Trial Outcomes & Findings for Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer (NCT NCT00835978)

NCT ID: NCT00835978

Last Updated: 2017-05-30

Results Overview

ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as \>=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 213 participants
• Primary outcome timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.
• Results posted on: 2017-05-30

Participant Flow

This study was conducted at 49 centers in Czech Republic, Germany, Japan, Russian Federation, Spain, and the United States (US).

Participants were enrolled in a 4-week lead-in period, during which they received axitinib 5 milligram (mg) twice a day (BID). After the lead-in period, participants meeting randomization criteria were then randomized to one of the two treatment arms. Participants, not meeting criteria, continued study without dose titration (non-randomized arm).

Participant milestones

Measure	Active Titration Arm Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	Discontinued Prior to Randomization Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
Overall Study STARTED	56	56	91	10
Overall Study Treated	56	56	91	10
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	56	56	91	10

Reasons for withdrawal

Measure	Active Titration Arm Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	Discontinued Prior to Randomization Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
Overall Study Death	33	40	49	4
Overall Study Lost to Follow-up	3	4	2	1
Overall Study Other	5	1	8	0
Overall Study Objective progression or relapse	2	0	1	0
Overall Study Adverse Event	1	0	1	0
Overall Study Withdrawal by Subject	0	3	0	5
Overall Study Study terminated by sponsor	12	8	30	0

Baseline Characteristics

Axitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer

Baseline characteristics by cohort

Measure	Active Titration Arm n=56 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	Discontinued Prior to Randomization n=10 Participants Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.	Total n=213 Participants Total of all reporting groups
Age, Continuous	59.7 Years STANDARD_DEVIATION 10.2 • n=5 Participants	59.6 Years STANDARD_DEVIATION 10.5 • n=7 Participants	62.9 Years STANDARD_DEVIATION 8.9 • n=5 Participants	62.9 Years STANDARD_DEVIATION 7.5 • n=4 Participants	61.2 Years STANDARD_DEVIATION 9.7 • n=21 Participants
Age, Customized < 65 Years	38 Participants n=5 Participants	38 Participants n=7 Participants	54 Participants n=5 Participants	6 Participants n=4 Participants	136 Participants n=21 Participants
Age, Customized >= 65 Years	18 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants	4 Participants n=4 Participants	77 Participants n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	11 Participants n=7 Participants	36 Participants n=5 Participants	4 Participants n=4 Participants	70 Participants n=21 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	45 Participants n=7 Participants	55 Participants n=5 Participants	6 Participants n=4 Participants	143 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Population: The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

ORR was defined as the proportion of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.0). CR was defined as complete disappearance of all target lesions and non-target disease. No new lesions. PR was defined as >=30% decrease on study under baseline of the sum of longest diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions.

Outcome measures

Measure	Active Titration Arm n=56 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants n=213 Participants All enrolled participants (randomized and non-randomized)
Objective Response Rate (ORR) - Percentage of Participants With Objective Response	53.6 Percentage of Participants Interval 39.7 to 67.0	33.9 Percentage of Participants Interval 21.8 to 47.8	59.3 Percentage of Participants Interval 48.5 to 69.5	48.4 Percentage of Participants Interval 41.5 to 55.3

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Population: The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

The time from first dose administration to first documentation of objective tumor progression or to death due to any cause. PFS in each arm was assessed using the Kaplan-Meier method and estimates of the PFS curves from the Kaplan-Meier method were presented.

Outcome measures

Measure	Active Titration Arm n=56 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants n=213 Participants All enrolled participants (randomized and non-randomized)
Progression-Free Survival (PFS)	14.5 Months Interval 9.2 to 24.5	15.7 Months Interval 8.3 to 19.4	16.6 Months Interval 11.2 to 22.5	14.6 Months Interval 11.5 to 17.5

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks

Population: Subset of Full Analysis (FA) and Safety Analysis (SA) patients who achieved confirmed complete or partial response. FA included all randomized patients and was based on randomized treatment assignment regardless of whether or not study drug was administered. SA included all non randomized patients who received at least one dose of study medication.

DR was defined as the time from the first documentation of objective tumor response (complete response - CR or Partial response - PR) to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. The median values were estimated based on Kaplan-Meier method. 95% confidence interval was based on the Brookmeyer and Crowley method.

Outcome measures

Measure	Active Titration Arm n=30 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=19 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=54 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Duration of Response (DR)	NA Months Interval 10.8 to The median duration of tumor response among responders was not reached in the active treatment group.	21.2 Months Interval 11.1 to 25.8	23.3 Months Interval 15.7 to 28.6	—

SECONDARY outcome

Timeframe: Baseline up to disease progression, death, or withdrawal; performed at baseline and repeated every 8 weeks for 24 weeks, then every 12 weeks.

Population: The Full Analysis (FA) population included all randomized participants who received study drug or different drug to which they were randomized. The Safety Analysis (SA) population included all non-randomized patients who received at least 1 dose of study medication with treatment assignments designated according to actual study treatment received.

OS was defined as the time from date of the first dose of the study medication to date of death due to any cause. For participants who did not die, their survival times were to be censored at the last date they were known to be alive.

Outcome measures

Measure	Active Titration Arm n=56 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Overall Survival (OS)	42.7 Months Interval 24.7 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	30.4 Months Interval 23.7 to 45.0	41.6 Months Interval 33.0 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	—

SECONDARY outcome

Timeframe: Cycle 2 Day 15 (C2D15): pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Cmax for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Maximum Observed Plasma Concentration (Cmax) of Axitinib	31.74 ng/mL Interval 21.63 to 46.58	23.05 ng/mL Interval 16.36 to 32.49	—	—

SECONDARY outcome

Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Tmax for steady-state axitinib was evaluated on Cycle 2 Day 15.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Axitinib,	2.04 hrs Interval 1.0 to 6.0	2.00 hrs Interval 0.0 to 6.0	—	—

SECONDARY outcome

Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Area under the plasma concentration time-curve from zero to the last measurable concentration (AUClast). AUClast for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Axitinib	105.33 ng.hr/mL Interval 70.16 to 158.14	78.44 ng.hr/mL Interval 54.53 to 112.82	—	—

SECONDARY outcome

Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Area under the plasma concentration time-curve from zero 24 hours[AUC(0-24). AUC(0-24) for steady-state axitinib was evaluated on Cycle 2 Day 15. Results were normalized to axitinib 7 mg dose for active titration arm and axitinib 5 mg dose for placebo titration arm.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Area Under the Curve From Time Zero to 24 Hours[AUC(0-24)] for Axitinib	258.68 ng.hr/mL Interval 150.47 to 444.72	161.38 ng.hr/mL Interval 102.09 to 255.12	—	—

SECONDARY outcome

Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. Plasma decay half life for steady-state axitinib was evaluated on Cycle 2 Day 15.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Plasma Decay Half-Life (t1/2) for Axitinib	2.48 hr Standard Deviation 1.902	2.81 hr Standard Deviation 1.685	—	—

SECONDARY outcome

Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Clearance (CL) of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed (F). Clearance is defined as the volume of blood from which drug can be completely removed per unit of time. CL/F for steady-state axitinib was evaluated on Cycle 2 Day 15.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Apparent Oral Clearance (CL/F) of Axitinib	54.15 L/hr Interval 31.49 to 93.12	61.93 L/hr Interval 39.17 to 97.91	—	—

SECONDARY outcome

Timeframe: C2D15: pre-dose, 0.5, 1, 2, 4, and 6 hours post-dose

Population: The pharmacokinetic (PK) population included all participants who were treated and had at least 1 concentration on 1 PK assessment day. The PK parameter analysis data set included all participants treated who had at least 1 estimated PK parameter of primary interest.

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vz/F is influenced by the fraction absorbed. Vz/F for steady-state axitinb was evaluated on Cycle 2 Day 15.

Outcome measures

Measure	Active Titration Arm n=16 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=20 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Apparent Volume of Distribution During the Elimination Phase (Vz/F) for Axitinib	158.18 L Interval 98.38 to 254.34	216.62 L Interval 145.0 to 323.6	—	—

SECONDARY outcome

Timeframe: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.

Population: The SA population consists of all participatns who received at least one dose of study medication.

Value at respective visit minus value at baseline

Outcome measures

Measure	Active Titration Arm n=56 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Change From Baseline in Systolic Blood Pressure Cycle 1 Day 1 (n=52,51,73)	-4.3 mmHg Standard Deviation 11.1	-2.9 mmHg Standard Deviation 9.2	-1.8 mmHg Standard Deviation 14.2	—
Change From Baseline in Systolic Blood Pressure Cycle 1 Day 15 (n=56,56,91)	3.8 mmHg Standard Deviation 12.2	4.1 mmHg Standard Deviation 12.5	11.5 mmHg Standard Deviation 18.0	—
Change From Baseline in Systolic Blood Pressure Cycle 2 Day 1 (n=56,56,91)	1.9 mmHg Standard Deviation 12.4	0.9 mmHg Standard Deviation 13.6	9.9 mmHg Standard Deviation 18.7	—
Change From Baseline in Systolic Blood Pressure Cycle 2 Day 15 (n=55,55,86)	3.6 mmHg Standard Deviation 13.8	2.7 mmHg Standard Deviation 16.6	5.9 mmHg Standard Deviation 20.3	—
Change From Baseline in Systolic Blood Pressure Cycle 3 Day 1 (n=48,49,84)	3.5 mmHg Standard Deviation 15.1	8.4 mmHg Standard Deviation 15.4	5.2 mmHg Standard Deviation 20.2	—
Change From Baseline in Systolic Blood Pressure Cycle 4 Day 1 (n=45,48,79)	4.3 mmHg Standard Deviation 12.7	3.5 mmHg Standard Deviation 13.0	5.5 mmHg Standard Deviation 18.2	—
Change From Baseline in Systolic Blood Pressure End of treatment (n=35,44,51)	2.4 mmHg Standard Deviation 17.0	1.7 mmHg Standard Deviation 14.0	-2.8 mmHg Standard Deviation 19.0	—
Change From Baseline in Systolic Blood Pressure Follow-up (n=16,25,36)	-3.6 mmHg Standard Deviation 16.9	-0.4 mmHg Standard Deviation 16.3	-0.6 mmHg Standard Deviation 16.7	—

SECONDARY outcome

Timeframe: At screening (D-14 to D-1); lead-in period: Cycle 1 - Day 1 and Day 15; Cycle 2 - Day 1 and Day 15; Cycle 3 & subsequent cycles Day 1; end of study and follow-up 28 days after last dose.

Population: The SA population consists of all participatns who received at least one dose of study medication.

Value at respective visit minus value at baseline.

Outcome measures

Measure	Active Titration Arm n=56 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Change From Baseline in Diastolic Blood Pressure Cycle 1 Day 1 (n=52,51,73)	-1.6 mmHg Standard Deviation 8.2	-2.6 mmHg Standard Deviation 7.4	0.5 mmHg Standard Deviation 8.4	—
Change From Baseline in Diastolic Blood Pressure Cycle 1 Day 15 (n=56,56,91)	4.8 mmHg Standard Deviation 8.5	3.0 mmHg Standard Deviation 7.7	11.5 mmHg Standard Deviation 10.0	—
Change From Baseline in Diastolic Blood Pressure Cycle 2 Day 1 (n=56,56,91)	4.2 mmHg Standard Deviation 9.0	3.5 mmHg Standard Deviation 8.0	10.5 mmHg Standard Deviation 10.5	—
Change From Baseline in Diastolic Blood Pressure Cycle 2 Day 15 (n=55,55,86)	5.5 mmHg Standard Deviation 10.5	4.4 mmHg Standard Deviation 10.7	9.7 mmHg Standard Deviation 11.3	—
Change From Baseline in Diastolic Blood Pressure Cycle 3 Day 1 (n=48,49,84)	6.6 mmHg Standard Deviation 8.3	5.9 mmHg Standard Deviation 9.3	9.1 mmHg Standard Deviation 13.6	—
Change From Baseline in Diastolic Blood Pressure Cycle 4 Day 1 (n=45,48,79)	7.4 mmHg Standard Deviation 8.2	4.6 mmHg Standard Deviation 8.5	8.7 mmHg Standard Deviation 11.8	—
Change From Baseline in Diastolic Blood Pressure End of treatment (n=35,44,51)	0.6 mmHg Standard Deviation 10.8	3.5 mmHg Standard Deviation 6.3	3.0 mmHg Standard Deviation 10.5	—
Change From Baseline in Diastolic Blood Pressure Follow-up (n=16,25,36)	-4.5 mmHg Standard Deviation 10.1	-1.3 mmHg Standard Deviation 8.5	1.8 mmHg Standard Deviation 9.0	—

SECONDARY outcome

Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Population: The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ mean fluorescence intensity (MFI) platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-Vascular endothelial growth factor receptor (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.

Outcome measures

Measure	Active Titration Arm n=17 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=22 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=20 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline Baseline CECs Count (n=17,22,20)	23584 Fluorescent Intensity Unit (FIU) Standard Deviation 18213.1	28544 Fluorescent Intensity Unit (FIU) Standard Deviation 27694.4	29663 Fluorescent Intensity Unit (FIU) Standard Deviation 30651.0	—
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline Baseline MFI PDGFR-BETA (n=17,22,20)	346815 Fluorescent Intensity Unit (FIU) Standard Deviation 179563	455238 Fluorescent Intensity Unit (FIU) Standard Deviation 238157	327567 Fluorescent Intensity Unit (FIU) Standard Deviation 167728	—
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline Baseline MFI pPDGFR-BETA (n=17,22,20)	401226 Fluorescent Intensity Unit (FIU) Standard Deviation 195445	395509 Fluorescent Intensity Unit (FIU) Standard Deviation 136933	397672 Fluorescent Intensity Unit (FIU) Standard Deviation 193172	—
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline Baseline MFI pVEGFR (n=16,22,20)	456086 Fluorescent Intensity Unit (FIU) Standard Deviation 290174	436197 Fluorescent Intensity Unit (FIU) Standard Deviation 128225	398754 Fluorescent Intensity Unit (FIU) Standard Deviation 188137	—
Comparison of Circulating Endothelial Cells (CECs) in Blood: Cluster of Differentiation (CD)146+/CD105+ at Baseline Baseline MFI VEGFR (n=16,22,20)	367799 Fluorescent Intensity Unit (FIU) Standard Deviation 181320	473290 Fluorescent Intensity Unit (FIU) Standard Deviation 228619	359092 Fluorescent Intensity Unit (FIU) Standard Deviation 167706	—

SECONDARY outcome

Timeframe: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)

Population: The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD146+/CD105+ CECs, CD146+/CD105+ MFI platelet derived growth factor receptor (PDGFR)-beta, CD146+/CD105+ MFI phospho-PDGFR (pPDGFR)-beta, CD146+/CD105+ phospho-VEGFR (pVEGFR), CD146+/CD105+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.

Outcome measures

Measure	Active Titration Arm n=17 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=22 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=20 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C1D15:C1D1 CECs Count (n=11,18,14)	2.3 Ratio Standard Deviation 2.52	3.7 Ratio Standard Deviation 6.92	2.2 Ratio Standard Deviation 3.10	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C2D15:C1D1 CECs Count (n=13,16,11)	1.3 Ratio Standard Deviation 1.43	4.4 Ratio Standard Deviation 9.27	1.3 Ratio Standard Deviation 1.22	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline EOT:C1D1 CECs Count (n=7,9,4)	2.8 Ratio Standard Deviation 4.81	8.9 Ratio Standard Deviation 21.70	1.2 Ratio Standard Deviation 1.50	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C1D15:C1D1 MFI PDGFRBETA (n=11,17,13)	1.3 Ratio Standard Deviation 1.03	1.5 Ratio Standard Deviation 1.14	1.1 Ratio Standard Deviation 0.73	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C2D15:C1D1 MFI PDGFRBETA (n=13,16,11)	1.4 Ratio Standard Deviation 1.24	1.1 Ratio Standard Deviation 1.14	2.2 Ratio Standard Deviation 1.62	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline EOT:C1D1 MFI PDGFRBETA (n=7,9,4)	1.5 Ratio Standard Deviation 1.75	0.6 Ratio Standard Deviation 0.52	1.2 Ratio Standard Deviation 1.78	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C1D15:C1D1 MFI pPDGFR-BETA (n=11,17,13)	1.1 Ratio Standard Deviation 0.63	1.2 Ratio Standard Deviation 0.77	1.0 Ratio Standard Deviation 1.12	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C2D15:C1D1 MFI pPDGFR-BETA (n=13,16,11)	1.0 Ratio Standard Deviation 0.69	0.8 Ratio Standard Deviation 0.45	1.2 Ratio Standard Deviation 0.79	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline EOT:C1D1 MFI pPDGFRBETA (n=7,9,4)	0.8 Ratio Standard Deviation 0.71	0.8 Ratio Standard Deviation 0.93	1.9 Ratio Standard Deviation 1.57	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C1D15:C1D1 MFI pVEGFR (n=10,18,14)	1.0 Ratio Standard Deviation 0.46	1.2 Ratio Standard Deviation 0.88	1.2 Ratio Standard Deviation 1.00	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C2D15:C1D1 MFI pVEGFR (n=12,16,11)	1.0 Ratio Standard Deviation 0.74	0.9 Ratio Standard Deviation 0.82	1.2 Ratio Standard Deviation 0.80	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline EOT:C1D1 MFI pVEGFR (n=7,9,4)	0.8 Ratio Standard Deviation 0.53	1.3 Ratio Standard Deviation 0.96	3.0 Ratio Standard Deviation 1.16	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C1D15:C1D1 MFI VEGFR (n=10,18,14)	1.4 Ratio Standard Deviation 1.25	1.3 Ratio Standard Deviation 0.94	1.0 Ratio Standard Deviation 0.64	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline C2D15:C1D1 MFI VEGFR (n=12,16,11)	1.5 Ratio Standard Deviation 1.48	1.3 Ratio Standard Deviation 0.99	2.1 Ratio Standard Deviation 1.72	—
Comparison of the Ratio of CECs in Blood: CD146+/CD105+ at Each Time Point to Baseline EOT:C1D1 MFI VEGFR (n=7,9,4)	1.1 Ratio Standard Deviation 1.03	0.7 Ratio Standard Deviation 0.48	1.9 Ratio Standard Deviation 1.63	—

SECONDARY outcome

Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Population: The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.

Outcome measures

Measure	Active Titration Arm n=17 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=22 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=20 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+ Baseline CECs Count (n=17,22,20)	74668 Fluorescent Intensity Unit (FIU) Standard Deviation 50558.9	76258 Fluorescent Intensity Unit (FIU) Standard Deviation 46779.5	77437 Fluorescent Intensity Unit (FIU) Standard Deviation 63419.4	—
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+ Baseline MFI PDGFR-BETA (n=17,21,20)	333760 Fluorescent Intensity Unit (FIU) Standard Deviation 164604	380886 Fluorescent Intensity Unit (FIU) Standard Deviation 147261	442642 Fluorescent Intensity Unit (FIU) Standard Deviation 267436	—
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+ Baseline MFI pPDGFR-BETA (n=17,21,20)	380139 Fluorescent Intensity Unit (FIU) Standard Deviation 205600	355441 Fluorescent Intensity Unit (FIU) Standard Deviation 147046	383202 Fluorescent Intensity Unit (FIU) Standard Deviation 211174	—
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+ Baseline MFI pVEGFR (n=17,22,20)	385617 Fluorescent Intensity Unit (FIU) Standard Deviation 203956	352644 Fluorescent Intensity Unit (FIU) Standard Deviation 128803	380184 Fluorescent Intensity Unit (FIU) Standard Deviation 173578	—
Circulating Endothelial Cells (CECs) in Blood: CD31+/CD146+ Baseline MFI VEGFR (n=17,22,20)	330333 Fluorescent Intensity Unit (FIU) Standard Deviation 151710	401909 Fluorescent Intensity Unit (FIU) Standard Deviation 165235	359097 Fluorescent Intensity Unit (FIU) Standard Deviation 146943	—

SECONDARY outcome

Timeframe: At end of the lead-in period (Cycle 1 Day 15), Cycle 2 Day 15 and End of therapy (EOT)

Population: The Biomarker Analysis Set included participants receiving at least one dose of treatment, with a Cycle 1 Day 1 biomarker result for at least one biomarker.

CECs are noninvasive marker of vascular damage, remodeling, and dysfunction. Samples were collected and following proteins were analyzed: CD31+/CD146+ CECs, CD31+/CD146+ MFI PDGFR-beta, CD31+/CD146+ MFI pPDGFR-beta, CD31+/CD146+ pVEGFR, CD31+/CD146+ MFI VEGFR. The ratio of plasma levels of the biomarkers at the selected time point vs baseline is reported.

Outcome measures

Measure	Active Titration Arm n=17 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=22 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=20 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C1D15:C1D1 CECs Count (n=11,18,14)	2.7 Ratio Standard Deviation 3.17	1.6 Ratio Standard Deviation 2.32	1.5 Ratio Standard Deviation 2.31	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C2D15:C1D1 CECs Count (n=13,16,11)	1.4 Ratio Standard Deviation 1.38	2.2 Ratio Standard Deviation 3.91	2.5 Ratio Standard Deviation 3.98	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline EOT:C1D1 CECs COUNT (n=7,9,4)	1.5 Ratio Standard Deviation 1.95	1.4 Ratio Standard Deviation 2.66	0.6 Ratio Standard Deviation 0.71	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C1D15:C1D1 MFI PDGFRBETA (n=11,15,13)	1.2 Ratio Standard Deviation 0.74	1.3 Ratio Standard Deviation 0.89	0.8 Ratio Standard Deviation 0.51	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C2D15:C1D1 MFI PDGFRBETA (n=13,14,11)	1.4 Ratio Standard Deviation 1.36	1.1 Ratio Standard Deviation 1.03	2.2 Ratio Standard Deviation 2.64	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline EOT:C1D1 MFI PDGFRBETA (n=6,8,4)	1.2 Ratio Standard Deviation 1.23	0.6 Ratio Standard Deviation 0.51	1.7 Ratio Standard Deviation 1.49	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C1D15:C1D1 MFI pPDGFR-BETA (n=11,15,13)	1.2 Ratio Standard Deviation 1.07	1.4 Ratio Standard Deviation 0.81	1.0 Ratio Standard Deviation 0.87	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C2D15:C1D1 MFI pPDGFR-BETA (n=13,14,11)	1.2 Ratio Standard Deviation 0.89	0.8 Ratio Standard Deviation 0.38	1.1 Ratio Standard Deviation 0.71	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline EOT:C1D1 MFI pPDGFRBETA (n=6,8,4)	0.7 Ratio Standard Deviation 0.63	0.8 Ratio Standard Deviation 0.91	3.0 Ratio Standard Deviation 0.47	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C1D15:C1D1 MFI pVEGFR (n=11,18,14)	1.1 Ratio Standard Deviation 0.75	1.4 Ratio Standard Deviation 0.74	1.2 Ratio Standard Deviation 0.90	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C2D15:C1D1 MFI pVEGFR (n=13,16,10)	1.2 Ratio Standard Deviation 1.00	0.9 Ratio Standard Deviation 0.68	1.3 Ratio Standard Deviation 0.70	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline EOT:C1D1 MFI pVEGFR (n=7,9,4)	0.7 Ratio Standard Deviation 0.59	1.1 Ratio Standard Deviation 1.24	3.1 Ratio Standard Deviation 0.95	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C1D15:C1D1 MFI VEGFR (n=11,18,14)	1.3 Ratio Standard Deviation 0.93	1.3 Ratio Standard Deviation 0.90	1.0 Ratio Standard Deviation 0.57	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline C2D15:C1D1 MFI VEGFR n=13,16,10)	1.5 Ratio Standard Deviation 1.44	1.2 Ratio Standard Deviation 0.96	2.1 Ratio Standard Deviation 1.80	—
Comparison of Ratio of CECs in Blood: CD31+/CD146+ at Each Time Point to Baseline EOT:C1D1 MFI VEGFR (n=7,9,4)	1.2 Ratio Standard Deviation 1.27	1.1 Ratio Standard Deviation 0.90	1.5 Ratio Standard Deviation 1.42	—

SECONDARY outcome

Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Population: The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.

ORR, defined as proportion of participants with CR or PR according to RECIST, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms.

Outcome measures

Measure	Active Titration Arm n=49 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=49 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=79 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs699947 Genotype: A/A (n = 7, 9, 14)	85.7 Percentage of participants Interval 42.1 to 99.6	22.2 Percentage of participants Interval 2.8 to 60.0	42.9 Percentage of participants Interval 17.7 to 71.1	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs699947 Genotype: A/C (n = 22, 20, 41)	54.5 Percentage of participants Interval 32.2 to 75.6	35.0 Percentage of participants Interval 15.4 to 59.2	65.9 Percentage of participants Interval 49.4 to 79.9	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs699947 Genotype: C/C (n = 14, 14, 24)	50.0 Percentage of participants Interval 23.0 to 77.0	35.7 Percentage of participants Interval 12.8 to 64.9	66.7 Percentage of participants Interval 44.7 to 84.4	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs1570360 Genotype: G/G (n = 22, 23, 43)	59.1 Percentage of participants Interval 36.4 to 79.3	39.1 Percentage of participants Interval 19.7 to 61.5	67.4 Percentage of participants Interval 51.5 to 80.9	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs1570360 Genotype: G/A (n = 19, 16, 29)	57.9 Percentage of participants Interval 33.5 to 79.7	18.8 Percentage of participants Interval 4.0 to 45.6	58.6 Percentage of participants Interval 38.9 to 76.5	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs1570360 Genotype: A/A (n = 2, 4, 7)	50.0 Percentage of participants Interval 1.3 to 98.7	50.0 Percentage of participants Interval 6.8 to 93.2	42.9 Percentage of participants Interval 9.9 to 81.6	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs448012 Genotype: G/G (n = 16, 15, 28)	81.3 Percentage of participants Interval 54.4 to 96.0	53.3 Percentage of participants Interval 26.6 to 78.7	60.7 Percentage of participants Interval 40.6 to 78.5	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs448012 Genotype: G/C (n = 22, 22, 35)	45.5 Percentage of participants Interval 24.4 to 67.8	18.2 Percentage of participants Interval 5.2 to 40.3	57.1 Percentage of participants Interval 39.4 to 73.7	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs448012 Genotype: C/C (n = 5, 6, 16)	40.0 Percentage of participants Interval 5.3 to 85.3	33.3 Percentage of participants Interval 4.3 to 77.7	75.0 Percentage of participants Interval 47.6 to 92.7	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307826 Genotype: A/A (n = 36, 39, 79)	58.3 Percentage of participants Interval 40.8 to 74.5	30.8 Percentage of participants Interval 17.0 to 47.6	64.3 Percentage of participants Interval 51.9 to 75.4	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307826 Genotype: A/G (n = 6, 4, 9)	50.0 Percentage of participants Interval 11.8 to 88.2	50.0 Percentage of participants Interval 6.8 to 93.2	44.4 Percentage of participants Interval 13.7 to 78.8	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307826 Genotype: G/G (n = 1, 0, 0)	100.0 Percentage of participants Interval 2.5 to 100.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307821 Genotype: G/G (n = 36, 38, 79)	55.6 Percentage of participants Interval 38.1 to 72.1	28.9 Percentage of participants Interval 15.4 to 45.9	65.2 Percentage of participants Interval 52.8 to 76.3	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307821 Genotype: G/T (n = 6, 5, 10)	66.7 Percentage of participants Interval 22.3 to 95.7	60.0 Percentage of participants Interval 14.7 to 94.7	40.0 Percentage of participants Interval 12.2 to 73.8	—
ORR in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307821 Genotype: T/T (n = 1, 0, 0)	100.0 Percentage of participants Interval 2.5 to 100.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: At baseline - Beginning of the lead-in period (Cycle 1 Day 1)

Population: The Safety Analysis (SA) population consisted of all participants who received at least one dose of study medication with treatment assignments designated according to actual study treatment received.

PFS, defined as the time from randomization to first documentation of objective tumor progression or to death due to any cause, in subgroups that were defined by VEGFA or VEGFR3 polymorphisms. Estimates of the PFS curves from the Kaplan-Meier method were presented.

Outcome measures

Measure	Active Titration Arm n=43 Participants Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=43 Participants Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=79 Participants Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	All Participants All enrolled participants (randomized and non-randomized)
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs699947 Genotype: A/A (n = 7, 9, 14)	NA Months Interval 1.74 to Values were not calculable due to the large number of censored event times	11.50 Months Interval 3.58 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	7.33 Months Interval 5.06 to 13.83	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs699947 Genotype: A/C (n = 22, 20, 41)	11.07 Months Interval 3.02 to 17.44	9.67 Months Interval 1.91 to 16.59	16.59 Months Interval 10.97 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs699947 Genotype: C/C (n = 14, 14, 41)	18.74 Months Interval 1.84 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	24.64 Months Interval 4.01 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	25.13 Months Interval 8.28 to 30.45	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs1570360 Genotype: G/G (n = 22, 23, 43)	14.62 Months Interval 7.39 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	19.42 Months Interval 5.81 to 27.63	25.13 Months Interval 11.47 to 30.45	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs1570360 Genotype: G/A (n = 19, 16, 29)	12.78 Months Interval 1.84 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	8.34 Months Interval 1.91 to 16.59	13.90 Months Interval 8.28 to 22.54	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFA/rs1570360 Genotype: A/A (n = 2, 4, 29)	NA Months Interval 1.74 to Values were not calculable due to the large number of censored event times	10.04 Months Interval 3.58 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	8.57 Months Interval 1.74 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs448012 Genotype: G/G (n = 16, 15, 28)	17.44 Months Interval 12.78 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	19.42 Months Interval 5.35 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	22.54 Months Interval 8.08 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs448012 Genotype: G/C (n = 22, 22, 35)	9.18 Months Interval 1.84 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	8.31 Months Interval 3.58 to 16.52	13.83 Months Interval 5.62 to 16.59	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs448012 Genotype: C/C (n = 5, 6, 16)	11.07 Months Interval 1.84 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	15.67 Months Interval 1.91 to 27.63	NA Months Interval 8.57 to Values were not calculable due to the large number of censored event times	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307826 Genotype: A/A (n = 36, 39, 70)	13.73 Months Interval 8.28 to 24.47	15.67 Months Interval 8.21 to 22.17	16.56 Months Interval 10.28 to 25.13	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307826 Genotype: A/G (n = 6, 4, 9)	16.52 Months Interval 1.18 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	7.93 Months Interval 1.84 to 11.86	16.26 Months Interval 2.66 to 30.45	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307826 Genotype: G/G (n = 0, 0, 0)	NA Months Number of participants with an event in this category was 0	NA Months Number of participants with an event in this category was 0	NA Months Number of participants with an event in this category was 0	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307821 Genotype: G/G (n = 36, 38, 69)	12.78 Months Interval 7.39 to 24.47	15.67 Months Interval 8.21 to 23.95	16.59 Months Interval 10.28 to 28.52	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307821 Genotype: G/T (n = 36, 38, 10)	24.80 Months Interval 1.18 to Upper limit of the confidence interval was not calculable due to the large number of censored event times	8.34 Months Interval 1.84 to 11.86	13.86 Months Interval 2.66 to 30.45	—
PFS in Subgroups That Were Defined by Vascular Endothelial Growth Factor A (VEGFA) or Vascular Endothelial Growth Factor Receptor 3 (VEGFR3) Polymorphisms VEGFR3/rs307821 Genotype: T/T (n = 1, 0, 0)	NA Months Number of participants with an event in this category was 1	NA Months Number of participants with an event in this category was 0	NA Months Number of participants with an event in this category was 0	—

Adverse Events

Active Titration Arm

Serious events: 25 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo Titration Arm

Serious events: 14 serious events

Other events: 51 other events

Deaths: 0 deaths

Non-randomized Arm

Serious events: 39 serious events

Other events: 91 other events

Deaths: 0 deaths

Discontinued Prior to Randomization

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Active Titration Arm n=56 participants at risk Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 participants at risk Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 participants at risk Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	Discontinued Prior to Randomization n=10 participants at risk Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
Blood and lymphatic system disorders Neutropenia	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Anaemia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial ischaemia	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Acute myocardial infarction	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Angina pectoris	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Coronary artery stenosis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Diastolic dysfunction	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial infarction	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Eye disorders Cataract	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diverticulum intestinal haemorrhagic	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ascites	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Crohn's disease	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Enterocolitis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrointestinal hypomotility	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/1 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Ileus	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Pancreatitis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Disease progression	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders General physical health deterioration	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholecystitis chronic	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Biliary colic	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Cholelithiasis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Cystitis	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lung abscess	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Appendicitis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Infection	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Lung infection	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Osteomyelitis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Peritonitis bacterial	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Postoperative wound infection	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Overdose	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Postoperative hernia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Postoperative wound complication	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood sodium decreased	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebrovascular insufficiency	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Syncope	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Encephalopathy	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Presyncope	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Somnolence	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Delirium	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal colic	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Postrenal failure	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Renal failure	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Acute kidney injury	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Urinary retention	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Reproductive system and breast disorders Pelvic prolapse	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Atelectasis	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dermatitis	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Incisional hernia repair	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Circulatory collapse	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertensive crisis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Orthostatic hypotension	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Acute coronary syndrome	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Atrial fibrillation	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Cardiac failure	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Coronary artery disease	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Small intestinal obstruction	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gingivitis	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Cervical vertebral fracture	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Incisional hernia	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Postoperative ileus	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebrovascular accident	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Monoparesis	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Measure	Active Titration Arm n=56 participants at risk Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib \[blinded therapy\] 5 mg BID).	Placebo Titration Arm n=56 participants at risk Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator's clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo \[blinded therapy\] 5 mg BID).	Non-randomized Arm n=91 participants at risk Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.	Discontinued Prior to Randomization n=10 participants at risk Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
Blood and lymphatic system disorders Anaemia	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.9% 9/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Sinus tachycardia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Endocrine disorders Hypothyroidism	32.1% 18/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.2% 13/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	45.1% 41/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain	16.1% 9/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.1% 9/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.1% 11/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal pain upper	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.1% 11/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Constipation	19.6% 11/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	29.7% 27/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Diarrhoea	60.7% 34/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	62.5% 35/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	63.7% 58/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dry Mouth	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 7/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dyspepsia	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.8% 18/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Flatulence	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Haemorrhoids	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Nausea	42.9% 24/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.9% 19/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	36.3% 33/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Stomatitis	17.9% 10/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	18.7% 17/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	32.1% 18/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	21.4% 12/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	27.5% 25/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Asthenia	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	48.2% 27/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	46.4% 26/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	53.8% 49/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	40.0% 4/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Mucosal inflammation	21.4% 12/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 13/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Rhinitis	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Alanine aminotransferase increased	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.1% 9/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.2% 12/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Aspartate aminotransferase increased	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	17.9% 10/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.2% 12/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood creatinine increased	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 14/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose increased	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.0% 10/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Fibrin D dimer increased	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Weight decreased	28.6% 16/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	21.4% 12/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	27.5% 25/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Decreased appetite	37.5% 21/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	28.6% 16/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	40.7% 37/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyponatraemia	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Arthralgia	23.2% 13/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	19.6% 11/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	18.7% 17/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Back pain	23.2% 13/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	18.7% 17/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.5% 15/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dysgeusia	16.1% 9/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	23.1% 21/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Headache	16.1% 9/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	26.8% 15/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	29.7% 27/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Hypoaesthesia	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Paraesthesia	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Confusional state	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Insomnia	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.8% 8/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Haemoglobinuria	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Proteinuria	21.4% 12/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	21.4% 12/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	44.0% 40/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.9% 19/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dysphonia	32.1% 18/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	35.7% 20/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	48.4% 44/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	30.0% 3/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	29.7% 27/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Dry skin	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 7/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	32.1% 18/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	17.9% 10/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	44.0% 40/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Pruritus	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 13/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Rash	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.9% 19/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypertension	62.5% 35/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	42.9% 24/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	83.5% 76/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	50.0% 5/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Blood and lymphatic system disorders Thrombocytopenia	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.5% 15/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal distension	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastritis	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.9% 9/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Gastrooesophageal reflux disease	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Oedema peripheral	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 14/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pain	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Upper respiratory tract infection	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood alkaline phosphatase increased	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood glucose decreased	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood potassium increased	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood thyroid stimulating hormone increased	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	12.5% 7/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.9% 9/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperkalaemia	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 7/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperuricaemia	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.9% 9/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoalbuminaemia	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypophosphataemia	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Bone pain	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscular weakness	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Myalgia	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.8% 8/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Neck pain	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.1% 9/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	25.3% 23/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.0% 2/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dizziness	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	17.9% 10/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 14/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Transient ischaemic attack	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Epistaxis	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	13.2% 12/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	8.8% 8/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Alopecia	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	15.4% 14/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Ear and labyrinth disorders Tinnitus	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Abdominal discomfort	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Dysphagia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Proctalgia	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Toothache	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chest pain	8.9% 5/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Chills	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders General physical health deterioration	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Pyrexia	10.7% 6/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders Hepatic function abnormal	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Nasopharyngitis	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	20.9% 19/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Respiratory tract infection	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sinusitis	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Urinary tract infection	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	11.0% 10/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood albumin decreased	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood sodium decreased	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Blood triglycerides increased	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Haemoglobin decreased	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hyperglycaemia	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.2% 2/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Flank pain	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.4% 4/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Muscle spasms	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Dyskinesia	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Peripheral sensory neuropathy	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Anxiety	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.7% 7/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Delirium	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	10.0% 1/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Depression	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Renal and urinary disorders Dysuria	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.3% 3/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Erythema	1.8% 1/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	6.6% 6/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Skin and subcutaneous tissue disorders Hyperkeratosis	3.6% 2/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	7.1% 4/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.5% 5/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Surgical and medical procedures Tooth extraction	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	5.4% 3/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.1% 1/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Vascular disorders Hypotension	0.00% 0/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	14.3% 8/56 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	9.9% 9/91 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/10 • AEs were reported until follow up visit. Non-SAEs: up to 28 days post last dose or upon starting new anticancer treatment, whichever was first. SAEs: up to 28 days post last dose, irrespective of new anticancer treatment. The same event may be referred to as (serious and non-serious) AEs. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER