Trial Outcomes & Findings for Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma (NCT NCT01703949)

Last Updated: 2026-05-12

Results Overview

No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is ≥20% in Arm A or ≥40% in Arm B.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

28 participants

Primary outcome timeframe

For Arm A: Up to 5 weeks after completion of study treatment (an average of 1 month). For Arm B: within 6 months following treatment (an average of 1 month).

Results posted on

2026-05-12

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A (Brentuximab Vedotin) Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm B (Brentuximab Vedotin, Nivolumab) Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Study STARTED	8	20
Overall Study COMPLETED	3	17
Overall Study NOT COMPLETED	5	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brentuximab Vedotin With or Without Nivolumab in Treating Patients With Relapsed or Refractory CD30+ Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (Brentuximab Vedotin) n=8 Participants Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm B (Brentuximab Vedotin, Nivolumab) n=20 Participants Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=1512 Participants	17 Participants n=504 Participants	24 Participants n=2016 Participants
Age, Categorical >=65 years	1 Participants n=1512 Participants	3 Participants n=504 Participants	4 Participants n=2016 Participants
Age, Continuous	43 years n=1512 Participants	42 years n=504 Participants	42 years n=2016 Participants
Sex: Female, Male Female	3 Participants n=1512 Participants	4 Participants n=504 Participants	7 Participants n=2016 Participants
Sex: Female, Male Male	5 Participants n=1512 Participants	16 Participants n=504 Participants	21 Participants n=2016 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=1512 Participants	2 Participants n=504 Participants	2 Participants n=2016 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=1512 Participants	18 Participants n=504 Participants	24 Participants n=2016 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=1512 Participants	0 Participants n=504 Participants	2 Participants n=2016 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Asian	0 Participants n=1512 Participants	2 Participants n=504 Participants	2 Participants n=2016 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Black or African American	0 Participants n=1512 Participants	1 Participants n=504 Participants	1 Participants n=2016 Participants
Race (NIH/OMB) White	8 Participants n=1512 Participants	17 Participants n=504 Participants	25 Participants n=2016 Participants
Race (NIH/OMB) More than one race	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=1512 Participants	0 Participants n=504 Participants	0 Participants n=2016 Participants
Region of Enrollment United States	8 participants n=1512 Participants	20 participants n=504 Participants	28 participants n=2016 Participants

PRIMARY outcome

Timeframe: For Arm A: Up to 5 weeks after completion of study treatment (an average of 1 month). For Arm B: within 6 months following treatment (an average of 1 month).

No formal statistical measures will be pre-specified. This protocol will be deemed a "success" if the absolute response rate in this group of patients is ≥20% in Arm A or ≥40% in Arm B.

Outcome measures

Outcome measures
Measure	Arm A (Brentuximab Vedotin) n=8 Participants Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm B (Brentuximab Vedotin, Nivolumab) n=20 Participants Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Overall Response Rate as Measured by the Cheson 2007 Criteria	1 Participants	7 Participants

Adverse Events

Arm A (Brentuximab Vedotin)

Serious events: 2 serious events

Other events: 7 other events

Deaths: 1 deaths

Arm B (Brentuximab Vedotin, Nivolumab)

Serious events: 4 serious events

Other events: 19 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (Brentuximab Vedotin) n=8 participants at risk Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm B (Brentuximab Vedotin, Nivolumab) n=20 participants at risk Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Psychiatric disorders Confusion	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Respiratory, thoracic and mediastinal disorders Lung infection	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Seizure	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Cardiac disorders Cardiac arrest	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Brain herniation	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Anoxic brain injury	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Hematochezia	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.

Other adverse events

Additional Information

Ajay Gopal, MD

University of Washington

Phone: 2066062037

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A (Brentuximab Vedotin) n=8 participants at risk Patients receive brentuximab vedotin IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies	Arm B (Brentuximab Vedotin, Nivolumab) n=20 participants at risk Patients receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30-60 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Brentuximab Vedotin: Given IV Laboratory Biomarker Analysis: Correlative studies Nivolumab: Given IV
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Skin and subcutaneous tissue disorders Alopecia	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	15.0% 3/20 • Number of events 3 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Musculoskeletal and connective tissue disorders Back pain	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
General disorders Chills	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Constipation	37.5% 3/8 • Number of events 3 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	20.0% 4/20 • Number of events 4 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Diarrhea	50.0% 4/8 • Number of events 4 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	15.0% 3/20 • Number of events 4 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Reproductive system and breast disorders Erectile dysfunction	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
General disorders Fatigue	75.0% 6/8 • Number of events 6 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	35.0% 7/20 • Number of events 7 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
General disorders Fever	50.0% 4/8 • Number of events 4 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	15.0% 3/20 • Number of events 3 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Metabolism and nutrition disorders Hypokalemia	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Musculoskeletal and connective tissue disorders Myalgia	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Nausea	37.5% 3/8 • Number of events 3 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	25.0% 5/20 • Number of events 6 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Peripheral neuropathy	62.5% 5/8 • Number of events 5 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	25.0% 5/20 • Number of events 5 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Pancreatitis	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	0.00% 0/20 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	25.0% 5/20 • Number of events 6 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Vascular disorders Flushing	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
General disorders Night sweats	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Infections and infestations Upper respiratory infection	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Gastrointestinal disorders Vomiting	25.0% 2/8 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	20.0% 4/20 • Number of events 4 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Investigations Alanine aminotransferase increased	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	20.0% 4/20 • Number of events 6 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	15.0% 3/20 • Number of events 4 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Headache	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	15.0% 3/20 • Number of events 3 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Infections and infestations Pneumonia	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
General disorders Infusion related reaction	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	30.0% 6/20 • Number of events 7 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Nervous system disorders Shoulder pain	12.5% 1/8 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	5.0% 1/20 • Number of events 1 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
Investigations Neutrophil count decreased	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	15.0% 3/20 • Number of events 5 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.
General disorders Non-cardiac chest pain	0.00% 0/8 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.	10.0% 2/20 • Number of events 2 • Serious and other AEs were monitored from the time of study enrollment through 30 days following the end of study treatment (up to 3 months). All-cause mortality was monitored from the time of study enrollment up to 5 years.