Trial Outcomes & Findings for Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver (NCT NCT04175912)

Last Updated: 2025-11-17

Results Overview

Response was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Objective response includes complete response (CR) and partial response (PR). CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Every 3 months for the first year and every 6 months for years 2-3

Results posted on

2025-11-17

Participant Flow

A total of 40 patients were enrolled between March 16, 2020 and March 22, 2023.

Participant milestones

Participant milestones
Measure	Arm A (Pevonedistat) Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Overall Study STARTED	20	20
Overall Study Received Treatment	17	17
Overall Study Eligible and Treated	17	17
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	20	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (Pevonedistat) Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Overall Study Disease progression- relapse during active treatment	17	13
Overall Study Adverse Event	0	3
Overall Study Never started treatment	3	3
Overall Study Death	0	1

Baseline Characteristics

Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Pevonedistat) n=17 Participants Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) n=17 Participants Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.	Total n=34 Participants Total of all reporting groups
Age, Continuous	63.4 years n=202 Participants	62.3 years n=283 Participants	63.1 years n=120 Participants
Sex: Female, Male Female	10 Participants n=202 Participants	11 Participants n=283 Participants	21 Participants n=120 Participants
Sex: Female, Male Male	7 Participants n=202 Participants	6 Participants n=283 Participants	13 Participants n=120 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=202 Participants	15 Participants n=283 Participants	31 Participants n=120 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=202 Participants	2 Participants n=283 Participants	3 Participants n=120 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Asian	1 Participants n=202 Participants	0 Participants n=283 Participants	1 Participants n=120 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Black or African American	5 Participants n=202 Participants	1 Participants n=283 Participants	6 Participants n=120 Participants
Race (NIH/OMB) White	10 Participants n=202 Participants	15 Participants n=283 Participants	25 Participants n=120 Participants
Race (NIH/OMB) More than one race	0 Participants n=202 Participants	0 Participants n=283 Participants	0 Participants n=120 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=202 Participants	1 Participants n=283 Participants	2 Participants n=120 Participants

PRIMARY outcome

Timeframe: Every 3 months for the first year and every 6 months for years 2-3

Population: Eligible and treated patients are included in this analysis

Outcome measures

Outcome measures
Measure	Arm A (Pevonedistat) n=17 Participants Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) n=17 Participants Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Objective Response With Objective Response	0 Participants	0 Participants
Objective Response Without Objective Response	17 Participants	17 Participants

SECONDARY outcome

Timeframe: Every 3 months for the first year and every 6 months for years 2-3

Population: Eligible and treated patients are included in this analysis

Clinical benefit was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), including complete response (CR), partial response (PR) and stable disease (SD) that lasted greater than or equal to 24 weeks. CR is defined as disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Arm A (Pevonedistat) n=17 Participants Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) n=17 Participants Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Clinical Benefit With Clinical Benefit	0 Participants	1 Participants
Clinical Benefit Without Clinical Benefit	17 Participants	16 Participants

SECONDARY outcome

Timeframe: Every 3 months for the first year and every 6 months for years 2-3

Population: Eligible and treated patients are included in this analysis

PFS was defined as the time from randomization to progression or death, whichever came first; patients alive without evidence of disease progression were censored at the date of last disease assessment. Patients who died without documented progression and the death occurred \> 6 weeks of last disease assessment will be censored at the date of last disease assessment that showed progression-free. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1), defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions is also considered as progression.

Outcome measures

Outcome measures
Measure	Arm A (Pevonedistat) n=17 Participants Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) n=17 Participants Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Progression-free Survival (PFS)	1.54 months Interval 1.41 to 2.1	2.92 months Interval 1.71 to 5.55

SECONDARY outcome

Timeframe: Every 3 months for the first year and every 6 months for years 2-3

Population: Eligible and treated patients are included in this analysis

OS was defined as the time from randomization to death from any cause, and patients still living were censored at the date last known alive.

Outcome measures

Outcome measures
Measure	Arm A (Pevonedistat) n=17 Participants Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) n=17 Participants Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Overall Survival (OS)	4.80 months Interval 4.04 to 12.5	6.54 months Interval 4.2 to 14.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months for the first year and every 6 months for years 2-3

Associations between response and overexpression of NEDD8, NAE1, and UBC12 will be evaluated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline

To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

To bank specimens for further future investigations

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Pevonedistat)

Serious events: 8 serious events

Other events: 17 other events

Deaths: 17 deaths

Arm B (Pevonedistat, Paclitaxel, Carboplatin)

Serious events: 12 serious events

Other events: 17 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Arm A (Pevonedistat) n=17 participants at risk Patients receive pevonedistat IV over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.	Arm B (Pevonedistat, Paclitaxel, Carboplatin) n=17 participants at risk Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.
Blood and lymphatic system disorders Anemia	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	17.6% 3/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
General disorders Death NOS	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
General disorders Fatigue	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
General disorders Fever	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
General disorders Disease progression	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Abdominal distension	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Abdominal pain	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Ascites	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Colonic perforation	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Constipation	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Gastroparesis	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Ileus	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Nausea	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Gastrointestinal disorders Vomiting	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Hepatobiliary disorders Cholecystitis	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Hepatobiliary disorders Hepatobiliary disorders - Other, specify	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Infections and infestations Biliary tract infection	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Infections and infestations Hepatic infection	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Infections and infestations Sepsis	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Investigations INR increased	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Investigations Neutrophil count decreased	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Investigations Platelet count decreased	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Investigations White blood cell decreased	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Metabolism and nutrition disorders Dehydration	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Metabolism and nutrition disorders Hypercalcemia	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Metabolism and nutrition disorders Hypomagnesemia	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Musculoskeletal and connective tissue disorders Back pain	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Nervous system disorders Edema cerebral	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Nervous system disorders Intracranial hemorrhage	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Nervous system disorders Syncope	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Respiratory, thoracic and mediastinal disorders Dyspnea	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Renal and urinary disorders Acute kidney injury	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Vascular disorders Hypertension	11.8% 2/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Vascular disorders Hypotension	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.
Vascular disorders Superior vena cava syndrome	0.00% 0/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.	5.9% 1/17 • Assessed every 3 weeks while on treatment and for 30 days after the end of treatment, up to 3 years All treated patients are included in this analysis.