Evaluation of Brentuximab Vedotin for Diffuse Cutaneous Systemic Sclerosis BRAVOS: A Phase 1/2 Multicenter Randomized, Double Blinded, Safety Study (ITN075AI)
Acronym
BRAVOS
Organization
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Status Module
Record Verification Date
Apr 2026
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Sep 20, 2017Actual
Primary Completion Date
Apr 10, 2023Actual
Completion Date
Apr 10, 2023Actual
First Submitted Date
Jul 17, 2017
First Submission Date that Met QC Criteria
Jul 18, 2017
First Posted Date
Jul 19, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Mar 11, 2024
Results First Submitted that Met QC Criteria
Apr 22, 2024
Results First Posted Date
May 17, 2024Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 22, 2026
Last Update Posted Date
May 5, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)NIH
Collaborators
Name
Class
Immune Tolerance Network (ITN)
NETWORK
Seagen Inc.
INDUSTRY
PPD Development, LP
INDUSTRY
Rho Federal Systems Division, Inc.
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
There is significant unmet need for effective treatment options for Diffuse Cutaneous Systemic Sclerosis (dcSSc). The present study will be a dose-escalation safety trial of brentuximab vedotin, a drug-antibody conjugate approved for the treatment of lymphoma and targeted to the protein CD30 molecule expressed on activated immune cells There is evidence for CD30 involvement in SSc. This study represents the first step in determining safety and tolerability of brentuximab vedotin in SSc.
Detailed Description
This is a multicenter prospective double blind placebo controlled dose escalation safety clinical trial with brentuximab vedotin and stable background immunosuppressive therapy in adult individuals with Diffuse Cutaneous Systemic Sclerosis (dcSSc). Adult male and female participants with dcSSc will be recruited by a collaborative group of clinical sites in the United States. Participants who meet the eligibility criteria will be enrolled without regard to gender, race, or ethnicity.
Eligible participants will be randomly assigned to study treatment, either brentuximab vedotin or placebo equivalent in a 6:2 ratio favoring brentuximab vedotin. Three dose cohorts are planned with 8 participants in each cohort, for a total of 24 participants who receive sufficient doses of the investigational medication to assess safety.
The doses planned for each ascending dose cohort include 0.6mg/kg, 1.2 mg/kg, and 1.8 mg/kg brentuximab vedotin or placebo equivalent. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses. Following completion of treatment, participants will undergo follow-up visits at weeks 24, 28, 36 and 48.
Conditions Module
Conditions
Diffuse Cutaneous Systemic Sclerosis
Scleroderma
dcSSc
Keywords
Diffuse Cutaneous Systemic Sclerosis (dcSSc)
Phase 1/2 clinical trial
dose escalation randomized trial
Brentuximab vedotin
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
17Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: 0.6 mg/kg brentuximab vedotin
Experimental
This is the first of three ascending dose cohorts. Participants in this cohort will receive 0.6 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes.
Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Biological: Brentuximab Vedotin
Cohort 1: placebo
Placebo Comparator
0.6 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 0.6 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes.
Cohort 1 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Biological: Placebo
Cohort 2: 1.2 mg/kg brentuximab vedotin
Experimental
This is the second of three ascending dose cohorts. Participants in this cohort will receive 1.2 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes.
Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Biological: Brentuximab Vedotin
Cohort 2: placebo
Placebo Comparator
1.2 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.2 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes.
Cohort 2 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Brentuximab Vedotin
Biological
Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
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.
Baseline through end of study (48 weeks for participants who complete the study)
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
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.
Baseline through end of study (48 weeks)
Secondary Outcomes
Measure
Description
Time Frame
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36.
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.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Classification of Systemic Sclerosis (SSc), as defined using the 2013 American College of Rheumatology/European Union League Against Rheumatism classification of SSc;
Diagnosis of Diffuse Cutaneous Systemic Sclerosis (dcSSc), as defined by LeRoy and Medsger, Criteria for the classification of early systemic sclerosis. J Rheumatol, 2001. 28(7): p. 1573-6;
Disease duration ≤ 60 months (defined as time from the first non-Raynaud phenomenon manifestation);
Modified Rodnan Skin Score (mRSS) units ≥ 15 and ≤ 45, and both of the following:
At least mild skin thickening (≥ 1+ mRSS) of the forearm, and
At least moderate skin thickening (≥ 2+ mRSS) at the planned forearm skin biopsy site.
Documentation of at least 12 weeks of ongoing immunosuppressive therapy for SSc at the time of enrollment, and at least 4 weeks at a stable dose, of one of the following:
Methotrexate ≤ 25 mg/week, or
Mycophenolate mofetil ≤3 grams/day or mycophenolate sodium ≤2.16 grams/day, or
Azathioprine ≤3mg/kg/day.
Ability to provide informed consent.
Exclusion Criteria:
Rheumatic disease other than Diffuse Cutaneous Systemic Sclerosis (dcSSc); it is acceptable to include patients with osteoarthritis, fibromyalgia, sicca symptoms, and scleroderma-associated myopathy;
Limited cutaneous Systemic Sclerosis (SSc) or sine scleroderma;
Pulmonary disease with Forced Vital Capacity (FVC) ≤60% of predicted, or Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) (corrected for hemoglobin) ≤60% of predicted;
Pulmonary hypertension (PH) or moderate to severe left ventricular dysfunction, defined as one of the following:
Transthoracic echocardiography demonstrating at least one of the following (unless subsequent right heart catheterization does not demonstrate PH; or unless prior right heart catheterization within one year did not demonstrate PH and echocardiography results are not significantly changed):
Tricuspid regurgitation jet >2.8 m/sec or estimated right ventricular systolic pressure > 42 mm Hg. or
At least one of the following:
Abnormality of right atrial size, shape, or wall thickness consistent with PH, or
Abnormality of right ventricular size, shape, or wall thickness consistent with PH, or
Abnormal septal wall shape consistent with PH.
Left Ventricular Ejection Fraction (LVEF) <50%.
Right heart catheterization showing mean pulmonary artery pressure ≥25 mm Hg at rest;
Current use of approved medications for PH. It is acceptable to use phosphodiesterase type 5 (PDE-5) inhibitors for Raynaud's, digital ulcers, and intermittently for erectile dysfunction.
Active scleroderma renal crisis within the 4 months prior to enrollment;
History of moderate-to-severe lower gastrointestinal dysmotility such as current use of parenteral nutrition and/or recent history of intestinal pseudo-obstruction within 3 months prior to enrollment;
The following medications:
Oral corticosteroids >10 mg/day of prednisone or equivalent within 2 weeks prior to enrollment;
Treatment with Intravenous Immunoglobulin (IVIG) within 12 weeks prior to enrollment;
Treatment with cyclophosphamide within 6 months prior to enrollment;
Use of investigational biologic or non-biologic medication within the past 90 days, or 5 half-lives prior to enrollment, whichever is greater;
Use of anti-TNF medication or other biologic medications within the past 90 days, or 5 half-lives prior to enrollment, whichever is greater;
Prior treatment with anti-CD20 if either of the following are true:
B cells ≤ lower limit of normal (LLN), or
Treatment with anti-CD20 has been within 12 months prior to enrollment.
Any prior treatment with cell-depleting therapies other than anti-CD20, including investigational agents, including but not limited to, CAMPATH(R), anti- CD4, anti-CD5, anti-CD3, anti-CD19; or
Any prior treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation.
Receipt of a live-attenuated vaccine within 3 months of study enrollment;
Concomitant malignancies or a history of malignancy, with the exception of adequately treated basal and squamous cell carcinoma of the skin, or carcinoma in situ of the cervix;
Major surgery (including joint surgery) within 8 weeks prior to enrollment;
History of solid organ or hematopoietic stem cell transplantation;
History of primary immunodeficiency;
Comorbidities requiring systemic corticosteroid therapy, including those which have required three or more courses of systemic corticosteroids within the 12 months prior to enrollment;
Current substance abuse or history of substance abuse within 12 months prior to enrollment;
History of severe depression or severe psychiatric condition;
Lack of peripheral venous access;
Known hypersensitivity to brentuximab vedotin, a component thereof, or the excipient contained in the drug formulation;
Severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, or neurological disease (or, in the investigator's opinion, any other concomitant medical condition that places the participant at risk by participating in this study), including but not limited to:
Uncompensated congestive heart failure (New York Heart Association Class III or VI);
Clinically significant active coronary artery disease (e.g., unstable angina or acute myocardial infarction within 6 months prior to enrollment);
Recently active cerebrovascular disease (e.g., stroke or transient ischemic attack within 6 months prior to enrollment);
Uncontrolled systemic hypertension;
Confirmed diagnosis of diabetes mellitus;
Pancreatitis within 30 days prior to enrollment; or
History or presence of peripheral neuropathy, such as mononeuritis multiplex, acute or chronic inflammatory demyelinating polyneuropathy, axonal sensorimotor neuropathies, or drug related neuropathy or neuritis.
Evidence of infection:
Any infected ulcer at enrollment;
Active bacterial, viral, fungal, or opportunistic infections requiring systemic anti-infective therapy;
Evidence of current or prior infection with tuberculosis:
Positive QuantiFERON® - TB Gold or TB Gold Plus test results.
Note: Purified protein derivative (PPD) tuberculin test may be substituted for QuantiFERON® - TB Gold or TB fold Plus test.
Indeterminant QuantiFERON® - TB Gold test results, unless followed by a subsequent negative PPD or negative QuantiFERON® and clearance by local Infectious Disease department.
Evidence of current or prior infection with:
Human Immunodeficiency Virus (HIV), or
Hepatitis B Virus (as assessed by hepatitis B surface antigen, HBsAg and antibody to hepatitis B core antigen, anti-HBc), or
Hepatitis C Virus (HCV), with the exception of adequately treated HCV with documentation of sustained virologic response, defined as undetectable HCV RNA at least 12 weeks after the end of treatment.
History of progressive multifocal leukoencephalopathy (PML);
Hospitalization for treatment of infections, or parenteral (intravenous or intramuscular) antibacterials, antivirals, anti-fungals, or anti-parasitic agents within the past 60 days prior to enrollment;
Chronic infection that is currently being treated with systemic suppressive antibiotic or antiviral therapy, including but not limited to tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria.
History of significant infection or recurrent infection that, in the investigator's opinion, places the participant at risk by participating in this study.
Positive polymerase chain reaction (PCR) test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) within 14 days prior to enrollment.
Moderately severe anemia (hemoglobin, Hgb < 10 g/dL);
Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], or alkaline phosphatase) results that are ≥ 1.5 times the upper limit of normal;
Serum total bilirubin > 1.5 times the upper limit of normal, or > 3 times the upper limit of normal in the presence of Gilbert's syndrome; or
Serum amylase and serum lipase > 1.5 times the upper limit of normal.
Renal dysfunction, defined as either one of the following:
Serum creatinine > 1.5 times the upper limit of normal; or
Unwillingness to use two forms of medically acceptable contraception methods by participants and their partners (if of reproductive potential) during the study and for at least 6 months after last dose of study drug; or
Inability to comply with study and follow-up procedures.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Dinesh Khanna, MD, MSc
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Study Chair
David Fox, MD
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
UCLA Medical Center: Division of Rheumatology
Los Angeles
California
90095
United States
Georgetown University Medical Center: Division of Rheumatology
References Module
Citations
Not provided
See Also Links
Label
URL
National Institute of Allergy and Infectious Diseases (NIAID)
Participants receive intravenous administration of 0.6 mg/kg Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
FG001
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.
FG002
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
FG003
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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0006 subjects
FG0012 subjects
FG0027 subjects
FG0032 subjects
COMPLETED
FG0006 subjects
FG0012 subjects
FG0025 subjects
FG0032 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Randomized participants in each cohort were randomized 6:2 to Brentuximab Vedotin or placebo, respectively.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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.
BG001
Cohort 1 Placebo
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
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.
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.
Posted
Number
95% Confidence Interval
Proportion of participants
Baseline through end of study (48 weeks for participants who complete the study)
ID
Title
Adverse Events Module
Frequency Threshold
5
Time Frame
Adverse events were collected from the time a participant signed informed consent until study completion (week 48) or until 30 days after a participant withdrew early from the study.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
0.6 mg/kg 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.
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
17.1
Systematic Assessment
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
17.1
Systematic Assessment
More Info Module
Limitations and Caveats
Due to slow enrollment the study was stopped before fully enrolling cohort 2 (1.2 mg/kg) and before starting cohort 3 (1.8 mg/kg).
This is the third/last of three ascending dose cohorts. Participants in this cohort will receive 1.8 mg/kg brentuximab vedotin (to a maximum dose 60 mg) every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Brentuximab vedotin will be administered as an intravenous infusion over 30 minutes.
Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Biological: Brentuximab Vedotin
Cohort 3: placebo
Placebo Comparator
1.8 mg/kg placebo (to a maximum dose 60 mg). Participants in this cohort will receive 1.8 mg/kg placebo every 3 weeks from week 0 (initial dose) to week 21, a total of 8 treatments. Placebo will be administered as an intravenous infusion over 30 minutes.
Cohort 3 Randomization schedule: N=6 assigned to brentuximab vedotin: N=2 assigned to placebo.
Biological: Placebo
Cohort 1: 0.6 mg/kg brentuximab vedotin
Cohort 2: 1.2 mg/kg brentuximab vedotin
Cohort 3: 1.8 mg/kg brentuximab vedotin
Adcetris®
Placebo
Biological
Placebo control for blinding (masking), 0.95% normal saline.
Cohort 1: placebo
Cohort 2: placebo
Cohort 3: placebo
Placebo for brentuximab vedotin
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
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12
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.
Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.
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.
Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.
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.
Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.
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.
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
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12
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.
Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.
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.
Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.
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.
Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 48.
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.
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48.
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.
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
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12
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.
Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 24.
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.
Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 36.
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.
Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 48.
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.
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48.
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.
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
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12
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.
Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 24.
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.
Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 36.
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.
Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 48.
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.
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
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.
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.
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
Washington D.C.
District of Columbia
20057
United States
University of Michigan Health System: Department of Internal Medicine, Division of Rheumatology
Ann Arbor
Michigan
48109
United States
Hospital for Special Surgery, New York: Division of Rheumatology
New York
New York
10021
United States
Duke University Medical Center: Division of Rheumatology and Immunology
Durham
North Carolina
27710
United States
University of Pittsburgh Medical Center: Division of Rheumatology and Clinical
Pittsburgh
Pennsylvania
15217
United States
Medical University of South Carolina: Division of Rheumatology & Immunology
Charleston
South Carolina
29425
United States
University of Texas Houston Medical School: Division of Rheumatology and Clinical Immunogenetics
Houston
Texas
77030
United States
0 subjects
COVID-19 related
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
BG002
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.
BG003
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.
BG004
Total
Total of all reporting groups
6
BG0012
BG0027
BG0032
BG00417
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG0030
BG0040
Between 18 and 65 years
BG0005
BG0012
BG0027
BG0032
BG004
>=65 years
BG0001
BG0010
BG0020
BG0030
BG004
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00048.0± 16.52
BG00142.0± 22.63
BG00253.1± 7.97
BG00347.0± 7.07
BG00449.3± 12.59
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0011
BG0026
BG0032
BG00412
Male
BG0003
BG0011
BG0021
BG0030
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0011
BG0020
BG0031
BG0044
Not Hispanic or Latino
BG0004
BG0011
BG0027
BG0031
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0021
BG0030
BG0041
Asian
BG0001
BG0010
BG0020
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0001
BG0010
BG0021
BG0030
BG004
White
BG0004
BG0012
BG0025
BG0032
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0006
BG0012
BG0027
BG0032
BG00417
Body Mass Index (BMI)
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00026.73± 5.397
BG00132.49± 0.939
BG00226.37± 4.831
BG00322.21± 0.784
BG00426.73± 4.971
Disease Duration from Onset of Raynaud's Symptoms
Raynaud's phenomenon are symptoms including localized numbness, discoloration, and sensations of cold. It is indicative of other diseases including the diffuse cutaneous form of systemic sclerosis.
Mean
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00027.3± 24.05
BG00145.4± 9.80
BG00219.2± 7.44
BG00324.7± 17.12
BG00426.6± 17.35
Disease Duration from Onset of Non-Raynaud's Symptoms
Mean
Standard Deviation
Months
Title
Denominators
Categories
Title
Measurements
BG00017.5± 6.70
BG00146.4± 8.43
BG00219.0± 8.65
BG00326.2± 14.98
BG00422.5± 12.18
Baseline Modified Rodnan Skin Score (mRSS) Total Score
Modified Rodnan Skin Score measures the thickness of skin. The score ranges from 0 - 3, with 0 = normal and 3 = severe. The mRSS test was performed at screening, Day 0, & at weeks 12, 24, and 48 after randomization. The baseline mRSS total score is the summation of each mRSS at these sites: right fingers, left fingers, right dorsum of hand, left dorsum of hand, right forearm, left forearm, right upper arm, left upper arm, right thigh, left thigh, right lower leg, left lower leg, right dorsum of foot, left dorsum of foot, face, anterior chest, & abdomen. The total score ranges from 0 to 51.
Mean
Standard Deviation
Score
Title
Denominators
Categories
Title
Measurements
BG00031.3± 6.53
BG00124.5± 2.12
BG00229.0± 11.58
BG00319.5± 2.12
BG00428.2± 8.90
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0006
OG0012
OG0027
OG0032
OG00413
OG0054
Title
Denominators
Categories
Title
Measurements
OG0000.333(0.043 to 0.777)
OG0010.000(0.000 to 0.842)
OG0020.571(0.184 to 0.901)
OG0030.000(0.000 to 0.842)
OG0040.462(0.192 to 0.749)
OG0050.000(0.000 to 0.602)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 48
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 48
Fisher Exact
0.444
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
Primary
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through end of study (48 weeks)
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.400(0.053 to 0.853)
OG0010.000(0.000 to 0.842)
OG0020.667(0.094 to 0.992)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 48
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 48
Secondary
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 12, 24, and 36.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
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
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0006
OG0012
OG0027
OG003
Title
Denominators
Categories
Week 12
Title
Measurements
OG0000.167(0.004 to 0.641)
OG0010.000(0.000 to 0.842)
OG0020.143(0.004 to 0.579)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 12
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 12
Secondary
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Week12
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.
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
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through Week 12 study visit or 12 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.200(0.005 to 0.716)
OG0010.000(0.000 to 0.842)
OG0020.200(0.005 to 0.716)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 12
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 12
Secondary
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 24.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through Week 24 study visit or 24 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.400(0.053 to 0.853)
OG0010.000(0.000 to 0.842)
OG0020.500(0.068 to 0.932)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 24
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 24
Secondary
Proportion of Participants That Experience at Least One Grade 3 or Higher Adverse Event at or Before Weeks 36.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through Week 36 study visit or 36 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.400(0.053 to 0.853)
OG0010.000(0.000 to 0.842)
OG0020.667(0.094 to 0.992)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 36
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 36
Secondary
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12, 24, 36, and 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
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
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0006
OG0012
OG0027
OG003
Title
Denominators
Categories
Week 12
Title
Measurements
OG0000.833(0.359 to 0.996)
OG0010.500(0.013 to 0.987)
OG0020.429(0.099 to 0.816)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 12
Fisher Exact
0.464
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 12
Secondary
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 12
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.800(0.284 to 0.995)
OG0010.500(0.013 to 0.987)
OG0020.600(0.147 to 0.947)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 12
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 12
Secondary
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 24.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.000(0.478 to 1.000)
OG0010.500(0.013 to 0.987)
OG0021.000(0.398 to 1.000)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 24
Fisher Exact
0.286
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 24
Secondary
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 36.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.000(0.478 to 1.000)
OG0011.000(0.158 to 1.000)
OG0021.000(0.292 to 1.000)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
Treatment start to Week 36
Fisher Exact
0.100
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
Secondary
Proportion of Participants That Experience at Least One Grade 2 or Higher Adverse Event at or Before Weeks 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0001.000(0.478 to 1.000)
OG0011.000(0.158 to 1.000)
OG0021.000(0.292 to 1.000)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG002
OG003
Treatment start to Week 48
Fisher Exact
0.100
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
Secondary
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12, 24, 36, and 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
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
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0006
OG0012
OG0027
OG003
Title
Denominators
Categories
Week 12
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG003
Secondary
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 12
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.522)
OG003
Secondary
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 24.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.602)
OG003
Secondary
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 36.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.708)
OG003
Secondary
Proportion of Participants With Grade 2 or Higher Peripheral Neuropathy at or Before Weeks 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.708)
OG003
Secondary
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12, 24, 36, and 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
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
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0006
OG0012
OG0027
OG003
Title
Denominators
Categories
Week 12
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG003
Secondary
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 12
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 12 study visit or 12 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0025
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.522)
OG003
Secondary
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 24.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 24 study visit or 24 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0024
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.602)
OG003
Secondary
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 36.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 36 study visit or 36 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.708)
OG003
Secondary
Proportion of Participants With Grade 3 or Higher Neutropenia at or Before Weeks 48.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.0(0.000 to 0.522)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.708)
OG003
Secondary
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.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0006
OG0012
OG0027
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.167(0.004 to 0.641)
OG0010.000(0.000 to 0.842)
OG0020.143(0.004 to 0.579)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Treatment start to Week 48
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 48
Secondary
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.
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.
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.
Posted
Number
95% Confidence Interval
proportion of participants
Baseline through the Week 48 study visit or 48 weeks on study if the visit was missed.
ID
Title
Description
OG000
0.6 mg/kg 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.
OG001
0.6 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG002
1.2 mg/kg 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.
OG003
1.2 mg/kg Placebo
Participants receive intravenous administration of 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
OG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
OG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
Units
Counts
Participants
OG0005
OG0012
OG0023
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.200(0.005 to 0.716)
OG0010.000(0.000 to 0.842)
OG0020.333(0.008 to 0.906)
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 48
0
6
1
6
6
6
EG001
0.6 mg/kg Placebo
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.
0
2
0
2
2
2
EG002
1.2 mg/kg 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.
0
7
2
7
6
7
EG003
1.2 mg/kg Placebo
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.
0
2
0
2
0
2
EG004
Brentuximab Vedotin in Pooled Participants
Participants receive intravenous administration of Brentuximab Vedotin every 3 weeks for 21 weeks, for a total of 8 doses.
0
13
3
13
12
13
EG005
Placebo in Pooled Participants
Participants receive intravenous administration of a 0.9% Normal Saline solution every 3 weeks for 21 weeks, for a total of 8 doses.
0
4
0
4
2
4
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
COVID-19
Infections and infestations
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Cytomegalovirus infection reactivation
Infections and infestations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected4 at risk
Eosinophilia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Lymphopenia
Blood and lymphatic system disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected4 at risk
Ventricular arrhythmia
Cardiac disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected4 at risk
Diarrhoea
Gastrointestinal disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Mouth ulceration
Gastrointestinal disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Fatigue
General disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Bronchitis
Infections and infestations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
COVID-19
Infections and infestations
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Helicobacter infection
Infections and infestations
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Impetigo
Infections and infestations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Oesophageal candidiasis
Infections and infestations
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Pneumonia
Infections and infestations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Sinusitis
Infections and infestations
17.1
Systematic Assessment
EG0006 events2 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0046 events2 affected13 at risk
EG0050 events0 affected4 at risk
Tooth abscess
Infections and infestations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Upper respiratory tract infection
Infections and infestations
17.1
Systematic Assessment
EG0003 events2 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0043 events2 affected13 at risk
EG0050 events0 affected4 at risk
Forced expiratory volume decreased
Investigations
17.1
Systematic Assessment
EG0002 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0043 events2 affected13 at risk
EG0050 events0 affected4 at risk
Forced vital capacity decreased
Investigations
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Lung diffusion test decreased
Investigations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Lymphocyte count decreased
Investigations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected4 at risk
Weight increased
Investigations
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Abnormal loss of weight
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Hypoalbuminaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Hypokalaemia
Metabolism and nutrition disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected4 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Arthritis
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Osteoporosis
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected4 at risk
Synovitis
Musculoskeletal and connective tissue disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Depression
Psychiatric disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Azotaemia
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0021 events1 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Chronic kidney disease
Renal and urinary disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0012 events1 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected13 at risk
EG0052 events1 affected4 at risk
Gynaecomastia
Reproductive system and breast disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Cough
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Productive cough
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Sleep apnoea syndrome
Respiratory, thoracic and mediastinal disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0011 events1 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected13 at risk
EG0051 events1 affected4 at risk
Eczema
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0002 events2 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected4 at risk
Psoriasis
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Rash
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0001 events1 affected6 at risk
EG0010 events0 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0041 events1 affected13 at risk
EG0050 events0 affected4 at risk
Skin ulcer
Skin and subcutaneous tissue disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0015 events1 affected2 at risk
EG0020 events0 affected7 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected13 at risk
EG0055 events1 affected4 at risk
Hypertension
Vascular disorders
17.1
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected2 at risk
EG0022 events2 affected7 at risk
EG0030 events0 affected2 at risk
EG0042 events2 affected13 at risk
EG0050 events0 affected4 at risk
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D000911
Antibodies, Monoclonal
D000906
Antibodies
D007136
Immunoglobulins
D007162
Immunoproteins
D001798
Blood Proteins
D011506
Proteins
D012712
Serum Globulins
D005916
Globulins
16
1
5
13
0
1
0
2
13
0
0
2
OG0048
OG0054
0.000
(0.000 to 0.842)
OG0040.500(0.157 to 0.843)
OG0050.000(0.000 to 0.602)
Fisher Exact
0.400
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG00413
OG0054
0.000
(0.000 to 0.842)
OG0040.154(0.019 to 0.454)
OG0050.000(0.000 to 0.602)
Week 24
Title
Measurements
OG0000.333(0.043 to 0.777)
OG0010.000(0.000 to 0.842)
OG0020.286(0.037 to 0.710)
OG0030.000(0.000 to 0.842)
OG0040.308(0.091 to 0.614)
OG0050.000(0.000 to 0.602)
Week 36
Title
Measurements
OG0000.333(0.043 to 0.777)
OG0010.000(0.000 to 0.842)
OG0020.429(0.099 to 0.816)
OG0030.000(0.000 to 0.842)
OG0040.385(0.139 to 0.684)
OG0050.000(0.000 to 0.602)
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG000
OG001
Treatment start to Week 24
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 24
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG000
OG001
Treatment start to Week 36
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 36
Fisher Exact
0.500
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG00410
OG0054
0.000
(0.000 to 0.842)
OG0040.200(0.025 to 0.556)
OG0050.000(0.000 to 0.602)
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG0049
OG0054
0.000
(0.000 to 0.842)
OG0040.444(0.137 to 0.788)
OG0050.000(0.000 to 0.602)
Fisher Exact
0.467
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG0048
OG0054
0.000
(0.000 to 0.842)
OG0040.500(0.157 to 0.843)
OG0050.00(0.000 to 0.602)
Fisher Exact
0.400
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG00413
OG0054
0.000
(0.000 to 0.842)
OG0040.615(0.316 to 0.861)
OG0050.250(0.006 to 0.806)
Week 24
Title
Measurements
OG0001.000(0.541 to 1.000)
OG0010.500(0.013 to 0.987)
OG0020.714(0.290 to 0.963)
OG0030.000(0.000 to 0.842)
OG0040.846(0.546 to 0.981)
OG0050.250(0.006 to 0.806)
Week 36
Title
Measurements
OG0001.000(0.541 to 1.000)
OG0011.000(0.158 to 1.000)
OG0020.857(0.421 to 0.996)
OG0030.000(0.000 to 0.842)
OG0040.923(0.640 to 0.998)
OG0050.500(0.068 to 0.932)
Week 48
Title
Measurements
OG0001.000(0.541 to 1.000)
OG0011.000(0.158 to 1.000)
OG0020.857(0.421 to 0.996)
OG0030.000(0.000 to 0.842)
OG0040.923(0.640 to 0.998)
OG0050.500(0.068 to 0.932)
Fisher Exact
0.500
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG000
OG001
Treatment start to Week 24
Fisher Exact
0.250
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 24
Fisher Exact
0.167
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 36
Fisher Exact
0.083
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
OG002
OG003
Treatment start to Week 48
Fisher Exact
0.083
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG00410
OG0054
0.000
(0.000 to 0.842)
OG0040.700(0.348 to 0.933)
OG0050.250(0.006 to 0.806)
Fisher Exact
0.429
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG0049
OG0054
0.000
(0.000 to 0.842)
OG0041.000(0.664 to 1.000)
OG0050.250(0.006 to 0.806)
Fisher Exact
0.067
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG0048
OG0054
0.000
(0.000 to 0.842)
OG0041.000(0.631 to 1.000)
OG0050.500(0.068 to 0.932)
2
OG0048
OG0054
0.000
(0.000 to 0.842)
OG0041.000(0.631 to 1.000)
OG0050.500(0.068 to 0.932)
2
OG00413
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
Week 24
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG0030.0(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
Week 36
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG0030.0(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
Week 48
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG0030.0(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
2
OG00410
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.308)
OG0050.0(0.000 to 0.602)
2
OG0049
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.336)
OG0050.0(0.000 to 0.602)
2
OG0048
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.369)
OG0050.0(0.000 to 0.602)
2
OG0048
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.369)
OG0050.0(0.000 to 0.602)
2
OG00413
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
Week 24
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG0030.0(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
Week 36
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG0030.0(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
Week 48
Title
Measurements
OG0000.0(0.000 to 0.459)
OG0010.0(0.000 to 0.842)
OG0020.0(0.000 to 0.410)
OG0030.0(0.000 to 0.842)
OG0040.0(0.000 to 0.247)
OG0050.0(0.000 to 0.602)
2
OG00410
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.308)
OG0050.0(0.000 to 0.602)
2
OG0049
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.336)
OG0050.0(0.000 to 0.602)
2
OG0048
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.369)
OG0050.0(0.000 to 0.602)
2
OG0048
OG0054
0.0
(0.000 to 0.842)
OG0040.0(0.000 to 0.369)
OG0050.0(0.000 to 0.602)
2
OG00413
OG0054
0.000
(0.000 to 0.842)
OG0040.154(0.019 to 0.454)
OG0050.000(0.000 to 0.602)
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.
Superiority
2
OG0048
OG0054
0.000
(0.000 to 0.842)
OG0040.250(0.032 to 0.651)
OG0050.000(0.000 to 0.602)
Fisher Exact
1.000
P-value is from comparing the number of participants with the AEs of interest between the two treatment groups using Fisher's exact test.