Trial Outcomes & Findings for Palbociclib After CDK and Endocrine Therapy (PACE) (NCT NCT03147287)

NCT ID: NCT03147287

Last Updated: 2025-09-29

Results Overview

Progression-Free Survival (PFS), according to RECIST v1.1 criteria (investigator assessment): the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression were censored at date of last disease assessment (tumor assessments). The date of progression was the first date that recurrent or progressive disease was objectively documented; if death was the defining event, it must have happened within 2 intervals of the last disease assessment, otherwise PFS was censored at last disease assessment. The length of PFS was calculated as PFS time (months) =\[progression/death date(censor date) - randomization date + 1\]/30.4375.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 220 participants
• Primary outcome timeframe: Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median PFS follow-up time at database lock was 12.1 months (range 1 day to 50.1 months).
• Results posted on: 2025-09-29

Participant Flow

The study was conducted at 18 sites that randomized 220 participants between September 5, 2017 and February 23 2022. Eligible participants were to have HR+/HER2- advanced breast cancer, with prior objective progression on an endocrine + CDK4/6 inhibitor regimen; 0-1 prior lines of chemotherapy for ABC, no prior fulvestrant.

Participant milestones

Measure	Fulvestrant -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib * Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye * Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab * Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye * Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly * Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Overall Study STARTED	55	111	54
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	55	111	54

Reasons for withdrawal

Measure	Fulvestrant -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib * Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye * Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab * Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye * Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly * Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Overall Study Randomized Not Treated	2	1	1
Overall Study Progressive Disease RECIST	31	72	32
Overall Study Progressive Disease not RECIST	13	21	13
Overall Study Physician Decision	1	2	1
Overall Study Intercurrent illness	0	1	0
Overall Study Withdrawal by Subject	2	3	2
Overall Study Patient Non-Compliance	0	2	0
Overall Study Patient moved	0	1	0
Overall Study Arm A crossover without PD	1	0	0
Overall Study Ongoing at date of cut-off (11 Jul 2022)	5	8	5

Baseline Characteristics

Palbociclib After CDK and Endocrine Therapy (PACE)

Baseline characteristics by cohort

Measure	Fulvestrant n=55 Participants -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib n=111 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab n=54 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells	Total n=220 Participants Total of all reporting groups
Age, Continuous	58.2 years STANDARD_DEVIATION 9.2 • n=5 Participants	54.2 years STANDARD_DEVIATION 11.9 • n=7 Participants	57.0 years STANDARD_DEVIATION 11.4 • n=5 Participants	55.9 years STANDARD_DEVIATION 11.2 • n=4 Participants
Sex/Gender, Customized Sex and menopausal status · Male	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex/Gender, Customized Sex and menopausal status · Female premenopausal	8 Participants n=5 Participants	22 Participants n=7 Participants	10 Participants n=5 Participants	40 Participants n=4 Participants
Sex/Gender, Customized Sex and menopausal status · Female postmenopausal	47 Participants n=5 Participants	87 Participants n=7 Participants	44 Participants n=5 Participants	178 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	47 Participants n=5 Participants	88 Participants n=7 Participants	44 Participants n=5 Participants	179 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=5 Participants	13 Participants n=7 Participants	4 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Race/Ethnicity, Customized Race · More Than One Race	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other	5 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Prior chemotherapy between prior CDK4/6i and randomization (stratification factor)	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants
De novo metastatic breast cancer	28 Participants n=5 Participants	40 Participants n=7 Participants	20 Participants n=5 Participants	88 Participants n=4 Participants
Visceral disease	29 Participants n=5 Participants	70 Participants n=7 Participants	33 Participants n=5 Participants	132 Participants n=4 Participants

PRIMARY outcome

Timeframe: Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median PFS follow-up time at database lock was 12.1 months (range 1 day to 50.1 months).

Progression-Free Survival (PFS), according to RECIST v1.1 criteria (investigator assessment): the time from randomization to the earlier of progression or death due to any cause. Participants alive without disease progression were censored at date of last disease assessment (tumor assessments). The date of progression was the first date that recurrent or progressive disease was objectively documented; if death was the defining event, it must have happened within 2 intervals of the last disease assessment, otherwise PFS was censored at last disease assessment. The length of PFS was calculated as PFS time (months) =[progression/death date(censor date) - randomization date + 1]/30.4375.

Outcome measures

Measure	Fulvestrant n=55 Participants -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib n=111 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab n=54 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Progression-Free Survival (PFS), According to RECIST v1.1 Criteria (Investigator Assessment)	4.8 months Interval 2.1 to 8.2	4.6 months Interval 3.6 to 5.9	8.1 months Interval 3.2 to 10.7

SECONDARY outcome

Timeframe: Tumor were assessed every 8 weeks until 24 weeks, then every 12 weeks. The median follow-up time for overall response rate at database lock was 12.1 months (range 1 day to 50.1 months).

Objective Response (OR): best overall response of complete response or partial response. Response was primarily evaluated in this study using the criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). For example, target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. See RECIST 1.1 manuscript for further details on overall assessment based on target lesions, non-target lesions and new lesions. The Overall Response Rate (with 2-sided 90% CIs) were estimated according to treatment assignment and subgroup.

Outcome measures

Measure	Fulvestrant n=55 Participants -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib n=111 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab n=54 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Overall Response Rate, According to RECIST v1.1 Criteria (Investigator Assessment)	7.3 percentage of participants analyzed Interval 1.5 to 13.0	9.0 percentage of participants analyzed Interval 4.5 to 13.5	13.0 percentage of participants analyzed Interval 5.4 to 20.5

SECONDARY outcome

Timeframe: The median follow-up time for adverse event was 5.4 months (range 1.6 months to 51.2 months).

Population: Of 220 patients in the ITT population, 216 initiated protocol-assigned treatment(s) and comprise the safety population.

The frequency (and %) of patients who are reported as having grade 3-5 treatment-related adverse events were summarized. From starting the first dose of study treatment to 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported.

Outcome measures

Measure	Fulvestrant n=53 Participants -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib n=110 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab n=53 Participants -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability)	1 Participants	46 Participants	37 Participants

Adverse Events

Fulvestrant

Serious events: 1 serious events

Other events: 47 other events

Deaths: 23 deaths

Fulvestrant With Palbociclib

Serious events: 46 serious events

Other events: 105 other events

Deaths: 43 deaths

Fulvestrant With Palbociclib and Avelumab

Serious events: 37 serious events

Other events: 53 other events

Deaths: 17 deaths

Serious adverse events

Measure	Fulvestrant n=53 participants at risk -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib n=110 participants at risk -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab n=53 participants at risk -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Blood and lymphatic system disorders Anemia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Diarrhea	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Mucositis oral	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Infustion related reaction	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Fatigue	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Irritability	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Non-cardiac chest pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Hepatobiliary disorders Hepatic failure	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Bruising	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Alanine aminotransferase increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Aspartate aminotransferase increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Cardiac troponin T increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Lymphocyte count decreased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.3% 6/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Neutrophil count decreased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	32.7% 36/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	49.1% 26/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Platelet count decreased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations White blood cell decreased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.6% 15/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	20.8% 11/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Anorexia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Agitation	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Thromboembolic event	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.

Other adverse events

Measure	Fulvestrant n=53 participants at risk -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib n=110 participants at risk -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen	Fulvestrant With Palbociclib and Avelumab n=53 participants at risk -Palbociclib should be taken orally, once per day for 21 days on a 28 days cyclye -Fulvestrant will be administered in the clinic as two IM injections on Cycle 1 Days 1, 15, then monthly -Avelumab will be administered intravebously once every 2 weeks Palbociclib: Palbociclib is a drug that may stop cancer cells from growing Fulvestrant: Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen Avelumab: Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
Blood and lymphatic system disorders Anemia	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	22.7% 25/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	39.6% 21/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Atrial fibrillation	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Chest pain - cardiac	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Myocardial infarction	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Palpitations	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Pericardial effusion	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Pericarditis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Sinus bradycardia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Sinus tachycardia	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Cardiac disorders Supraventricular tachycardia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Ear and labyrinth disorders Ear pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Ear and labyrinth disorders Tinnitus	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Ear and labyrinth disorders Vertigo	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Endocrine disorders Adrenal insufficiency	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Endocrine disorders Endocrine disorders - Other, specify	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Endocrine disorders Hyperthyroidism	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Endocrine disorders Hypothyroidism	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Blurred vision	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Cataract	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Dry eye	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Eye disorders - Other, specify	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Eye pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Keratitis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Papilledema	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Scleral disorder	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Eye disorders Watering eyes	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Abdominal distension	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Abdominal pain	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	6.4% 7/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.3% 6/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Ascites	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Colitis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Constipation	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.6% 15/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	26.4% 14/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Dental caries	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Diarrhea	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	19.1% 21/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	26.4% 14/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Dry mouth	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Dyspepsia	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Enterocolitis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Fecal incontinence	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Flatulence	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Gastric perforation	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Gastric ulcer	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Gastroparesis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Gingival pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Ileal obstruction	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Mucositis oral	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.8% 13/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Nausea	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	18.2% 20/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	26.4% 14/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Obstruction gastric	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Oral pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Pancreatitis	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Salivary duct inflammation	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Stomach pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Toothache	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Gastrointestinal disorders Vomiting	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.5% 6/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Infusion related reaction	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Chills	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Edema limbs	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	8.2% 9/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Facial pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Fatigue	43.4% 23/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	41.8% 46/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	83.0% 44/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Fever	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	17.0% 9/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Flu like symptoms	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders General disorders and administration site conditions - Other, specify	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Injection site reaction	11.3% 6/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.8% 13/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Irritability	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Localized edema	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Non-cardiac chest pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
General disorders Pain	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	18.2% 20/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	24.5% 13/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Hepatobiliary disorders Cholecystitis	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Abdominal infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Bronchial infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Conjunctivitis infective	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Eye infection	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Infections and infestations - Other, specify	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Laryngitis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Lung infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Mucosal infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Nail infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Papulopustular rash	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Pharyngitis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Sepsis	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Sinusitis	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Skin infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Upper respiratory infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Urinary tract infection	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Infections and infestations Uterine infection	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Bruising	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Burn	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Fallopian tube anastomotic leak	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Fracture	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Intraoperative hepatobiliary injury	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Postoperative thoracic procedure complication	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Prolapse of intestinal stoma	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Radiation recall reaction (dermatologic)	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Injury, poisoning and procedural complications Uterine anastomotic leak	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Alanine aminotransferase increased	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.1% 10/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Alkaline phosphatase increased	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	12.7% 14/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Aspartate aminotransferase increased	22.6% 12/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	12.7% 14/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	18.9% 10/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Blood bilirubin increased	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Blood corticotrophin decreased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations CD4 lymphocytes decreased	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations CPK increased	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Cardiac troponin I increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Creatinine increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.3% 8/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	18.9% 10/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations INR increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Investigations - Other, specify	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Lipase increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Lymphocyte count decreased	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	19.1% 21/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	24.5% 13/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Lymphocyte count increased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Neutrophil count decreased	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	53.6% 59/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	66.0% 35/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Platelet count decreased	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	15.5% 17/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	30.2% 16/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Weight gain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations Weight loss	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.3% 6/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Investigations White blood cell decreased	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	33.6% 37/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	41.5% 22/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Acidosis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Anorexia	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	8.2% 9/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	22.6% 12/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Dehydration	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypercalcemia	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hyperglycemia	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.8% 13/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hyperkalemia	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypermagnesemia	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypoalbuminemia	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	6.4% 7/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypocalcemia	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypoglycemia	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypokalemia	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypomagnesemia	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	6.4% 7/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hyponatremia	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Hypophosphatemia	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Arthralgia	18.9% 10/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	15.1% 8/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Back pain	20.8% 11/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	15.5% 17/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	17.0% 9/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Bone pain	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.1% 10/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Buttock pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Chest wall pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Growth suppression	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Myalgia	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.5% 6/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Neck pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.5% 6/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	26.4% 14/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Musculoskeletal and connective tissue disorders Soft tissue necrosis upper limb	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Brachial plexopathy	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Cognitive disturbance	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Concentration impairment	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Depressed level of consciousness	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Dizziness	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	6.4% 7/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	18.9% 10/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Dysesthesia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Dysgeusia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Edema cerebral	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Facial nerve disorder	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Headache	17.0% 9/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	12.7% 14/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Memory impairment	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Nervous system disorders - Other, specify	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Peripheral motor neuropathy	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Peripheral sensory neuropathy	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Presyncope	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Radiculitis	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Seizure	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Sinus pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Syncope	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Nervous system disorders Tremor	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Agitation	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Anxiety	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.6% 4/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Confusion	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Depression	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Insomnia	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.6% 15/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	18.9% 10/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Psychiatric disorders Psychiatric disorders - Other, specify	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Acute kidney injury	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Bladder spasm	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Chronic kidney disease	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Hematuria	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Proteinuria	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Renal and urinary disorders - Other, specify	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Urinary frequency	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Urinary incontinence	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Urinary retention	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Renal and urinary disorders Urinary tract pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Reproductive system and breast disorders Breast pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Reproductive system and breast disorders Pelvic pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Reproductive system and breast disorders Vaginal dryness	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Reproductive system and breast disorders Vaginal hemorrhage	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Reproductive system and breast disorders Vaginal pain	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.6% 15/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	17.0% 9/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Laryngeal obstruction	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pharyngeal mucositis	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.8% 2/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary fistula	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	16.4% 18/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Bullous dermatitis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	11.3% 6/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Hirsutism	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Nail loss	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Pain of skin	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Photosensitivity	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Pruritus	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.3% 8/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Rash acneiform	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.3% 8/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	9.4% 5/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	2.7% 3/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	7.5% 4/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Flushing	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Hot flashes	18.9% 10/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.5% 6/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Hypertension	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	14.5% 16/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	13.2% 7/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Hypotension	5.7% 3/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.91% 1/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Lymphedema	1.9% 1/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	4.5% 5/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.
Vascular disorders Thromboembolic event	0.00% 0/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	5.5% 6/110 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.	3.8% 2/53 • After starting the first dose of study treatment and ended 30 days (90 days for arm C) after last dose administration of study treatment or study discontinuation/termination, whichever was earlier. Afterwards only SAEs attributed to study treatment were reported. The median follow-up time for adverse events was 5.4 months (range 1.6 months to 51.2 months). The median follow-up time for all-cause mortality was 23.6 months (range 1 day to 50.2 months). The maximum grade of each adverse event (AE) type was summarized as frequency (and %) of patients experiencing the AE, tabulated according to body system and AE type, separately according to treatment group. Serious Adverse Events (SAEs) were defined as treatment-related grade 3-5 adverse events. Other Adverse Events (OAEs) were defined as adverse events that are not SAEs. All 220 patients were assessed for mortality, and the 216 patients who initiated study treatment were assessed for AEs.

Additional Information

Project Manager

Dana-Farber Cancer Institute

Phone: 617-632-3800

Email: ctopm@dfci.harvard.edu

Results disclosure agreements

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