Trial Outcomes & Findings for Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer (NCT NCT00433511)

NCT ID: NCT00433511

Last Updated: 2025-12-03

Results Overview

Invasive disease-free survival (IDFS) was defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 4994 participants
• Primary outcome timeframe: Assessed at 5 years
• Results posted on: 2025-12-03

Participant Flow

Accrual to Step 1 of E5103 was activated November 2, 2007 and closed February 28, 2011; 4994 patients were entered. Upon unblinding of Step 1 treatment assignment, only patients treated on Arm C during Step 1 who had not ended protocol treatment early were eligible to register to Step 2 (Arm D) and 1316 patients were enrolled to Step 2.

Participant milestones

Measure	Arm A (Chemo + Placebo) Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Within the following 2 months, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
Step 1 STARTED	1000	1986	2008
Step 1 Patients Who Received Treatment	972	1922	1942
Step 1 Patients in Genetic Ancestry Analysis	575	1126	1158
Step 1 COMPLETED	864	1601	1618
Step 1 NOT COMPLETED	136	385	390
Step 2 (Arm D) STARTED	0	0	1316
Step 2 (Arm D) Patients Who Received Treatment	0	0	1168
Step 2 (Arm D) COMPLETED	0	0	825
Step 2 (Arm D) NOT COMPLETED	0	0	491

Reasons for withdrawal

Measure	Arm A (Chemo + Placebo) Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Within the following 2 months, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
Step 1 Adverse Event	50	157	153
Step 1 Withdrawal by Subject	45	143	154
Step 1 Death	3	1	1
Step 1 Physician Decision	1	4	3
Step 1 Never started protocol therapy	28	64	66
Step 1 Alternative therapy	2	1	3
Step 1 Disease progression, relapse	5	3	3
Step 1 Other complicating disease	2	6	3
Step 1 Non-breast cancer surgery/wound issues	0	4	1
Step 1 Suspected recurrence	0	1	0
Step 1 Insurance/drug distribution issues	0	1	2
Step 1 Patient moved	0	0	1
Step 2 (Arm D) Adverse Event	0	0	135
Step 2 (Arm D) Withdrawal by Subject	0	0	181
Step 2 (Arm D) Never started protocol therapy	0	0	148
Step 2 (Arm D) Physician Decision	0	0	9
Step 2 (Arm D) Disease progression, relapse	0	0	7
Step 2 (Arm D) Other complicating disease	0	0	3
Step 2 (Arm D) Non-breast cancer surgery/wound issues	0	0	2
Step 2 (Arm D) Suspected recurrence	0	0	1
Step 2 (Arm D) Insurance/drug distribution issues	0	0	4
Step 2 (Arm D) Unknown (Missing off treatment form)	0	0	1

Baseline Characteristics

Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

Baseline characteristics by cohort

Measure	Arm A (Chemo + Placebo) n=1000 Participants Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) n=1986 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) n=2008 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.	Total n=4994 Participants Total of all reporting groups
Age, Continuous	51.8 years n=3 Participants	51.7 years n=3 Participants	51.6 years n=6 Participants	51.7 years n=24 Participants
Sex: Female, Male Female	995 Participants n=3 Participants	1976 Participants n=3 Participants	2000 Participants n=6 Participants	4971 Participants n=24 Participants
Sex: Female, Male Male	5 Participants n=3 Participants	10 Participants n=3 Participants	8 Participants n=6 Participants	23 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	70 Participants n=3 Participants	136 Participants n=3 Participants	160 Participants n=6 Participants	366 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	891 Participants n=3 Participants	1757 Participants n=3 Participants	1752 Participants n=6 Participants	4400 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=3 Participants	93 Participants n=3 Participants	96 Participants n=6 Participants	228 Participants n=24 Participants

PRIMARY outcome

Timeframe: Assessed at 5 years

Population: All randomized patients at Step 1

Invasive disease-free survival (IDFS) was defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation.

Outcome measures

Measure	Arm A (Chemo + Placebo) n=1000 Participants Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) n=1986 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) n=2008 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
Invasive Disease-free Survival (IDFS) Rate at 5 Years	0.77 proportion of participants Interval 0.71 to 0.81	0.76 proportion of participants Interval 0.72 to 0.8	0.80 proportion of participants Interval 0.77 to 0.83

SECONDARY outcome

Timeframe: Assessed at 5 years

Population: All randomized patients at Step 1

Overall survival (OS) was defined as time from date of randomization to death from any cause, otherwise cases were censored at date last known to be alive.

Outcome measures

Measure	Arm A (Chemo + Placebo) n=1000 Participants Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) n=1986 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) n=2008 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
5-year Overall Survival (OS)	0.90 proportion of participants Interval 0.87 to 0.92	0.86 proportion of participants Interval 0.83 to 0.88	0.90 proportion of participants Interval 0.88 to 0.92

SECONDARY outcome

Timeframe: Assessed at 3 years

Population: Only patients with genetic ancestry as European ancestry or African ancestry were included in the analysis.

Invasive disease-free survival (IDFS) is defined as time from from date of randomization to first treatment failure (invasive ipsilateral, local/regional, or distant recurrence, invasive contralateral breast cancer, invasive non-breast second primary malignancy or death from any cause, whichever occurred first). Cases with incomplete follow-up, without documented IDFS event including those who developed squamous or basal cell skin cancers or insitu carcinomas of any site as their only event were censored at the date of last disease evaluation. Three-year IDFS rate was reported by genetic ancestry and IDFS was compared between patients with European ancestry and patients with African ancestry.

Outcome measures

Measure	Arm A (Chemo + Placebo) n=2473 Participants Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) n=386 Participants Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as arm D in this study.
The Association Between IDFS and Genotype	0.887 proportion of participants Interval 0.875 to 0.9	0.832 proportion of participants Interval 0.793 to 0.872	—

Adverse Events

Arm A (Chemo + Placebo)

Serious events: 473 serious events

Other events: 245 other events

Deaths: 0 deaths

Arm B (Chemo + Bevacizumab)

Serious events: 1090 serious events

Other events: 513 other events

Deaths: 0 deaths

Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy)

Serious events: 1136 serious events

Other events: 479 other events

Deaths: 0 deaths

Arm D (Bevacizumab Cycles 9-18 of Arm C)

Serious events: 462 serious events

Other events: 233 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (Chemo + Placebo) n=972 participants at risk Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) n=1922 participants at risk Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) n=1942 participants at risk Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as Arm D in this study.	Arm D (Bevacizumab Cycles 9-18 of Arm C) n=1168 participants at risk After completion of 4 cycles of paclitaxel and bevacizumab in arm C, patients then receive bevacizumab IV over 30-90 minutes on day 1 every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as Arm D in this study.
Infections and infestations Infection Gr0-2 neut, vagina	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, vein	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, vulva	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, wound	0.62% 6/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.78% 15/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.62% 12/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC anal/perianal	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC catheter related	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC dental-tooth	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC foreign body	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC gallbladder	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC lung	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC meninges	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC sinus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC skin (cellulitis)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC ungual (nails)	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC urinary tract NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ unk ANC wound	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Opportunistic infection lymphopenia>=gr1	0.31% 3/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, blood	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.42% 8/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, blood	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.42% 8/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.57% 11/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection-other	0.31% 3/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Edema head and neck	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Edema limb	0.41% 4/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.62% 12/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.51% 6/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Edema trunk/genital	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Edema visceral	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Lymphedema-related fibrosis	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Blood and lymphatic system disorders Lymphatics-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Alanine aminotransferase increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Aspartate aminotransferase increased	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Blood bilirubin increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Hypercholesterolemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations CPK increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Creatinine increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hyperglycemia	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Lipase increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypokalemia	0.31% 3/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Proteinuria	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.7% 20/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hyponatremia	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.42% 8/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hypertriglyceridemia	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Extremity-lower (gait/walking)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Extremity upper (function)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Fibrosis-deep connective tissue	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Fracture	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.43% 5/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Joint effusion	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Local complication - device/prosthesis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Nonneuropathic lower extr muscle weak	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Nonneuropathic upper extr muscle weak	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Osteonecrosis (avascular necrosis)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Psychiatric disorders Confusion	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Seroma	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Soft tissue necrosis, neck	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Soft tissue necrosis, thoracic	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Apnea	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Ataxia	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders CNS cerebrovascular ischemia	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.43% 5/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Cognitive disturbance	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Dizziness	1.1% 11/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.78% 15/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.93% 18/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Encephalopathy	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Hydrocephalus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Laryngeal nerve dysfunction	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Memory impairment	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Mental status	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Psychiatric disorders Agitation	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Psychiatric disorders Anxiety	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Psychiatric disorders Depression	0.93% 9/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.73% 14/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.82% 16/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.68% 8/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Eye disorders Neuropathy CN II vision	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Neuropathy CN V jaw / face-sensory	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Neuropathy-motor	0.72% 7/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.52% 10/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.51% 10/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Neuropathy-sensory	8.4% 82/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	8.0% 153/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	8.9% 172/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	4.2% 49/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Psychiatric disorders Psychosis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Seizure	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Depressed level of consciousness	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Speech impairment	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Syncope	1.2% 12/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.8% 34/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.1% 22/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.68% 8/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Tremor	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Neurologic-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Eye disorders Cataract	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Eye disorders Dry eye syndrome	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Eye disorders Double vision	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Eye disorders Vision-blurred	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Eye disorders Tearing	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Abdomen, pain	0.82% 8/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 25/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.5% 29/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.0% 12/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Anus, pain	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Back, pain	1.0% 10/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.57% 11/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.46% 9/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.68% 8/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Bladder, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Bone, pain	0.51% 5/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.88% 17/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Breast, pain	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Buttock, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Cardiac/heart, pain	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Chest wall, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Chest/thoracic pain NOS	1.0% 10/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 25/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 25/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.77% 9/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Dental/teeth/peridontal, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Ear and labyrinth disorders External ear, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	0.62% 6/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Hepatobiliary disorders Gallbladder, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Head/headache	2.4% 23/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.8% 73/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.7% 72/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.2% 26/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Joint, pain	2.7% 26/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.9% 37/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.2% 43/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.4% 40/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Ear and labyrinth disorders Middle ear, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Muscle, pain	2.2% 21/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.0% 38/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.5% 30/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.1% 24/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Musculoskeletal and connective tissue disorders Neck, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Neuropathic, pain	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Oral cavity, pain	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Pain NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Perineum, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Pleura, pain	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Rectum, pain	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.42% 8/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Sinus, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Skin, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Stomach, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Vagina, pain	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Pain-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders (ARDS)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations (DLCO) decreased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Cough	0.72% 7/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.94% 18/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.98% 19/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.77% 9/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 32/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.1% 60/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.2% 63/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.5% 18/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.51% 5/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.47% 9/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.46% 9/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reaction	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	0.82% 8/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.4% 27/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.82% 16/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Cystitis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Bladder spasms	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Obstruction-ureteral	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Renal failure	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Urinary frequency/urgency	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Renal/GU-other	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary malignancy	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Flu-like syndrome	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Intra-op injury Breast	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Intra-op injury Parathyroid	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Intra-op injury Pharynx	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Irregular menses	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.52% 10/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.77% 9/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Vaginitis (not due to infection)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Sexual/Reproductive function-Other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Immune system disorders Cytokine release syndrome	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Syndromes-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Vascular access,Thrombosis/embolism	0.62% 6/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.68% 13/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.51% 10/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Thrombosis/thrombus/embolism	4.0% 39/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.7% 71/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.3% 65/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 15/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Vessel injury Extremity-upper	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Vascular-Other (Specify)	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Immune system disorders Allergic reaction	1.2% 12/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.83% 16/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.82% 16/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Ear and labyrinth disorders Hearing w/o audiogr not in monitor prg	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Ear and labyrinth disorders Hearing-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Blood and lymphatic system disorders Anemia	1.5% 15/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.7% 32/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 26/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.43% 5/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Leukocytes decreased	3.3% 32/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	4.8% 92/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	5.0% 98/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Lymphopenia	0.72% 7/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.68% 13/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplasia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Neutrophils decreased	17.1% 166/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	20.2% 389/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	20.6% 400/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.51% 6/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Platelets decreased	0.41% 4/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.57% 11/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.98% 19/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Atrial fibrillation	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Atrial flutter	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Sinus arrhythmia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Sinus bradycardia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Sinus tachycardia	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Supraventricular arrhythmia NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Vasovagal episode	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders PVCs	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Torsade de pointes	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Ventricular tachycardia	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Cardiac-ischemia	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Cardiac troponin I (cTnI) increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Cardiac troponin T (cTnT) increased	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders C-P arrest, non-fatal, cause unknown	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Hypertension	2.1% 20/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	7.6% 147/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	7.1% 138/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	11.2% 131/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Hypotension	0.31% 3/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.57% 11/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Left ventricular diastolic dysfunction	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.46% 9/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Left ventricular systolic dysfunction	0.93% 9/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.0% 38/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.2% 43/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.9% 34/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Pericardial effusion (non-malignant)	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Cardiomyopathy, restrictive	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Cor Pulmonale	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders Valvular heart disease	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Cardiac disorders cardiac-other	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Fatigue	6.8% 66/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	9.8% 188/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	10.0% 195/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.7% 31/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Fever w/o neutropenia	0.62% 6/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Psychiatric disorders Insomnia	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Obesity	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Rigors/chills	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Weight gain	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Weight loss	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.86% 10/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Constitutional, other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations INR increased	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.46% 9/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Activated partial thromboplastin time prolonged	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Investigations Coagulation-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Burn	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Induration/fibrosis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Injection site reaction	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Nail changes	0.62% 6/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.62% 12/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.57% 11/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Pruritus/itching	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Rash/desquamation	1.1% 11/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.7% 32/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 26/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.5% 17/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Chemoradiation dermatitis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Radiation dermatitis	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.0% 12/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Hand-foot reaction	0.82% 8/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.4% 26/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.0% 20/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Ulceration	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Urticaria	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Wound - non-infectious	0.41% 4/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.88% 17/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.62% 12/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.5% 17/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Skin and subcutaneous tissue disorders Skin-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Death NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Death - disease progression NOS	0.41% 4/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
General disorders Death - sudden death	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Hot flashes	0.41% 4/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.47% 9/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Pancreatic glucose intolerance	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Endocrine disorders Hyopthyroidism	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Anorexia	0.82% 8/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.4% 26/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.5% 29/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Colitis	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Constipation	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.57% 11/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Metabolism and nutrition disorders Dehydration	1.9% 18/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.8% 54/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.9% 37/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Periodontal disease	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Teeth	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Diarrhea w/o prior colostomy	3.0% 29/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	3.4% 66/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.4% 46/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.94% 11/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Dysphagia	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Enteritis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Esophagitis	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Fistula, Abdomen NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Fistula, Anus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Fistula, Rectum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Fistula, Small bowel NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Gastritis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Dyspepsia	0.82% 8/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.73% 14/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.51% 10/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Hemorrhoids	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Ileus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Leak, incl. anastomotic, biliary tree	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Leak, incl. anastomotic, Leak NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis by exam, pharynx	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Muco/stomatitis by exam, rectum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Muco/stomatitis (symptom) esophagus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	1.4% 14/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.9% 55/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.9% 57/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis (symptom) pharynx	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Nausea	2.6% 25/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.8% 54/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.9% 57/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.43% 5/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Muco/stomatitis (symptom) rectum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Obstruction, cecum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Obstruction, colon	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Obstruction, small bowel NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Perforation, appendix	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Perforation, colon	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Perforation, small bowel NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Stenosis (incl anastomotic) esophagus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Ulcer, anus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Ulcer, duodenum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Vomiting	1.5% 15/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.5% 49/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	2.3% 44/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.68% 8/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders GI-other	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Hematoma	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders CNS, hemorrhage	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Abdomen, hemorrhage NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Lower GI, hemorrhage NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Rectum, hemorrhage	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Stomach, hemorrhage	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Upper GI, hemorrhage NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Bladder, hemorrhage	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Renal and urinary disorders Urinary hemorrhage NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Uterus, hemorrhage	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Reproductive system and breast disorders Vagina, hemorrhage	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Lung, hemorrhage	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Injury, poisoning and procedural complications Surgical hemorrhage	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Vascular disorders Hemorrhage-other	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Hepatobiliary disorders Cholecystitis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.34% 4/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Hepatobiliary disorders Liver dysfunction/failure	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Gastrointestinal disorders Pancreatitis	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Hepatobiliary disorders Hepatic-other	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Colitis, infectious (e.g. C.diff)	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Blood and lymphatic system disorders Febrile neutropenia	3.4% 33/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	4.0% 77/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	4.7% 91/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, anal/perianal	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, bladder	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, bronchus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, catheter relate	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, colon	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.42% 8/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, dental-tooth	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, external ear	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, foreign body	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, joint	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, kidney	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, lip/perioral	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, lung	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.42% 8/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, lymphatic	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, mediastinum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, middle ear	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, mucosa	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, neck NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, oral cavity	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, paranasal	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, rectum	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, sinus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, skin	0.51% 5/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.62% 12/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, sm bowel NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, soft tissue NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, upper airway	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, urinary tract	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.52% 10/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.41% 8/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, vagina	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, vulva	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection w/ gr3-4 neut, wound	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, abdomen	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, anal/perianl	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, appendix	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, bladder	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, bone	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, bronchus	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, catheter	0.41% 4/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.47% 9/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.82% 16/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, colon	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.31% 6/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, dental-tooth	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, external ear	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, eye NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, foreign body	0.31% 3/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, gallbladder	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, heart	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, kidney	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, lip/perioral	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.10% 2/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, lung	0.93% 9/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.99% 19/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.4% 27/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, lymphatic	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, meninges	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, middle ear	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, muscle	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, nerve-periph	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, nose	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, oral cavity	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, pancreas	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, pelvis NOS	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, pharynx	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, rectum	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, sinus	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, skin	2.0% 19/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.3% 25/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	1.1% 22/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.77% 9/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, sm bowel	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, soft tissue	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.15% 3/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.17% 2/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, stomach	0.00% 0/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.05% 1/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, ungual	0.10% 1/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.16% 3/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.09% 1/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, upper airway	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 5/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Infections and infestations Infection Gr0-2 neut, urinary tract	0.21% 2/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.36% 7/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.21% 4/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.26% 3/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.

Other adverse events

Measure	Arm A (Chemo + Placebo) n=972 participants at risk Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.	Arm B (Chemo + Bevacizumab) n=1922 participants at risk Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.	Arm C (Chemo + Bevacizumab Then Bevacizumab Monotherapy) n=1942 participants at risk Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm A and bevacizumab as in arm B. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm A and bevacizumab as in arm B. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as Arm D in this study.	Arm D (Bevacizumab Cycles 9-18 of Arm C) n=1168 participants at risk After completion of 4 cycles of paclitaxel and bevacizumab in arm C, patients then receive bevacizumab IV over 30-90 minutes on day 1 every 3 weeks for 10 courses. The monotherapy of bevacizumab is considered as Arm D in this study.
Cardiac disorders Left ventricular systolic dysfunction	3.8% 37/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	5.4% 103/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	4.5% 87/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	5.5% 64/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Nervous system disorders Neuropathy-sensory	19.3% 188/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	18.5% 356/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	17.2% 334/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	15.6% 182/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.3% 52/972 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	6.1% 117/1922 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	6.1% 119/1942 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.	0.00% 0/1168 • Adverse events (AEs) were assessed every cycle. Post protocol treatment, assessment and documentation of AEs continued 3 months post treatment for all AEs, and 6, 9, and 12 months post treatment for select AEs. The assessment and documentation of the select ≥ grade 4 hematologic and the select ≥ grade 2 non-hematologic AEs continued every 3 months until 1 year post protocol treatment. The assessment and documentation of ≥ grade 3 non-hematologic AEs took place 3 months post protocol treatment. Adverse event data collection in this trial was limited to ≥ grade 4 hematologic events, ≥ grade 2 non-hematologic events for a group of specific adverse events, and ≥ grade 3 non-hematologic events otherwise. All attributions were included. Detailed information on the select events could be found in the protocol.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: eatrials@jimmy.harvard.edu

Results disclosure agreements

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

Restriction type: LTE60