A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL)... | NCT01716806 | Trialant
NCT01716806
Sponsor
Seagen Inc.
Status
Completed
Last Update Posted
Jun 11, 2024Actual
Enrollment
131Actual
Phase
Phase 2
Conditions
Hodgkin Disease
Peripheral T Cell Lymphoma
Interventions
brentuximab vedotin
bendamustine
dacarbazine
nivolumab
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01716806
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SGN35-015
Secondary IDs
Not provided
Brief Title
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Official Title
A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy
Acronym
Not provided
Organization
Seagen Inc.INDUSTRY
Status Module
Record Verification Date
May 2024
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
Oct 31, 2012Actual
Primary Completion Date
Apr 7, 2023Actual
Completion Date
Sep 12, 2023Actual
First Submitted Date
Oct 16, 2012
First Submission Date that Met QC Criteria
Oct 25, 2012
First Posted Date
Oct 30, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 4, 2024
Results First Submitted that Met QC Criteria
May 14, 2024
Results First Posted Date
Jun 11, 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
May 14, 2024
Last Update Posted Date
Jun 11, 2024Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Seagen Inc.INDUSTRY
Collaborators
Name
Class
Bristol-Myers Squibb
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Detailed Description
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
Conditions Module
Conditions
Hodgkin Disease
Peripheral T Cell Lymphoma
Keywords
Antibody-Drug Conjugate
Antibodies, Monoclonal
Hematologic Diseases
Hodgkin Disease
Antigens, CD30
Lymphoma
monomethylauristatin E
Drug Therapy
CD30-expression
PTCL
Seattle Genetics
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
131Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Brentuximab Vedotin in HL Patients
Experimental
Drug: brentuximab vedotin
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
Experimental
Drug: brentuximab vedotin
Drug: dacarbazine
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
Experimental
Drug: brentuximab vedotin
Drug: bendamustine
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
Experimental
Drug: brentuximab vedotin
Drug: nivolumab
Part E: Brentuximab Vedotin in HL Patients
Experimental
Drug: brentuximab vedotin
Part F: Brentuximab Vedotin in PTCL Patients
Experimental
Drug: brentuximab vedotin
Interventions
Name
Type
Description
Arm Group Labels
Other Names
brentuximab vedotin
Drug
1.8 mg/kg every 3 weeks by IV infusion
Part A: Brentuximab Vedotin in HL Patients
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Up to 81 months
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
Up to 60 months
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
Up to 31 months
Secondary Outcomes
Measure
Description
Time Frame
Number of Participants With Adverse Events
A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Parts A, B, C, and D: 60 years of age or older
Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
Treatment-naive patients with CD30-expressing PTCL (Part F)
Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
A CIRS score of 10 or greater
Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
Measurable disease of at least 1.5 cm as documented by radiographic technique
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
Exclusion Criteria:
Symptomatic neurologic disease compromising IADLs or requiring medication
History of progressive multifocal leukoencephalopathy
Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
Concurrent use of other investigational agents
Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
Part D only:
Received any prior immune-oncology therapy
History of known or suspected autoimmune disease
Prior allogeneic stem cell transplant
History of cerebral vascular event within 6 months of first dose of study drug
Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
Known history of pancreatitis
Parts D, E, and F only:
Known cerebral/meningeal disease related to the underlying malignancy
Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Robert Sims, MD
Seagen Inc.
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Alabama at Birmingham
Birmingham
Alabama
35249
United States
University of South Alabama - Mitchell Cancer Institute
Friedberg JW, Bordoni R, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak CA. Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy for older patients ineligible for chemotherapy. Blood. 2024 Feb 29;143(9):786-795. doi: 10.1182/blood.2022019536.
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
FG001
Part B
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
May 5, 2020
Apr 4, 2024
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
Part E: Brentuximab Vedotin in HL Patients
Part F: Brentuximab Vedotin in PTCL Patients
Adcetris; SGN-35
bendamustine
Drug
70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
Part C: Brentuximab Vedotin + Bendamustine in HL Patients
dacarbazine
Drug
375 mg/m^2 every 3 weeks by IV infusion
Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
nivolumab
Drug
3 mg/kg every 3 weeks by IV infusion
Part D: Brentuximab Vedotin + Nivolumab in HL Patients
Up to 122 months
Number of Participants With Laboratory Abnormalities
Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Up to 30 months
Complete Response Rate
Complete response rate is defined as the percentage of patients with CR
Up to 81 months
Duration of Complete Response
Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Up to 81 months
Duration of Objective Response
Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Up to 81 months
Progression-free Survival
Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Up to 83 months
Disease Control Rate
Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.
Up to 81 months
ORR According to Lugano Criteria Per BICR (Parts E and F)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.
Up to 31 months
B Symptom Resolution Rate
B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Up to 42 weeks
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Up to 30 months
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
Up to 30 months
Overall Survival (Parts E and F Only)
Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.
Up to 44 months
Mobile
Alabama
36604
United States
Alaska Urological Institute
Anchorage
Alaska
99503
United States
Banner MD Anderson Cancer Center
Gilbert
Arizona
85234
United States
Arizona Oncology Associates, PC - HOPE
Tucson
Arizona
85710
United States
Arizona Cancer Center / University of Arizona
Tucson
Arizona
85724-5024
United States
Highlands Oncology Group
Springdale
Arkansas
J. Thaddeus Beck
United States
Providence St Joseph Medical Center
Burbank
California
91505
United States
City of Hope National Medical Center
Duarte
California
91010
United States
Wilshire Oncology Medical Group Inc.
Pomona
California
91767
United States
Rocky Mountain Cancer Centers - Aurora
Aurora
Colorado
80012
United States
Florida Cancer Affiliates
Trinity
Florida
34655
United States
IACT Health
Columbus
Georgia
31904
United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute
Sandy Springs
Georgia
30341
United States
Rush University Medical Center
Chicago
Illinois
60612
United States
Illinois Cancer Specialists / Advocate Lutheran General Hospital
Niles
Illinois
60714
United States
American Oncology Networks LLC
Bethesda
Maryland
20817
United States
Karmanos Cancer Institute / Wayne State University
Detroit
Michigan
48201
United States
Minnesota Oncology Hematology P.A.
Minneapolis
Minnesota
55404
United States
Nebraska Cancer Specialists
Omaha
Nebraska
68130
United States
Comprehensive Cancer Centers of Nevada
Las Vegas
Nevada
89169
United States
Morristown Medical Center/ Carol G. Simon Cancer Center
Morristown
New Jersey
07960
United States
Rutgers Cancer Institute of New Jersey
New Brunswick
New Jersey
08903
United States
New York Oncology Hematology, P.C.
Albany
New York
12208
United States
Columbia University Medical Center
New York
New York
10032
United States
James P. Wilmot Cancer Center / University of Rochester Medical Center
Rochester
New York
14642
United States
Oncology Hematology Care
Cincinnati
Ohio
45242
United States
James Cancer Hospital / Ohio State University
Columbus
Ohio
43210
United States
Willamette Valley Cancer Institute and Research Center
Eugene
Oregon
97401
United States
Northwest Cancer Specialists, P.C.
Tigard
Oregon
97223
United States
Prisma Health
Greenville
South Carolina
29615
United States
Arlington Cancer Center
Arlington
Texas
76012
United States
Texas Oncology - Bedford
Bedford
Texas
76022
United States
Texas Oncology - Presbyterian Cancer Center Dallas
Dallas
Texas
75231
United States
Texas Oncology - Denton South
Denton
Texas
Kurkul
United States
Texas Oncology - Fort Worth 12th Avenue
Fort Worth
Texas
76104
United States
Houston Methodist Cancer Center
Houston
Texas
77030
United States
MD Anderson Cancer Center / University of Texas
Houston
Texas
77030
United States
Texas Oncology - Longview
Longview
Texas
75601
United States
Texas Oncology - McAllen
McAllen
Texas
78503
United States
Texas Oncology - Seton Williamson
Round Rock
Texas
78665
United States
Virginia Cancer Specialists, PC
Fairfax
Virginia
22031
United States
Virginia Commonwealth University Medical Center
Richmond
Virginia
23298
United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
Salem
Virginia
24153
United States
Shenandoah Oncology P.C.
Winchester
Virginia
22601
United States
Benaroya Research Institute/Virginia Mason Medical Center
Seattle
Washington
98101
United States
Swedish Cancer Institute
Seattle
Washington
98104
United States
Wenatchee Valley Medical Center
Wenatchee
Washington
98821
United States
Carbone Cancer Center / University of Wisconsin
Madison
Wisconsin
53792
United States
University of Alberta / Cross Cancer Institute
Edmonton
Alberta
T6G 1Z2
Canada
London Health Sciences Centre - Victoria Hospital
London
Ontario
N6A 5W9
Canada
CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
Montreal
Quebec
H1T 2M4
Canada
Jewish General Hospital
Montreal
Quebec
H3T 1E2
Canada
Royal Victoria Hospital, McGill University Health Centre
Montreal
Quebec
H4A 3J1
Canada
Derived
Friedberg JW, Forero-Torres A, Bordoni RE, Cline VJM, Patel Donnelly D, Flynn PJ, Olsen G, Chen R, Fong A, Wang Y, Yasenchak CA. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged >/=60 years with HL. Blood. 2017 Dec 28;130(26):2829-2837. doi: 10.1182/blood-2017-06-787200. Epub 2017 Oct 16.
Forero-Torres A, Holkova B, Goldschmidt J, Chen R, Olsen G, Boccia RV, Bordoni RE, Friedberg JW, Sharman JP, Palanca-Wessels MC, Wang Y, Yasenchak CA. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015 Dec 24;126(26):2798-804. doi: 10.1182/blood-2015-06-644336. Epub 2015 Sep 16.
Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. doi: 10.3109/10428194.2013.876496. Epub 2014 Feb 24.
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
FG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
FG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
FG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
FG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
FG00028 subjects
FG00122 subjects
FG00222 subjects
FG00321 subjects
FG00431 subjects
FG0057 subjects
Received at Least One Dose of Study Drug
FG00027 subjects
FG00122 subjects
FG00220 subjects
FG00321 subjects
FG00430 subjects
FG0057 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00028 subjects
FG00122 subjects
FG00222 subjects
FG00321 subjects
FG00431 subjects
FG0057 subjects
Type
Comment
Reasons
Patient withdrawal of consent
FG0004 subjects
FG0012 subjects
FG0024 subjects
FG0033 subjects
FG0042 subjects
FG0050 subjects
Lost to Follow-up
FG0003 subjects
FG0013 subjects
FG0020 subjects
FG0032 subjects
FG004
Death
FG00013 subjects
FG0019 subjects
FG00212 subjects
FG0034 subjects
FG004
Received treatment past data cutoff of up to 16 doses of BV. AEs collected until end of study.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
PI decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Change in performance status
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor terminated enrollment into Part C
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Sponsor direction
FG0007 subjects
FG0018 subjects
FG0025 subjects
FG00312 subjects
FG004
The Full Analysis Set includes all participants who received any amount of brentuximab vedotin.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
BG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
BG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
BG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
BG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
BG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00122
BG00220
BG00321
BG00430
BG0057
BG006127
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
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Eastern Cooperative Oncology Group (ECOG) Performance Status
0=Normal activity, 1=Symptoms but ambulatory, 2=In bed <50% of the time, 3=In bed >50% of the time, 4=100% bedridden, 5=Dead
Count of Participants
Participants
Title
Denominators
Categories
Grade 0
Title
Measurements
BG0009
BG0016
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
Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
All subjects who received at least one dose of study drug
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 81 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Units
Counts
Participants
OG00027
OG00122
OG00220
Title
Denominators
Categories
Title
Measurements
OG00093(75.7 to 99.1)
OG00195(77.2 to 99.9)
OG00285(62.1 to 96.8)
Primary
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
All subjects who received at least one dose of study drug
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 60 months
ID
Title
Description
OG000
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG000
Primary
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
All subjects who received at least one dose of study drug
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 31 months
ID
Title
Description
OG000
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG001
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
Secondary
Number of Participants With Adverse Events
A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
All subjects who received at least one dose of study drug
Posted
Count of Participants
Participants
Up to 122 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Secondary
Number of Participants With Laboratory Abnormalities
Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
All subjects who received at least one dose of study drug
Posted
Count of Participants
Participants
Up to 30 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Secondary
Complete Response Rate
Complete response rate is defined as the percentage of patients with CR
All subjects who received at least one dose of study drug
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 81 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
OG003
Secondary
Duration of Complete Response
Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
All subjects with CR
Posted
Median
95% Confidence Interval
Months
Up to 81 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Secondary
Duration of Objective Response
Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
All subjects with CR/PR
Posted
Median
95% Confidence Interval
Months
Up to 81 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Secondary
Progression-free Survival
Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
All subjects who received at least one dose of study drug
Posted
Median
95% Confidence Interval
Months
Up to 83 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Secondary
Disease Control Rate
Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.
All subjects who received at least one dose of study drug
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 81 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Secondary
ORR According to Lugano Criteria Per BICR (Parts E and F)
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.
All subjects who received at least one dose of study drug
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 31 months
ID
Title
Description
OG000
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG001
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
Secondary
B Symptom Resolution Rate
B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Subjects with any B symptom at baseline.
Posted
Number
95% Confidence Interval
Percentage of participants
Up to 42 weeks
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
Secondary
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Subjects with a baseline and at least one post-baseline sample.
Posted
Count of Participants
Participants
Up to 30 months
ID
Title
Description
OG000
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
OG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
OG003
Part D
Secondary
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
Subject with baseline negative anti-drug antibody (ADA)
Posted
Count of Participants
Participants
Up to 30 months
ID
Title
Description
OG000
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00017
Secondary
Overall Survival (Parts E and F Only)
Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.
All subjects who received at least one dose of study drug
Posted
Median
95% Confidence Interval
Months
Up to 44 months
ID
Title
Description
OG000
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG001
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG000
Time Frame
Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
Description
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
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
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
13
27
5
27
27
27
EG001
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
9
22
4
22
22
22
EG002
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
12
20
13
20
20
20
EG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
4
21
4
21
21
21
EG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
10
30
14
30
27
30
EG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
5
7
4
7
7
7
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected21 at risk
EG0041 events1 affected30 at risk
EG0050 events0 affected7 at risk
Disseminated intravascular coagulation
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected20 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Atrial flutter
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Inappropriate antidiuretic hormone secretion
Endocrine disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Erosive oesophagitis
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Haematochezia
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Lower gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Asthenia
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected20 at risk
EG003
Gait disturbance
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
General physical health deterioration
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Pyrexia
General disorders
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Sudden death
General disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
COVID-19
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
COVID-19 pneumonia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Cellulitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Pneumonia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0022 events2 affected20 at risk
EG003
Sepsis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Septic shock
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Staphylococcal sepsis
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0011 events1 affected22 at risk
EG0022 events2 affected20 at risk
EG003
Anaesthetic complication
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0001 events1 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Fibula fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Failure to thrive
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Hypervolaemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0021 events1 affected20 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Tumour lysis syndrome
Metabolism and nutrition disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v26.0
Systematic Assessment
EG0000 events0 affected27 at risk
EG0010 events0 affected22 at risk
EG0020 events0 affected20 at risk
EG003
Hodgkin's disease
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00027
OG00122
OG00220
OG00321
OG00430
OG0057
Title
Denominators
Categories
Any TEAE
Title
Measurements
OG00027
OG00122
OG00220
OG00321
OG00430
OG0057
Treatment-related TEAE
Title
Measurements
OG00025
OG00122
OG00219
OG003
Any grade 3 or higher TEAE
Title
Measurements
OG00017
OG00110
OG00218
OG003
Treatment-related grade 3 or higher TEAE
Title
Measurements
OG00013
OG0019
OG00216
OG003
Any treatment-emergent (TE) serious adverse event (SAE)
Title
Measurements
OG0005
OG0014
OG00213
OG003
Treatment-related TE SAE
Title
Measurements
OG0003
OG0013
OG0029
OG003
TEAE leading to treatment discontinuation
Title
Measurements
OG00011
OG00111
OG00212
OG003
Treatment-related TEAE leading to treatment discontinuation
Title
Measurements
OG00011
OG0019
OG0028
OG003
TEAE leading to death
Title
Measurements
OG0000
OG0010
OG0023
OG003
Treatment-related TEAE leading to death
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00027
OG00122
OG00220
OG00321
OG00430
OG0057
Title
Denominators
Categories
Title
Measurements
OG00070(49.8 to 86.2)
OG00164(40.7 to 82.8)
OG00275(50.9 to 91.3)
OG00367(43.0 to 85.4)
OG00430(14.7 to 49.4)
OG00543(9.9 to 81.6)
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00019
OG00114
OG00215
OG00314
OG00410
OG0052
Title
Denominators
Categories
Title
Measurements
OG0007.4(5.1 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG001NA(14.7 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG002NA(2.8 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG003NA(6.6 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG004NA(7.4 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG005NA(NA to NA)Follow-up duration too short relative to event accumulation to estimate median, upper limit, and lower limit.
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00025
OG00121
OG00217
OG00318
OG00418
OG0053
Title
Denominators
Categories
Title
Measurements
OG0007.6(5.1 to 67.7)
OG00146.0(8.5 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG002NA(3.6 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG003NA(12.7 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG0047.4(7.4 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG005NA(11.3 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00027
OG00122
OG00220
OG00321
OG00430
OG0057
Title
Denominators
Categories
Title
Measurements
OG0008.6(6.3 to 40.1)
OG00147.2(10.8 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG00232.5(4.0 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG003NA(9.4 to NA)Follow-up duration too short relative to event accumulation to estimate median and upper limit.
OG0048.7(5.1 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG00510.5(0.5 to NA)Follow-up duration too short relative to event accumulation to estimate upper limit.
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG00027
OG00122
OG00220
OG00321
OG00430
OG0057
Title
Denominators
Categories
Title
Measurements
OG000100(87.2 to 100.0)
OG00195(77.2 to 99.9)
OG00285(62.1 to 96.8)
OG00390(69.6 to 98.8)
OG00477(57.7 to 90.1)
OG00557(18.4 to 90.1)
OG00030
OG0017
Title
Denominators
Categories
Title
Measurements
OG00067(47.2 to 82.7)
OG00143(9.9 to 81.6)
OG003
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
Units
Counts
Participants
OG0005
OG0016
OG0027
OG0036
OG0049
OG0052
Title
Denominators
Categories
Title
Measurements
OG000100(47.8 to 100.0)
OG001100(54.1 to 100.0)
OG00286(42.1 to 99.6)
OG00367(22.3 to 95.7)
OG0040(NA to NA)No participants achieved B symptom resolution
OG0050(NA to NA)No participants achieved B symptom resolution
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG004
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
OG005
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.