Trial Outcomes & Findings for Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL. (NCT NCT03150329)

NCT ID: NCT03150329

Last Updated: 2025-09-03

Results Overview

Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE1
• Target enrollment: 52 participants
• Primary outcome timeframe: From initial study treatment to 90 days post-last dose, up to 27 months.
• Results posted on: 2025-09-03

Participant Flow

Participant milestones

Measure	Vorinostat 100mg + Pembrolizumab 200mg Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	6	46
Overall Study COMPLETED	6	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.

Baseline characteristics by cohort

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 Participants Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 Participants Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Total n=52 Participants Total of all reporting groups
Age, Continuous	53 years n=5 Participants	39 years n=7 Participants	40 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	30 Participants n=7 Participants	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	35 Participants n=7 Participants	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	31 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	46 participants n=7 Participants	52 participants n=5 Participants

PRIMARY outcome

Timeframe: From initial study treatment to 90 days post-last dose, up to 27 months.

Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

Outcome measures

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 Participants Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 Participants Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Number of Patients With Grade 3-5 Adverse Events	3 participants	28 participants

PRIMARY outcome

Timeframe: From initial study treatment to two cycles of study treatment

MTD is defined as the highest dose level at which < 33% of evaluable subjects experienced DLT, when at least 6 patients were treated at that dose level. The MTD was considered the recommended phase II dose (RP2D), however the principal investigator may ultimately choose a lower dose level as the RP2D, depending on toxicity considerations, dose reduction on subsequent cycles, and other considerations.

Outcome measures

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=52 Participants Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Maximum Tolerated Dose (MTD) on Vorinostat	200 mg	—

PRIMARY outcome

Timeframe: From initial study treatment to two cycles of study treatment, up to 42 days.

The dose-limiting toxicity (DLT) observation period was 42 days (2 cycles). DLT assessment occurred on cycle 3, day 1 prior to receipt of cycle 3, day 1 of study therapy. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, Version 4.03).

Outcome measures

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 Participants Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 Participants Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Number of Participants With Dose-limiting Toxicities (DLT)	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From initial study treatment up to 36 21-day cycles

ORR was calculated as the proportion of evaluable patients that had confirmed complete response (CR) or partial response (PR), as defined according to the 2014 Lugano Classification, exact 95% confidence intervals were calculated for these estimates.

Outcome measures

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 Participants Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 Participants Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Overall Response Rate (ORR)	50 percentage of participants Interval 12.0 to 88.0	61 percentage of participants Interval 45.0 to 75.0

SECONDARY outcome

Timeframe: From the initial treatment to 36 21-day cycles.

CR was calculated as the proportion of evaluable patients that had confirmed complete response, as defined according to the 2014 Lugano Classification, exact 95% confidence intervals were calculated for these estimates.

Outcome measures

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 Participants Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 Participants Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Complete Response Rate (CR)	17 percentage of participants Interval 0.4 to 64.0	35 percentage of participants Interval 21.0 to 50.0

Adverse Events

Vorinostat 100mg + Pembrolizumab 200mg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 1 deaths

Vorinostat 200mg + Pembrolizumab 200mg

Serious events: 8 serious events

Other events: 46 other events

Deaths: 16 deaths

Serious adverse events

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 participants at risk Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 participants at risk Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders Mucositis oral	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	0.00% 0/46 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders Fatigue	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders Fever	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders Confusion	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders Depression	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.

Other adverse events

Measure	Vorinostat 100mg + Pembrolizumab 200mg n=6 participants at risk Patients receive Vorinostat 100mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.	Vorinostat 200mg + Pembrolizumab 200mg n=46 participants at risk Patients receive Vorinostat 200mg PO BID on days 1-5 and 8-12 and pembrolizumab 200mg IV over 30 minutes on day 1. Cycles repeat every 21 days for 24 months in the absence of disease progression or unacceptable toxicity.
Gastrointestinal disorders MUCOSITIS ORAL	16.7% 1/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders NAUSEA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	73.9% 34/46 • Number of events 114 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders ORAL PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	10.9% 5/46 • Number of events 7 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders SALIVARY DUCT INFLAMMATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders TOOTHACHE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders VOMITING	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	43.5% 20/46 • Number of events 35 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders CHILLS	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	15.2% 7/46 • Number of events 10 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders EDEMA LIMBS	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders FATIGUE	50.0% 3/6 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	67.4% 31/46 • Number of events 115 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders FEVER	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 20 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders FINGER TIP PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders FLU LIKE SYMPTOMS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders GAIT DISTURBANCE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders HANDS SWOLLEN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Blood and lymphatic system disorders ANEMIA	33.3% 2/6 • Number of events 5 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	52.2% 24/46 • Number of events 66 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Blood and lymphatic system disorders LYMPH NODE PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Cardiac disorders ATRIOVENTRICULAR BLOCK FIRST DEGREE	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	13.0% 6/46 • Number of events 10 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Cardiac disorders RIGHT VENTRICULAR DYSFUNCTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Cardiac disorders SINUS BRADYCARDIA	50.0% 3/6 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	34.8% 16/46 • Number of events 37 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Cardiac disorders SINUS TACHYCARDIA	33.3% 2/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	41.3% 19/46 • Number of events 39 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Cardiac disorders VENTRICULAR ARRHYTHMIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Ear and labyrinth disorders EAR PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Ear and labyrinth disorders MIDDLE EAR INFLAMMATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Ear and labyrinth disorders TINNITUS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Endocrine disorders HYPERTHYROIDISM	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	13.0% 6/46 • Number of events 7 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Eye disorders BLEPHARITIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Eye disorders BLURRED VISION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Eye disorders DRY EYE	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 5 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Eye disorders EYE PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Eye disorders FLASHING LIGHTS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Eye disorders WATERING EYES	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders ABDOMINAL DISTENSION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders ABDOMINAL PAIN	16.7% 1/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	52.2% 24/46 • Number of events 93 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders ASCITES	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders BLOATING	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders CHEILITIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders CONSTIPATION	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	30.4% 14/46 • Number of events 22 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders DIARRHEA	33.3% 2/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	58.7% 27/46 • Number of events 126 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders DRY MOUTH	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	13.0% 6/46 • Number of events 8 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders DUODENAL ULCER	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders DYSPEPSIA	50.0% 3/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 10 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders ESOPHAGEAL ULCER	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders ESOPHAGITIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders FECAL INCONTINENCE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders FLATULENCE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 8 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders GASTROESOPHAGEAL REFLUX DISEASE	33.3% 2/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders GASTROINTESTINAL PAIN	16.7% 1/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	0.00% 0/46 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Gastrointestinal disorders GERD	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders INFUSION RELATED REACTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders INJECTION SITE REACTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders MALAISE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	13.0% 6/46 • Number of events 10 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	15.2% 7/46 • Number of events 16 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	23.9% 11/46 • Number of events 11 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
General disorders SWOLLEN HANDS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations BRONCHIAL INFECTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations COMMON COLD	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations CORONAVIRUS: HKU1	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations COVID-19	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations LUNG INFECTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations PAPULOPUSTULAR RASH	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 7 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations SEPSIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations SINUSITIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations SKIN INFECTION	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations UPPER RESPIRATORY INFECTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Injury, poisoning and procedural complications BRUISING	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Injury, poisoning and procedural complications FALL	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Injury, poisoning and procedural complications VASCULAR ACCESS COMPLICATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	15.2% 7/46 • Number of events 8 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations ALKALINE PHOSPHATASE INCREASED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	17.4% 8/46 • Number of events 12 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	21.7% 10/46 • Number of events 13 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 9 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations CARDIAC TROPONIN I INCREASED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations CHOLESTEROL HIGH	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations CREATININE INCREASED	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	26.1% 12/46 • Number of events 23 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations ELECTROCARDIOGRAM QT CORRECTED INTERVAL PROLONGED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	10.9% 5/46 • Number of events 7 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations LYMPHOCYTE COUNT DECREASED	100.0% 6/6 • Number of events 8 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 29 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations LYMPHOCYTE COUNT INCREASED	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations NEUTROPHIL COUNT DECREASED	50.0% 3/6 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	41.3% 19/46 • Number of events 69 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations PLATELET COUNT DECREASED	16.7% 1/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	43.5% 20/46 • Number of events 62 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations WEIGHT GAIN	16.7% 1/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	39.1% 18/46 • Number of events 41 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations WEIGHT LOSS	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	39.1% 18/46 • Number of events 39 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Investigations WHITE BLOOD CELL DECREASED	83.3% 5/6 • Number of events 7 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	43.5% 20/46 • Number of events 75 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders ANOREXIA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	34.8% 16/46 • Number of events 26 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders DEHYDRATION	50.0% 3/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERCALCEMIA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERGLYCEMIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	10.9% 5/46 • Number of events 9 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERKALEMIA	50.0% 3/6 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERMAGNESEMIA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	17.4% 8/46 • Number of events 12 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERNATREMIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERTRIGLYCERIDEMIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPERURICEMIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPOALBUMINEMIA	33.3% 2/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 18 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPOCALCEMIA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 5 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPOGLYCEMIA	33.3% 2/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	32.6% 15/46 • Number of events 23 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPOKALEMIA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	30.4% 14/46 • Number of events 21 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPOMAGNESEMIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPONATREMIA	33.3% 2/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	54.3% 25/46 • Number of events 66 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders HYPOPHOSPHATEMIA	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	37.0% 17/46 • Number of events 49 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Metabolism and nutrition disorders OBESITY	16.7% 1/6 • Number of events 5 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	21.7% 10/46 • Number of events 22 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	17.4% 8/46 • Number of events 15 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	15.2% 7/46 • Number of events 9 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders GENERALIZED MUSCLE WEAKNESS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	15.2% 7/46 • Number of events 10 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders MYALGIA	33.3% 2/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	28.3% 13/46 • Number of events 45 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders NECK PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 15 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DISEASE PROGRESSION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) HEPATIC CYST	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) POLYPS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders CONCENTRATION IMPAIRMENT	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders DIZZINESS	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	23.9% 11/46 • Number of events 46 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders DYSGEUSIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	10.9% 5/46 • Number of events 11 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders HEADACHE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	28.3% 13/46 • Number of events 47 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders MEMORY IMPAIRMENT	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders PARESTHESIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders PERIPHERAL MOTOR NEUROPATHY	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	28.3% 13/46 • Number of events 28 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders PRESYNCOPE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders SYNCOPE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Nervous system disorders TREMOR	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders AGITATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders ANXIETY	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	21.7% 10/46 • Number of events 15 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders CONFUSION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders DELIRIUM	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders DEPRESSION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders HALLUCINATIONS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders INSOMNIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	26.1% 12/46 • Number of events 12 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders RESTLESSNESS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 11 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders ACUTE KIDNEY INJURY	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders DYSURIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders HEMATURIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders PROTEINURIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	10.9% 5/46 • Number of events 5 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders RENAL COLIC	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders URINARY RETENTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Renal and urinary disorders URINE DISCOLORATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Reproductive system and breast disorders BREAST PAIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Reproductive system and breast disorders IRREGULAR MENSTRUATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders ALLERGIES	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders COUGH	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	43.5% 20/46 • Number of events 28 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders DYSPNEA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	23.9% 11/46 • Number of events 15 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders HOARSENESS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 9 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	6.5% 3/46 • Number of events 3 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY EDEMA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders RUNNY NOSE	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Respiratory, thoracic and mediastinal disorders SORE THROAT	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	21.7% 10/46 • Number of events 13 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders ALOPECIA	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 4 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders BULLOUS DERMATITIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders DERMATITIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders DRY SKIN	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	8.7% 4/46 • Number of events 5 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders HYPERHIDROSIS	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	10.9% 5/46 • Number of events 6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders PRURITUS	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	19.6% 9/46 • Number of events 14 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders RASH ACNEIFORM	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	33.3% 2/6 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	28.3% 13/46 • Number of events 23 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders SKIN HYPERPIGMENTATION	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Skin and subcutaneous tissue disorders WART	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Vascular disorders FLUSHING	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Vascular disorders HOT FLASHES	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	4.3% 2/46 • Number of events 2 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Vascular disorders HYPERTENSION	83.3% 5/6 • Number of events 10 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	89.1% 41/46 • Number of events 199 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Vascular disorders HYPOTENSION	16.7% 1/6 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	32.6% 15/46 • Number of events 25 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.
Vascular disorders THROMBOEMBOLIC EVENT	0.00% 0/6 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.	2.2% 1/46 • Number of events 1 • Adverse Events were monitored/assessed at each 21-day cycle treatment and up to 30 days post-last dose (up to 25 months) for AE or 90 days post-last dose (up to 27 months) for SAE. All-Cause Mortality was monitored/assessed up to 57 months post-treatment.

Additional Information

Dr. Alex Herrera

City of Hope Medical Center

Phone: 626-359-8111

Email: aherrera@coh.org

Results disclosure agreements

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