Trial Outcomes & Findings for A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL) (NCT NCT05673785)

Last Updated: 2026-06-12

Results Overview

Laboratory parameters like Potassium, Aspartate Aminotransferase (AST), Bilirubin, Serum Gamma-glutamyl Transferase (GGT), High Glucose (Hyperglycemia), Neutrophils, Leukocytes, Platelets, and Hemoglobin were assessed. Intensity of changes in laboratory parameters were evaluated using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

52 participants

Primary outcome timeframe

Up to approximately 7 months

Results posted on

2026-06-12

Participant Flow

Participants took part in the study at 14 investigative sites in China from 10 February 2023 to 27 April 2025. The study is ongoing.

A total of 52 participants with newly diagnosed CD30-positive (CD30+) peripheral T-cell lymphomas (PTCL) were enrolled in the study and treated with brentuximab vedotin in combination with cyclophosphamide, doxorubicin (hydroxydaunorubicin) and prednisone (CHP). The results presented are until the primary completion date.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin + CHP Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 milligrams per square meter (mg/m\^2) and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurred first.
Overall Study STARTED	52
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin + CHP Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 milligrams per square meter (mg/m\^2) and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurred first.
Overall Study Death	3
Overall Study Lost to follow up	1
Overall Study Withdrawal by Subject	2
Overall Study Ongoing	46

Baseline Characteristics

A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Age, Continuous	48.9 years STANDARD_DEVIATION 15.49 • n=9 Participants
Sex: Female, Male Female	23 Participants n=9 Participants
Sex: Female, Male Male	29 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants
Race (NIH/OMB) Asian	52 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants
Race (NIH/OMB) White	0 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants

PRIMARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

ORR by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment Per Revised Response Criteria for Malignant Lymphoma	96.2 percentage of participants Interval 86.8 to 99.5

PRIMARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Percentage of Participants Who Experienced at Least One Treatment Emergent Adverse Event (TEAE)	100 percentage of participants

PRIMARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From Grade 0 to Grade 3 Bilirubin	1 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From Grade 0 to Grade 3 Serum GGT	2 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From Grade 0 to Grade 3 High Glucose (Hyperglycemia),	2 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From Grade 0 to Grade 4 Low Potassium	1 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From Grade 0 to Grade 3 AST	1 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From Grade 0 to Grade 3 Low Potassuium	2 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Serum Total Bilirubin >=2 ULN	0 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Neutrophil Count	8 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Leukocyte Count	6 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 4 Low Platelet Count	1 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Leukocyte Count	6 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Neutrophil Count	3 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Platelet Count	2 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 0 to Grade 3 Low Hemoglobin	1 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 1 to Grade 3 Low Hemoglobin	3 Participants
Number of Participants With Abnormal Changes From Baseline in Laboratory Measurements Postbaseline Shift From CTCAE Grade 1 to Grade 3 Low Leucocyte Count	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Number of Participants With Abnormal Changes From Baseline in Vital Sign Measurements (Blood Pressure)	1 Participants

SECONDARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

CR rate by IRF assessment following the completion of study treatment was defined as the percentage of participants who achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR was defined as disappearance of all evidence of disease.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
CR Rate by IRF Assessment Per Revised Response Criteria for Malignant Lymphoma	75.0 percentage of participants Interval 61.1 to 86.0

SECONDARY outcome

Timeframe: Month 12

The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

ORR by IRF per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
ORR by IRF Per 2014 Lugano Classification	92.3 percentage of participants Interval 81.5 to 97.9

SECONDARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

ORR by investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
ORR by Investigator Assessment Per 2014 Lugano Classification	94.2 percentage of participants Interval 84.1 to 98.8

SECONDARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

CR rate by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was defined as the percentage of participants who achieved a CR by IRF following the completion of study treatment. CR was defined as disappearance of all evidence of disease.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
CR Rate by IRF Per 2014 Lugano Classification	76.9 percentage of participants Interval 63.2 to 87.5

SECONDARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants.

CR rate by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by investigator assessment following the completion of study treatment. CR was defined as disappearance of all evidence of disease

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
CR Rate by Investigator Assessment Per 2014 Lugano Classification	76.9 percentage of participants Interval 63.2 to 87.5

SECONDARY outcome

Timeframe: Up to approximately 7 months

Population: The FAS consisted of all enrolled participants. Here, "overall number of participants analyzed" signifies the number of participants with data available for analysis of this outcome measure.

TTR by IRF per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by IRF following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=48 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Time to Response (TTR) by IRF Per 2014 Lugano Classification	2.727 months Interval 2.694 to 2.76

SECONDARY outcome

Timeframe: Up to approximately 7 months

TTR by investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses was the time from date of first study drug administration to date of first documented objective response (CR or PR) by investigator assessment following the completion of study treatment for responders. CR was defined as disappearance of all evidence of disease. PR was defined as regression of measurable disease and no new sites.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=49 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Time to Response (TTR) by Investigator Assessment Per 2014 Lugano Classification	2.727 months Interval 2.694 to 2.76

SECONDARY outcome

Timeframe: Month 12

The 1-year PFS rate by IRF per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

The 1-year PFS rate by investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 36 months

DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1:Predose on Day1 and at 30minutes (min),48and 96hours postdose;Cycle 2:Predose on Day1 and at 30min,48 and 168hours postdose;Predose on Day1 of Cycles3,5,6,7;Anytime once on Days15,21 of Cycles4,6,8;30 days post-last dose; each cycle=21days

Population: The pharmacokinetic analysis set comprised of all participants who are in the FAS with at least 1 pharmacokinetic parameter. Here, "number analyzed" are the number of participants with data available for analysis at specified time-point.

Antibody-Drug Conjugates (ADCs) are targeted cancer therapies that combine a monoclonal antibody with a cytotoxic drug to selectively deliver treatment to cancer cells while minimizing damage to healthy cells.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 1 - Predose	NA nanograms per milliliter (ng/mL) Standard Deviation NA Mean and standard deviation were not estimable as no participant had detectable ADC at the pre-dose collection time point.
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 1 - End of infusion (30 min)	32278.6310 nanograms per milliliter (ng/mL) Standard Deviation 6782.22537
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 1 - Day 3 (48 hr)	8017.2624 nanograms per milliliter (ng/mL) Standard Deviation 3262.42585
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 1 - Day 5 (96 hr)	4703.5579 nanograms per milliliter (ng/mL) Standard Deviation 1795.74382
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 2 - Predose	364.0768 nanograms per milliliter (ng/mL) Standard Deviation 151.95902
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 2 - End of infusion (30 min)	31953.2729 nanograms per milliliter (ng/mL) Standard Deviation 8062.68391
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 2 - Day 3 (48 hr)	8944.7727 nanograms per milliliter (ng/mL) Standard Deviation 3432.10921
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 2 - Day 8 (168 hr)	2674.7550 nanograms per milliliter (ng/mL) Standard Deviation 626.08923
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 3 - Predose	558.8526 nanograms per milliliter (ng/mL) Standard Deviation 181.81833
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 4 - 15 to 21 Days Postdose	1044.3557 nanograms per milliliter (ng/mL) Standard Deviation 361.75958
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 5 - Predose	617.9578 nanograms per milliliter (ng/mL) Standard Deviation 247.80106
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 6 - Predose	623.6881 nanograms per milliliter (ng/mL) Standard Deviation 178.29961
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 6 - 15 to 21 Days Postdose	1052.5095 nanograms per milliliter (ng/mL) Standard Deviation 412.67066
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 7 - Predose	660.0101 nanograms per milliliter (ng/mL) Standard Deviation 198.78143
Serum Antibody-Drug Conjugate (ADC) Concentration Cycle 8 - 15 to 21 Days Postdose	1091.6060 nanograms per milliliter (ng/mL) Standard Deviation 364.72862
Serum Antibody-Drug Conjugate (ADC) Concentration Last - 15 to 21 Days Postdose	1071.2758 nanograms per milliliter (ng/mL) Standard Deviation 386.93255

SECONDARY outcome

The plasma concentration of MMAE is a critical factor in determining the efficacy and safety of ADCs.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 1 - Day 5 (96 hr)	3664.39 picogram per milliliter (pg/mL) Standard Deviation 2682.503
Plasma Monomethyl Auristatin E (MMAE) Concentration Last - 15 to 21 Days Postdose	286.70 picogram per milliliter (pg/mL) Standard Deviation 267.333
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 1 - Predose	1070.00 picogram per milliliter (pg/mL) Standard Deviation NA Standard deviation was not estimable as only one participant had a quantifiable pre-dose concentration; the remaining values were below the limit of quantification (BLQ).
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 1 - End of infusion (30 min)	342.80 picogram per milliliter (pg/mL) Standard Deviation 430.172
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 1 - Day 3 (48 hr)	4038.50 picogram per milliliter (pg/mL) Standard Deviation 2251.734
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 2 - Predose	94.35 picogram per milliliter (pg/mL) Standard Deviation 83.847
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 2 - End of infusion (30 min)	211.03 picogram per milliliter (pg/mL) Standard Deviation 142.401
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 2 - Day 3 (48 hr)	1799.23 picogram per milliliter (pg/mL) Standard Deviation 502.966
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 2 - Day 8 (168 hr)	1481.65 picogram per milliliter (pg/mL) Standard Deviation 661.914
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 3 - Predose	91.21 picogram per milliliter (pg/mL) Standard Deviation 52.715
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 4 - 15 to 21 Days Postdose	294.93 picogram per milliliter (pg/mL) Standard Deviation 251.617
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 5 - Predose	107.18 picogram per milliliter (pg/mL) Standard Deviation 91.718
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 6 - Predose	103.79 picogram per milliliter (pg/mL) Standard Deviation 77.201
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 6 - 15 to 21 Days Postdose	329.65 picogram per milliliter (pg/mL) Standard Deviation 317.291
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 7 - Predose	118.26 picogram per milliliter (pg/mL) Standard Deviation 93.931
Plasma Monomethyl Auristatin E (MMAE) Concentration Cycle 8 - 15 to 21 Days Postdose	241.97 picogram per milliliter (pg/mL) Standard Deviation 200.011

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.

Population: The immunogenicity analysis set consisted of participants who received at least 1 dose of any of the study treatments and had an ADA status assessment at baseline and at least 1 postbaseline sample.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive Baseline Positive and Post-baseline Transiently Positive	0 Participants
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive Baseline Negative and Post-baseline Transiently Positive	0 Participants
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive Baseline Positive and Post-baseline Persistently Positive	0 Participants
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive Baseline Negative and Post-baseline Persistently Positive	0 Participants
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive Baseline Negative and Post-baseline Negative	51 Participants
Number of Participants Who Are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive Baseline Positive and Post-baseline Negative	1 Participants

SECONDARY outcome

Timeframe: Pre-infusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days.

Population: The immunogenicity analysis set consisted of participants who have received at least 1 dose of any of the study treatments and have had an ADA status assessment at baseline and at least 1 postbaseline sample.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Preinfusion on Day 1 of each cycle up to Cycle 8, and anytime within 30 days after last dose; each cycle = 21 days

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin + CHP n=52 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb) NAb Positive	0 Participants
Number of Participants With Negative and Positive Neutralizing Antibody Status (NAb) NAb Negative	52 Participants

Adverse Events

Brentuximab Vedotin + CHP

Serious events: 18 serious events

Other events: 52 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin + CHP n=52 participants at risk Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Infections and infestations Bacteraemia	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Blood and lymphatic system disorders Febrile neutropenia	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations Gastrointestinal infection	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Immune system disorders Haemophagocytic lymphohistiocytosis	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Neutrophil count decreased	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Platelet count decreased	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations Pneumonia	23.1% 12/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations Soft tissue infection	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations Upper respiratory tract infection	1.9% 1/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations White blood cell count decreased	3.8% 2/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin + CHP n=52 participants at risk Participants received brentuximab vedotin 1.8 mg/kg, IV infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2, on Day 1 of each 21-day cycle, and prednisone tablets, 100 mg daily, orally, on Days 1 through 5, for up to 8 cycles (6 months) or until PD, unacceptable toxicity, whichever occurred first.
Gastrointestinal disorders Abdominal pain	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Alanine aminotransferase increased	50.0% 26/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Skin and subcutaneous tissue disorders Alopecia	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Blood and lymphatic system disorders Anaemia	67.3% 35/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Aspartate aminotransferase increased	42.3% 22/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
General disorders Asthenia	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Blood alkaline phosphatase increased	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Blood bilirubin increased	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Blood lactate dehydrogenase increased	11.5% 6/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations C-reactive protein increased	17.3% 9/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations COVID-19	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Gastrointestinal disorders Constipation	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Respiratory, thoracic and mediastinal disorders Cough	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Decreased appetite	11.5% 6/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Gastrointestinal disorders Diarrhoea	11.5% 6/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Faecal occult blood positive	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
General disorders Fatigue	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Blood and lymphatic system disorders Febrile neutropenia	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Gamma-glutamyltransferase increased	15.4% 8/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Nervous system disorders Headache	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Hepatobiliary disorders Hepatic function abnormal	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypercholesterolaemia	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hyperglycaemia	17.3% 9/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hyperlipidaemia	11.5% 6/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hyperphosphataemia	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypertriglyceridaemia	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hyperuricaemia	30.8% 16/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Nervous system disorders Hypoaesthesia	17.3% 9/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypoalbuminaemia	21.2% 11/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypocalcaemia	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypochloraemia	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypoglycaemia	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypokalaemia	30.8% 16/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hyponatraemia	21.2% 11/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Metabolism and nutrition disorders Hypoproteinaemia	15.4% 8/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Injury, poisoning and procedural complications Infusion related reaction	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Psychiatric disorders Insomnia	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Blood and lymphatic system disorders Leukopenia	9.6% 5/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Lymphocyte count decreased	51.9% 27/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Blood and lymphatic system disorders Lymphopenia	11.5% 6/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
General disorders Malaise	13.5% 7/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Gastrointestinal disorders Mouth ulceration	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Gastrointestinal disorders Nausea	34.6% 18/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Blood and lymphatic system disorders Neutropenia	26.9% 14/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Neutrophil count decreased	67.3% 35/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
General disorders Oedema peripheral	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Nervous system disorders Peripheral sensory neuropathy	15.4% 8/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Platelet count decreased	40.4% 21/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations Pneumonia	15.4% 8/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Procalcitonin increased	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
General disorders Pyrexia	15.4% 8/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Skin and subcutaneous tissue disorders Rash	7.7% 4/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Gastrointestinal disorders Stomatitis	5.8% 3/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Infections and infestations Upper respiratory tract infection	17.3% 9/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Gastrointestinal disorders Vomiting	34.6% 18/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Weight decreased	21.2% 11/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations Weight increased	15.4% 8/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.
Investigations White blood cell count decreased	71.2% 37/52 • AEs including SAEs were recorded from signing the consent form up to 30 days after last dose of study treatment (approximately 7 months). Only Treatment-related SAEs were continued to be recorded during long-term follow up (up to a total of approximately 27 months). The FAS consisted of all enrolled participants.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place