Trial Outcomes & Findings for Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (NCT NCT03772925)

Last Updated: 2026-03-03

Results Overview

Determined by the number of patients with treatment dosing level toxicities (DLT's). DLT's will be defined in cycle 1 as pre-specified adverse events that are considered by the investigator to be related to therapy with MLN4924 (pevonedistat) and/or belinostat.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Up to the end of cycle 1, 21 days.

Results posted on

2026-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 1 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 5 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV
Overall Study STARTED	3	3	3	4	5
Overall Study COMPLETED	3	3	3	4	3
Overall Study NOT COMPLETED	0	0	0	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 1 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 5 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV
Overall Study Adverse Event	0	0	0	0	1
Overall Study Physician Decision	0	0	0	0	1

Baseline Characteristics

Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Belinostat, Pevonedistat) Dose 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose 1 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose 4 n=4 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose 5 n=5 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants	0 Participants n=196 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=35 Participants	2 Participants n=41 Participants	0 Participants n=76 Participants	3 Participants n=565 Participants	1 Participants n=196 Participants	8 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=35 Participants	1 Participants n=41 Participants	3 Participants n=76 Participants	1 Participants n=565 Participants	4 Participants n=196 Participants	10 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=35 Participants	2 Participants n=41 Participants	1 Participants n=76 Participants	4 Participants n=565 Participants	3 Participants n=196 Participants	12 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=35 Participants	1 Participants n=41 Participants	2 Participants n=76 Participants	0 Participants n=565 Participants	2 Participants n=196 Participants	6 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	1 Participants n=565 Participants	0 Participants n=196 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=35 Participants	3 Participants n=41 Participants	3 Participants n=76 Participants	3 Participants n=565 Participants	4 Participants n=196 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants	1 Participants n=196 Participants	1 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants	0 Participants n=196 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants	0 Participants n=196 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants	0 Participants n=196 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=35 Participants	1 Participants n=41 Participants	2 Participants n=76 Participants	1 Participants n=565 Participants	2 Participants n=196 Participants	6 Participants n=4 Participants
Race (NIH/OMB) White	2 Participants n=35 Participants	2 Participants n=41 Participants	1 Participants n=76 Participants	2 Participants n=565 Participants	3 Participants n=196 Participants	10 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants	0 Participants n=196 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants	0 Participants n=41 Participants	0 Participants n=76 Participants	1 Participants n=565 Participants	0 Participants n=196 Participants	2 Participants n=4 Participants
Region of Enrollment United States	3 participants n=35 Participants	3 participants n=41 Participants	3 participants n=76 Participants	4 participants n=565 Participants	5 participants n=196 Participants	18 participants n=4 Participants
Disease Histology Acute Myeloid Leukemia (AML)	2 Participants n=35 Participants	3 Participants n=41 Participants	2 Participants n=76 Participants	4 Participants n=565 Participants	5 Participants n=196 Participants	16 Participants n=4 Participants
Disease Histology Myelodysplastic Syndrome (MDS)	1 Participants n=35 Participants	0 Participants n=41 Participants	1 Participants n=76 Participants	0 Participants n=565 Participants	0 Participants n=196 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to the end of cycle 1, 21 days.

Population: 2 patients in dose level 5 did not complete treatment.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Recommended Phase 2 Dose (RP2D) for the Combination of MLN4924 (Pevonedistat) and Belinostat	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.

Number of graded Adverse Events (AEs) reported using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=5 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Incidence of Adverse Events (AEs) Number of Grade 5 AE's	0 Adverse Events Reported	1 Adverse Events Reported	0 Adverse Events Reported	1 Adverse Events Reported	0 Adverse Events Reported
Incidence of Adverse Events (AEs) Number of Grade 4 AE's	1 Adverse Events Reported	1 Adverse Events Reported	4 Adverse Events Reported	9 Adverse Events Reported	5 Adverse Events Reported
Incidence of Adverse Events (AEs) Number of Grade 1 AE's	127 Adverse Events Reported	57 Adverse Events Reported	34 Adverse Events Reported	75 Adverse Events Reported	49 Adverse Events Reported
Incidence of Adverse Events (AEs) Number of Grade 2 AE's	17 Adverse Events Reported	19 Adverse Events Reported	11 Adverse Events Reported	69 Adverse Events Reported	42 Adverse Events Reported
Incidence of Adverse Events (AEs) Number of Grade 3 AE's	7 Adverse Events Reported	13 Adverse Events Reported	6 Adverse Events Reported	33 Adverse Events Reported	19 Adverse Events Reported

SECONDARY outcome

Timeframe: From day 1 until final response measured, up to 188 days.

Population: 4 participants not assessed. (1 patient receiving dose level 1, 3 receiving dose level 4) These patients stopped treatment too early to assess response.

The percentage of participants that experience a decrease in tumor size (partial response), or disappearance of tumor (complete response), classified according to International Working Group (IWG) and European Leukemia Net (ELN) criteria for response assessment in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=5 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=2 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=1 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Treatment Response Complete Response	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Treatment Response Stable Disease	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Treatment Response Partial Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Treatment Response Progression	3 Participants	2 Participants	3 Participants	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From documentation of tumor response to disease progression or death assessed up to 188 days.

Population: 5 participants that had either complete response or stable disease were measured.

Number of days patients remained in stable or complete response.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=2 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=2 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=1 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Duration of Stable and Complete Response	125.5 Days Interval 63.0 to 188.0	—	—	95.0 Days Interval 42.0 to 148.0	4.0 Days Interval 4.0 to 4.0

SECONDARY outcome

Timeframe: From Day 1 of protocol treatment to the time of documentation of tumor response, assessed up to 188 days.

Population: 4 participants not assessed (1 receiving dose level 1, 3 receiving dose level 4 due to stopping treatment too early to measure response.)

Number of days from day 1 of therapy to best response.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=5 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=2 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=1 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Time to Response	40.6 Days Interval 11.0 to 98.0	31.5 Days Interval 28.0 to 35.0	35.3 Days Interval 35.0 to 36.0	35.3 Days Interval 34.0 to 36.0	122.0 Days Interval 122.0 to 122.0

SECONDARY outcome

Timeframe: Baseline up to cycle 1 day 1

Population: 2 participants receiving dose level 5 had insufficient blast% to analyze the sample, per the protocol

Pharmacokinetic parameters in MLN4924 belinostat will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Change in MLN4924 Belinostat Plasma Concentrations	113.7 ng/ml Standard Deviation 29.4	109.0 ng/ml Standard Deviation 144.5	119.6 ng/ml Standard Deviation 50.3	124.9 ng/ml Standard Deviation 35.0	96.5 ng/ml Standard Deviation 46.0

SECONDARY outcome

Timeframe: Baseline up to cycle 1 day 1

Population: Change in MLN4924 pevonedistat plasma concentrations specimens were drawn, but were not analyzed at dose level #5 because the PK studies were done by the pharmaceutical sponsor (Takeda). As Takeda had decided to terminate the trial, they elected not to complete the pevonedistat PK analysis at dose level #5. The samples will not be analyzed in the future.

Pharmacokinetic (PK) parameters in MLN4924 pevonedistat will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Change in MLN4924 Pevonedistat Plasma Concentrations	—	278 ng/ml Standard Deviation 311	372 ng/ml Standard Deviation 93.2	897 ng/ml Standard Deviation 26.0	841 ng/ml Standard Deviation 455

SECONDARY outcome

Timeframe: Baseline up to cycle 1 day 1

Pharmacokinetic parameters in MLN4924 belinostat glucuronide will be calculated using standard non-compartmental methods and summarized as geometric mean and geometric coefficient of variation.

Outcome measures

Outcome measures
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 Participants Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV
Change in MLN4924 Belinostat Glucuronide Plasma Concentrations	193.0 ng/ml Standard Deviation 18.8	178.4 ng/ml Standard Deviation 246.7	141.9 ng/ml Standard Deviation 18.8	144.2 ng/ml Standard Deviation 30.0	214.0 ng/ml Standard Deviation 86.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Screening

TP53 and FLT3 mutational status by NGS compared to best clinical response classified according to International Working Group (IWG) and European Leukemia Net (ELN) criteria for response assessment in AML and MDS using a specific hematologic and blast count thresholds to define outcomes like Complete Remission (CR) or Hematologic Improvement (HI), focusing on blood counts (Hb, ANC, Platelets) and bone marrow (BM) blasts, with recent updates (IWG 2023/2024) emphasizing clearer definitions, limited recovery categories (CRi, CRL), and incorporating transfusion dependency/independence for better clinical relevance. Scoring isn't a single number but categorizing responses (CR, CRi, HI, Failure).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Treatment (Belinostat, Pevonedistat) Dose Level 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Treatment (Belinostat, Pevonedistat) Dose Level 2

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Treatment (Belinostat, Pevonedistat) Dose Level 3

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Treatment (Belinostat, Pevonedistat) Dose Level 4

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Treatment (Belinostat, Pevonedistat) Dose Level 5

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=5 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV
Cardiac disorders Atrial Flutter	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Infections and infestations Catheter Related Infection	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Chest Pain	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Chills	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Disease Progression w Death	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Infections and infestations Fungemia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Fatigue	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Vascular disorders Hypertension	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Palpitations	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Peripheral motor Neuropathy	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.

Other adverse events

Other adverse events
Measure	Treatment (Belinostat, Pevonedistat) Dose Level 1 n=3 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 20 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 2 n=3 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 25 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 3 n=3 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 800 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 4 n=4 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 37 mg/m2/day Given IV	Treatment (Belinostat, Pevonedistat) Dose Level 5 n=5 participants at risk Patients receive belinostat IV QD over 30 minutes on days 1-5 and pevonedistat IV QD over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Belinostat: 1000 mg/m2/day Given IV Pevonedistat: 50 mg/m2/day Given IV
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	100.0% 3/3 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	100.0% 3/3 • Number of events 23 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Atrial flutter	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Chest pain - cardiac	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Palpitations	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Right Bundle Brunch Block	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Eye disorders Stye	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Sinus bradycardia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Cardiac disorders Sinus tachycardia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Eye disorders Periorbital edema	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Eye disorders Vitreous hemorrhage	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Eye disorders itchy eyes	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Constipation	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 9 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Diarrhea	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 6 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Fecal incontinence	66.7% 2/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Gingival pain	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	80.0% 4/5 • Number of events 6 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Oral pain	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	40.0% 2/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Urgency bowel movement	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Gastrointestinal disorders Vomiting	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	60.0% 3/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Chills	66.7% 2/3 • Number of events 5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Edema face	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Edema limbs	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Fatigue	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Fever	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Gait disturbance	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Injection site reaction	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Localized edema	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Malaise	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Non-cardiac chest pain	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders Pain	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
General disorders mild pain( soreness) at port site	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Infections and infestations Catheter related infection	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Infections and infestations Lung infection	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Infections and infestations Mucosal infection	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Infections and infestations Sepsis	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	40.0% 2/5 • Number of events 6 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Alkaline phosphatase increased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	60.0% 3/5 • Number of events 8 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Blood bilirubin increased	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	40.0% 2/5 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Creatinine increased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Electrocardiogram QT corrected interv	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	80.0% 4/5 • Number of events 16 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Lipase increased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Low blood level of Vitamin B12	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Lymphocyte count decreased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 12 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Neutrophil count decreased	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 22 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 10 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Platelet count decreased	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	100.0% 3/3 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	100.0% 3/3 • Number of events 7 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	75.0% 3/4 • Number of events 17 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations Weight loss	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations White blood cell decreased	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	100.0% 3/3 • Number of events 13 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Investigations e-GRF decreased	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Anorexia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 6 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypernatremia	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypoalbuminemia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypocalcemia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypokalemia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypomagnesemia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hyponatremia	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Hypophosphatemia	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Metabolism and nutrition disorders Obesity	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Muscle weakness lower limb	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	50.0% 2/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	60.0% 3/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Dysgeusia	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Headache	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Paresthesia	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 6 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Nervous system disorders Tremor	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Psychiatric disorders Insomnia	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	40.0% 2/5 • Number of events 5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Psychiatric disorders Restlessness	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Renal and urinary disorders Dysuria	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Renal and urinary disorders Proteinuria	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Renal and urinary disorders Urinary frequency	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Renal and urinary disorders Urinary incontinence	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Reproductive system and breast disorders Vaginal pain	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	100.0% 3/3 • Number of events 11 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	40.0% 2/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	40.0% 2/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Nail changes	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Photosensitivity	33.3% 1/3 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Scalp pain	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Abrasion on right ring finger	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Uticaria	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Skin abrasion rt wrist	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Skin and subcutaneous tissue disorders Tooth abscess	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Vascular disorders Flushing	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	60.0% 3/5 • Number of events 3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Vascular disorders Hypertension	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	20.0% 1/5 • Number of events 2 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Vascular disorders Hypotension	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	66.7% 2/3 • Number of events 5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	25.0% 1/4 • Number of events 1 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.
Vascular disorders Thromboembolic event	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/3 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	33.3% 1/3 • Number of events 4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/4 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.	0.00% 0/5 • Adverse Events (AE's) were collected starting Cycle 1 Day 1 through 30 days following treatment up to 1 year, 6 months.

Additional Information

Massey IIT Research Operations

Virginia Commonwealth University Massey Comprehensive Cancer Center

Phone: 804-628-6430

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60