants who had CR or PR.

DOR was defined as the time (in months) from the date of first observation of confirmed response (PR or CR) to the date of the first observation of progression based on the investigator's assessment utilizing RECIST 1.1 for non-HGG cohorts and RANO for HGG cohort, or date of death, whatever the cause. CR: 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 \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD was defined as 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.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=2 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Duration of Response (DOR)	—	2.4 months Interval 2.1 to Upper limit of 95% Confidence Interval could not be estimated as insufficient number of participants were available for analysis.	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days)

Population: Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only.

AUC0-t of lenvatinib was quantified using validated liquid chromatography tandem mass spectrometry (LC-MS/MS) methods.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of Lenvatinib (AUC[0-t Hours]) Cycle 1 Day 1	2338.0 nanogramhour per milliliter (nghr/mL) Standard Deviation 1633.41	3281.1 nanogramhour per milliliter (nghr/mL) Standard Deviation 1064.72	—
Phase 1: Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration of Lenvatinib (AUC[0-t Hours]) Cycle 1 Day 15	1328.0 nanogramhour per milliliter (nghr/mL) Standard Deviation 520.69	2139.8 nanogramhour per milliliter (nghr/mL) Standard Deviation 1156.48	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days)

Cmax of lenvatinib was quantified using validated liquid LC-MS/MS methods.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Maximum Plasma Concentration of Lenvatinib (Cmax) Cycle 1 Day 1	240.20 nanogram per milliliter (ng/mL) Standard Deviation 130.892	404.13 nanogram per milliliter (ng/mL) Standard Deviation 121.473	—
Phase 1: Maximum Plasma Concentration of Lenvatinib (Cmax) Cycle 1 Day 15	314.20 nanogram per milliliter (ng/mL) Standard Deviation 149.527	447.62 nanogram per milliliter (ng/mL) Standard Deviation 272.790	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days)

Tmax of lenvatinib was quantified using validated liquid LC-MS/MS methods.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Time to Reach Maximum Plasma Concentration (Cmax) of Lenvatinib (Tmax) Cycle 1 Day 1	3.000 hours Interval 2.0 to 4.0	2.890 hours Interval 1.0 to 7.78	—
Phase 1: Time to Reach Maximum Plasma Concentration (Cmax) of Lenvatinib (Tmax) Cycle 1 Day 15	3.950 hours Interval 2.0 to 8.05	2.950 hours Interval 0.0 to 8.02	—

SECONDARY outcome

Timeframe: Cycle 1 Days 1, 2, 15 and 22: Pre-dose (Cycle length=28 days)

Population: Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only.

Trough concentrations of everolimus was quantified using validated liquid LC-MS/MS methods.

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=5 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=17 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib Cycle 1 Day 1: Pre-dose	0.0 ng/mL Standard Deviation 0.0	0.0 ng/mL Standard Deviation 0.00	—
Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib Cycle 1 Day 2: Pre-dose	2.1 ng/mL Standard Deviation 1.34	2.2 ng/mL Standard Deviation 1.13	—
Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib Cycle 1 Day 15: Pre-dose	3.2 ng/mL Standard Deviation 2.42	5.1 ng/mL Standard Deviation 2.98	—
Phase 1: Trough Concentrations (Ctrough) of Everolimus When Administered in Combination With Lenvatinib Cycle 1 Day 22: Pre-dose	2.8 ng/mL Standard Deviation 1.96	4.2 ng/mL Standard Deviation 2.73	—

SECONDARY outcome

Timeframe: From date of first dose up to 28 days after the last dose of study treatment (up to 7.5 months)

Population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=10 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=20 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG n=11 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	10 Participants	19 Participants	11 Participants

SECONDARY outcome

Timeframe: From date of first dose up to 28 days after the last dose of study treatment (up to 7.5 months)

Population: SAS included all participants who received at least one dose of study drug (Lenvatinib or Everolimus).

Outcome measures

Outcome measures
Measure	Phase 1: Lenvatinib + Everolimus (All Participants) n=10 Participants Participants with recurrent or refractory solid tumors received lenvatinib 8 or 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=20 Participants Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 3, HGG n=11 Participants Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Phase 2: Number of Participants With Any Treatment-emergent Serious Adverse Event (TESAE)	6 Participants	8 Participants	8 Participants

Adverse Events

Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2

Serious events: 2 serious events

Other events: 5 other events

Deaths: 4 deaths

Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2

Serious events: 12 serious events

Other events: 18 other events

Deaths: 14 deaths

Phase 2: Cohort 1, Ewing Sarcoma

Serious events: 6 serious events

Other events: 10 other events

Deaths: 9 deaths

Phase 2: Cohort 2, Rhabdomyosarcoma

Serious events: 8 serious events

Other events: 19 other events

Deaths: 17 deaths

Phase 2: Cohort 3, HGG

Serious events: 8 serious events

Other events: 11 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 n=5 participants at risk Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 participants at risk Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 1, Ewing Sarcoma n=10 participants at risk Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 2, Rhabdomyosarcoma n=20 participants at risk Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 3, HGG n=11 participants at risk Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Dysphagia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Nausea	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Vomiting	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Pain	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Face oedema	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Pyrexia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Pneumonia aspiration	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Sepsis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Upper respiratory tract infections	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Alanine aminotransferase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Aspartate aminotransferase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Dysarthria	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Headache	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Nystagmus	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Seizure	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Mental status changes	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Vascular disorders Hypotension	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Endocrine disorders Hypothyroidism	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Eye disorders Eyelid oedema	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Oral cavity fistula	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Pneumatosis intestinalis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Cerebrospinal fluid leakage	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Depressed level of consciousness	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Encephalopathy	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Hydrocephalus	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Optic neuritis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Paraesthesia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Vascular disorders Deep vein thrombosis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Pneumonia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).

Other adverse events

Other adverse events
Measure	Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 n=5 participants at risk Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 n=18 participants at risk Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.	Phase 2: Cohort 1, Ewing Sarcoma n=10 participants at risk Participants with recurrent or refractory ewing sarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 2, Rhabdomyosarcoma n=20 participants at risk Participants with recurrent or refractory rhabdomyosarcoma received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.	Phase 2: Cohort 3, HGG n=11 participants at risk Participants with recurrent or refractory HGG received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily for up to 7 cycles (each cycle was 28 days) unless participant discontinued early from the study.
Investigations Electrocardiogram QT prolonged	40.0% 2/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Haemoglobin increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Gamma-glutamyltransferase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations International normalised ratio increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Blood and lymphatic system disorders Anaemia	40.0% 2/5 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 16 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 5/10 • Number of events 17 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	35.0% 7/20 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Cardiac disorders Sinus bradycardia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Blood and lymphatic system disorders Neutropenia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Cardiac disorders Bradycardia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Cardiac disorders Sinus tachycardia	40.0% 2/5 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Cardiac disorders Tachycardia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Cardiac disorders Wolff-Parkinson-White syndrome	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Ear and labyrinth disorders Ear pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Endocrine disorders Hyperthyroidism	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Endocrine disorders Hypothyroidism	40.0% 2/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	55.6% 10/18 • Number of events 13 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 8/20 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	54.5% 6/11 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Endocrine disorders Hyperparathyroidism	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Eye disorders Dry eye	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Eye disorders Miosis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Eye disorders Eye pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Eye disorders Vision blurred	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Abdominal distension	20.0% 1/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Abdominal pain	60.0% 3/5 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 9/18 • Number of events 16 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	35.0% 7/20 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	36.4% 4/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Anal incontinence	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Aphthous ulcer	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Cheilitis	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Constipation	40.0% 2/5 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 4/10 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 8 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Diarrhoea	60.0% 3/5 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	55.6% 10/18 • Number of events 23 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 5/10 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 8/20 • Number of events 11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	63.6% 7/11 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Dry mouth	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Dysphagia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Gingival pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Nausea	80.0% 4/5 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.8% 5/18 • Number of events 8 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	45.0% 9/20 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	36.4% 4/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Oral pain	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Stomatitis	80.0% 4/5 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.8% 5/18 • Number of events 8 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	45.0% 9/20 • Number of events 21 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Toothache	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Vomiting	60.0% 3/5 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	61.1% 11/18 • Number of events 20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	35.0% 7/20 • Number of events 11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	63.6% 7/11 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Pancreatitis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Gastrointestinal disorders Flatulence	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Fatigue	60.0% 3/5 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	60.0% 6/10 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	55.0% 11/20 • Number of events 16 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Influenza like illness	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Localised oedema	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Pyrexia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.8% 5/18 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 4/10 • Number of events 8 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Pain	60.0% 3/5 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Oedema peripheral	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Malaise	20.0% 1/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Non-cardiac chest pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	25.0% 5/20 • Number of events 8 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Peripheral swelling	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Asthenia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Face oedema	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
General disorders Gait disturbances	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Hepatobiliary disorders Steatohepatitis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Immune system disorders Contrast media allergy	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Conjunctivitis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Device related infection	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Oral candidiasis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Otitis media	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Pharyngitis	20.0% 1/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Sinusitis	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Skin infection	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Upper respiratory tract infections	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Urinary tract infection	40.0% 2/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Otitis media acute	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Rash pustular	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Respiratory tract infection viral	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Allergic transfusion reaction	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Contusion	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Fall	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Stoma site pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Tendon rupture	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Procedural pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Wound complication	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Injury, poisoning and procedural complications Wound dehiscence	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Alanine aminotransferase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.8% 5/18 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	35.0% 7/20 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Amylase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Aspartate aminotransferase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.8% 5/18 • Number of events 13 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 4/10 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 8/20 • Number of events 13 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	36.4% 4/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Blood alkaline phosphatase increased	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Blood cholesterol increased	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 23 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	55.0% 11/20 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	36.4% 4/11 • Number of events 12 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Blood creatinine increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Blood thyroid stimulating hormone increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Blood fibrinogen decreased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Blood lactate dehydrogenase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Ejection fraction decreased	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Lipase increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Lymphocyte count decreased	60.0% 3/5 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 13 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	80.0% 8/10 • Number of events 27 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	55.0% 11/20 • Number of events 32 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Neutrophil count decreased	60.0% 3/5 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 12 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	35.0% 7/20 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Platelet count decreased	40.0% 2/5 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	38.9% 7/18 • Number of events 22 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 5/10 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 10/20 • Number of events 21 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Platelet count increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations SARS-CoV-2 test positive	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Weight decreased	40.0% 2/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 12 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations Weight increased	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Investigations White blood cell count decreased	40.0% 2/5 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 16 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	60.0% 6/10 • Number of events 17 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 8/20 • Number of events 24 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 8 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Decreased appetite	80.0% 4/5 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Dehydration	40.0% 2/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypercholesterolaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hyperkalaemia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypertriglyceridaemia	40.0% 2/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	61.1% 11/18 • Number of events 51 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 5/10 • Number of events 18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	60.0% 12/20 • Number of events 26 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	54.5% 6/11 • Number of events 22 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 5/10 • Number of events 13 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 5/10 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypocholesterolaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypokalaemia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 4/10 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hyponatraemia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	33.3% 6/18 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	70.0% 7/10 • Number of events 15 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypophosphataemia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	80.0% 8/10 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypernatraemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Back pain	80.0% 4/5 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Muscular weakness	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Myalgia	60.0% 3/5 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	25.0% 5/20 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Bone pain	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Joint range of motion decreased	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Periostitis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Musculoskeletal and connective tissue disorders Spinal pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Fibrous cortical defect	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Ataxia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Dizziness	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Dysarthria	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Dysgeusia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Headache	60.0% 3/5 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	44.4% 8/18 • Number of events 10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	25.0% 5/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	45.5% 5/11 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Hydrocephalus	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Hypersomnia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Lethargy	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Seizure	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Somnolence	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Tremor	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Intracranial haematoma	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Nervous system disorders Haemorrhage intracranial	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Anxiety	20.0% 1/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Depression	40.0% 2/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Agitation	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Irritability	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Restlessness	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Proteinuria	20.0% 1/5 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	44.4% 8/18 • Number of events 37 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	80.0% 8/10 • Number of events 15 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 10/20 • Number of events 23 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	36.4% 4/11 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Haematuria	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	40.0% 4/10 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	27.3% 3/11 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Dysuria	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Micturition urgency	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Pollakiuria	40.0% 2/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Urinary incontinence	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Urinary retention	20.0% 1/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Urinary tract pain	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Glycosuria	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Renal and urinary disorders Renal tubular dysfunction	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Reproductive system and breast disorders Pelvic pain	20.0% 1/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Cough	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 7 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 4/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 6/20 • Number of events 9 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Nasal congestion	40.0% 2/5 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	25.0% 5/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	35.0% 7/20 • Number of events 12 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Respiratory, thoracic and mediastinal disorders Respiratory distress	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Alopecia	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Dermatitis acneiform	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Dry skin	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	22.2% 4/18 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	20.0% 1/5 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	18.2% 2/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 6 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	15.0% 3/20 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Scab	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Skin atrophy	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Vascular disorders Hot flush	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Vascular disorders Hypertension	80.0% 4/5 • Number of events 14 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	72.2% 13/18 • Number of events 19 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	30.0% 3/10 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	50.0% 10/20 • Number of events 18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	36.4% 4/11 • Number of events 5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Vascular disorders Hypotension	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Infections and infestations Pneumonia	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	16.7% 3/18 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	20.0% 2/10 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Product Issues Device dislocation	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.6% 1/18 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/10 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Psychiatric disorders Insomnia	40.0% 2/5 • Number of events 3 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	11.1% 2/18 • Number of events 4 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 2/20 • Number of events 2 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	9.1% 1/11 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Erythemas	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/20 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/5 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/18 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	10.0% 1/10 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	5.0% 1/20 • Number of events 1 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).	0.00% 0/11 • From date of first dose up to 28 days after the last dose of study treatment (Phase 1: Up to 17.5 months; Phase 2: Up to 7.5 months) SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: [email protected]

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Principal investigator is a sponsor employee
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