Trial Outcomes & Findings for Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery (NCT NCT01814813)

Last Updated: 2025-01-24

Results Overview

The primary endpoint is overall survival (OS), which is defined as the date from study\> registration to the date of death, due to any cause.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

90 participants

Primary outcome timeframe

Up to 5 years post-surgery

Results posted on

2025-01-24

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 2, HSPPC-96 With Bevacizumab at Progression HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)\> \> NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous	Arm 1, HSPPC-96 + Concomitant Bevacizumab HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous
Overall Study STARTED	30	31	29
Overall Study COMPLETED	30	31	29
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vaccine Therapy With Bevacizumab Versus Bevacizumab Alone in Treating Patients With Recurrent Glioblastoma Multiforme That Can Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1, HSPPC-96 + Concomitant Bevacizumab n=29 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous	Arm 2, HSPPC-96 With Bevacizumab at Progression n=30 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days) NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab n=31 Participants Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous	Total n=90 Participants Total of all reporting groups
Age, Customized <55	13 Participants n=5 Participants	12 Participants n=7 Participants	14 Participants n=5 Participants	39 Participants n=4 Participants
Age, Customized >=55	16 Participants n=5 Participants	18 Participants n=7 Participants	17 Participants n=5 Participants	51 Participants n=4 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	25 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	17 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	26 Participants n=7 Participants	26 Participants n=5 Participants	80 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Karnofsky PS 70	6 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	19 Participants n=4 Participants
Karnofsky PS 80-100	23 Participants n=5 Participants	23 Participants n=7 Participants	25 Participants n=5 Participants	71 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 5 years post-surgery

The primary endpoint is overall survival (OS), which is defined as the date from study\> registration to the date of death, due to any cause.

Outcome measures

Outcome measures
Measure	Arm 1, HSPPC-96 + Concomitant Bevacizumab n=29 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous	Arm 2, HSPPC-96 With Bevacizumab at Progression n=30 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)\> \> NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab n=31 Participants Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
Overall Survival (OS)	6.6 months Interval 5.4 to 10.4	9.2 months Interval 5.7 to 11.6	10.7 months Interval 8.8 to 17.2

SECONDARY outcome

Timeframe: Up to 5 years post-surgery

Time to progression free survival: which is defined as the date from study registration to the date of first observation of disease progression or death due to any cause (whichever comes first). Progressive disease is defined as one or more of the following:New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids, increase by \> 50% enhancement from the first post-surgical scan, or a subsequent scan with smaller tumor size, and the scan 8 weeks or later on stable or increasing doses of corticosteroids, clinical deterioration not attributable to concurrent medication or comorbid conditions is sufficient to declare progression on current treatment, for patients receiving bevacizumab therapy, significant increase in T2/FLAIR non-enhancing lesion.

Outcome measures

Outcome measures
Measure	Arm 1, HSPPC-96 + Concomitant Bevacizumab n=29 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous	Arm 2, HSPPC-96 With Bevacizumab at Progression n=30 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)\> \> NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab n=31 Participants Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
Progression Free Survival (PFS)	3.7 months Interval 2.9 to 5.4	2.5 months Interval 2.0 to 3.5	5.3 months Interval 3.7 to 8.0

SECONDARY outcome

Timeframe: Up to 3 years

Population: Patients who started at least one cycle of treatment and were assessed for adverse events were included in this analysis.

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.

Outcome measures

Outcome measures
Measure	Arm 1, HSPPC-96 + Concomitant Bevacizumab n=25 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous	Arm 2, HSPPC-96 With Bevacizumab at Progression n=28 Participants HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days)\> \> NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab n=20 Participants Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5) Grade 3	4 Participants	3 Participants	5 Participants
Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5) Grade 4/5	1 Participants	2 Participants	1 Participants

Adverse Events

Arm 1, HSPPC-96 + Concomitant Bevacizumab

Serious events: 6 serious events

Other events: 20 other events

Deaths: 0 deaths

Arm 2, HSPPC-96 With Bevacizumab at Progression

Serious events: 10 serious events

Other events: 23 other events

Deaths: 2 deaths

Arm 3, Bevacizumab

Serious events: 4 serious events

Other events: 18 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Ian Parney, MD, PhD

Mayo Clinic

Phone: 507-284-8167

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Arm 1, HSPPC-96 + Concomitant Bevacizumab n=25 participants at risk HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous	Arm 2, HSPPC-96 With Bevacizumab at Progression n=28 participants at risk HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days) NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab n=20 participants at risk Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
Cardiac disorders Sinus tachycardia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Intra-abdominal hemorrhage	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Vomiting	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	7.1% 2/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Death NOS	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Meningitis	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Sepsis	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Soft tissue infection	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Injury, poisoning and procedural complications Wound dehiscence	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Dehydration	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	7.1% 2/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Metabolism and nutrition disorders Hyponatremia	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Encephalopathy	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Headache	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Hydrocephalus	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Intracranial hemorrhage	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Lethargy	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Nervous system disorders - Other, specify	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Paresthesia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Seizure	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	7.1% 2/28 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	10.0% 2/20 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Somnolence	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Nervous system disorders Tremor	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Psychiatric disorders Agitation	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Psychiatric disorders Confusion	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	10.7% 3/28 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Hematoma	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Vascular disorders Thromboembolic event	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.

Other adverse events
Measure	Arm 1, HSPPC-96 + Concomitant Bevacizumab n=25 participants at risk HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles), plus bevacizumab 10 mg/kg intravenous (IV) on day 1 of each cycle, until progression. HSPPC-96 should be administered at least 60 minutes prior to starting bevacizumab infusion. (1 cycle=14 days) Note: If HSPPC-96 treatment has ended but there is no evidence of disease progression, the patient should continue to receive bevacizumab at the specified dose until progression. HSPPC-96: intradermal infusion bevacizumab: intravenous	Arm 2, HSPPC-96 With Bevacizumab at Progression n=28 participants at risk HSPPC-96 0.4mL intradermal on days 1 and 8 of cycles 1 and 2, then on day 1 of each cycle, up to a maximum of 12 doses (10 cycles). At progression: bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until further progression. (1 cycle = 14 days) NOTE: It is possible that HSPPC-96 vaccination may end prior to evidence of progression. In this instance it is important to wait until there is confirmed evidence of progression before initiating treatment with bevacizumab. Upon confirmation of progression the patient should initiate bevacizumab within 7-42 days from the last dose of vaccine. HSPPC-96: intradermal infusion. bevacizumab: intravenous	Arm 3, Bevacizumab n=20 participants at risk Bevacizumab 10mg/kg intravenous (IV) on day 1 of each cycle, until progression. (1 cycle = 14 days) bevacizumab: intravenous
Blood and lymphatic system disorders Anemia	16.0% 4/25 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	7.1% 2/28 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Cardiac disorders Palpitations	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Cardiac disorders Supraventricular tachycardia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Ear and labyrinth disorders Tinnitus	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Ear and labyrinth disorders Vertigo	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Eye disorders Blurred vision	8.0% 2/25 • Number of events 9 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Eye disorders Eye disorders - Other, specify	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Eye disorders Optic nerve disorder	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Eye disorders Photophobia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Abdominal pain	8.0% 2/25 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 7 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Anal hemorrhage	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Bloating	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 9 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Constipation	8.0% 2/25 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Diarrhea	4.0% 1/25 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 14 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	20.0% 4/20 • Number of events 21 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Dysphagia	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Fecal incontinence	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Flatulence	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Gastroesophageal reflux disease	4.0% 1/25 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Hemorrhoidal hemorrhage	4.0% 1/25 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Hemorrhoids	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Mucositis oral	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Nausea	8.0% 2/25 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	20.0% 4/20 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Gastrointestinal disorders Vomiting	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	7.1% 2/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Chills	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Edema face	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Edema limbs	8.0% 2/25 • Number of events 6 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Fatigue	32.0% 8/25 • Number of events 35 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	28.6% 8/28 • Number of events 27 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	30.0% 6/20 • Number of events 40 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Fever	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Flu like symptoms	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Gait disturbance	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	7.1% 2/28 • Number of events 8 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Infusion related reaction	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Injection site reaction	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	14.3% 4/28 • Number of events 4 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Non-cardiac chest pain	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
General disorders Pain	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Immune system disorders Allergic reaction	4.0% 1/25 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Gum infection	4.0% 1/25 • Number of events 3 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/28 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 5 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	5.0% 1/20 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Otitis media	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 1 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
Infections and infestations Skin infection	0.00% 0/25 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	3.6% 1/28 • Number of events 2 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.	0.00% 0/20 • Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 5 years. Each CTCAE term is a representation of a specific event used for medical documentation \& analysis \& is a single MedDRA Lowest Level Term (LLT). All graded AEs are reported for patients who completed at least 1 cycle of tx \& AEs were assessed. Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.