Trial Outcomes & Findings for A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma (NCT NCT05442554)

Last Updated: 2025-09-18

Results Overview

ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) that lasts at least 4 months. CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral involvement using computed tomography (CT) scan, and for the participants with mycosis fungoides (MF) only, detection of circulating Sezary cells. Response Criteria were based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

10 participants

Primary outcome timeframe

Up to 58 weeks

Results posted on

2025-09-18

Participant Flow

Participants took part in the study at 3 investigative sites in China from 28 November 2022 to 09 August 2024.

Participants with cluster of differentiation 30-positive mycosis fungoides (CD30+ MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL) histologically confirmed by local pathology assessment participated in the study to receive brentuximab vedotin.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Overall Study STARTED	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin Participants received brentuximab vedotin 1.8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Overall Study Adverse Event	1

Baseline Characteristics

A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Age, Continuous	57.1 years STANDARD_DEVIATION 13.26 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 58 weeks

Population: The response-evaluable population included a subset of the full analysis set (FAS) participants with measurable disease at baseline and with at least 1 post-baseline response assessment. FAS consisted of all enrolled participants identified as CD30+ and received at least 1 dose of the study drug.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Overall Response Rate (ORR) Lasting at Least 4 Months in Participants With CD30+ MF or pcALCL	60.0 percentage of participants Interval 26.2 to 87.8

SECONDARY outcome

Timeframe: Up to 58 weeks

Population: The response-evaluable population included a subset of the FAS participants with measurable disease at baseline and with at least 1 post-baseline response assessment. FAS consisted of all enrolled participants identified as CD30+ and received at least 1 dose of the study drug.

CR rate is defined as the percentage of participants with CR. CR is defined as complete disappearance of all clinical evidence of disease. CR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using computed tomography (CT) scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Complete Response (CR) Rate	0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: Up to 58 weeks

ORR is defined as the percentage of participants who achieve complete response (CR) or partial response (PR). CR is defined as complete disappearance of all clinical evidence of disease and PR is defined as regression of measurable disease. ORR was determined based on GRS which consisted of a skin assessment by the investigator using the mSWAT, nodal and visceral involvement using CT scan, and for the participants with MF only, detection of circulating Sezary cells. Response Criteria were based on ISCL, USCLC and EORTC Consensus guidelines.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Overall Response Rate (ORR)	70.0 percentage of participants Interval 34.8 to 93.3

SECONDARY outcome

Timeframe: Up to 58 weeks

Duration of response was assessed in participants with CR or PR and is defined as the time between first documentation of response and progressive disease (PD). Response criteria were based on ISCL, USCLC and EORTC Consensus guidelines. Participants who were lost to follow-up, withdrew consent, or discontinued treatment due to undocumented PD after the last adequate disease assessment were censored at the last disease assessment.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=7 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Duration of Response (DOR)	NA months Median and confidence interval (CI) was not estimable as no participants with the event were reported.

SECONDARY outcome

Timeframe: From first dose of study drug through 30 days after the last dose of study drug (up to approximately 58 weeks)

Population: The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; 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. TEAE is defined as an adverse event with an onset that occurs after receiving study drug. SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event. TEAE and SAE were determined as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) TEAEs	10 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) SAEs	4 Participants

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Population: The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug. Number of participants analyzed is the number of participants with data available for analysis at the specified time points.

Vital signs included seated blood pressure (systolic and diastolic) measurements.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure Systolic Blood Pressure: Baseline	125.6 millimeters of mercury (mmHg) Standard Deviation 11.04
Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure Systolic Blood Pressure: Change from Baseline at the End of Treatment	-2.9 millimeters of mercury (mmHg) Standard Deviation 8.81
Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure Diastolic Blood Pressure: Baseline	76.5 millimeters of mercury (mmHg) Standard Deviation 6.36
Changes From Baseline in Participant's Vital Sign: Systolic and Diastolic Blood Pressure Diastolic Blood Pressure: Change from Baseline at the End of Treatment	-4.4 millimeters of mercury (mmHg) Standard Deviation 4.61

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Vital signs included heart rate (beats per minute) measurements.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Changes From Baseline in Participant's Vital Sign: Heart Rate Baseline	87.4 beats per minute Standard Deviation 10.11
Changes From Baseline in Participant's Vital Sign: Heart Rate Change from Baseline at the End of Treatment	-10.3 beats per minute Standard Deviation 14.34

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Vital signs included body temperature (degree Celsius) measurements.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Changes From Baseline in Participant's Vital Sign: Body Temperature Baseline	36.62 degree Celsius (°C) Standard Deviation 0.368
Changes From Baseline in Participant's Vital Sign: Body Temperature Change from Baseline at the End of Treatment	0.00 degree Celsius (°C) Standard Deviation 0.361

SECONDARY outcome

Timeframe: Baseline up to 30 days after the last dose of study drug (up to approximately 58 weeks)

Population: The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.

ECOG scale was used to assess performance status of participants. Grades range from 0 (fully active) to 5 (dead) where Grade 0: Normal activity. Grade 1: Symptoms but ambulatory. Grade 2: In bed \<50% of the time. Grade 3: In bed \>50% of the time. Grade 4: 100% bedridden. Grade 5: Dead. Lower grades indicate improvement. Reported here is the number of participants in each reported baseline grade to their worst post-baseline grade assessment on the ECOG scale.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale Participants with Baseline Grade: 0 to Worst Post-Baseline Grade: 0	2 Participants
Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale Participants with Baseline Grade: 1 to Worst Post-Baseline Grade: 1	7 Participants
Number of Participants From Baseline to Worst Post-Baseline Assessment Categories Based on Eastern Cooperative Oncology Group (ECOG) Performance Status Scale Participants with Baseline Grade: 1 to Worst Post-Baseline Grade: 3	1 Participants

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Hematology Parameter: Hemoglobin Baseline	126.3 grams per liter (g/L) Standard Deviation 23.00
Change From Baseline in Hematology Parameter: Hemoglobin Change from baseline at the End of Treatment	-5.4 grams per liter (g/L) Standard Deviation 16.46

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Hematology Parameter: Neutrophil Count Baseline	3.949 10^9 cells/liter (L) Standard Deviation 2.2230
Change From Baseline in Hematology Parameter: Neutrophil Count Change from Baseline at the End of Treatment	0.189 10^9 cells/liter (L) Standard Deviation 4.4084

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Hematology Parameter: Platelet Count Baseline	279.2 10^9 cells/L Standard Deviation 78.24
Change From Baseline in Hematology Parameter: Platelet Count Change from Baseline at the End of Treatment	-97.0 10^9 cells/L Standard Deviation 86.87

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Hematology Parameter: Lymphocyte Count Baseline	1.530 10^9 cells/L Standard Deviation 0.7367
Change From Baseline in Hematology Parameter: Lymphocyte Count Change from Baseline at the End of Treatment	-0.101 10^9 cells/L Standard Deviation 0.3355

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Hematology Parameter: Leukocyte Count Baseline	7.082 10^9 cells/L Standard Deviation 3.1018
Change From Baseline in Hematology Parameter: Leukocyte Count Change from Baseline at the End of Treatment	-0.862 10^9 cells/L Standard Deviation 3.5380

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP) Baseline	89.0 Units per liter (U/L) Standard Deviation 29.66
Change From Baseline in Serum Chemistry Parameter: Alkaline Phosphatase (ALP) Change from Baseline at the End of Treatment	26.3 Units per liter (U/L) Standard Deviation 36.10

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT) Baseline	18.9 U/L Standard Deviation 10.45
Change From Baseline in Serum Chemistry Parameter: Alanine Aminotransferase (ALT) Change from Baseline at the End of Treatment	8.2 U/L Standard Deviation 15.52

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST) Baseline	19.0 U/L Standard Deviation 5.85
Change From Baseline in Serum Chemistry Parameter: Aspartate Aminotransferase (AST) Change from Baseline at the End of Treatment	10.7 U/L Standard Deviation 10.40

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Serum Chemistry Parameter: Total Bilirubin Baseline	8.82 micromoles per liter (µmol/L) Standard Deviation 3.879
Change From Baseline in Serum Chemistry Parameter: Total Bilirubin Change from Baseline at the End of Treatment	1.93 micromoles per liter (µmol/L) Standard Deviation 3.947

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Serum Chemistry Parameter: Lipase Baseline	35.96 U/L Standard Deviation 10.726
Change From Baseline in Serum Chemistry Parameter: Lipase Change from Baseline at the End of Treatment	4.90 U/L Standard Deviation 11.837

SECONDARY outcome

Timeframe: Baseline, at end of treatment (approximately Week 54)

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin n=10 Participants Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Change From Baseline in Serum Chemistry Parameter: Amylase Baseline	64.0 U/L Standard Deviation 24.55
Change From Baseline in Serum Chemistry Parameter: Amylase Change from Baseline at the End of Treatment	10.9 U/L Standard Deviation 25.80

Adverse Events

Brentuximab Vedotin

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin n=10 participants at risk Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Renal and urinary disorders Dysuria	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Renal and urinary disorders Renal tubular necrosis	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations White blood cell count decreased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin n=10 participants at risk Participants received brentuximab vedotin 1.8 mg/kg, IV on Day 1 of each 21-day cycle for up to a total of 16 cycles.
Investigations Alanine aminotransferase increased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Alopecia	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Amylase increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Anaemia	30.0% 3/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Aspartate aminotransferase increased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Bile acids increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Blood alkaline phosphatase increased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Blood creatine phosphokinase increased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Blood creatinine decreased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Blood uric acid increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Constipation	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Cystatin C increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Decreased appetite	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis allergic	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Eczema	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Erythema multiforme	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
General disorders Fatigue	30.0% 3/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Gamma-glutamyltransferase increased	30.0% 3/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Hepatobiliary disorders Hepatic function abnormal	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypercalcaemia	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Vascular disorders Hypertension	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypertriglyceridaemia	30.0% 3/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyperuricaemia	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hyponatraemia	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Metabolism and nutrition disorders Hypoproteinaemia	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Infusion related reaction	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Inguinal hernia	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Cardiac disorders Left ventricular dysfunction	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Lipase increased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Lymphocyte count decreased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Gastrointestinal disorders Nausea	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Neuropathy peripheral	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Neutrophil count decreased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
General disorders Oedema peripheral	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Nervous system disorders Paraesthesia	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
General disorders Pyrexia	40.0% 4/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Rash	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Red blood cell sedimentation rate increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Cardiac disorders Sinus tachycardia	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Cardiac disorders Tricuspid valve incompetence	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders Urticaria	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations Weight increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations White blood cell count decreased	20.0% 2/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.
Investigations White blood cell count increased	10.0% 1/10 • Up to 58 weeks The safety analysis set consisted of all enrolled participants who received at least 1 dose of study drug.

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