Trial Outcomes & Findings for Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer (NCT NCT00942331)

NCT ID: NCT00942331

Last Updated: 2023-10-16

Results Overview

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 506 participants
• Primary outcome timeframe: From date of randomization to date of death due to any cause, assessed up to 7 years
• Results posted on: 2023-10-16

Participant Flow

Participant milestones

Measure	Arm II (GCB) Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	252	254
Overall Study COMPLETED	237	232
Overall Study NOT COMPLETED	15	22

Reasons for withdrawal

Measure	Arm II (GCB) Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Study Did not start treatment	15	22

Baseline Characteristics

Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer

Baseline characteristics by cohort

Measure	Arm II (GCB) n=252 Participants Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=254 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Total n=506 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	56 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	199 Participants n=5 Participants	198 Participants n=7 Participants	397 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	229 Participants n=5 Participants	235 Participants n=7 Participants	464 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	10 Participants n=7 Participants	17 Participants n=5 Participants
ECOG Performance Status 0	146 Participants n=5 Participants	132 Participants n=7 Participants	278 Participants n=5 Participants
ECOG Performance Status 1	106 Participants n=5 Participants	122 Participants n=7 Participants	228 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of randomization to date of death due to any cause, assessed up to 7 years

Population: Intent to treat (ITT) analysis population

Overall survival time is defined as the time from randomization to death due to any cause. The median and 95% confidence intervals are estimated using the Kaplan-Meier estimator.The stratified log-rank statistic will be the primary analysis to compare the two treatment arms on OS with the stratification factors: presence of visceral metastases (no, yes) and prior chemotherapy (no, yes). In addition, the proportional hazards model will be used to assess the importance of the treatment arm adjusting on patient characteristics, stratification variables and other important covariates in predicting OS.

Outcome measures

Measure	Arm II (GCB) n=252 Participants Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=254 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	14.5 months Interval 13.5 to 16.2	14.3 months Interval 12.1 to 16.2

SECONDARY outcome

Timeframe: From the date of randomization to date of progression or death due to any cause, whichever occurs first, assessed up to 7 years

The primary analysis of PFS will be a two-sided stratified log-rank test comparing arm A and arm B. The stratification factors will consist of the two stratification factors used for patient randomization: prior nephrectomy (yes vs. no) and Motzer score (0 vs. 1-2 vs. 3+). Results from unstratified log-rank tests will also be provided. Kaplan-Meier methodology will be used to estimate median PFS for each treatment arm.

Outcome measures

Measure	Arm II (GCB) n=252 Participants Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=254 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Progression-free Survival (PFS)	8.0 months Interval 7.1 to 8.5	6.7 months Interval 6.3 to 7.4

SECONDARY outcome

Timeframe: Up to 7 years

Population: All patients registered, eligible and assessed for a response are included in this analysis.

Objective response is defined as confirmed complete and partial responses using Response Evaluation Criteria in Solid Tumors criteria. A complete response (CR) is defined as a disappearance of all target lesions. A partial response (PR) is defined as having at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum.

In each arm, the number of patients reporting a CR or PR was divided by the number of patients evaluable in each arm to obtain the proportion.

Outcome measures

Measure	Arm II (GCB) n=213 Participants Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=209 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Objective Response	0.4 proportion of participants	0.36 proportion of participants

SECONDARY outcome

Timeframe: Up to 7 years

Population: Patients who started treatment are evaluable for adverse events.

The number of patients experiencing grade 3 or higher toxicity (adverse events considered at least possibly related to treatment) is reported below.

Outcome measures

Measure	Arm II (GCB) n=237 Participants Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=232 Participants Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Number of Patients Experiencing Grade 3+ Toxicity	183 Participants	163 Participants

Adverse Events

Arm II (GCB)

Serious events: 95 serious events

Other events: 215 other events

Deaths: 207 deaths

Arm I (GCP)

Serious events: 87 serious events

Other events: 205 other events

Deaths: 216 deaths

Serious adverse events

Measure	Arm II (GCB) n=237 participants at risk Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=232 participants at risk Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Blood disorder	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Febrile neutropenia	2.1% 5/237 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Hemoglobin decreased	30.4% 72/237 • Number of events 92 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	27.2% 63/232 • Number of events 78 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Atrial fibrillation	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Cardiac disorder	0.84% 2/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Cardiac pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Conduction disorder	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Left ventricular failure	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Myocardial ischemia	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Pericardial effusion	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Ventricular fibrillation	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Ear and labyrinth disorders Hearing impaired	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Eye disorders Eye pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Abdominal pain	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Ascites	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Colitis	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Colonic obstruction	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Colonic perforation	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Constipation	3.8% 9/237 • Number of events 9 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Diarrhea	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Dry mouth	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Duodenal hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Duodenal obstruction	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Duodenal ulcer	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Gastrointestinal disorder	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Ileus	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Mucositis oral (clin exam)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Mucositis oral (funct/sympt)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Nausea	4.2% 10/237 • Number of events 10 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 9 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Oral hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Pancreatitis	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Small intestinal obstruction	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Vomiting	8.0% 19/237 • Number of events 20 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	12.5% 29/232 • Number of events 36 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Chest pain	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Chills	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Death NOS	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Disease progression	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Edema limbs	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Fatigue	30.0% 71/237 • Number of events 91 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	24.6% 57/232 • Number of events 77 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Fever	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders General symptom	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Ill-defined disorder	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Localized edema	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Pain	1.3% 3/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Sudden death	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Hepatobiliary disorders Cholecystitis	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Hepatobiliary disorders Gallbladder obstruction	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Hepatobiliary disorders Hepatic failure	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Bladder infection(gr 3/4 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Bladder infection(unknown ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Catheter related infection	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Catheter related infection(gr 3/4 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Gingival infection(unknown ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Infection(gr 0/1/2 ANC)	2.1% 5/237 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Kidney infection(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Kidney infection(gr 3/4 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Opportunistic infection	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Phlebitis infective	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Pneumonia(gr 3/4 ANC)	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Sepsis(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Sepsis(unknown ANC)	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Skin infection	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Skin infection(gr 3/4 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Soft tissue infection(gr 0/1/2 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Tooth infection(gr 3/4 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Upper respiratory infectn(gr 0/1/2 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Urinary tract infection(gr 0/1/2 ANC)	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Urinary tract infection(gr 3/4 ANC)	1.7% 4/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Urinary tract infection(unknown ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Fracture	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Intraoperative complications	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Postoperative hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Vascular access complication	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Activated partial throm time prolonged	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Alanine aminotransferase increased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Alkaline phosphatase increased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Aspartate aminotransferase increased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Blood bilirubin increased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Cardiac troponin I increased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Creatinine increased	14.8% 35/237 • Number of events 40 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	16.8% 39/232 • Number of events 54 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations INR increased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Leukocyte count decreased	2.5% 6/237 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Lymphocyte count decreased	2.5% 6/237 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Neutrophil count decreased	13.1% 31/237 • Number of events 39 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	12.5% 29/232 • Number of events 32 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Platelet count decreased	21.1% 50/237 • Number of events 67 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	16.4% 38/232 • Number of events 46 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Weight gain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Anorexia	1.7% 4/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Blood glucose increased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Dehydration	4.2% 10/237 • Number of events 10 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Obesity	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum albumin decreased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum calcium decreased	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum calcium increased	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum glucose decreased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium decreased	7.6% 18/237 • Number of events 19 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	8.6% 20/232 • Number of events 23 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum phosphate decreased	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum potassium decreased	5.5% 13/237 • Number of events 14 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	6.5% 15/232 • Number of events 18 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum potassium increased	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum sodium decreased	4.6% 11/237 • Number of events 12 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Arthralgia	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Back pain	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Bone pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Buttock pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Myalgia	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Pain in extremity	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Cognitive disturbance	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Dizziness	2.1% 5/237 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Dysgeusia	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Encephalopathy	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Headache	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Ischemia cerebrovascular	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Leukoencephalopathy	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Neurological disorder NOS	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Peripheral motor neuropathy	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Peripheral sensory neuropathy	5.9% 14/237 • Number of events 24 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	6.9% 16/232 • Number of events 20 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Seizure	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Syncope	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Anxiety	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Confusion	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Depression	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Psychosis	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Bladder hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Cystitis	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Glomerular filtration rate decreased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Hemorrhage urinary tract	3.0% 7/237 • Number of events 11 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Kidney pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Kidney perforation	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Proteinuria	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Renal failure	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Ureteric obstruction	1.7% 4/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Ureteric perforation	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urethral obstruction	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urinary frequency	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urinary incontinence	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urine discoloration	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urogenital disorder	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Reproductive system and breast disorders Scrotal pain	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Reproductive system and breast disorders Testicular pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Cough	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Dyspnea	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Epistaxis	5.5% 13/237 • Number of events 14 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Decubitus ulcer	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Rash desquamating	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Sweating	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Hematoma	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Hypertension	5.1% 12/237 • Number of events 14 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Hypotension	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Lymphedema	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Thrombosis	2.5% 6/237 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	8.2% 19/232 • Number of events 24 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Vascular disorder	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).

Other adverse events

Measure	Arm II (GCB) n=237 participants at risk Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	Arm I (GCP) n=232 participants at risk Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
Infections and infestations Kidney infection(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Phlebitis infective	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Infection(gr 0/1/2 ANC)	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Dysphagia	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Esophagitis	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Flatulence	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Gastric hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Gastritis	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Gastrointestinal disorder	1.7% 4/237 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Hemorrhoids	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Ileus	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Mucositis oral (clin exam)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Mucositis oral (funct/sympt)	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Nausea	6.8% 16/237 • Number of events 27 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	10.8% 25/232 • Number of events 41 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Periodontal disease	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Proctitis	0.42% 1/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Rectal pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Tooth disorder	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Toothache	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Vomiting	26.2% 62/237 • Number of events 122 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	28.9% 67/232 • Number of events 175 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Chest pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Chills	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Edema limbs	1.7% 4/237 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 14 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Fatigue	81.0% 192/237 • Number of events 1119 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	77.6% 180/232 • Number of events 1076 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Fever	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Flu-like symptoms	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders General symptom	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Localized edema	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
General disorders Pain	1.3% 3/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 13 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Immune system disorders Hypersensitivity	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Anal infection(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Anorectal infection(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Catheter related infection	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Catheter related infection(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Catheter related infection(gr 3/4 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Blood disorder	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Febrile neutropenia	1.7% 4/237 • Number of events 9 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Hemoglobin decreased	77.6% 184/237 • Number of events 1066 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	75.9% 176/232 • Number of events 1079 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Hemolysis	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Blood and lymphatic system disorders Lymphatic disorder	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Atrial tachycardia	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Myocardial ischemia	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Cardiac disorders Sinus tachycardia	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Ear and labyrinth disorders Ear disorder	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Ear and labyrinth disorders Ear pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Ear and labyrinth disorders Hearing impaired	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.0% 7/232 • Number of events 55 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Ear and labyrinth disorders Tinnitus	1.3% 3/237 • Number of events 9 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Endocrine disorders Adrenal insufficiency	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Eye disorders Vision blurred	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Abdominal distension	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Abdominal pain	2.1% 5/237 • Number of events 12 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Anal fistula	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Anal hemorrhage	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Anal mucositis (clin exam)	0.42% 1/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Constipation	6.3% 15/237 • Number of events 34 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	6.9% 16/232 • Number of events 27 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Dental prosthesis user	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Diarrhea	1.7% 4/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.2% 5/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Dry mouth	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Gastrointestinal disorders Dyspepsia	0.84% 2/237 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Phlebitis infective(gr 3/4 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Pneumonia(gr 3/4 ANC)	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Sepsis(gr 3/4 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Sinusitis(gr 3/4 ANC)	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Skin infection	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Skin infection(gr 3/4 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Upper respiratory infection(gr 3/4 ANC)	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Upper respiratory infectn(gr 0/1/2 ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Urinary tract infection(gr 0/1/2 ANC)	0.42% 1/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Urinary tract infection(gr 3/4 ANC)	1.7% 4/237 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Infections and infestations Urinary tract infection(unknown ANC)	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Bruising	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Fracture	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Injury, poisoning and procedural complications Vascular access complication	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Activated partial throm time prolonged	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Alanine aminotransferase increased	4.2% 10/237 • Number of events 20 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Alkaline phosphatase increased	2.1% 5/237 • Number of events 10 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 11 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Amylase increased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Aspartate aminotransferase increased	2.1% 5/237 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Blood bilirubin increased	0.84% 2/237 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations CD4 lymphocytes decreased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Creatinine increased	48.9% 116/237 • Number of events 630 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	44.0% 102/232 • Number of events 464 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations INR increased	1.7% 4/237 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Laboratory test abnormal	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Leukocyte count decreased	9.7% 23/237 • Number of events 31 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	12.5% 29/232 • Number of events 53 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Lymphocyte count decreased	4.2% 10/237 • Number of events 15 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 15 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Neutrophil count decreased	62.9% 149/237 • Number of events 397 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	56.0% 130/232 • Number of events 370 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Platelet count decreased	59.1% 140/237 • Number of events 557 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	45.7% 106/232 • Number of events 331 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Serum cholesterol increased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 16 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Weight gain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Investigations Weight loss	2.1% 5/237 • Number of events 10 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Anorexia	6.3% 15/237 • Number of events 22 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	2.6% 6/232 • Number of events 11 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Blood bicarbonate decreased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Blood glucose increased	5.9% 14/237 • Number of events 39 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	7.3% 17/232 • Number of events 33 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Dehydration	2.5% 6/237 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Obesity	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum albumin decreased	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum calcium decreased	1.7% 4/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum glucose decreased	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium decreased	20.7% 49/237 • Number of events 135 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	19.0% 44/232 • Number of events 129 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum magnesium increased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum potassium decreased	16.0% 38/237 • Number of events 60 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	17.2% 40/232 • Number of events 62 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum potassium increased	3.4% 8/237 • Number of events 10 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum sodium decreased	7.2% 17/237 • Number of events 27 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.4% 8/232 • Number of events 13 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum sodium increased	0.42% 1/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Metabolism and nutrition disorders Serum triglycerides increased	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Arthralgia	2.1% 5/237 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Arthritis	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Back pain	3.8% 9/237 • Number of events 15 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	4.3% 10/232 • Number of events 17 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Bone pain	1.7% 4/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Muscle weakness	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Musculoskeletal disorder	0.84% 2/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Myalgia	1.3% 3/237 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Neck pain	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Pain in extremity	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Musculoskeletal and connective tissue disorders Upper extremity dysfunction	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplasia	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Acoustic nerve disorder NOS	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Dizziness	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Dysgeusia	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Headache	5.1% 12/237 • Number of events 24 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Neurological disorder NOS	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Peripheral motor neuropathy	7.6% 18/237 • Number of events 35 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	8.6% 20/232 • Number of events 96 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Peripheral sensory neuropathy	35.9% 85/237 • Number of events 533 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	37.5% 87/232 • Number of events 549 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Syncope	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Nervous system disorders Tremor	0.42% 1/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Anxiety	0.84% 2/237 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 13 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Depression	1.3% 3/237 • Number of events 10 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 4 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Psychiatric disorders Insomnia	2.1% 5/237 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Bladder pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Bladder spasm	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Cystitis	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Glomerular filtration rate decreased	0.84% 2/237 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Hemorrhage urinary tract	18.6% 44/237 • Number of events 155 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	19.0% 44/232 • Number of events 176 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Proteinuria	8.9% 21/237 • Number of events 49 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	3.0% 7/232 • Number of events 12 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Renal failure	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Renal hemorrhage	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Ureteric hemorrhage	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urethral pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urinary frequency	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urinary incontinence	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urinary retention	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Renal and urinary disorders Urogenital disorder	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Reproductive system and breast disorders Erectile dysfunction	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Reproductive system and breast disorders Pelvic pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Reproductive system and breast disorders Scrotal pain	0.42% 1/237 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Reproductive system and breast disorders Vaginal pain	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.42% 1/237 • Number of events 5 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Cough	1.7% 4/237 • Number of events 9 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Dyspnea	2.1% 5/237 • Number of events 13 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.7% 4/232 • Number of events 7 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Epistaxis	29.5% 70/237 • Number of events 220 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	6.5% 15/232 • Number of events 23 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Hiccups	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Laryngeal pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Pulmonary hemorrhage	2.5% 6/237 • Number of events 16 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Respiratory disorder	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Sinus pain	0.84% 2/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Respiratory, thoracic and mediastinal disorders Voice alteration	1.3% 3/237 • Number of events 11 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Alopecia	2.5% 6/237 • Number of events 17 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 9 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Dry skin	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Pruritus	1.3% 3/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Rash acneiform	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Rash desquamating	2.1% 5/237 • Number of events 8 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	1.3% 3/232 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Scalp pain	0.42% 1/237 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.84% 2/237 • Number of events 3 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.00% 0/232 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Hypertension	21.1% 50/237 • Number of events 175 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	6.5% 15/232 • Number of events 29 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Lymphedema	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 1 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Peripheral ischemia	0.00% 0/237 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.43% 1/232 • Number of events 6 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Phlebitis	0.84% 2/237 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	0.86% 2/232 • Number of events 2 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).
Vascular disorders Thrombosis	10.1% 24/237 • Number of events 63 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).	8.2% 19/232 • Number of events 32 • Up to 7 years All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).

Additional Information

Jonathan Rosenberg, MD

Memorial Sloan-Kettering Cancer Center

Phone: 646-422-4461

Email: rosenbj1@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60