Trial Outcomes & Findings for Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma (NCT NCT04751383)

Last Updated: 2026-01-21

Results Overview

Percentage of evaluable patients experiencing grade 3 or higher adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 stratified by dose level.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days)

Results posted on

2026-01-21

Participant Flow

Two 'no treatment' patients were excluded from Arm A. There were zero patients assigned to Arm B/Expansion Cohort.

Participant milestones

Participant milestones
Measure	Arm A: Magrolimab 30 mg/kg Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy
Overall Study STARTED	7	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A: Magrolimab 30 mg/kg Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy
Overall Study Adverse Event	1	1
Overall Study Lack of Efficacy	6	3
Overall Study Protocol-Specified Withdrawal Criterion Met	0	1

Baseline Characteristics

Testing the Combination of Two Immunotherapy Drugs (Magrolimab and Dinutuximab) in Patients With Relapsed or Refractory Neuroblastoma or Relapsed Osteosarcoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A: Magrolimab 30 mg/kg n=7 Participants Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=5 Participants Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm B1: Magrolimab at the RP2D in Patients With Confirmed Neuroblastoma Expansion Cohort B1: Participants with confirmed neuroblastoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B2: Magrolimab at the RP2D in Patients With Evaluable Neuroblastoma Expansion Cohort B2: Participants with evaluable neuroblastoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B3: Magrolimab at the RP2D in Patients With Measurable Osteosarcoma Expansion Cohort B3: Participants with measurable osteosarcoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B4: Magrolimab at the RP2D in Patients With Resectable, Pulmonary Only Relapsed Osteosarcoma Expansion Cohort B4: Participants with resectable, pulmonary only relapsed osteosarcoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	7 Participants n=37 Participants	5 Participants n=44 Participants	—	—	—	—	12 Participants n=33 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	0 Participants n=33 Participants
Age, Categorical >=65 years	0 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	0 Participants n=33 Participants
Age, Continuous	12.2 years n=37 Participants	11.9 years n=44 Participants	—	—	—	—	12.1 years n=33 Participants
Sex: Female, Male Female	1 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	1 Participants n=33 Participants
Sex: Female, Male Male	6 Participants n=37 Participants	5 Participants n=44 Participants	—	—	—	—	11 Participants n=33 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	2 Participants n=33 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=37 Participants	2 Participants n=44 Participants	—	—	—	—	7 Participants n=33 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=37 Participants	3 Participants n=44 Participants	—	—	—	—	3 Participants n=33 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=37 Participants	1 Participants n=44 Participants	—	—	—	—	1 Participants n=33 Participants
Race (NIH/OMB) Asian	0 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	0 Participants n=33 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	0 Participants n=33 Participants
Race (NIH/OMB) Black or African American	0 Participants n=37 Participants	0 Participants n=44 Participants	—	—	—	—	0 Participants n=33 Participants
Race (NIH/OMB) White	4 Participants n=37 Participants	1 Participants n=44 Participants	—	—	—	—	5 Participants n=33 Participants
Race (NIH/OMB) More than one race	1 Participants n=37 Participants	1 Participants n=44 Participants	—	—	—	—	2 Participants n=33 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=37 Participants	2 Participants n=44 Participants	—	—	—	—	4 Participants n=33 Participants

PRIMARY outcome

Timeframe: Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days)

Population: 2 patients excluded as they did not receive treatment

Outcome measures

Outcome measures
Measure	Arm A: Magrolimab 30 mg/kg n=7 Participants Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=5 Participants Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy
Percent (95% CI) of Participants With Grade 3 or Higher Adverse Events (Dose Finding Cohort)	71.4 percentage of participants Interval 29.0 to 96.3	100 percentage of participants Interval 47.8 to 100.0

PRIMARY outcome

Timeframe: During cycle 1 (21 days)

Population: There were 11 evaluable patients

Percent of DLT-evaluable subjects experiencing dose limiting toxicities during cycle 1 stratified by dose level.

Outcome measures

Outcome measures
Measure	Arm A: Magrolimab 30 mg/kg n=6 Participants Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=5 Participants Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy
Cycle 1 Dose Limiting Toxicities of Magrolimab	33.3 percentage of participants Interval 4.3 to 77.7	40 percentage of participants Interval 5.3 to 85.3

PRIMARY outcome

Timeframe: Within 3 weeks of surgery

Population: There were zero patients assigned to Arm B, therefore no data are available

Percentage of evaluable patients experiencing grade 3 or higher AEs will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Assessed at day 1, 8, and 15 of the safety lead in, day 1, 8, and 15 of cycle 1

Population: All patients for whom PK were collected on a given timepoint are represented here. No samples collected from participants in the "Arm A: Magrolimab 20 mg/kg" Arm/Group during the Safety Lead-In day 8 and day 15

Median (min, max) serum concentration versus time curve of Hu5F9-G4 (magrolimab) assessed at day 1, 8, and 15 of the safety lead in, day 1, 8, and 15 of cycle 1.

Outcome measures

Outcome measures
Measure	Arm A: Magrolimab 30 mg/kg n=7 Participants Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=3 Participants Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy
Serum Concentration Versus Time Curve of Hu5F9-G4 ARM A: Cycle 1 Week 3 Day 15	357 mcg/mL Interval 86.5 to 386.0	63 mcg/mL Interval to 87.1 concentrations too small to measure
Serum Concentration Versus Time Curve of Hu5F9-G4 ARM A:Cycle 1 Week 2 Day 8	131 mcg/mL Interval 13.3 to 312.0	52.2 mcg/mL Interval 47.7 to 56.7
Serum Concentration Versus Time Curve of Hu5F9-G4 ARM A:Cycle 1 Week 2 Day 1	NA mcg/mL Interval to 272.0 concentrations too small to measure	NA mcg/mL concentrations too small to measure
Serum Concentration Versus Time Curve of Hu5F9-G4 ARM A: Safety Lead-In day 1 (Week 1)	NA mcg/mL concentrations too small to measure	NA mcg/mL concentrations too small to measure
Serum Concentration Versus Time Curve of Hu5F9-G4 ARM A: Safety Lead-In Day 8 (Week 2)	NA mcg/mL concentrations too small to measure	—
Serum Concentration Versus Time Curve of Hu5F9-G4 ARM A: Safety Lead-In Day 15 (Week 3)	214 mcg/mL Interval 132.0 to 334.0	—

SECONDARY outcome

Timeframe: Up to 3 years

Population: There were 11 evaluable patients

Percent of response-evaluable patients with best response of partial response (PR) or complete response (CR) stratified by dose level.

Outcome measures

Outcome measures
Measure	Arm A: Magrolimab 30 mg/kg n=6 Participants Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=5 Participants Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy
Percent (95% CI) of Responders Among Response-evaluable Participants	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 52.2

SECONDARY outcome

Timeframe: Up to 1 year

Population: There were zero patients assigned to Arm B, therefore no data are available

The Kaplan-Meier method will be used to estimate 1-year event free survival (EFS) with 95% confidence interval as the time from study entry until relapse, secondary malignancy, or death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 years post treatment

Population: There were zero patients assigned to Arm B, therefore no data are available

Percent of response-evaluable subjects with neuroblastoma with best response of complete response (CR) or partial response (PR) measured by Response Evaluation Criteria in Solid Tumors version 1.1.

Outcome measures

Outcome data not reported

Adverse Events

Arm A: Magrolimab 30 mg/kg

Serious events: 6 serious events

Other events: 7 other events

Deaths: 5 deaths

Arm A: Magrolimab 20 mg/kg

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Arm B1: Magrolimab at the RP2D in Patients With Confirmed Neuroblastoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B2: Magrolimab at the RP2D in Patients With Evaluable Neuroblastoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B3: Magrolimab at the RP2D in Patients With Measurable Osteosarcoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm B4: Magrolimab at the RP2D in Patients With Resectable, Pulmonary Only Relapsed Osteosarcoma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A: Magrolimab 30 mg/kg n=7 participants at risk Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=5 participants at risk Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm B1: Magrolimab at the RP2D in Patients With Confirmed Neuroblastoma Expansion Cohort B1: Participants with confirmed neuroblastoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B2: Magrolimab at the RP2D in Patients With Evaluable Neuroblastoma Expansion Cohort B2: Participants with evaluable neuroblastoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B3: Magrolimab at the RP2D in Patients With Measurable Osteosarcoma Expansion Cohort B3: Participants with measurable osteosarcoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B4: Magrolimab at the RP2D in Patients With Resectable, Pulmonary Only Relapsed Osteosarcoma Expansion Cohort B4: Participants with resectable, pulmonary only relapsed osteosarcoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy
Blood and lymphatic system disorders Anemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	80.0% 4/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Blood antidiuretic hormone abnormal	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Constipation	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Diarrhea	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Dysphasia	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Edema cerebral	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Fatigue	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Blood and lymphatic system disorders Hemolysis	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Fever	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hyperkalemia	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Vascular disorders Hypertension	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Vascular disorders Hypotension	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Intracranial hemorrhage	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Lymphocyte count decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Nausea	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Neutrophil count decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Platelet count decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Sepsis	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Immune system disorders Serum sickness	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Skin infection	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Small intestinal obstruction	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Spinal cord compression	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Urinary tract infection	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations White blood cell decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Disease progression	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Localized edema	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Reversible posterior leukoencephalopathy syndrome	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.

Other adverse events

Other adverse events
Measure	Arm A: Magrolimab 30 mg/kg n=7 participants at risk Dose Level 1: Participants were administered single agent Hu5F9-G4 (magrolimab) 30 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm A: Magrolimab 20 mg/kg n=5 participants at risk Dose Level -1: Participants were administered single agent Hu5F9-G4 (magrolimab) 20 mg/kg IV on day 1 of weeks 2 and 3 for a 21-day cycle safety lead-in cycle followed by Hu5F9-G4 (magrolimab) in combination with a fixed dose of dinutuximab in cycle 1 for up to a maximum of 12 cycles of combination therapy	Arm B1: Magrolimab at the RP2D in Patients With Confirmed Neuroblastoma Expansion Cohort B1: Participants with confirmed neuroblastoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B2: Magrolimab at the RP2D in Patients With Evaluable Neuroblastoma Expansion Cohort B2: Participants with evaluable neuroblastoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B3: Magrolimab at the RP2D in Patients With Measurable Osteosarcoma Expansion Cohort B3: Participants with measurable osteosarcoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy	Arm B4: Magrolimab at the RP2D in Patients With Resectable, Pulmonary Only Relapsed Osteosarcoma Expansion Cohort B4: Participants with resectable, pulmonary only relapsed osteosarcoma were administered a priming dose of Hu5F9-G4 (magrolimab) (1 mg/kg) on day 1 of week 1, RP2D followed by fixed dose of dinutuximab IV on days 2-5 of week 2, and RP2D on day 1 of week 3 and 4 for up to a maximum of 12 cycles of combination therapy
Gastrointestinal disorders Abdominal distension	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Alanine aminotransferase increased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Alkaline phosphatase increased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Immune system disorders Allergic reaction	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Blood and lymphatic system disorders Anemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Anorexia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Psychiatric disorders Anxiety	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Ascites	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Bladder infection	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Blood bilirubin increased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Blood lactate dehydrogenase increased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Eye disorders Blurred vision	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Vascular disorders Capillary leak syndrome	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Cardiac disorders Cardiac disorders - Other, specify	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Cheilitis	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Chills	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Conjunctivitis	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Constipation	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Creatinine increased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Diarrhea	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Blood and lymphatic system disorders Disseminated intravascular coagulation	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Dysgeusia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Dyspepsia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Dyspnea	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Renal and urinary disorders Dysuria	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Edema face	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Epistaxis	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Fatigue	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Fever	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Generalized edema	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Haptoglobin decreased	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Headache	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypercalcemia	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Skin and subcutaneous tissue disorders Hyperhidrosis	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Vascular disorders Hypertension	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Vascular disorders Hypotension	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Psychiatric disorders Insomnia	28.6% 2/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Lip pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Lipase increased	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Lymphocyte count decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Malaise	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Reproductive system and breast disorders Menorrhagia	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Nausea	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	80.0% 4/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Neck pain	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Neutrophil count decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Oral pain	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Paresthesia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Reproductive system and breast disorders Penile pain	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Peripheral sensory neuropathy	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Pharyngitis	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Eye disorders Photophobia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Platelet count decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Renal and urinary disorders Proteinuria	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Cardiac disorders Sinus tachycardia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	60.0% 3/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Vascular disorders Thromboembolic event	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Somnolence	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Thrush	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Upper respiratory infection	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Renal and urinary disorders Urinary incontinence	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Renal and urinary disorders Urinary retention	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Cardiac disorders Ventricular tachycardia	42.9% 3/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Gastrointestinal disorders Vomiting	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Weight gain	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations Weight loss	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Investigations White blood cell decreased	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	40.0% 2/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
General disorders and administration site conditions Edema limbs	14.3% 1/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	0.00% 0/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Infections and infestations Lung infection	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Eye disorders Periorbital edema	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.
Nervous system disorders Dysesthesia	0.00% 0/7 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	20.0% 1/5 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.	— 0/0 • Up to 30 days after last dose, maximum treatment duration 12 cycles (1 cycle = 21 days) Adverse event reporting is collected routinely using case report forms. The SAE table reflects NCI Common Terminology Criteria for Adverse Events (CTCAEs) submitted by the institution via expedited reporting (NCI AdEERs / CAeRs). All remaining CTCAEs collected by means other than expedited reporting are non-serious and are reported in the "AE Other" table. All-Cause Mortality includes all deaths collected on the study. Patients who didn't receive treatment are excluded from reporting of AEs.

Additional Information

Results Reporting Coordinator

Children's Oncology Group

Phone: 6262411500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60