Trial Outcomes & Findings for Brentuximab Vedotin for Systemic Sclerosis (NCT NCT03222492)

NCT ID: NCT03222492

Last Updated: 2024-05-17

Results Overview

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline through end of study (48 weeks for participants who complete the study)
• Results posted on: 2024-05-17

Participant Flow

Participant milestones

Measure	Cohort 1 Brentuximab Vedotin Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 1 Placebo Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 2 Brentuximab Vedotin Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses	Cohort 2 Placebo Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Overall Study STARTED	6	2	7	2
Overall Study COMPLETED	6	2	5	2
Overall Study NOT COMPLETED	0	0	2	0

Reasons for withdrawal

Measure	Cohort 1 Brentuximab Vedotin Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 1 Placebo Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 2 Brentuximab Vedotin Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses	Cohort 2 Placebo Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Overall Study Withdrawal by Subject	0	0	1	0
Overall Study COVID-19 related	0	0	1	0

Baseline Characteristics

Brentuximab Vedotin for Systemic Sclerosis

Baseline characteristics by cohort

Measure	Cohort 1 Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 1 Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 2 Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Cohort 2 Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Continuous	48.0 years STANDARD_DEVIATION 16.52 • n=5 Participants	42.0 years STANDARD_DEVIATION 22.63 • n=7 Participants	53.1 years STANDARD_DEVIATION 7.97 • n=5 Participants	47.0 years STANDARD_DEVIATION 7.07 • n=4 Participants	49.3 years STANDARD_DEVIATION 12.59 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	13 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	6 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	2 participants n=4 Participants	17 participants n=21 Participants
Body Mass Index (BMI)	26.73 kg/m^2 STANDARD_DEVIATION 5.397 • n=5 Participants	32.49 kg/m^2 STANDARD_DEVIATION 0.939 • n=7 Participants	26.37 kg/m^2 STANDARD_DEVIATION 4.831 • n=5 Participants	22.21 kg/m^2 STANDARD_DEVIATION 0.784 • n=4 Participants	26.73 kg/m^2 STANDARD_DEVIATION 4.971 • n=21 Participants
Disease Duration from Onset of Raynaud's Symptoms	27.3 Months STANDARD_DEVIATION 24.05 • n=5 Participants	45.4 Months STANDARD_DEVIATION 9.80 • n=7 Participants	19.2 Months STANDARD_DEVIATION 7.44 • n=5 Participants	24.7 Months STANDARD_DEVIATION 17.12 • n=4 Participants	26.6 Months STANDARD_DEVIATION 17.35 • n=21 Participants
Disease Duration from Onset of Non-Raynaud's Symptoms	17.5 Months STANDARD_DEVIATION 6.70 • n=5 Participants	46.4 Months STANDARD_DEVIATION 8.43 • n=7 Participants	19.0 Months STANDARD_DEVIATION 8.65 • n=5 Participants	26.2 Months STANDARD_DEVIATION 14.98 • n=4 Participants	22.5 Months STANDARD_DEVIATION 12.18 • n=21 Participants
Baseline Modified Rodnan Skin Score (mRSS) Total Score	31.3 Score STANDARD_DEVIATION 6.53 • n=5 Participants	24.5 Score STANDARD_DEVIATION 2.12 • n=7 Participants	29.0 Score STANDARD_DEVIATION 11.58 • n=5 Participants	19.5 Score STANDARD_DEVIATION 2.12 • n=4 Participants	28.2 Score STANDARD_DEVIATION 8.90 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline through end of study (48 weeks for participants who complete the study)

Population: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	0.333 Proportion of participants Interval 0.043 to 0.777	0.000 Proportion of participants Interval 0.0 to 0.842	0.571 Proportion of participants Interval 0.184 to 0.901	0.000 Proportion of participants Interval 0.0 to 0.842	0.462 Proportion of participants Interval 0.192 to 0.749	0.000 Proportion of participants Interval 0.0 to 0.602

PRIMARY outcome

Timeframe: Baseline through end of study (48 weeks)

Population: The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.	0.400 proportion of participants Interval 0.053 to 0.853	0.000 proportion of participants Interval 0.0 to 0.842	0.667 proportion of participants Interval 0.094 to 0.992	0.000 proportion of participants Interval 0.0 to 0.842	0.500 proportion of participants Interval 0.157 to 0.843	0.000 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through Week 12 study visit or 12 weeks on study if the visit was missed. Baseline through Week 24 study visit or 24 weeks on study if the visit was missed. Baseline through Week 36 study visit or 36 weeks on study if the visit was missed

Population: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36. Week 24	0.333 proportion of participants Interval 0.043 to 0.777	0.000 proportion of participants Interval 0.0 to 0.842	0.286 proportion of participants Interval 0.037 to 0.71	0.000 proportion of participants Interval 0.0 to 0.842	0.308 proportion of participants Interval 0.091 to 0.614	0.000 proportion of participants Interval 0.0 to 0.602
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36. Week 12	0.167 proportion of participants Interval 0.004 to 0.641	0.000 proportion of participants Interval 0.0 to 0.842	0.143 proportion of participants Interval 0.004 to 0.579	0.000 proportion of participants Interval 0.0 to 0.842	0.154 proportion of participants Interval 0.019 to 0.454	0.000 proportion of participants Interval 0.0 to 0.602
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36. Week 36	0.333 proportion of participants Interval 0.043 to 0.777	0.000 proportion of participants Interval 0.0 to 0.842	0.429 proportion of participants Interval 0.099 to 0.816	0.000 proportion of participants Interval 0.0 to 0.842	0.385 proportion of participants Interval 0.139 to 0.684	0.000 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.

Population: The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=10 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12	0.200 proportion of participants Interval 0.005 to 0.716	0.000 proportion of participants Interval 0.0 to 0.842	0.200 proportion of participants Interval 0.005 to 0.716	0.000 proportion of participants Interval 0.0 to 0.842	0.200 proportion of participants Interval 0.025 to 0.556	0.000 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.

Population: The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=4 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=9 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.	0.400 proportion of participants Interval 0.053 to 0.853	0.000 proportion of participants Interval 0.0 to 0.842	0.500 proportion of participants Interval 0.068 to 0.932	0.000 proportion of participants Interval 0.0 to 0.842	0.444 proportion of participants Interval 0.137 to 0.788	0.000 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.

Population: The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.	0.400 proportion of participants Interval 0.053 to 0.853	0.000 proportion of participants Interval 0.0 to 0.842	0.667 proportion of participants Interval 0.094 to 0.992	0.000 proportion of participants Interval 0.0 to 0.842	0.500 proportion of participants Interval 0.157 to 0.843	0.00 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed

Population: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48. Week 12	0.833 proportion of participants Interval 0.359 to 0.996	0.500 proportion of participants Interval 0.013 to 0.987	0.429 proportion of participants Interval 0.099 to 0.816	0.000 proportion of participants Interval 0.0 to 0.842	0.615 proportion of participants Interval 0.316 to 0.861	0.250 proportion of participants Interval 0.006 to 0.806
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48. Week 24	1.000 proportion of participants Interval 0.541 to 1.0	0.500 proportion of participants Interval 0.013 to 0.987	0.714 proportion of participants Interval 0.29 to 0.963	0.000 proportion of participants Interval 0.0 to 0.842	0.846 proportion of participants Interval 0.546 to 0.981	0.250 proportion of participants Interval 0.006 to 0.806
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48. Week 36	1.000 proportion of participants Interval 0.541 to 1.0	1.000 proportion of participants Interval 0.158 to 1.0	0.857 proportion of participants Interval 0.421 to 0.996	0.000 proportion of participants Interval 0.0 to 0.842	0.923 proportion of participants Interval 0.64 to 0.998	0.500 proportion of participants Interval 0.068 to 0.932
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48. Week 48	1.000 proportion of participants Interval 0.541 to 1.0	1.000 proportion of participants Interval 0.158 to 1.0	0.857 proportion of participants Interval 0.421 to 0.996	0.000 proportion of participants Interval 0.0 to 0.842	0.923 proportion of participants Interval 0.64 to 0.998	0.500 proportion of participants Interval 0.068 to 0.932

SECONDARY outcome

Timeframe: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed

Population: The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=10 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12	0.800 proportion of participants Interval 0.284 to 0.995	0.500 proportion of participants Interval 0.013 to 0.987	0.600 proportion of participants Interval 0.147 to 0.947	0.000 proportion of participants Interval 0.0 to 0.842	0.700 proportion of participants Interval 0.348 to 0.933	0.250 proportion of participants Interval 0.006 to 0.806

SECONDARY outcome

Timeframe: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.

Population: The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=4 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=9 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.	1.000 proportion of participants Interval 0.478 to 1.0	0.500 proportion of participants Interval 0.013 to 0.987	1.000 proportion of participants Interval 0.398 to 1.0	0.000 proportion of participants Interval 0.0 to 0.842	1.000 proportion of participants Interval 0.664 to 1.0	0.250 proportion of participants Interval 0.006 to 0.806

SECONDARY outcome

Timeframe: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.

Population: The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.	1.000 proportion of participants Interval 0.478 to 1.0	1.000 proportion of participants Interval 0.158 to 1.0	1.000 proportion of participants Interval 0.292 to 1.0	0.000 proportion of participants Interval 0.0 to 0.842	1.000 proportion of participants Interval 0.631 to 1.0	0.500 proportion of participants Interval 0.068 to 0.932

SECONDARY outcome

Timeframe: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Population: The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 48.	1.000 proportion of participants Interval 0.478 to 1.0	1.000 proportion of participants Interval 0.158 to 1.0	1.000 proportion of participants Interval 0.292 to 1.0	0.000 proportion of participants Interval 0.0 to 0.842	1.000 proportion of participants Interval 0.631 to 1.0	0.500 proportion of participants Interval 0.068 to 0.932

SECONDARY outcome

Timeframe: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed

Population: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48. Week 12	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48. Week 24	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48. Week 36	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48. Week 48	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.

Population: The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=10 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.308	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.

Population: The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=4 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=9 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 24.	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.602	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.336	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.

Population: The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 36.	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.708	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.369	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Population: 5 The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 48.	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.708	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.369	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline thru Week 12 visit or 12 weeks on study if visit was missed/thru Week 24 visit or 24 weeks on study if visit was missed/thru Week 36 visit or 36 weeks on study if visit was missed/thru Week 48 visit or 48 weeks on study if visit was missed

Population: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48. Week 12	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48. Week 24	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48. Week 36	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48. Week 48	0.0 proportion of participants Interval 0.0 to 0.459	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.41	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.247	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.

Population: The Per Protocol 12 (PP12) is defined as the treated participants who receive at least 4 of the 5 infusions over the first 12 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 12 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=10 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.308	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.

Population: The Per Protocol 24 (PP24) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 24 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=4 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=9 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 24.	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.602	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.336	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.

Population: The Per Protocol 36 (PP36) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 36 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 36.	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.708	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.369	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Population: The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 48.	0.0 proportion of participants Interval 0.0 to 0.522	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.708	0.0 proportion of participants Interval 0.0 to 0.842	0.0 proportion of participants Interval 0.0 to 0.369	0.0 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Population: The safety population is defined as all participants who receive any amount of the placebo or the brentuximab vedotin study drug. Safety population is conceptually equivalent to the standard intent-to-treat population.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=6 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Any of the Following Grade 3 or Higher AEs at or Before Week 48: Peripheral Neuropathy, Neutropenia, Infectious Adverse Events, Infusions Reactions, or Progressive Multifocal Leukoencephalopathy.	0.167 proportion of participants Interval 0.004 to 0.641	0.000 proportion of participants Interval 0.0 to 0.842	0.143 proportion of participants Interval 0.004 to 0.579	0.000 proportion of participants Interval 0.0 to 0.842	0.154 proportion of participants Interval 0.019 to 0.454	0.000 proportion of participants Interval 0.0 to 0.602

SECONDARY outcome

Timeframe: Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.

Population: The Per Protocol 48 (PP48) is defined as the treated participants who receive at least 7 of the 8 infusions over the first 21 weeks, and who have no major protocol deviations that would affect the safety outcomes through the first 48 weeks.

Adverse events were graded using the criteria set forth in the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for the grading of liver chemistry abnormalities. The scale ranges from grade 1 through 5, with grade 1 being the least severe and grade 5 being the most severe. Liver chemistry abnormalities were graded, from 1 through 4 (with 1 being least severe and 4 being most severe) relative to the upper limit of normal (ULN) with different grades depending on whether there was an increase in aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or blood bilirubin.

Outcome measures

Measure	0.6 mg/kg Brentuximab Vedotin n=5 Participants Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=3 Participants Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 Participants Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=8 Participants Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 Participants Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Proportion of Participants With Any of the Following Grade 3 or Higher AEs at or Before Week 48: Peripheral Neuropathy, Neutropenia, Infectious Adverse Events, Infusions Reactions, or Progressive Multifocal Leukoencephalopathy.	0.200 proportion of participants Interval 0.005 to 0.716	0.000 proportion of participants Interval 0.0 to 0.842	0.333 proportion of participants Interval 0.008 to 0.906	0.000 proportion of participants Interval 0.0 to 0.842	0.250 proportion of participants Interval 0.032 to 0.651	0.000 proportion of participants Interval 0.0 to 0.602

Adverse Events

0.6 mg/kg Brentuximab Vedotin

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

0.6 mg/kg Placebo

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

1.2 mg/kg Brentuximab Vedotin

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

1.2 mg/kg Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brentuximab Vedotin in Pooled Participants

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo in Pooled Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	0.6 mg/kg Brentuximab Vedotin n=6 participants at risk Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 participants at risk Participants receive intravenous administration of 0.6 mg/kg of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 participants at risk Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 participants at risk Participants receive intravenous administration of 1.2 mg/kg of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 participants at risk Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 participants at risk Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations COVID-19	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Cytomegalovirus infection reactivation	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.

Other adverse events

Measure	0.6 mg/kg Brentuximab Vedotin n=6 participants at risk Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	0.6 mg/kg Placebo n=2 participants at risk Participants receive intravenous administration of 0.6 mg/kg of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Brentuximab Vedotin n=7 participants at risk Participants receive intravenous administration of 1.2 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	1.2 mg/kg Placebo n=2 participants at risk Participants receive intravenous administration of 1.2 mg/kg of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.	Brentuximab Vedotin in Pooled Participants n=13 participants at risk Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.	Placebo in Pooled Participants n=4 participants at risk Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Infections and infestations Pneumonia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Blood and lymphatic system disorders Lymphopenia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Cardiac disorders Ventricular arrhythmia	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/13 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Gastrointestinal disorders Diarrhoea	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Gastrointestinal disorders Mouth ulceration	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Bronchitis	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations COVID-19	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Helicobacter infection	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Impetigo	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Oesophageal candidiasis	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Sinusitis	33.3% 2/6 • Number of events 6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Tooth abscess	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Infections and infestations Upper respiratory tract infection	33.3% 2/6 • Number of events 3 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 3 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Investigations Forced expiratory volume decreased	16.7% 1/6 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 3 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Investigations Forced vital capacity decreased	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Investigations Lung diffusion test decreased	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Investigations Lymphocyte count decreased	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Investigations Weight increased	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Metabolism and nutrition disorders Abnormal loss of weight	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Metabolism and nutrition disorders Hypoalbuminaemia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/13 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Musculoskeletal and connective tissue disorders Arthralgia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Musculoskeletal and connective tissue disorders Osteoporosis	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/13 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Musculoskeletal and connective tissue disorders Synovitis	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Renal and urinary disorders Azotaemia	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	14.3% 1/7 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Renal and urinary disorders Chronic kidney disease	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	50.0% 1/2 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/13 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	25.0% 1/4 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Reproductive system and breast disorders Gynaecomastia	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Respiratory, thoracic and mediastinal disorders Productive cough	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	50.0% 1/2 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/13 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	25.0% 1/4 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Skin and subcutaneous tissue disorders Eczema	33.3% 2/6 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Skin and subcutaneous tissue disorders Psoriasis	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	7.7% 1/13 • Number of events 1 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	50.0% 1/2 • Number of events 5 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/7 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/13 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	25.0% 1/4 • Number of events 5 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Vascular disorders Hypertension	0.00% 0/6 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	28.6% 2/7 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	15.4% 2/13 • Number of events 2 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.	0.00% 0/4 • Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.

Additional Information

Director, Clinical Research Operations Program

DAIT/NIAID

Phone: 301-594-7669

Email: DAITClinicalTrialsGov@niaid.nih.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place