Trial Outcomes & Findings for Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma (NCT NCT03173560)

NCT ID: NCT03173560

Last Updated: 2025-04-01

Results Overview

ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (\<) 10 millimeters (mm). PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 343 participants
• Primary outcome timeframe: At Week 24
• Results posted on: 2025-04-01

Participant Flow

Participants took part in the study at 82 investigative sites in Australia, Korea, Taiwan, Czech, Poland, Romania, Russia, Finland, Greece, Italy, Netherlands, Portugal, Spain, United Kingdom, Canada and the United States from 17 August 2017 to 20 June 2024.

A total of 489 participants were screened, of which 146 were screen failures and 343 were enrolled and randomized, out of which 341 participants were treated.

Participant milestones

Measure	Lenvatinib 14 mg + Everolimus 5 mg Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any greater than or equal to (\>=) Grade 3 treatment-emergent adverse events (TEAEs) that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length equals to (=) 28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Overall Study STARTED	172	171
Overall Study Treated Participants	172	169
Overall Study Safety Set	173	168
Overall Study COMPLETED	91	101
Overall Study NOT COMPLETED	81	70

Reasons for withdrawal

Measure	Lenvatinib 14 mg + Everolimus 5 mg Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any greater than or equal to (\>=) Grade 3 treatment-emergent adverse events (TEAEs) that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length equals to (=) 28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Overall Study Death	70	60
Overall Study Lost to Follow-up	1	4
Overall Study Withdrawal by Subject	10	5
Overall Study Other	0	1

Baseline Characteristics

Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

Baseline characteristics by cohort

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=172 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=171 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.	Total n=343 Participants Total of all reporting groups
Age, Continuous	60.5 years STANDARD_DEVIATION 9.59 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.90 • n=7 Participants	61.0 years STANDARD_DEVIATION 9.74 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants	42 Participants n=7 Participants	81 Participants n=5 Participants
Sex: Female, Male Male	133 Participants n=5 Participants	129 Participants n=7 Participants	262 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	163 Participants n=7 Participants	331 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	33 Participants n=5 Participants	27 Participants n=7 Participants	60 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	137 Participants n=5 Participants	140 Participants n=7 Participants	277 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 24

Population: Per-protocol analysis set 1 (PPAS1) included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to interactive voice and web response system (IxRS) issues.

ORR24W was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point, during treatment or within 28 days after the last dose date but on or prior to the start of new anticancer therapy based on investigator assessment according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to less than (<) 10 millimeters (mm). PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=156 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=155 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Objective Response Rate at Week 24 (ORR24W)	32.1 percentage of participants Interval 24.7 to 39.4	34.8 percentage of participants Interval 27.3 to 42.3

PRIMARY outcome

Timeframe: Up to Week 24

Population: Per-protocol safety analysis set included all randomized and treated participants minus 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues according to actual treatment received.

TEAE was defined as an adverse event (AE) with an onset that had occurred after receiving study drug. A severity grade was defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03. As per NCI-CTCAE, Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=157 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=152 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Percentage of Participants With Intolerable Grade 2 or Any Grade >=Grade 3 TEAEs Within 24 Weeks	82.8 percentage of participants Interval 76.9 to 88.7	79.6 percentage of participants Interval 73.2 to 86.0

SECONDARY outcome

Timeframe: From the date of randomization to the date of the first documentation of PD or date of death, whichever occurred first or up to date of data cutoff for the primary analysis (up to 29 months)

Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.

PFS was defined as the time from the date of randomization to the date of the first documentation of PD by investigator assessment or date of death, whichever occurred first according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameter (SOD) of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% confidence interval (CI). As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=156 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=155 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Progression-free Survival (PFS)	11.1 months Interval 9.0 to 12.9	14.7 months Interval 11.1 to 20.3

SECONDARY outcome

Timeframe: From date of randomization up to first documentation of PD or date of death, whichever occurred first or up to the date of data cut off for the primary analysis (up to 29 months)

Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.

ORR was defined as the percentage of participants with a BOR of CR or PR at the at the end of treatment based on investigator assessment according to RECIST v1.1. CR: defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis to <10 mm. PR: defined as at least a 30 % decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. To be considered a BOR, all responses had to be confirmed no less than 4 weeks after the initial assessment of response. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=156 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=155 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Objective Response Rate (ORR)	34.6 percentage of participants Interval 27.1 to 42.1	40.6 percentage of participants Interval 32.9 to 48.4

SECONDARY outcome

Timeframe: From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)

Population: Safety analysis set (SAS) included all participants who were randomized and received at least 1 dose of study drug according to the treatment starting dose actually received.

TEAEs were defined as those adverse events (AEs) that occurred (or worsened, if present at Baseline) after the first dose of study drug through 28 days after the last dose of study drug. An AE was defined as any untoward medical occurrence in a participants or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with medicinal product. A serious adverse event (SAE) was defined as any AE if it resulted in death or life-threatening AE or required inpatient hospitalization or prolongation of existing hospitalization or resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions or was a congenital anomaly/birth defect.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=173 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=168 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Number of Participants With TEAEs and Serious TEAEs Participants With TEAEs	173 Participants	167 Participants
Number of Participants With TEAEs and Serious TEAEs Participants With Serious TEAEs	92 Participants	87 Participants

SECONDARY outcome

Timeframe: From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months)

Population: FAS included all randomized participants.

Percentage of participants who discontinued treatment due to toxicity, defined as the percentage of participants who discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to NCI-CTCAE v4.03.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=172 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=171 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Percentage of Participants Who Discontinued Treatment Due to Toxicity	17.4 percentage of participants	25.1 percentage of participants

SECONDARY outcome

Timeframe: From the date of randomization to the date of discontinuation of study treatment due to TEAEs, or date of data cut off for the primary analysis (up to 29 months)

Population: FAS included all randomized participants.

Time to treatment failure due to toxicity was defined as the time from the date of randomization to the date that a participant discontinued study treatment due to TEAEs. Toxicity (except hypertension and non-infectious pneumonitis) was assessed according to CTCAE v4.03. As planned, data for this secondary outcome measure was collected and analyzed till the primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=172 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=171 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Time to Treatment Failure Due to Toxicity	3.15 months Interval 0.5 to 12.7	5.70 months Interval 0.8 to 24.6

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)

Population: Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma or everolimus whole blood concentration data. Here, "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable for this outcome measure at given time points.

PK sparse sampling was performed. As planned, the post-dose plasma sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=168 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=160 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Plasma Concentration of Lenvatinib Cycle 1 Day 1: 0.5-4 hours post-dose	57.9 nanogram per milliliter (ng/mL) Standard Deviation 96.54	82.3 nanogram per milliliter (ng/mL) Standard Deviation 119.89
Plasma Concentration of Lenvatinib Cycle 1 Day 1: 6-10 hours post-dose	136.3 nanogram per milliliter (ng/mL) Standard Deviation 66.53	193.7 nanogram per milliliter (ng/mL) Standard Deviation 93.08
Plasma Concentration of Lenvatinib Cycle 1 Day 15: Pre-dose	53.7 nanogram per milliliter (ng/mL) Standard Deviation 62.31	64.0 nanogram per milliliter (ng/mL) Standard Deviation 59.71
Plasma Concentration of Lenvatinib Cycle 1 Day 15: 0.5-4 hours post-dose	99.6 nanogram per milliliter (ng/mL) Standard Deviation 102.54	133.4 nanogram per milliliter (ng/mL) Standard Deviation 125.65
Plasma Concentration of Lenvatinib Cycle 1 Day 15: 6-10 hours post-dose	177.8 nanogram per milliliter (ng/mL) Standard Deviation 89.42	236.2 nanogram per milliliter (ng/mL) Standard Deviation 135.21
Plasma Concentration of Lenvatinib Cycle 2 Day 1: Pre-dose	42.8 nanogram per milliliter (ng/mL) Standard Deviation 42.84	50.6 nanogram per milliliter (ng/mL) Standard Deviation 46.06
Plasma Concentration of Lenvatinib Cycle 2 Day 1: 2-12 hours post-dose	172.8 nanogram per milliliter (ng/mL) Standard Deviation 130.90	190.3 nanogram per milliliter (ng/mL) Standard Deviation 114.85

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)

Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma or everolimus whole blood concentration data. Here, "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points.

PK sparse sampling was performed. As planned, the post-dose whole blood sample was collected anytime between 0.5 to 4 hours at Cycle 1 Days 1 and 15, between 6 to 10 hours at Cycle 1 Days 1 and 15, and between 2 to 12 hours at Cycle 2 Day 1. Only one sample was collected for each post-dose category between specified timepoints.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=120 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=117 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Whole Blood Concentration of Everolimus Cycle 1 Day 15: Pre-dose	8.4 ng/mL Standard Deviation 4.84	7.4 ng/mL Standard Deviation 5.51
Whole Blood Concentration of Everolimus Cycle 1 Day 1: 0.5-4 hours post-dose	18.3 ng/mL Standard Deviation 15.89	18.6 ng/mL Standard Deviation 16.39
Whole Blood Concentration of Everolimus Cycle 1 Day 1: 6-10 hours post-dose	9.2 ng/mL Standard Deviation 6.60	8.4 ng/mL Standard Deviation 5.64
Whole Blood Concentration of Everolimus Cycle 1 Day 15: 0.5-4 hours post-dose	23.7 ng/mL Standard Deviation 15.41	23.4 ng/mL Standard Deviation 16.96
Whole Blood Concentration of Everolimus Cycle 1 Day 15: 6-10 hours post-dose	14.3 ng/mL Standard Deviation 5.83	14.3 ng/mL Standard Deviation 9.22
Whole Blood Concentration of Everolimus Cycle 2 Day 1: Pre-dose	7.8 ng/mL Standard Deviation 5.44	5.9 ng/mL Standard Deviation 4.02
Whole Blood Concentration of Everolimus Cycle 2 Day 1: 2-12 hours post-dose	22.9 ng/mL Standard Deviation 12.67	19.5 ng/mL Standard Deviation 9.74

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)

Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.

Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib CL/F value was derived from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=48 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=443 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Model Predicted Apparent Total Clearance (CL/F) for Lenvatinib Alone and When Coadministration With Everolimus in Renal Cell Carcinoma (RCC) Participants to Assess Drug-Drug Interaction	6.37 liter per hour (L/h) Standard Deviation 2.01	5.77 liter per hour (L/h) Standard Deviation 2.01

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)

Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable lenvatinib plasma concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.

Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The lenvatinib concentration data was pooled from studies E7080 -G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) and from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for lenvatinib was fitted to the pooled dataset. Individual lenvatinib AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model. The outcome measure was assessed for lenvatinib 18 mg dose only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=48 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=443 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Model Predicted Dose Normalized Area Under the Plasma Concentration-time Curve (AUC) for Lenvatinib Alone and When Coadministration With Everolimus in RCC Participants to Assess Drug-Drug Interaction	3693 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 1295	4350 nanogram*hour per milliliter (ng*h/mL) Standard Deviation 2934

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)

Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable everolimus whole blood concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.

Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus CL/F value was derived from the final PK model.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=33 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=345 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Model Predicted CL/F for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction	22.3 liter per hour (L/h) Standard Deviation 10.5	19.4 liter per hour (L/h) Standard Deviation 7.9

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 0.5-4 hours and 6-10 hours post-dose; Cycle 1 Day 15: pre-dose, 0.5-4 hours and 6-10 hours post-dose; Cycle 2 Day 1: pre-dose and 2-12 hours post-dose (each cycle length =28 days)

Population: PK analysis set included all participants who received at least 1 dose of study drug with documented dosing history and had at least 1 evaluable everolimus whole blood concentration data. Population included participants from E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or current study E7080-G000-218 (NCT03173560). Here, "overall number of participants analyzed" are the participants who were evaluable for this outcome measure.

Sparse PK samples were collected and analyzed using a population PK approach to estimate PK parameters. The everolimus concentration data was pooled from studies E7080-G000-205 (NCT01136733), E7080-M001-221 (NCT02915783), E7080-J081-112 (NCT02454478) or from current study E7080-G000-218 (NCT03173560). A previously developed 3-compartment PK model for everolimus was fitted to the pooled dataset. Individual everolimus AUC at steady state based on the starting dose was derived as a function of starting dose from the final PK model.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=33 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=345 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Model Predicted Dose Normalized AUC for Everolimus Alone and When Coadministration With Lenvatinib in RCC Participants to Assess Drug-Drug Interaction	507.4 ng*hour/mL Standard Deviation 176.6	305.5 ng*hour/mL Standard Deviation 174.0

SECONDARY outcome

Timeframe: From the date of randomization until the date of death from any cause, or up to date of data cut off for the primary analysis (up to 29 months)

Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.

OS was defined as the time from the date of randomization until the date of death from any cause. In the absence of confirmation of death, participants will be censored either at the date that the participant was last known to be alive or the date of data cutoff for the primary analysis, whichever comes earlier. Median OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=156 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=155 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Overall Survival (OS)	27.0 months Interval 18.3 to Upper limit of 95% CI was not estimable because insufficient number of participants had events.	NA months Interval 23.8 to Median and upper limit of 95% CI was not estimable because insufficient number of participants had events.

SECONDARY outcome

Timeframe: At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)

Population: Quality of Life (QoL) analysis set consisted of all participants who had any QoL data. Here "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points.

The FKSI-DRS consisted of 9 items that experts and participants had indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts had indicated are primarily disease-related, as opposed to treatment-related. Symptoms assessed on the FKSI-DRS included lack of energy, fatigue, weight loss, pain, bone pain, shortness of breath, cough, fever, or hematuria. Each item was scored on a 5-point Likert-type scale (0 = not at all; 4 = very much) where total score ranged from 0 (worst) to 36 (best), where higher scores correspond to better outcomes. As pre-specified in the protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=169 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=162 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Baseline	29.69 score on a scale Standard Deviation 4.819	29 score on a scale Standard Deviation 5.886
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 2 Day 1	28.43 score on a scale Standard Deviation 5.269	28.31 score on a scale Standard Deviation 5.162
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 3 Day 1	28.26 score on a scale Standard Deviation 5.344	28.80 score on a scale Standard Deviation 5.455
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 4 Day 1	27.97 score on a scale Standard Deviation 5.524	29.11 score on a scale Standard Deviation 5.183
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 5 Day 1	28 score on a scale Standard Deviation 5.680	29.14 score on a scale Standard Deviation 5.081
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 6 Day 1	28.63 score on a scale Standard Deviation 5.185	29.46 score on a scale Standard Deviation 5.107
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 7 Day 1	28.31 score on a scale Standard Deviation 5.486	29.58 score on a scale Standard Deviation 4.803
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 8 Day 1	28.36 score on a scale Standard Deviation 6.204	29.85 score on a scale Standard Deviation 4.610
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 9 Day 1	28.58 score on a scale Standard Deviation 5.562	29.84 score on a scale Standard Deviation 5.005
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 10 Day 1	29.10 score on a scale Standard Deviation 5.294	30.70 score on a scale Standard Deviation 4.297
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 11 Day 1	29.56 score on a scale Standard Deviation 5.035	30.09 score on a scale Standard Deviation 5.316
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 12 Day 1	29.34 score on a scale Standard Deviation 5.149	30.75 score on a scale Standard Deviation 5.127
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 13 Day 1	29.26 score on a scale Standard Deviation 4.851	30.93 score on a scale Standard Deviation 4.201
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 14 Day 1	29.81 score on a scale Standard Deviation 4.752	31.06 score on a scale Standard Deviation 4.830
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 15 Day 1	30.09 score on a scale Standard Deviation 5.121	30.52 score on a scale Standard Deviation 4.417
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 16 Day 1	29.93 score on a scale Standard Deviation 5.293	30.91 score on a scale Standard Deviation 4.704
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 17 Day 1	29.36 score on a scale Standard Deviation 5.233	31.52 score on a scale Standard Deviation 4.875
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 18 Day 1	29.81 score on a scale Standard Deviation 4.293	31.41 score on a scale Standard Deviation 4.639
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 19 Day 1	28.48 score on a scale Standard Deviation 6.216	30.82 score on a scale Standard Deviation 4.469
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 20 Day 1	28.77 score on a scale Standard Deviation 6.058	30.69 score on a scale Standard Deviation 4.575
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 21 Day 1	29.35 score on a scale Standard Deviation 4.707	32 score on a scale Standard Deviation 3.243
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 22 Day 1	30.32 score on a scale Standard Deviation 4.978	30.59 score on a scale Standard Deviation 5.168
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 23 Day 1	30.53 score on a scale Standard Deviation 3.998	30.29 score on a scale Standard Deviation 5.544
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 24 Day 1	29.47 score on a scale Standard Deviation 5.041	31.58 score on a scale Standard Deviation 3.977
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 25 Day 1	27.92 score on a scale Standard Deviation 6.388	31.69 score on a scale Standard Deviation 4.270
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 26 Day 1	28.75 score on a scale Standard Deviation 4.862	29.82 score on a scale Standard Deviation 6.422
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 27 Day 1	29.83 score on a scale Standard Deviation 5.345	32.86 score on a scale Standard Deviation 2.854
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 28 Day 1	30.50 score on a scale Standard Deviation 4.435	33.67 score on a scale Standard Deviation 1.862
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 29 Day 1	29.50 score on a scale Standard Deviation 4.359	33.40 score on a scale Standard Deviation 1.342
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 30 Day 1	30.75 score on a scale Standard Deviation 4.031	36 score on a scale
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Cycle 31 Day 1	31 score on a scale	—
Health-Related Quality of Life (HRQoL) Assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) Scores Off-treatment Visit	27.42 score on a scale Standard Deviation 5.953	27.86 score on a scale Standard Deviation 6.500

SECONDARY outcome

Timeframe: At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)

Population: QoL analysis set consisted of all participants who had any QoL data. Here, overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points.

The EORT QLQ-C30 consisted of 30 questions comprising 9 multiple-item scales and 6 single items. Multiple-item scales of QLQ-C30 consisted of 5 functional scales (physical, role, emotional, cognitive, and social) and 3 symptom scales (fatigue, nausea and vomiting, pain) and a global health status/QOL score. Six single-item scales of QLQ-C30 involved dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. First 28 questions used a 4-point scale (1 = Not at all to 4 = Very much); and last 2 questions used a 7-point scale (1 = Very poor to 7 = Excellent). Scores for all scales range from 0 to 100. For the overall HRQoL and functioning scales, a higher score was correlated with better HRQoL, whereas a higher score for symptom scales represented worse HRQoL. As pre-specified in protocol, data for secondary outcome measure was collected and analyzed till primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=171 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=162 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 16 Day 1	70.33 score on a scale Standard Deviation 23.426	79.08 score on a scale Standard Deviation 21.272
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 25 Day 1	72.78 score on a scale Standard Deviation 15.688	84.17 score on a scale Standard Deviation 15.753
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 26 Day 1	76.67 score on a scale Standard Deviation 6.172	71.79 score on a scale Standard Deviation 29.833
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 27 Day 1	76.67 score on a scale Standard Deviation 6.992	85.71 score on a scale Standard Deviation 16.523
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 28 Day 1	78.33 score on a scale Standard Deviation 3.333	90 score on a scale Standard Deviation 15.635
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 29 Day 1	78.33 score on a scale Standard Deviation 3.333	86.67 score on a scale Standard Deviation 16.330
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 30 Day 1	76.67 score on a scale Standard Deviation 3.849	100 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 31 Day 1	80 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Off-treatment Visit	64.50 score on a scale Standard Deviation 25.891	70.41 score on a scale Standard Deviation 25.139
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Baseline	73.78 score on a scale Standard Deviation 27.471	75.72 score on a scale Standard Deviation 27.932
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 2 Day 1	68.25 score on a scale Standard Deviation 27.951	69.33 score on a scale Standard Deviation 27.449
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 3 Day 1	67 score on a scale Standard Deviation 28.136	72.18 score on a scale Standard Deviation 25.630
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 4 Day 1	66.67 score on a scale Standard Deviation 27.993	73.60 score on a scale Standard Deviation 26.169
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 5 Day 1	67.32 score on a scale Standard Deviation 28.479	72.44 score on a scale Standard Deviation 25.143
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 6 Day 1	68.16 score on a scale Standard Deviation 27.245	73.75 score on a scale Standard Deviation 27.557
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 7 Day 1	66.51 score on a scale Standard Deviation 27.424	73.97 score on a scale Standard Deviation 25.205
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 8 Day 1	68.20 score on a scale Standard Deviation 27.712	75.60 score on a scale Standard Deviation 26.139
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 17 Day 1	65.74 score on a scale Standard Deviation 22.868	83.75 score on a scale Standard Deviation 18.292
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 18 Day 1	67.74 score on a scale Standard Deviation 20.609	82.35 score on a scale Standard Deviation 22.073
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 19 Day 1	67.28 score on a scale Standard Deviation 28.300	77.45 score on a scale Standard Deviation 23.883
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 20 Day 1	70.37 score on a scale Standard Deviation 23.266	79.57 score on a scale Standard Deviation 24.612
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 21 Day 1	69.23 score on a scale Standard Deviation 21.956	81.55 score on a scale Standard Deviation 19.948
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 22 Day 1	75.44 score on a scale Standard Deviation 20.313	77.78 score on a scale Standard Deviation 22.169
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 23 Day 1	73.33 score on a scale Standard Deviation 25.040	79.86 score on a scale Standard Deviation 23.560
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 24 Day 1	78.89 score on a scale Standard Deviation 16.019	83.33 score on a scale Standard Deviation 19.245
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 9 Day 1	67.58 score on a scale Standard Deviation 26.101	75.91 score on a scale Standard Deviation 25.242
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 10 Day 1	68.52 score on a scale Standard Deviation 27.131	76.89 score on a scale Standard Deviation 24.027
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 25 Day 1	77.78 score on a scale Standard Deviation 17.885	82.29 score on a scale Standard Deviation 23.936
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 11 Day 1	69.57 score on a scale Standard Deviation 25.237	79.11 score on a scale Standard Deviation 23.691
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 26 Day 1	75 score on a scale Standard Deviation 12.599	69.23 score on a scale Standard Deviation 31.066
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 27 Day 1	77.78 score on a scale Standard Deviation 13.608	90.48 score on a scale Standard Deviation 16.265
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Baseline	63.35 score on a scale Standard Deviation 22.020	63.58 score on a scale Standard Deviation 21.340
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 2 Day 1	58.60 score on a scale Standard Deviation 21.234	60.93 score on a scale Standard Deviation 20.280
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 3 Day 1	56.43 score on a scale Standard Deviation 24.065	61.85 score on a scale Standard Deviation 20.202
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 4 Day 1	58.71 score on a scale Standard Deviation 19.754	62.62 score on a scale Standard Deviation 19.641
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 5 Day 1	59.38 score on a scale Standard Deviation 21.670	63.76 score on a scale Standard Deviation 20.339
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 6 Day 1	58.75 score on a scale Standard Deviation 21.028	63.73 score on a scale Standard Deviation 19.756
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 7 Day 1	58.72 score on a scale Standard Deviation 20.134	62.54 score on a scale Standard Deviation 20.153
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 8 Day 1	58.68 score on a scale Standard Deviation 20.409	62.11 score on a scale Standard Deviation 20.271
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 9 Day 1	58.97 score on a scale Standard Deviation 18.726	63.77 score on a scale Standard Deviation 20.429
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 10 Day 1	63.13 score on a scale Standard Deviation 19.612	66.44 score on a scale Standard Deviation 19.012
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 11 Day 1	60.87 score on a scale Standard Deviation 18.705	65.86 score on a scale Standard Deviation 21.173
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 12 Day 1	57.81 score on a scale Standard Deviation 18.891	66.94 score on a scale Standard Deviation 18.409
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 13 Day 1	59.39 score on a scale Standard Deviation 19.047	68.94 score on a scale Standard Deviation 18.388
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 14 Day 1	61.56 score on a scale Standard Deviation 17.498	70.35 score on a scale Standard Deviation 15.605
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 15 Day 1	62.98 score on a scale Standard Deviation 16.795	66.83 score on a scale Standard Deviation 16.955
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 16 Day 1	61.59 score on a scale Standard Deviation 17.567	64.54 score on a scale Standard Deviation 19.386
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 17 Day 1	60.88 score on a scale Standard Deviation 16.882	67.71 score on a scale Standard Deviation 18.794
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 18 Day 1	59.68 score on a scale Standard Deviation 16.258	68.38 score on a scale Standard Deviation 17.859
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 19 Day 1	58.33 score on a scale Standard Deviation 19.747	66.67 score on a scale Standard Deviation 15.215
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 22 Day 1	17.54 score on a scale Standard Deviation 20.393	12.35 score on a scale Standard Deviation 18.829
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 20 Day 1	58.95 score on a scale Standard Deviation 18.479	66.40 score on a scale Standard Deviation 15.736
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 21 Day 1	57.05 score on a scale Standard Deviation 18.362	71.13 score on a scale Standard Deviation 15.463
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 22 Day 1	62.72 score on a scale Standard Deviation 14.532	66.05 score on a scale Standard Deviation 17.438
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 23 Day 1	60 score on a scale Standard Deviation 15.494	66.67 score on a scale Standard Deviation 14.948
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 24 Day 1	64.44 score on a scale Standard Deviation 17.385	65.79 score on a scale Standard Deviation 18.818
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 25 Day 1	58.33 score on a scale Standard Deviation 16.667	69.79 score on a scale Standard Deviation 14.868
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 26 Day 1	59.38 score on a scale Standard Deviation 15.064	60.90 score on a scale Standard Deviation 18.442
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 27 Day 1	59.72 score on a scale Standard Deviation 18.572	71.43 score on a scale Standard Deviation 18.545
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 28 Day 1	58.33 score on a scale Standard Deviation 21.517	77.78 score on a scale Standard Deviation 13.608
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 29 Day 1	56.25 score on a scale Standard Deviation 18.478	75 score on a scale Standard Deviation 16.667
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 30 Day 1	54.17 score on a scale Standard Deviation 15.957	66.67 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Global Health Status/QoL Score; Off-treatment Visit	51.04 score on a scale Standard Deviation 23.133	56.05 score on a scale Standard Deviation 22.363
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Baseline	76.36 score on a scale Standard Deviation 19.282	76.60 score on a scale Standard Deviation 21.855
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 2 Day 1	73.54 score on a scale Standard Deviation 19.857	75.38 score on a scale Standard Deviation 19.706
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 3 Day 1	72.74 score on a scale Standard Deviation 21.227	76.15 score on a scale Standard Deviation 19.160
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 4 Day 1	70.90 score on a scale Standard Deviation 20.873	75.40 score on a scale Standard Deviation 20.155
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 5 Day 1	72.80 score on a scale Standard Deviation 19.284	77.85 score on a scale Standard Deviation 18.342
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 6 Day 1	72.17 score on a scale Standard Deviation 21.694	77.76 score on a scale Standard Deviation 18.562
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 7 Day 1	73.02 score on a scale Standard Deviation 20.769	78.41 score on a scale Standard Deviation 18.034
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 8 Day 1	72.77 score on a scale Standard Deviation 20.422	79.11 score on a scale Standard Deviation 17.707
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 9 Day 1	74.54 score on a scale Standard Deviation 19.389	80.60 score on a scale Standard Deviation 16.041
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 10 Day 1	75.06 score on a scale Standard Deviation 18.908	81.20 score on a scale Standard Deviation 16.271
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 11 Day 1	73.72 score on a scale Standard Deviation 18.073	81.13 score on a scale Standard Deviation 16.638
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 12 Day 1	75.52 score on a scale Standard Deviation 17.080	83.01 score on a scale Standard Deviation 15.254
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 13 Day 1	74.55 score on a scale Standard Deviation 17.874	80.24 score on a scale Standard Deviation 16.873
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 14 Day 1	75.78 score on a scale Standard Deviation 16.925	82.39 score on a scale Standard Deviation 16.387
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 15 Day 1	75.45 score on a scale Standard Deviation 16.629	80.92 score on a scale Standard Deviation 17.283
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 16 Day 1	73.46 score on a scale Standard Deviation 17.129	81.74 score on a scale Standard Deviation 15.982
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 17 Day 1	71.85 score on a scale Standard Deviation 17.896	82.33 score on a scale Standard Deviation 15.657
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 18 Day 1	75.48 score on a scale Standard Deviation 17.838	81.52 score on a scale Standard Deviation 16.135
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 19 Day 1	76.67 score on a scale Standard Deviation 15.771	81.57 score on a scale Standard Deviation 16.002
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 20 Day 1	73.09 score on a scale Standard Deviation 22.071	82.80 score on a scale Standard Deviation 13.854
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 21 Day 1	74.62 score on a scale Standard Deviation 18.668	84.29 score on a scale Standard Deviation 12.335
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 22 Day 1	80.35 score on a scale Standard Deviation 14.483	82.72 score on a scale Standard Deviation 15.164
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 23 Day 1	79.56 score on a scale Standard Deviation 14.357	81.39 score on a scale Standard Deviation 17.248
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Physical Functioning Score; Cycle 24 Day 1	77.33 score on a scale Standard Deviation 16.676	83.86 score on a scale Standard Deviation 13.755
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 12 Day 1	70.51 score on a scale Standard Deviation 24.785	80.91 score on a scale Standard Deviation 22.953
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 13 Day 1	69.64 score on a scale Standard Deviation 24.434	80 score on a scale Standard Deviation 24.721
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 14 Day 1	71.09 score on a scale Standard Deviation 24.242	81.13 score on a scale Standard Deviation 23.121
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 15 Day 1	72.73 score on a scale Standard Deviation 22.184	74.84 score on a scale Standard Deviation 25.685
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 23 Day 1	13.33 score on a scale Standard Deviation 21.082	11.11 score on a scale Standard Deviation 18.822
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 30 Day 1	87.50 score on a scale Standard Deviation 15.957	100 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Baseline	79.35 score on a scale Standard Deviation 19.704	80.06 score on a scale Standard Deviation 19.729
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 2 Day 1	79.41 score on a scale Standard Deviation 19.465	82.06 score on a scale Standard Deviation 19.167
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 13 Day 1	79.32 score on a scale Standard Deviation 17.908	87.27 score on a scale Standard Deviation 15.783
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 20 Day 1	16.67 score on a scale Standard Deviation 23.113	10.22 score on a scale Standard Deviation 15.915
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 23 Day 1	5.56 score on a scale Standard Deviation 12.062	6.25 score on a scale Standard Deviation 11.849
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 25 Day 1	13.89 score on a scale Standard Deviation 21.122	2.08 score on a scale Standard Deviation 8.333
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 26 Day 1	4.17 score on a scale Standard Deviation 7.715	14.10 score on a scale Standard Deviation 24.387
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 30 Day 1	8.33 score on a scale Standard Deviation 16.667	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Baseline	23.39 score on a scale Standard Deviation 25.410	23.77 score on a scale Standard Deviation 26.323
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 2 Day 1	26.79 score on a scale Standard Deviation 25.850	27.04 score on a scale Standard Deviation 23.862
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 3 Day 1	27.63 score on a scale Standard Deviation 24.103	25 score on a scale Standard Deviation 24.046
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 4 Day 1	26.67 score on a scale Standard Deviation 24.788	22.87 score on a scale Standard Deviation 21.486
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 5 Day 1	29.04 score on a scale Standard Deviation 26.805	22.97 score on a scale Standard Deviation 22.314
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 6 Day 1	26.29 score on a scale Standard Deviation 24.887	22.50 score on a scale Standard Deviation 25.716
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 8 Day 1	27.38 score on a scale Standard Deviation 23.722	23.20 score on a scale Standard Deviation 24.949
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 9 Day 1	27.11 score on a scale Standard Deviation 23.393	21.01 score on a scale Standard Deviation 20.053
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 11 Day 1	27.29 score on a scale Standard Deviation 22.319	18.06 score on a scale Standard Deviation 20.508
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 12 Day 1	26.41 score on a scale Standard Deviation 21.018	18.55 score on a scale Standard Deviation 19.814
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 13 Day 1	24.40 score on a scale Standard Deviation 20.092	18.48 score on a scale Standard Deviation 20.203
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 14 Day 1	22.11 score on a scale Standard Deviation 22.666	16.04 score on a scale Standard Deviation 19.601
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 15 Day 1	24.24 score on a scale Standard Deviation 23.966	17.65 score on a scale Standard Deviation 18.078
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 16 Day 1	29.67 score on a scale Standard Deviation 25.417	18.44 score on a scale Standard Deviation 20.628
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 17 Day 1	27.78 score on a scale Standard Deviation 25.198	17.50 score on a scale Standard Deviation 19.954
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 18 Day 1	25.27 score on a scale Standard Deviation 20.125	16.67 score on a scale Standard Deviation 18.803
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 19 Day 1	31.48 score on a scale Standard Deviation 23.266	19.61 score on a scale Standard Deviation 22.274
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 20 Day 1	29.63 score on a scale Standard Deviation 23.266	19.35 score on a scale Standard Deviation 21.558
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 21 Day 1	26.92 score on a scale Standard Deviation 23.131	17.86 score on a scale Standard Deviation 21.721
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 22 Day 1	23.68 score on a scale Standard Deviation 17.843	22.84 score on a scale Standard Deviation 24.085
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 23 Day 1	21.11 score on a scale Standard Deviation 14.729	18.06 score on a scale Standard Deviation 23.527
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 24 Day 1	22.22 score on a scale Standard Deviation 20.574	14.91 score on a scale Standard Deviation 19.160
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 25 Day 1	27.78 score on a scale Standard Deviation 23.925	15.63 score on a scale Standard Deviation 19.691
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 26 Day 1	27.08 score on a scale Standard Deviation 21.708	21.79 score on a scale Standard Deviation 27.542
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 27 Day 1	25 score on a scale Standard Deviation 20.412	11.90 score on a scale Standard Deviation 24.934
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 28 Day 1	25 score on a scale Standard Deviation 21.517	2.78 score on a scale Standard Deviation 6.804
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 29 Day 1	25 score on a scale Standard Deviation 21.517	6.67 score on a scale Standard Deviation 14.907
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 30 Day 1	25 score on a scale Standard Deviation 16.667	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Off-treatment Visit	28.33 score on a scale Standard Deviation 27.354	27.70 score on a scale Standard Deviation 28.171
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Baseline	21.18 score on a scale Standard Deviation 25.562	22.22 score on a scale Standard Deviation 26.006
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 2 Day 1	18.90 score on a scale Standard Deviation 24.248	19.56 score on a scale Standard Deviation 23.865
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 3 Day 1	20.63 score on a scale Standard Deviation 24.155	19.72 score on a scale Standard Deviation 23.871
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 4 Day 1	19.90 score on a scale Standard Deviation 24.224	17.52 score on a scale Standard Deviation 20.643
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 5 Day 1	19.16 score on a scale Standard Deviation 23.201	15.75 score on a scale Standard Deviation 20.925
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 6 Day 1	16.67 score on a scale Standard Deviation 21.104	18.89 score on a scale Standard Deviation 23.957
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 7 Day 1	19.37 score on a scale Standard Deviation 23.922	15.87 score on a scale Standard Deviation 21.728
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 8 Day 1	19.24 score on a scale Standard Deviation 23.489	14.09 score on a scale Standard Deviation 20.319
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 9 Day 1	15.93 score on a scale Standard Deviation 20.740	14.49 score on a scale Standard Deviation 21.712
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 10 Day 1	17.92 score on a scale Standard Deviation 21.832	11.56 score on a scale Standard Deviation 19.369
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 11 Day 1	18.63 score on a scale Standard Deviation 23.310	15.02 score on a scale Standard Deviation 23.764
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 12 Day 1	13.54 score on a scale Standard Deviation 21.998	12.90 score on a scale Standard Deviation 22.057
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 13 Day 1	13.69 score on a scale Standard Deviation 20.867	10.91 score on a scale Standard Deviation 20.341
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 14 Day 1	15.65 score on a scale Standard Deviation 21.626	10.69 score on a scale Standard Deviation 20.437
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 15 Day 1	15.15 score on a scale Standard Deviation 19.628	12.42 score on a scale Standard Deviation 21.040
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 16 Day 1	16.26 score on a scale Standard Deviation 22.512	9.93 score on a scale Standard Deviation 16.904
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 17 Day 1	15.74 score on a scale Standard Deviation 20.293	10 score on a scale Standard Deviation 20.255
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 18 Day 1	16.13 score on a scale Standard Deviation 20.854	10.78 score on a scale Standard Deviation 17.829
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 19 Day 1	15.38 score on a scale Standard Deviation 21.563	9.80 score on a scale Standard Deviation 17.465
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 20 Day 1	23.46 score on a scale Standard Deviation 20.286	11.83 score on a scale Standard Deviation 16.212
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 21 Day 1	15.38 score on a scale Standard Deviation 16.946	7.14 score on a scale Standard Deviation 13.929
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 24 Day 1	20 score on a scale Standard Deviation 21.082	12.28 score on a scale Standard Deviation 16.520
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 25 Day 1	22.22 score on a scale Standard Deviation 29.588	8.33 score on a scale Standard Deviation 14.907
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 26 Day 1	16.67 score on a scale Standard Deviation 17.817	15.38 score on a scale Standard Deviation 22.008
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 27 Day 1	11.11 score on a scale Standard Deviation 17.213	14.29 score on a scale Standard Deviation 17.817
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 28 Day 1	16.67 score on a scale Standard Deviation 19.245	16.67 score on a scale Standard Deviation 18.257
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 29 Day 1	25 score on a scale Standard Deviation 16.667	20 score on a scale Standard Deviation 18.257
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 30 Day 1	16.67 score on a scale Standard Deviation 19.245	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Dyspnea Score; Off-treatment Visit	24.68 score on a scale Standard Deviation 27.254	21.62 score on a scale Standard Deviation 28.898
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Baseline	23.08 score on a scale Standard Deviation 26.972	22.84 score on a scale Standard Deviation 27.671
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 2 Day 1	26.11 score on a scale Standard Deviation 27.038	19.91 score on a scale Standard Deviation 25.386
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 3 Day 1	30.39 score on a scale Standard Deviation 29.435	23 score on a scale Standard Deviation 25.477
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 4 Day 1	26.57 score on a scale Standard Deviation 28.057	20.19 score on a scale Standard Deviation 24.036
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 5 Day 1	23.02 score on a scale Standard Deviation 26.487	22.05 score on a scale Standard Deviation 24.205
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 6 Day 1	24.86 score on a scale Standard Deviation 26.955	17.50 score on a scale Standard Deviation 22.019
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 7 Day 1	25.08 score on a scale Standard Deviation 27.651	20 score on a scale Standard Deviation 25.149
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 8 Day 1	26.46 score on a scale Standard Deviation 28.843	19.59 score on a scale Standard Deviation 25.346
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 9 Day 1	25.56 score on a scale Standard Deviation 27.392	16.67 score on a scale Standard Deviation 21.255
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 10 Day 1	24.58 score on a scale Standard Deviation 25.844	18.22 score on a scale Standard Deviation 22.789
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 11 Day 1	24.02 score on a scale Standard Deviation 26.918	17.37 score on a scale Standard Deviation 24.468
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 12 Day 1	23.44 score on a scale Standard Deviation 23.518	13.98 score on a scale Standard Deviation 22.216
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 13 Day 1	21.43 score on a scale Standard Deviation 21.489	13.33 score on a scale Standard Deviation 21.849
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 14 Day 1	18.06 score on a scale Standard Deviation 23.778	11.95 score on a scale Standard Deviation 21.774
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 15 Day 1	18.94 score on a scale Standard Deviation 20.832	16 score on a scale Standard Deviation 23.561
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 16 Day 1	20.33 score on a scale Standard Deviation 20.921	14.89 score on a scale Standard Deviation 21.768
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 17 Day 1	17.59 score on a scale Standard Deviation 16.877	13.33 score on a scale Standard Deviation 21.082
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 18 Day 1	27.96 score on a scale Standard Deviation 25.958	11.76 score on a scale Standard Deviation 19.903
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 19 Day 1	24.69 score on a scale Standard Deviation 25.474	13.73 score on a scale Standard Deviation 21.893
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 20 Day 1	25.93 score on a scale Standard Deviation 25.036	12.90 score on a scale Standard Deviation 20.507
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 21 Day 1	23.08 score on a scale Standard Deviation 27.919	10.71 score on a scale Standard Deviation 18.265
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 22 Day 1	21.05 score on a scale Standard Deviation 19.909	6.17 score on a scale Standard Deviation 16.111
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 23 Day 1	26.67 score on a scale Standard Deviation 22.537	11.11 score on a scale Standard Deviation 23.399
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 24 Day 1	24.44 score on a scale Standard Deviation 26.627	12.28 score on a scale Standard Deviation 19.909
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 25 Day 1	16.67 score on a scale Standard Deviation 17.408	12.50 score on a scale Standard Deviation 20.638
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 26 Day 1	16.67 score on a scale Standard Deviation 17.817	20.51 score on a scale Standard Deviation 32.026
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 27 Day 1	22.22 score on a scale Standard Deviation 17.213	9.52 score on a scale Standard Deviation 16.265
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 28 Day 1	25 score on a scale Standard Deviation 16.667	11.11 score on a scale Standard Deviation 17.213
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 29 Day 1	25 score on a scale Standard Deviation 16.667	13.33 score on a scale Standard Deviation 18.257
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 16 Day 1	81.50 score on a scale Standard Deviation 17.432	87.41 score on a scale Standard Deviation 14.935
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 17 Day 1	79.63 score on a scale Standard Deviation 19.664	87.08 score on a scale Standard Deviation 16.118
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 18 Day 1	81.90 score on a scale Standard Deviation 15.330	86.76 score on a scale Standard Deviation 16.555
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 19 Day 1	81.17 score on a scale Standard Deviation 15.945	84.80 score on a scale Standard Deviation 18.403
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 20 Day 1	80.25 score on a scale Standard Deviation 17.925	86.56 score on a scale Standard Deviation 17.437
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 21 Day 1	81.73 score on a scale Standard Deviation 15.279	88.99 score on a scale Standard Deviation 14.174
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 22 Day 1	85.09 score on a scale Standard Deviation 16.096	89.20 score on a scale Standard Deviation 15.644
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 23 Day 1	86.67 score on a scale Standard Deviation 15.366	87.15 score on a scale Standard Deviation 15.922
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 24 Day 1	88.89 score on a scale Standard Deviation 14.319	87.28 score on a scale Standard Deviation 13.712
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 25 Day 1	83.33 score on a scale Standard Deviation 18.119	90.63 score on a scale Standard Deviation 12.500
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 26 Day 1	77.08 score on a scale Standard Deviation 23.038	85.26 score on a scale Standard Deviation 23.362
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 27 Day 1	80.56 score on a scale Standard Deviation 16.387	95.24 score on a scale Standard Deviation 12.599
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 28 Day 1	75 score on a scale Standard Deviation 16.667	100 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 29 Day 1	75 score on a scale Standard Deviation 16.667	100 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 30 Day 1	75 score on a scale Standard Deviation 16.667	100 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 31 Day 1	66.67 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Off-treatment Visit	69.62 score on a scale Standard Deviation 27.304	73.87 score on a scale Standard Deviation 25.145
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Baseline	87.91 score on a scale Standard Deviation 15.764	89.51 score on a scale Standard Deviation 15.529
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 2 Day 1	87.15 score on a scale Standard Deviation 15.661	88.85 score on a scale Standard Deviation 18.025
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 3 Day 1	84.45 score on a scale Standard Deviation 19.049	87.47 score on a scale Standard Deviation 17.946
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 4 Day 1	83.58 score on a scale Standard Deviation 19.461	90.32 score on a scale Standard Deviation 13.692
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 5 Day 1	83.99 score on a scale Standard Deviation 17.239	87.43 score on a scale Standard Deviation 17.086
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 6 Day 1	84.71 score on a scale Standard Deviation 16.886	87.68 score on a scale Standard Deviation 18.470
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 7 Day 1	82.40 score on a scale Standard Deviation 18.855	87.94 score on a scale Standard Deviation 14.708
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 8 Day 1	81.97 score on a scale Standard Deviation 21.227	88.49 score on a scale Standard Deviation 16.380
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 9 Day 1	83.70 score on a scale Standard Deviation 18.084	87.68 score on a scale Standard Deviation 17.095
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 10 Day 1	85.39 score on a scale Standard Deviation 17.947	90.44 score on a scale Standard Deviation 13.747
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 11 Day 1	84.06 score on a scale Standard Deviation 18.176	88.89 score on a scale Standard Deviation 15.824
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 12 Day 1	85.42 score on a scale Standard Deviation 16.400	88.61 score on a scale Standard Deviation 17.758
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 13 Day 1	83.93 score on a scale Standard Deviation 17.685	89.70 score on a scale Standard Deviation 12.624
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 14 Day 1	85.71 score on a scale Standard Deviation 18.634	87.18 score on a scale Standard Deviation 16.375
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 15 Day 1	84.85 score on a scale Standard Deviation 18.264	83.99 score on a scale Standard Deviation 17.308
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 16 Day 1	83.74 score on a scale Standard Deviation 18.062	89.36 score on a scale Standard Deviation 13.649
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 17 Day 1	82.87 score on a scale Standard Deviation 18.033	89.58 score on a scale Standard Deviation 14.465
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 18 Day 1	83.87 score on a scale Standard Deviation 17.994	90.20 score on a scale Standard Deviation 15.417
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 19 Day 1	80.25 score on a scale Standard Deviation 18.511	89.22 score on a scale Standard Deviation 14.727
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 20 Day 1	82.10 score on a scale Standard Deviation 17.250	91.94 score on a scale Standard Deviation 12.073
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 21 Day 1	81.41 score on a scale Standard Deviation 19.623	88.10 score on a scale Standard Deviation 12.715
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 22 Day 1	88.60 score on a scale Standard Deviation 14.754	90.12 score on a scale Standard Deviation 12.454
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 23 Day 1	83.33 score on a scale Standard Deviation 16.667	88.19 score on a scale Standard Deviation 14.311
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 24 Day 1	84.44 score on a scale Standard Deviation 16.019	92.11 score on a scale Standard Deviation 8.550
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 25 Day 1	84.72 score on a scale Standard Deviation 15.006	98.96 score on a scale Standard Deviation 4.167
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 26 Day 1	89.58 score on a scale Standard Deviation 12.400	92.31 score on a scale Standard Deviation 11.004
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 27 Day 1	83.33 score on a scale Standard Deviation 14.907	95.24 score on a scale Standard Deviation 12.599
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 28 Day 1	91.67 score on a scale Standard Deviation 9.623	100 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 29 Day 1	91.67 score on a scale Standard Deviation 9.623	100 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 30 Day 1	87.50 score on a scale Standard Deviation 15.957	100 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Cycle 31 Day 1	83.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Cognitive Functioning Score; Off-treatment Visit	75.21 score on a scale Standard Deviation 25.846	80.41 score on a scale Standard Deviation 23.304
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Baseline	77.29 score on a scale Standard Deviation 25.678	78.29 score on a scale Standard Deviation 27.243
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 2 Day 1	73.46 score on a scale Standard Deviation 25.386	77.15 score on a scale Standard Deviation 27.190
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 3 Day 1	72.04 score on a scale Standard Deviation 26.229	77.19 score on a scale Standard Deviation 25.309
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 4 Day 1	71.43 score on a scale Standard Deviation 24.837	77.33 score on a scale Standard Deviation 25.311
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 5 Day 1	71.78 score on a scale Standard Deviation 25.589	79.63 score on a scale Standard Deviation 23.934
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 6 Day 1	70.80 score on a scale Standard Deviation 26.812	78.71 score on a scale Standard Deviation 25.758
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 7 Day 1	71.70 score on a scale Standard Deviation 26.544	77.30 score on a scale Standard Deviation 24.691
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 8 Day 1	70.24 score on a scale Standard Deviation 28.139	79.04 score on a scale Standard Deviation 24.565
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 9 Day 1	72.16 score on a scale Standard Deviation 25.946	78.62 score on a scale Standard Deviation 20.573
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 10 Day 1	72.43 score on a scale Standard Deviation 28.156	85.14 score on a scale Standard Deviation 19.422
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 11 Day 1	73.91 score on a scale Standard Deviation 25.801	85.19 score on a scale Standard Deviation 19.086
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 12 Day 1	76.56 score on a scale Standard Deviation 24.073	83.89 score on a scale Standard Deviation 23.161
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 13 Day 1	72.92 score on a scale Standard Deviation 23.476	83.94 score on a scale Standard Deviation 21.508
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 14 Day 1	72.79 score on a scale Standard Deviation 22.997	83.97 score on a scale Standard Deviation 19.792
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 15 Day 1	72.73 score on a scale Standard Deviation 25.942	81.37 score on a scale Standard Deviation 22.273
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 16 Day 1	73.17 score on a scale Standard Deviation 24.403	80.80 score on a scale Standard Deviation 22.489
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 17 Day 1	70.37 score on a scale Standard Deviation 22.222	80.42 score on a scale Standard Deviation 24.134
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 18 Day 1	76.88 score on a scale Standard Deviation 20.493	82.84 score on a scale Standard Deviation 21.116
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 19 Day 1	74.07 score on a scale Standard Deviation 22.329	80.88 score on a scale Standard Deviation 25.667
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 20 Day 1	75.31 score on a scale Standard Deviation 24.183	81.72 score on a scale Standard Deviation 22.092
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 21 Day 1	73.72 score on a scale Standard Deviation 18.362	82.14 score on a scale Standard Deviation 24.398
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 22 Day 1	79.82 score on a scale Standard Deviation 17.194	82.10 score on a scale Standard Deviation 20.634
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 23 Day 1	82.22 score on a scale Standard Deviation 18.330	83.33 score on a scale Standard Deviation 22.522
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 24 Day 1	83.33 score on a scale Standard Deviation 17.817	84.21 score on a scale Standard Deviation 19.621
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 25 Day 1	87.50 score on a scale Standard Deviation 12.563	84.38 score on a scale Standard Deviation 18.727
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 26 Day 1	83.33 score on a scale Standard Deviation 15.430	76.92 score on a scale Standard Deviation 31.578
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 27 Day 1	80.56 score on a scale Standard Deviation 12.546	95.24 score on a scale Standard Deviation 12.599
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 28 Day 1	83.33 score on a scale Standard Deviation 19.245	100 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 29 Day 1	79.17 score on a scale Standard Deviation 15.957	100 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 30 Day 1	70.83 score on a scale Standard Deviation 8.333	100 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Cycle 31 Day 1	100 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Social Functioning Score; Off-treatment Visit	64.58 score on a scale Standard Deviation 31.419	66.89 score on a scale Standard Deviation 32.453
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Baseline	31.32 score on a scale Standard Deviation 21.379	31.76 score on a scale Standard Deviation 25.224
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 2 Day 1	39.21 score on a scale Standard Deviation 22.171	36.74 score on a scale Standard Deviation 23.665
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 3 Day 1	40.09 score on a scale Standard Deviation 24.095	36.62 score on a scale Standard Deviation 24.031
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 4 Day 1	40.21 score on a scale Standard Deviation 23.504	32.68 score on a scale Standard Deviation 23.829
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 5 Day 1	37.54 score on a scale Standard Deviation 23.329	35.17 score on a scale Standard Deviation 22.431
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 6 Day 1	38.80 score on a scale Standard Deviation 23.246	33.19 score on a scale Standard Deviation 23.696
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 7 Day 1	38.06 score on a scale Standard Deviation 21.850	30.79 score on a scale Standard Deviation 21.859
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 8 Day 1	36.14 score on a scale Standard Deviation 22.852	30.81 score on a scale Standard Deviation 23.268
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 9 Day 1	35.90 score on a scale Standard Deviation 21.281	30.80 score on a scale Standard Deviation 21.293
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 10 Day 1	34.57 score on a scale Standard Deviation 22.635	27.11 score on a scale Standard Deviation 20.278
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 11 Day 1	32.37 score on a scale Standard Deviation 20.851	27.46 score on a scale Standard Deviation 22.788
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 12 Day 1	32.82 score on a scale Standard Deviation 20.264	23.48 score on a scale Standard Deviation 21.302
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 13 Day 1	35.52 score on a scale Standard Deviation 18.882	25.05 score on a scale Standard Deviation 21.300
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 14 Day 1	30.84 score on a scale Standard Deviation 21.429	25.58 score on a scale Standard Deviation 20.276
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 15 Day 1	28.03 score on a scale Standard Deviation 20.682	28.98 score on a scale Standard Deviation 23.315
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 16 Day 1	33.33 score on a scale Standard Deviation 22.361	25.53 score on a scale Standard Deviation 20.581
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 17 Day 1	33.33 score on a scale Standard Deviation 21.902	25 score on a scale Standard Deviation 20.090
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 18 Day 1	34.05 score on a scale Standard Deviation 22.024	24.84 score on a scale Standard Deviation 19.546
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 19 Day 1	37.04 score on a scale Standard Deviation 23.061	27.45 score on a scale Standard Deviation 22.595
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 20 Day 1	34.57 score on a scale Standard Deviation 19.812	27.24 score on a scale Standard Deviation 22.192
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 21 Day 1	34.19 score on a scale Standard Deviation 20.828	23.02 score on a scale Standard Deviation 17.088
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 22 Day 1	26.32 score on a scale Standard Deviation 18.596	26.75 score on a scale Standard Deviation 20.033
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 23 Day 1	26.67 score on a scale Standard Deviation 20.053	29.17 score on a scale Standard Deviation 21.934
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 24 Day 1	28.15 score on a scale Standard Deviation 20.082	26.90 score on a scale Standard Deviation 17.496
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 25 Day 1	33.33 score on a scale Standard Deviation 19.534	25.69 score on a scale Standard Deviation 19.338
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 26 Day 1	26.39 score on a scale Standard Deviation 17.755	37.61 score on a scale Standard Deviation 28.160
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 27 Day 1	27.78 score on a scale Standard Deviation 16.851	20.63 score on a scale Standard Deviation 20.716
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 28 Day 1	22.22 score on a scale Standard Deviation 15.713	16.67 score on a scale Standard Deviation 19.563
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 29 Day 1	22.22 score on a scale Standard Deviation 15.713	15.56 score on a scale Standard Deviation 14.907
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 30 Day 1	25 score on a scale Standard Deviation 16.667	11.11 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Fatigue Score; Off-treatment Visit	43.47 score on a scale Standard Deviation 28.173	38.89 score on a scale Standard Deviation 28.977
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Baseline	7.60 score on a scale Standard Deviation 17.265	6.28 score on a scale Standard Deviation 14.510
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 2 Day 1	11.50 score on a scale Standard Deviation 18.229	9.56 score on a scale Standard Deviation 17.943
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 3 Day 1	14.86 score on a scale Standard Deviation 24.057	9.74 score on a scale Standard Deviation 18.219
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 4 Day 1	15.80 score on a scale Standard Deviation 21.386	12.17 score on a scale Standard Deviation 18.906
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 5 Day 1	12.07 score on a scale Standard Deviation 17.017	11.42 score on a scale Standard Deviation 18.270
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 6 Day 1	12.74 score on a scale Standard Deviation 19.215	10.14 score on a scale Standard Deviation 18.996
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 7 Day 1	12.46 score on a scale Standard Deviation 18.612	8.57 score on a scale Standard Deviation 13.696
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 8 Day 1	13.10 score on a scale Standard Deviation 21.836	10.14 score on a scale Standard Deviation 15.508
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 9 Day 1	12.27 score on a scale Standard Deviation 20.005	9.96 score on a scale Standard Deviation 17.306
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 10 Day 1	15.02 score on a scale Standard Deviation 22.299	7.78 score on a scale Standard Deviation 16.287
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 11 Day 1	11.11 score on a scale Standard Deviation 18.002	8.69 score on a scale Standard Deviation 15.394
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 12 Day 1	12.82 score on a scale Standard Deviation 19.042	6.99 score on a scale Standard Deviation 14.645
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 13 Day 1	12.20 score on a scale Standard Deviation 18.934	6.97 score on a scale Standard Deviation 13.867
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 16 Day 1	11.38 score on a scale Standard Deviation 19.874	9.22 score on a scale Standard Deviation 15.467
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 30 Day 1	25 score on a scale Standard Deviation 16.667	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Insomnia Score; Off-treatment Visit	32.05 score on a scale Standard Deviation 32.430	28.83 score on a scale Standard Deviation 31.850
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Baseline	15.79 score on a scale Standard Deviation 24.606	18.31 score on a scale Standard Deviation 27.060
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 2 Day 1	26.79 score on a scale Standard Deviation 31.129	27.56 score on a scale Standard Deviation 32.020
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 3 Day 1	31.97 score on a scale Standard Deviation 31.905	29.81 score on a scale Standard Deviation 31.687
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 4 Day 1	32.09 score on a scale Standard Deviation 31.239	30.90 score on a scale Standard Deviation 32.749
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 5 Day 1	30.47 score on a scale Standard Deviation 29.881	30.67 score on a scale Standard Deviation 32.129
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 6 Day 1	30.35 score on a scale Standard Deviation 31.365	26.11 score on a scale Standard Deviation 29.996
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 7 Day 1	29.28 score on a scale Standard Deviation 31.956	26.98 score on a scale Standard Deviation 28.154
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 8 Day 1	29.25 score on a scale Standard Deviation 31.483	25.00 score on a scale Standard Deviation 26.491
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 9 Day 1	29.30 score on a scale Standard Deviation 30.565	25.36 score on a scale Standard Deviation 27.678
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 10 Day 1	27.57 score on a scale Standard Deviation 29.716	22.22 score on a scale Standard Deviation 22.815
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 11 Day 1	24.15 score on a scale Standard Deviation 27.938	22.07 score on a scale Standard Deviation 26.988
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 12 Day 1	22.05 score on a scale Standard Deviation 24.493	18.82 score on a scale Standard Deviation 25.336
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 13 Day 1	23.21 score on a scale Standard Deviation 25.362	17.28 score on a scale Standard Deviation 21.221
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 14 Day 1	19.73 score on a scale Standard Deviation 24.456	17.61 score on a scale Standard Deviation 24.111
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 15 Day 1	17.42 score on a scale Standard Deviation 23.282	24.18 score on a scale Standard Deviation 30.608
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 16 Day 1	23.58 score on a scale Standard Deviation 27.125	22.70 score on a scale Standard Deviation 27.014
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 17 Day 1	20.37 score on a scale Standard Deviation 21.496	22.50 score on a scale Standard Deviation 25.473
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 18 Day 1	19.35 score on a scale Standard Deviation 22.401	22.22 score on a scale Standard Deviation 24.533
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 19 Day 1	19.75 score on a scale Standard Deviation 23.130	20.59 score on a scale Standard Deviation 25.969
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 20 Day 1	23.46 score on a scale Standard Deviation 25.844	21.51 score on a scale Standard Deviation 30.488
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 21 Day 1	23.08 score on a scale Standard Deviation 20.590	15.48 score on a scale Standard Deviation 21.242
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 22 Day 1	17.54 score on a scale Standard Deviation 20.393	17.28 score on a scale Standard Deviation 25.099
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 23 Day 1	17.78 score on a scale Standard Deviation 24.774	20.83 score on a scale Standard Deviation 27.474
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 24 Day 1	13.33 score on a scale Standard Deviation 24.560	15.79 score on a scale Standard Deviation 25.744
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 25 Day 1	19.44 score on a scale Standard Deviation 22.285	18.75 score on a scale Standard Deviation 29.736
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 26 Day 1	29.17 score on a scale Standard Deviation 27.817	23.08 score on a scale Standard Deviation 34.385
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 27 Day 1	16.67 score on a scale Standard Deviation 18.257	9.52 score on a scale Standard Deviation 16.265
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 28 Day 1	8.33 score on a scale Standard Deviation 16.667	11.11 score on a scale Standard Deviation 17.213
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 29 Day 1	16.67 score on a scale Standard Deviation 19.245	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 30 Day 1	8.33 score on a scale Standard Deviation 16.667	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Cycle 31 Day 1	0 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Appetite Loss Score; Off-treatment Visit	29.58 score on a scale Standard Deviation 31.820	25.23 score on a scale Standard Deviation 32.082
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Baseline	15.98 score on a scale Standard Deviation 24.876	12.55 score on a scale Standard Deviation 23.501
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 2 Day 1	10.40 score on a scale Standard Deviation 20.274	11.11 score on a scale Standard Deviation 21.035
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 3 Day 1	9.52 score on a scale Standard Deviation 20.644	10.80 score on a scale Standard Deviation 20.456
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 4 Day 1	11.11 score on a scale Standard Deviation 21.930	9.80 score on a scale Standard Deviation 19.081
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 5 Day 1	12.24 score on a scale Standard Deviation 20.438	9.87 score on a scale Standard Deviation 19.411
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 6 Day 1	8.47 score on a scale Standard Deviation 16.905	8.47 score on a scale Standard Deviation 19.090
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 7 Day 1	11.01 score on a scale Standard Deviation 22.874	7.44 score on a scale Standard Deviation 16.785
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 8 Day 1	9.62 score on a scale Standard Deviation 18.608	7.22 score on a scale Standard Deviation 14.614
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 9 Day 1	6.23 score on a scale Standard Deviation 15.644	9.42 score on a scale Standard Deviation 19.967
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 10 Day 1	6.58 score on a scale Standard Deviation 13.354	8.00 score on a scale Standard Deviation 18.042
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 11 Day 1	6.76 score on a scale Standard Deviation 15.739	7.98 score on a scale Standard Deviation 18.227
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 12 Day 1	5.64 score on a scale Standard Deviation 13.906	9.68 score on a scale Standard Deviation 18.492
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 13 Day 1	3.64 score on a scale Standard Deviation 12.294	9.09 score on a scale Standard Deviation 18.653
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 14 Day 1	5.44 score on a scale Standard Deviation 14.186	7.69 score on a scale Standard Deviation 16.978
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 15 Day 1	5.43 score on a scale Standard Deviation 17.714	9.33 score on a scale Standard Deviation 19.095
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 16 Day 1	5.98 score on a scale Standard Deviation 16.879	9.93 score on a scale Standard Deviation 18.277
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 17 Day 1	11.11 score on a scale Standard Deviation 22.537	5.00 score on a scale Standard Deviation 12.054
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 18 Day 1	7.53 score on a scale Standard Deviation 14.167	7.84 score on a scale Standard Deviation 16.532
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 19 Day 1	9.88 score on a scale Standard Deviation 18.057	9.80 score on a scale Standard Deviation 20.969
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 20 Day 1	8.64 score on a scale Standard Deviation 17.523	8.60 score on a scale Standard Deviation 22.718
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 21 Day 1	8.97 score on a scale Standard Deviation 17.783	7.14 score on a scale Standard Deviation 16.623
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 22 Day 1	7.02 score on a scale Standard Deviation 13.962	7.41 score on a scale Standard Deviation 19.245
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 23 Day 1	6.67 score on a scale Standard Deviation 13.801	11.11 score on a scale Standard Deviation 21.234
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 24 Day 1	4.44 score on a scale Standard Deviation 17.213	8.77 score on a scale Standard Deviation 21.779
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 25 Day 1	5.56 score on a scale Standard Deviation 12.975	18.75 score on a scale Standard Deviation 29.736
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 26 Day 1	8.33 score on a scale Standard Deviation 15.430	15.38 score on a scale Standard Deviation 25.875
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 27 Day 1	16.67 score on a scale Standard Deviation 27.889	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 28 Day 1	25.00 score on a scale Standard Deviation 31.914	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 29 Day 1	25.00 score on a scale Standard Deviation 31.914	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 30 Day 1	16.67 score on a scale Standard Deviation 33.333	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Constipation Score; Off-treatment Visit	13.33 score on a scale Standard Deviation 23.481	12.61 score on a scale Standard Deviation 21.863
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Baseline	6.43 score on a scale Standard Deviation 15.045	6.79 score on a scale Standard Deviation 15.823
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 2 Day 1	22.29 score on a scale Standard Deviation 29.572	17.66 score on a scale Standard Deviation 26.333
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 3 Day 1	32.21 score on a scale Standard Deviation 30.858	27.19 score on a scale Standard Deviation 32.023
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 4 Day 1	35.59 score on a scale Standard Deviation 33.634	29.41 score on a scale Standard Deviation 28.991
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 5 Day 1	28.61 score on a scale Standard Deviation 28.085	29.33 score on a scale Standard Deviation 29.207
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 6 Day 1	31.96 score on a scale Standard Deviation 30.550	26.89 score on a scale Standard Deviation 27.541
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 7 Day 1	33.64 score on a scale Standard Deviation 31.885	31.75 score on a scale Standard Deviation 27.881
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 8 Day 1	29.55 score on a scale Standard Deviation 28.818	31.27 score on a scale Standard Deviation 28.793
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 9 Day 1	34.43 score on a scale Standard Deviation 33.129	28.62 score on a scale Standard Deviation 28.637
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 10 Day 1	29.22 score on a scale Standard Deviation 29.992	29.33 score on a scale Standard Deviation 25.088
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 11 Day 1	28.02 score on a scale Standard Deviation 28.367	26.85 score on a scale Standard Deviation 26.619
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 12 Day 1	28.49 score on a scale Standard Deviation 31.273	22.78 score on a scale Standard Deviation 23.363
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 13 Day 1	26.19 score on a scale Standard Deviation 28.223	23.03 score on a scale Standard Deviation 25.558
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 14 Day 1	26.53 score on a scale Standard Deviation 25.440	24.36 score on a scale Standard Deviation 22.008
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 15 Day 1	29.55 score on a scale Standard Deviation 29.828	30.07 score on a scale Standard Deviation 26.038
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 16 Day 1	20.33 score on a scale Standard Deviation 27.767	23.40 score on a scale Standard Deviation 21.886
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 17 Day 1	21.30 score on a scale Standard Deviation 24.107	29.17 score on a scale Standard Deviation 28.432
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 18 Day 1	21.51 score on a scale Standard Deviation 25.164	25.49 score on a scale Standard Deviation 23.296
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 19 Day 1	23.46 score on a scale Standard Deviation 28.963	21.57 score on a scale Standard Deviation 21.528
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 20 Day 1	19.75 score on a scale Standard Deviation 23.130	22.58 score on a scale Standard Deviation 23.392
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 21 Day 1	20.51 score on a scale Standard Deviation 26.795	21.43 score on a scale Standard Deviation 18.624
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 22 Day 1	17.54 score on a scale Standard Deviation 20.393	24.69 score on a scale Standard Deviation 19.812
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 23 Day 1	15.56 score on a scale Standard Deviation 17.213	22.22 score on a scale Standard Deviation 16.051
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 24 Day 1	11.11 score on a scale Standard Deviation 16.265	19.30 score on a scale Standard Deviation 16.909
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 25 Day 1	19.44 score on a scale Standard Deviation 22.285	18.75 score on a scale Standard Deviation 17.078
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 26 Day 1	25.00 score on a scale Standard Deviation 29.547	17.95 score on a scale Standard Deviation 17.296
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 27 Day 1	33.33 score on a scale Standard Deviation 21.082	33.33 score on a scale Standard Deviation 19.245
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 28 Day 1	16.67 score on a scale Standard Deviation 19.245	22.22 score on a scale Standard Deviation 17.213
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 29 Day 1	8.33 score on a scale Standard Deviation 16.667	20.00 score on a scale Standard Deviation 18.257
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 27 Day 1	16.67 score on a scale Standard Deviation 18.257	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 30 Day 1	16.67 score on a scale Standard Deviation 19.245	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Cycle 31 Day 1	33.33 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Diarrhea Score; Off-treatment Visit	18.33 score on a scale Standard Deviation 25.380	12.16 score on a scale Standard Deviation 19.565
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Baseline	21.76 score on a scale Standard Deviation 28.382	20.37 score on a scale Standard Deviation 29.076
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 2 Day 1	21.08 score on a scale Standard Deviation 28.177	15.01 score on a scale Standard Deviation 24.852
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 3 Day 1	23.13 score on a scale Standard Deviation 27.201	18.20 score on a scale Standard Deviation 27.451
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 4 Day 1	22.90 score on a scale Standard Deviation 27.761	16.42 score on a scale Standard Deviation 25.113
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 5 Day 1	22.93 score on a scale Standard Deviation 28.213	18.78 score on a scale Standard Deviation 29.058
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 6 Day 1	25.00 score on a scale Standard Deviation 27.416	17.80 score on a scale Standard Deviation 25.666
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 7 Day 1	30.16 score on a scale Standard Deviation 31.866	15.87 score on a scale Standard Deviation 24.062
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 8 Day 1	25.43 score on a scale Standard Deviation 29.176	17.53 score on a scale Standard Deviation 24.576
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 9 Day 1	25.56 score on a scale Standard Deviation 30.002	16.67 score on a scale Standard Deviation 23.440
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 10 Day 1	22.50 score on a scale Standard Deviation 27.952	17.35 score on a scale Standard Deviation 24.913
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 11 Day 1	26.26 score on a scale Standard Deviation 30.108	16.20 score on a scale Standard Deviation 24.382
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 12 Day 1	24.87 score on a scale Standard Deviation 28.061	16.11 score on a scale Standard Deviation 24.156
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 13 Day 1	23.03 score on a scale Standard Deviation 26.351	19.14 score on a scale Standard Deviation 25.577
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 14 Day 1	20.83 score on a scale Standard Deviation 22.413	17.31 score on a scale Standard Deviation 25.127
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 15 Day 1	21.71 score on a scale Standard Deviation 27.103	19.61 score on a scale Standard Deviation 26.813
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 16 Day 1	21.67 score on a scale Standard Deviation 25.654	17.02 score on a scale Standard Deviation 24.937
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 17 Day 1	23.81 score on a scale Standard Deviation 27.501	19.17 score on a scale Standard Deviation 27.099
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 18 Day 1	17.20 score on a scale Standard Deviation 18.995	19.61 score on a scale Standard Deviation 28.566
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 19 Day 1	18.52 score on a scale Standard Deviation 19.245	20.59 score on a scale Standard Deviation 28.444
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 20 Day 1	16.05 score on a scale Standard Deviation 21.424	20.43 score on a scale Standard Deviation 30.644
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 21 Day 1	19.23 score on a scale Standard Deviation 21.444	20.24 score on a scale Standard Deviation 27.725
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 22 Day 1	24.56 score on a scale Standard Deviation 24.450	20.99 score on a scale Standard Deviation 29.451
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 23 Day 1	17.78 score on a scale Standard Deviation 17.213	23.61 score on a scale Standard Deviation 31.819
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 24 Day 1	17.78 score on a scale Standard Deviation 21.331	19.30 score on a scale Standard Deviation 25.618
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 25 Day 1	16.67 score on a scale Standard Deviation 22.473	16.67 score on a scale Standard Deviation 24.343
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 26 Day 1	20.83 score on a scale Standard Deviation 24.801	20.51 score on a scale Standard Deviation 32.026
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 28 Day 1	25.00 score on a scale Standard Deviation 16.667	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 29 Day 1	25.00 score on a scale Standard Deviation 16.667	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 30 Day 1	25.00 score on a scale Standard Deviation 16.667	0 score on a scale
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Cycle 31 Day 1	0 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Financial Difficulties Score; Off-treatment Visit	31.65 score on a scale Standard Deviation 32.423	25.11 score on a scale Standard Deviation 30.318
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 28 Day 1	79.17 score on a scale Standard Deviation 15.957	97.22 score on a scale Standard Deviation 6.804
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 29 Day 1	75 score on a scale Standard Deviation 9.623	96.67 score on a scale Standard Deviation 7.454
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Cycle 31 Day 1	66.67 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Role Functioning Score; Off-treatment Visit	60.97 score on a scale Standard Deviation 31.790	63.51 score on a scale Standard Deviation 31.656
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 3 Day 1	78.47 score on a scale Standard Deviation 21.642	82.90 score on a scale Standard Deviation 19.314
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 4 Day 1	78.26 score on a scale Standard Deviation 18.854	84.19 score on a scale Standard Deviation 18.517
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 5 Day 1	75.85 score on a scale Standard Deviation 21.767	84.52 score on a scale Standard Deviation 15.766
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 6 Day 1	80.60 score on a scale Standard Deviation 18.703	84.38 score on a scale Standard Deviation 18.365
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 7 Day 1	77.18 score on a scale Standard Deviation 19.571	84.29 score on a scale Standard Deviation 16.356
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 8 Day 1	79.08 score on a scale Standard Deviation 19.744	84.88 score on a scale Standard Deviation 18.215
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 9 Day 1	78.75 score on a scale Standard Deviation 22.127	85.96 score on a scale Standard Deviation 17.512
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 10 Day 1	80.04 score on a scale Standard Deviation 19.440	87.84 score on a scale Standard Deviation 15.433
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 11 Day 1	82.25 score on a scale Standard Deviation 20.558	87.15 score on a scale Standard Deviation 16.247
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 12 Day 1	81.51 score on a scale Standard Deviation 19.157	86.67 score on a scale Standard Deviation 15.358
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 14 Day 1	81.35 score on a scale Standard Deviation 16.782	87.50 score on a scale Standard Deviation 17.110
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Emotional Functioning Score; Cycle 15 Day 1	80.30 score on a scale Standard Deviation 18.336	87.25 score on a scale Standard Deviation 15.398
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 14 Day 1	14.97 score on a scale Standard Deviation 21.849	7.55 score on a scale Standard Deviation 16.527
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 15 Day 1	14.02 score on a scale Standard Deviation 20.631	8.82 score on a scale Standard Deviation 15.038
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 17 Day 1	14.35 score on a scale Standard Deviation 22.940	5 score on a scale Standard Deviation 13.183
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 18 Day 1	10.75 score on a scale Standard Deviation 22.587	9.31 score on a scale Standard Deviation 15.457
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 19 Day 1	16.67 score on a scale Standard Deviation 27.347	7.35 score on a scale Standard Deviation 15.457
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 21 Day 1	12.82 score on a scale Standard Deviation 20.714	7.74 score on a scale Standard Deviation 12.408
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 22 Day 1	7.02 score on a scale Standard Deviation 11.541	8.64 score on a scale Standard Deviation 13.374
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 24 Day 1	6.67 score on a scale Standard Deviation 13.801	7.89 score on a scale Standard Deviation 17.004
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 27 Day 1	5.56 score on a scale Standard Deviation 13.608	16.67 score on a scale Standard Deviation 28.868
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 28 Day 1	12.50 score on a scale Standard Deviation 15.957	8.33 score on a scale Standard Deviation 20.412
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 29 Day 1	16.67 score on a scale Standard Deviation 13.608	0 score on a scale Standard Deviation 0
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Cycle 31 Day 1	16.67 score on a scale	—
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Nausea and Vomiting Score; Off-treatment Visit	13.33 score on a scale Standard Deviation 22.564	6.76 score on a scale Standard Deviation 13.207
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 7 Day 1	28.04 score on a scale Standard Deviation 23.189	23.65 score on a scale Standard Deviation 22.142
HRQoL Assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 Scores Pain Score; Cycle 10 Day 1	26.95 score on a scale Standard Deviation 22.603	19.33 score on a scale Standard Deviation 18.792

SECONDARY outcome

Timeframe: At baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle (cycle length =28 days), and at the Off-treatment visit (up to 29 months)

Population: QoL analysis set consisted of all participants who had any QoL data. Here "overall number of participants analyzed" are the participants who were evaluable for the outcome measure and "number analyzed" were the participants who were evaluable at given time points. . As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till primary analysis only.

The EQ-5D-3L is a health profile questionnaire assessing quality of life along 5 dimensions. Participants rate 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) by choosing from 3 answering options (1=no problems; 2=some problems; 3=extreme problems). The summed score ranges from 5-15 with "5" corresponding to no problems and "15" corresponding to severe problems in the 5 dimensions. The EQ-5D index was calculated by applying preference-based weights (tariffs) to the scores of the five health state dimensions. Index values can range from -1 to 1, with 0 representing a health state equivalent to death and 1 representing perfect health. EQ-5D-3L also included an EQ visual analogue scale (VAS) that ranges between 100 (best imaginable health) and 0 (worst imaginable health). Decrease from baseline in EQ-5D-3L signifies improvement. Total index EQ-5D-3L summary score was weighted with a range of -0.594 (worst) to 1.0 (best).

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=168 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=161 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 21 Day 1	0.73 score on a scale Standard Deviation 0.223	0.83 score on a scale Standard Deviation 0.180
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 14 Day 1	0.77 score on a scale Standard Deviation 0.186	0.83 score on a scale Standard Deviation 0.163
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 15 Day 1	0.76 score on a scale Standard Deviation 0.191	0.81 score on a scale Standard Deviation 0.165
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 16 Day 1	0.73 score on a scale Standard Deviation 0.179	0.81 score on a scale Standard Deviation 0.212
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 17 Day 1	0.73 score on a scale Standard Deviation 0.211	0.83 score on a scale Standard Deviation 0.158
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 18 Day 1	0.76 score on a scale Standard Deviation 0.148	0.84 score on a scale Standard Deviation 0.177
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 19 Day 1	0.69 score on a scale Standard Deviation 0.266	0.79 score on a scale Standard Deviation 0.205
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 20 Day 1	0.70 score on a scale Standard Deviation 0.259	0.82 score on a scale Standard Deviation 0.167
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 22 Day 1	0.74 score on a scale Standard Deviation 0.157	0.85 score on a scale Standard Deviation 0.173
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 23 Day 1	0.74 score on a scale Standard Deviation 0.149	0.82 score on a scale Standard Deviation 0.242
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 24 Day 1	0.75 score on a scale Standard Deviation 0.172	0.84 score on a scale Standard Deviation 0.156
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 25 Day 1	0.70 score on a scale Standard Deviation 0.245	0.83 score on a scale Standard Deviation 0.175
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 26 Day 1	0.72 score on a scale Standard Deviation 0.170	0.73 score on a scale Standard Deviation 0.438
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 27 Day 1	0.77 score on a scale Standard Deviation 0.135	0.93 score on a scale Standard Deviation 0.117
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 28 Day 1	0.73 score on a scale Standard Deviation 0.112	0.97 score on a scale Standard Deviation 0.067
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 29 Day 1	0.74 score on a scale Standard Deviation 0.120	0.96 score on a scale Standard Deviation 0.075
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 30 Day 1	0.61 score on a scale Standard Deviation 0.391	1 score on a scale
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 31 Day 1	0.87 score on a scale	—
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Off-treatment Visit	0.61 score on a scale Standard Deviation 0.331	0.68 score on a scale Standard Deviation 0.314
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Baseline	68.57 score on a scale Standard Deviation 18.348	70.01 score on a scale Standard Deviation 20.552
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 2 Day 1	66.05 score on a scale Standard Deviation 18.531	69.52 score on a scale Standard Deviation 19.155
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 3 Day 1	66.22 score on a scale Standard Deviation 17.804	70.71 score on a scale Standard Deviation 17.648
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 4 Day 1	65.69 score on a scale Standard Deviation 18.265	69.66 score on a scale Standard Deviation 17.784
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 5 Day 1	65.86 score on a scale Standard Deviation 18.908	70.30 score on a scale Standard Deviation 19.492
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 6 Day 1	65.53 score on a scale Standard Deviation 20.027	71.73 score on a scale Standard Deviation 17.366
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 7 Day 1	65.74 score on a scale Standard Deviation 18.063	70.39 score on a scale Standard Deviation 19.387
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 8 Day 1	64.16 score on a scale Standard Deviation 18.969	70.40 score on a scale Standard Deviation 20.130
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 9 Day 1	65.51 score on a scale Standard Deviation 17.670	69.92 score on a scale Standard Deviation 19.452
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 10 Day 1	66.92 score on a scale Standard Deviation 17.747	73.18 score on a scale Standard Deviation 20.167
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 11 Day 1	67.74 score on a scale Standard Deviation 16.850	73.21 score on a scale Standard Deviation 19.310
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 12 Day 1	66.46 score on a scale Standard Deviation 18.680	74.46 score on a scale Standard Deviation 17.139
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 13 Day 1	65.64 score on a scale Standard Deviation 19.690	74.35 score on a scale Standard Deviation 17.766
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 14 Day 1	66.41 score on a scale Standard Deviation 17.839	74.40 score on a scale Standard Deviation 17.678
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 15 Day 1	67.05 score on a scale Standard Deviation 17.847	72.58 score on a scale Standard Deviation 19.060
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 16 Day 1	66.54 score on a scale Standard Deviation 18.118	72.80 score on a scale Standard Deviation 17.733
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 17 Day 1	65.78 score on a scale Standard Deviation 17.755	73.80 score on a scale Standard Deviation 17.593
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 18 Day 1	64.70 score on a scale Standard Deviation 18.170	73.71 score on a scale Standard Deviation 16.665
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 19 Day 1	62.15 score on a scale Standard Deviation 20.676	71.76 score on a scale Standard Deviation 19.272
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 20 Day 1	62.70 score on a scale Standard Deviation 19.779	72.07 score on a scale Standard Deviation 19.293
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 21 Day 1	62.12 score on a scale Standard Deviation 17.974	76.46 score on a scale Standard Deviation 16.836
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 22 Day 1	65.21 score on a scale Standard Deviation 14.722	74.44 score on a scale Standard Deviation 16.860
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 23 Day 1	67.73 score on a scale Standard Deviation 15.650	73.67 score on a scale Standard Deviation 17.704
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 24 Day 1	65.27 score on a scale Standard Deviation 19.381	71.21 score on a scale Standard Deviation 21.212
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 25 Day 1	60.58 score on a scale Standard Deviation 19.313	72.81 score on a scale Standard Deviation 16.897
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 26 Day 1	64.13 score on a scale Standard Deviation 16.313	65.23 score on a scale Standard Deviation 25.652
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 27 Day 1	61.83 score on a scale Standard Deviation 18.357	77.43 score on a scale Standard Deviation 16.762
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 28 Day 1	54.25 score on a scale Standard Deviation 8.694	77.50 score on a scale Standard Deviation 20.907
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 29 Day 1	52.75 score on a scale Standard Deviation 12.093	74 score on a scale Standard Deviation 21.036
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 30 Day 1	51.75 score on a scale Standard Deviation 11.295	50 score on a scale
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Cycle 31 Day 1	35 score on a scale	—
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-VAS Score; Off-treatment Visit	58.48 score on a scale Standard Deviation 23.516	62.66 score on a scale Standard Deviation 22.252
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Baseline	0.76 score on a scale Standard Deviation 0.216	0.78 score on a scale Standard Deviation 0.232
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 2 Day 1	0.76 score on a scale Standard Deviation 0.178	0.76 score on a scale Standard Deviation 0.230
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 3 Day 1	0.73 score on a scale Standard Deviation 0.232	0.78 score on a scale Standard Deviation 0.239
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 4 Day 1	0.73 score on a scale Standard Deviation 0.213	0.78 score on a scale Standard Deviation 0.236
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 5 Day 1	0.73 score on a scale Standard Deviation 0.212	0.78 score on a scale Standard Deviation 0.199
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 6 Day 1	0.73 score on a scale Standard Deviation 0.220	0.77 score on a scale Standard Deviation 0.225
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 7 Day 1	0.71 score on a scale Standard Deviation 0.219	0.78 score on a scale Standard Deviation 0.196
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 8 Day 1	0.75 score on a scale Standard Deviation 0.187	0.80 score on a scale Standard Deviation 0.187
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 9 Day 1	0.73 score on a scale Standard Deviation 0.192	0.79 score on a scale Standard Deviation 0.192
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 10 Day 1	0.76 score on a scale Standard Deviation 0.186	0.81 score on a scale Standard Deviation 0.177
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 11 Day 1	0.77 score on a scale Standard Deviation 0.185	0.82 score on a scale Standard Deviation 0.82
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 12 Day 1	0.77 score on a scale Standard Deviation 0.173	0.83 score on a scale Standard Deviation 0.161
HRQoL Assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) Index Score and Visual Analogue Scale (VAS) EQ-5D Index Score; Cycle 13 Day 1	0.76 score on a scale Standard Deviation 0.157	0.82 score on a scale Standard Deviation 0.179

SECONDARY outcome

Timeframe: From the time of randomization to the date of PD after next line of therapy or death from any cause or the date of data cutoff for the primary analysis, whichever occurs first (up to 29 months)

Population: PPAS1 included all randomized participants minus the 32 participants who had received \>=2 incorrect lenvatinib doses due to IxRS issues.

PFS2, defined as the time from randomization to the date of PD after next line of therapy or death from any cause, whichever occurred first based on investigator assessment according to RECIST v1.1. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Median PFS2 was analyzed using the Kaplan-Meier product-limit estimates for each treatment group and presented with 2-sided 95% CI. As pre-specified in protocol, data for this secondary outcome measure was collected and analyzed till the primary analysis only.

Outcome measures

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=156 Participants Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. Participants who had no intolerable Grade 2 or any \>=Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), had lenvatinib dose titrated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length =28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=155 Participants Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Progression-free Survival After Next Line of Therapy (PFS2)	18.2 months Interval 13.1 to 22.5	19.5 months Interval 14.1 to 23.8

Adverse Events

Lenvatinib 14 mg + Everolimus 5 mg

Serious events: 92 serious events

Other events: 172 other events

Deaths: 71 deaths

Lenvatinib 18 mg + Everolimus 5 mg

Serious events: 87 serious events

Other events: 166 other events

Deaths: 60 deaths

Serious adverse events

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=173 participants at risk Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. If there were no intolerable Grade 2 or any \>= Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), lenvatinib dose was escalated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length = 28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=168 participants at risk Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Infections and infestations Tonsillitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Urinary tract infection	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Urosepsis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Viral diarrhoea	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Injury, poisoning and procedural complications Procedural pain	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Injury, poisoning and procedural complications Subdural haemorrhage	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Injury, poisoning and procedural complications Wound dehiscence	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Amylase increased	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Blood creatinine increased	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	2.4% 4/168 • Number of events 5 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Lipase increased	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Troponin increased	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Decreased appetite	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Dehydration	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Electrolyte imbalance	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Fluid overload	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Gout	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypercalcaemia	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hyperglycaemia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypocalcaemia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hyponatraemia	1.2% 2/173 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Back pain	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Fracture pain	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Muscular weakness	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Pathological fracture	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant pleural effusion	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	2.9% 5/173 • Number of events 6 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.0% 5/168 • Number of events 5 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Bronchitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Cholecystitis infective	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Chronic sinusitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Empyema	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Encephalitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Gastroenteritis	2.3% 4/173 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Gastroenteritis viral	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Herpes virus infection	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Herpes zoster	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Infection	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Influenza	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Intestinal sepsis	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Large intestine infection	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Liver abscess	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Lower respiratory tract infection	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Lung abscess	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Lymphangitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Paracancerous pneumonia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Perihepatic abscess	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Perineal abscess	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Peritonitis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Pneumonia	7.5% 13/173 • Number of events 17 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	4.2% 7/168 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Pneumonia fungal	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Pyelonephritis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Respiratory tract infection	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Sepsis	1.7% 3/173 • Number of events 5 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Septic shock	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Blood and lymphatic system disorders Anaemia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Blood and lymphatic system disorders Splenic vein thrombosis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Acute myocardial infarction	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Cardiac arrest	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Cardiac failure	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Cardiac failure congestive	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Cardiopulmonary failure	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Cardiovascular disorder	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Coronary artery disease	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Myocardial infarction	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Ear and labyrinth disorders Vertigo	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Endocrine disorders Adrenal insufficiency	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Endocrine disorders Inappropriate antidiuretic hormone secretion	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Eye disorders Blindness	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Abdominal pain	1.7% 3/173 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Abdominal pain upper	0.58% 1/173 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Anal fistula	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Aphthous ulcer	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Colitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Constipation	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Diarrhoea	6.4% 11/173 • Number of events 11 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.6% 6/168 • Number of events 6 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Enterocolitis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Gastric ulcer	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Gastric ulcer perforation	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Gastritis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Inguinal hernia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Intestinal obstruction	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Intestinal perforation	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Large intestinal obstruction	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Large intestine perforation	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Pancreatitis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Pancreatitis acute	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Small intestinal perforation	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Stomatitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Vomiting	3.5% 6/173 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Asthenia	1.2% 2/173 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Chest pain	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Death	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Fatigue	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders General physical health deterioration	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Localised oedema	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Multiple organ dysfunction syndrome	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Non-cardiac chest pain	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Oedema peripheral	1.2% 2/173 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Pyrexia	2.3% 4/173 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Sudden death	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Bile duct stenosis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Bile duct stone	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Cholangitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Cholecystitis	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Cholecystitis acute	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Hepatic failure	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Hepatitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Malignant biliary obstruction	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Anal abscess	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Appendiceal abscess	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Appendicitis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Appendicitis perforated	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Bacteraemia	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour necrosis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour obstruction	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Ataxia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Cerebrovascular accident	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Dizziness	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Hemiparesis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Intraventricular haemorrhage	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Neuralgia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Partial seizures	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Seizure	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Syncope	1.2% 2/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Psychiatric disorders Confusional state	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Psychiatric disorders Mental status changes	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Acute kidney injury	1.7% 3/173 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.6% 6/168 • Number of events 10 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Calculus bladder	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Chronic kidney disease	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Haematuria	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Nephropathy toxic	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Proteinuria	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Renal failure	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Tubulointerstitial nephritis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Reproductive system and breast disorders Prostatitis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Cough	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.8% 3/168 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.8% 3/168 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Hydrothorax	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.2% 2/173 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.8% 3/168 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.2% 2/173 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.58% 1/173 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary cavitation	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.8% 3/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Acute febrile neutrophilic dermatosis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Angioedema	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Aortic thrombosis	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Deep vein thrombosis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Hypertension	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Hypotension	1.7% 3/173 • Number of events 3 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Hypovolaemic shock	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Peripheral venous disease	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Shock	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Myocardial ischaemia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Cardiac disorders Acute coronary syndrome	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Ascites	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Faeces hard	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Ileus	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	1.2% 2/168 • Number of events 2 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Nausea	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Hepatobiliary disorders Cholangitis acute	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Pulmonary tuberculosis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations COVID-19	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations COVID-19 pneumonia	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Haematoma muscle	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Rib deformity	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer fatigue	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic renal cell carcinoma	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oncologic complication	0.00% 0/173 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.60% 1/168 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Livedo reticularis	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Haemorrhage	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Peripheral artery occlusion	0.58% 1/173 • Number of events 1 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	0.00% 0/168 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.

Other adverse events

Measure	Lenvatinib 14 mg + Everolimus 5 mg n=173 participants at risk Participants received lenvatinib 14 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until progressive disease (PD), development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first. If there were no intolerable Grade 2 or any \>= Grade 3 TEAEs that required dose reduction in the first 28-day cycle (that is, the first 4 weeks of treatment), lenvatinib dose was escalated to 18 mg once daily (along with everolimus 5 mg) beginning in Cycle 2 or later (cycle length = 28 days) during randomization phase.	Lenvatinib 18 mg + Everolimus 5 mg n=168 participants at risk Participants received lenvatinib 18 mg, capsule, orally, once daily along with everolimus 5 mg, tablet, orally, once daily as the starting dose for in a 28-day treatment cycle until PD, development of unacceptable toxicity, participant requested to discontinue treatment, withdrew consent or lost to follow-up, until the end of the study, or until study termination by the sponsor, whichever occurred first.
Blood and lymphatic system disorders Anaemia	21.4% 37/173 • Number of events 56 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	17.3% 29/168 • Number of events 74 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Blood and lymphatic system disorders Thrombocytopenia	5.8% 10/173 • Number of events 13 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.0% 10/168 • Number of events 29 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Endocrine disorders Hyperthyroidism	2.9% 5/173 • Number of events 6 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	5.4% 9/168 • Number of events 11 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Endocrine disorders Hypothyroidism	17.3% 30/173 • Number of events 38 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	20.8% 35/168 • Number of events 42 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Abdominal pain	16.8% 29/173 • Number of events 46 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	16.7% 28/168 • Number of events 40 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Abdominal pain upper	8.7% 15/173 • Number of events 20 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.7% 13/168 • Number of events 21 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Constipation	12.7% 22/173 • Number of events 25 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	14.9% 25/168 • Number of events 32 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Diarrhoea	67.6% 117/173 • Number of events 352 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	73.2% 123/168 • Number of events 394 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Dyspepsia	8.1% 14/173 • Number of events 21 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	8.9% 15/168 • Number of events 23 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Nausea	31.2% 54/173 • Number of events 104 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	31.0% 52/168 • Number of events 103 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Stomatitis	35.3% 61/173 • Number of events 120 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	29.2% 49/168 • Number of events 92 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Toothache	4.6% 8/173 • Number of events 10 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.5% 11/168 • Number of events 11 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Gastrointestinal disorders Vomiting	23.7% 41/173 • Number of events 85 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	25.6% 43/168 • Number of events 85 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Asthenia	24.3% 42/173 • Number of events 104 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	23.2% 39/168 • Number of events 100 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Fatigue	29.5% 51/173 • Number of events 93 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	29.8% 50/168 • Number of events 104 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Oedema peripheral	12.1% 21/173 • Number of events 31 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	13.7% 23/168 • Number of events 44 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
General disorders Pyrexia	9.8% 17/173 • Number of events 22 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	9.5% 16/168 • Number of events 21 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Upper respiratory tract infection	2.3% 4/173 • Number of events 4 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	5.4% 9/168 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Urinary tract infection	6.4% 11/173 • Number of events 16 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	5.4% 9/168 • Number of events 14 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Alanine aminotransferase increased	6.4% 11/173 • Number of events 21 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	8.3% 14/168 • Number of events 21 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Amylase increased	5.2% 9/173 • Number of events 15 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	4.8% 8/168 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Aspartate aminotransferase increased	7.5% 13/173 • Number of events 17 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.1% 12/168 • Number of events 16 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Blood alkaline phosphatase increased	6.4% 11/173 • Number of events 11 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	5.4% 9/168 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Blood cholesterol increased	7.5% 13/173 • Number of events 19 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	13.1% 22/168 • Number of events 37 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Blood creatinine increased	13.3% 23/173 • Number of events 30 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	14.9% 25/168 • Number of events 42 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Blood thyroid stimulating hormone increased	6.4% 11/173 • Number of events 17 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.0% 5/168 • Number of events 6 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Blood triglycerides increased	4.0% 7/173 • Number of events 19 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.7% 13/168 • Number of events 36 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Lipase increased	10.4% 18/173 • Number of events 33 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	9.5% 16/168 • Number of events 26 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Platelet count decreased	5.2% 9/173 • Number of events 22 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.1% 12/168 • Number of events 20 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Investigations Weight decreased	20.8% 36/173 • Number of events 63 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	24.4% 41/168 • Number of events 73 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Decreased appetite	37.0% 64/173 • Number of events 130 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	33.9% 57/168 • Number of events 137 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypercholesterolaemia	17.9% 31/173 • Number of events 64 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	15.5% 26/168 • Number of events 49 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hyperglycaemia	7.5% 13/173 • Number of events 20 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.1% 12/168 • Number of events 36 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypertriglyceridaemia	21.4% 37/173 • Number of events 112 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	22.6% 38/168 • Number of events 136 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypoalbuminaemia	4.6% 8/173 • Number of events 10 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.0% 10/168 • Number of events 18 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypocalcaemia	4.0% 7/173 • Number of events 11 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.7% 13/168 • Number of events 21 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypokalaemia	5.8% 10/173 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	11.3% 19/168 • Number of events 31 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypomagnesaemia	6.4% 11/173 • Number of events 11 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.5% 11/168 • Number of events 23 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hyponatraemia	6.4% 11/173 • Number of events 18 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.7% 13/168 • Number of events 26 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hypophosphataemia	9.2% 16/173 • Number of events 24 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.5% 11/168 • Number of events 19 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 23/173 • Number of events 29 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	10.1% 17/168 • Number of events 31 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Back pain	10.4% 18/173 • Number of events 23 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	10.1% 17/168 • Number of events 26 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.2% 9/173 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.1% 12/168 • Number of events 16 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	6.9% 12/173 • Number of events 20 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.0% 5/168 • Number of events 8 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Musculoskeletal and connective tissue disorders Pain in extremity	4.6% 8/173 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.7% 13/168 • Number of events 19 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Nervous system disorders Headache	13.9% 24/173 • Number of events 34 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	11.9% 20/168 • Number of events 28 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Psychiatric disorders Insomnia	6.9% 12/173 • Number of events 14 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	9.5% 16/168 • Number of events 19 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Renal and urinary disorders Proteinuria	23.1% 40/173 • Number of events 133 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	39.3% 66/168 • Number of events 186 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Cough	7.5% 13/173 • Number of events 16 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	17.9% 30/168 • Number of events 47 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	11.6% 20/173 • Number of events 28 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	14.3% 24/168 • Number of events 25 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.7% 15/173 • Number of events 23 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	14.9% 25/168 • Number of events 33 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	15.0% 26/173 • Number of events 36 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	14.3% 24/168 • Number of events 28 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	13.9% 24/173 • Number of events 36 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	15.5% 26/168 • Number of events 26 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Pruritus	3.5% 6/173 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	7.1% 12/168 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Skin and subcutaneous tissue disorders Rash	16.2% 28/173 • Number of events 41 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	17.3% 29/168 • Number of events 43 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Hypertension	31.2% 54/173 • Number of events 113 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	35.1% 59/168 • Number of events 101 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Vascular disorders Hypotension	4.0% 7/173 • Number of events 7 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.0% 10/168 • Number of events 16 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Infections and infestations Pneumonia	5.2% 9/173 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.6% 6/168 • Number of events 6 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Dehydration	5.2% 9/173 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	3.0% 5/168 • Number of events 9 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.
Metabolism and nutrition disorders Hyperkalaemia	5.2% 9/173 • Number of events 14 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.	6.0% 10/168 • Number of events 12 • From date of first dose of study drug up to 28 days after last dose of study drug (up to 71 months) Reported deaths included all anticipated and unanticipated deaths due to any cause in the study.

Additional Information

Eisai Medical Information

Eisai Inc.

Phone: 1-888-274-2378

Email: esi_oncmedinfo@eisai.com

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