Study of Nivolumab in Patients With Classical Hodgkin's L... | NCT02181738 | Trialant
NCT02181738
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Nov 28, 2023Actual
Enrollment
294Actual
Phase
Phase 2
Conditions
Hodgkin Disease
Interventions
Nivolumab
Doxorubicin
Vinblastine
Dacarbazine
Countries
United States
Austria
Belgium
Canada
Czechia
Germany
Italy
Netherlands
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02181738
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CA209-205
Secondary IDs
ID
Type
Description
Link
2014-001509-42
EudraCT Number
Brief Title
Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational)
Official Title
Non-Comparative, Multi-Cohort, Single Arm, Open-Label, Phase 2 Study of Nivolumab (BMS-936558) in Classical Hodgkin Lymphoma (cHL) Subjects
Acronym
CheckMate 205
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Nov 2023
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
Aug 12, 2014Actual
Primary Completion Date
Aug 31, 2017Actual
Completion Date
Dec 27, 2022Actual
First Submitted Date
Jul 1, 2014
First Submission Date that Met QC Criteria
Jul 3, 2014
First Posted Date
Jul 4, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 31, 2018
Results First Submitted that Met QC Criteria
Nov 26, 2018
Results First Posted Date
Dec 11, 2018Actual
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
Nov 27, 2023
Last Update Posted Date
Nov 28, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
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
The purpose of this study is to evaluate the efficacy and safety of Nivolumab in previously treated (cohorts, A, B & C) or newly diagnosed (cohort D) classical Hodgkin Lymphoma participants.
Detailed Description
Not provided
Conditions Module
Conditions
Hodgkin Disease
Keywords
Not provided
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
294Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Nivolumab (Cohort A, B, C and D)
Experimental
Cohort (A, B, C): Nivolumab: Specified dose on specified days
Cohort (D): Nivolumab: Specified dose on specified days + Doxorubicin: Specified dose on specified days + Vinblastine: Specified dose on specified days + Dacarbazine: Specified dose on specified days
Drug: Nivolumab
Drug: Doxorubicin
Drug: Vinblastine
Drug: Dacarbazine
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Nivolumab
Drug
Specified dose on specified days
Nivolumab (Cohort A, B, C and D)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
Secondary Outcomes
Measure
Description
Time Frame
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Computed using Kaplan-Meier method.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Must have received prior high-dose conditioning chemotherapy followed by autologous stem cell transplant (ASCT) as a part of salvage therapy for cHL (cohort A, B & C - enrollment closed)
Participants may be Brentuximab vedotin- naïve, or may have had prior Brentuximab vedotin treatment (cohort A, B & C - enrollment closed)
Newly diagnosed and previously untreated classical Hodgkin Lymphoma (cohort D)
Exclusion Criteria:
Known central nervous system lymphoma
Participants with nodular lymphocyte-predominant Hodgkin Lymphoma
Prior allogeneic stem cell transplantation (SCT)
Chest radiation ≤ 24 weeks prior to first dose
Carmustine ≥ 600 mg/m² received as part of the pre-transplant conditioning regimen
243 participants were treated at 34 sites in 10 countries for cohorts A, B, and C. Cohort D enrolled separately. 51 participants were treated in cohort D for a total of 294 participants treated all together.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Aug 22, 2019
Oct 30, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
France
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group 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
BMS-936558
Doxorubicin
Drug
Specified dose on specified days
Nivolumab (Cohort A, B, C and D)
Vinblastine
Drug
Specified dose on specified days
Nivolumab (Cohort A, B, C and D)
Dacarbazine
Drug
Specified dose on specified days
Nivolumab (Cohort A, B, C and D)
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).
Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C
The CR rate was defined as the percent of participants with a BOR of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C
The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by >=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Computed using Kaplan-Meier method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C
The PR rate was defined as the percent of participants with a BOR of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Duration of PR Based on IRRC Assessments in Cohorts A, B, and C
The duration of PR was only evaluated in participants with BOR of PR and was defined as the time from first documentation of PR (regression of measurable disease and no new sites) to the date of initial objectively documented progression (any new lesion or increase by >=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Computed using Kaplan-Meier method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Computed using Kaplan-Meier method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Treatment Discontinuation Rate in Cohort D
Treatment discontinuation rate (TDR) is the number of treated participants who received <4 doses of monotherapy or <12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed.
Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.
From first dose up until the date of treatment discontinuation (up to approximately 100 months).
Number of Participants Who Died in Cohort D
Number of participants who died in Cohort D within 100 days after last dose of study therapy.
From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months)
Number of Participants With Adverse Events (AEs) in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
Number of Participants With Serious Adverse Events (SAEs) in Cohort D
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
Number of Participants With AEs Leading to Discontinuation in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
Number of Participants With AEs Leading to Dose Delay in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
Number of Participants With Select AEs in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)
Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D
CR rate is the percent of participants who show CR (disappearance of all evidence of disease) according to the 2007 IWG criteria at the planned end of study therapy radiographic tumor assessment.
Confidence interval based on the Klopper and Pearson method.
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
Los Angeles
California
90095
United States
Local Institution - 0001
Atlanta
Georgia
30322
United States
Local Institution - 0002
Boston
Massachusetts
02215
United States
Local Institution - 0025
Boston
Massachusetts
02215
United States
Local Institution - 0041
Boston
Massachusetts
02215
United States
Local Institution - 0008
Detroit
Michigan
48201
United States
Local Institution - 0003
Rochester
Minnesota
55905
United States
Local Institution - 0047
Hackensack
New Jersey
07601
United States
Local Institution - 0040
Basking Ridge
New York
07920
United States
Local Institution - 0005
New York
New York
10021
United States
Local Institution - 0006
Allentown
Pennsylvania
18103
United States
Local Institution - 0004
Nashville
Tennessee
37232-6307
United States
Local Institution - 0007
Houston
Texas
77030
United States
Local Institution - 0032
Innsbruck
6020
Austria
Local Institution - 0031
Vienna
1090
Austria
Local Institution - 0014
B-leuven
3000
Belgium
Local Institution - 0015
Ghent
9000
Belgium
Local Institution - 0046
Vancouver
British Columbia
V5Z 4E6
Canada
Local Institution - 0042
Toronto
Ontario
M5G 2M9
Canada
Local Institution - 0044
Prague
128 08
Czechia
Local Institution - 0037
Berlin
10117
Germany
Local Institution - 0033
Cologne
50937
Germany
Local Institution - 0036
Hamburg
20099
Germany
Local Institution - 0034
Ulm
89081
Germany
Local Institution - 0019
Bologna
40126
Italy
Local Institution - 0020
Naples
80131
Italy
Local Institution - 0035
Rozzano (milano)
20089
Italy
Local Institution - 0016
Amsterdam
1066 CX
Netherlands
Local Institution - 0038
Groningen
9713 GZ
Netherlands
Local Institution - 0017
Utrecht
3584 CX
Netherlands
Local Institution - 0022
Hospitalet Llobregat- Barcelona
9908
Spain
Local Institution - 0027
Majadahonda - Madrid
28222
Spain
Local Institution - 0023
Marbella
29603
Spain
Local Institution - 0043
Swansea
Carmarthenshire
SA2 8QA
United Kingdom
Local Institution - 0012
Withington
Manchester
M20 4BX
United Kingdom
Local Institution - 0026
Oxford
Oxfordshire
OX3 7LJ
United Kingdom
Local Institution - 0013
Sutton
SM2 5PT
United Kingdom
Derived
Ramchandren R, Domingo-Domenech E, Rueda A, Trneny M, Feldman TA, Lee HJ, Provencio M, Sillaber C, Cohen JB, Savage KJ, Willenbacher W, Ligon AH, Ouyang J, Redd R, Rodig SJ, Shipp MA, Sacchi M, Sumbul A, Armand P, Ansell SM. Nivolumab for Newly Diagnosed Advanced-Stage Classic Hodgkin Lymphoma: Safety and Efficacy in the Phase II CheckMate 205 Study. J Clin Oncol. 2019 Aug 10;37(23):1997-2007. doi: 10.1200/JCO.19.00315. Epub 2019 May 21.
Armand P, Engert A, Younes A, Fanale M, Santoro A, Zinzani PL, Timmerman JM, Collins GP, Ramchandren R, Cohen JB, De Boer JP, Kuruvilla J, Savage KJ, Trneny M, Shipp MA, Kato K, Sumbul A, Farsaci B, Ansell SM. Nivolumab for Relapsed/Refractory Classic Hodgkin Lymphoma After Failure of Autologous Hematopoietic Cell Transplantation: Extended Follow-Up of the Multicohort Single-Arm Phase II CheckMate 205 Trial. J Clin Oncol. 2018 May 10;36(14):1428-1439. doi: 10.1200/JCO.2017.76.0793. Epub 2018 Mar 27.
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
FG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
FG003
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
FG00063 subjects
FG00180 subjects
FG002100 subjects
FG00351 subjects
N-AVD Combination Therapy Phase
Received N-AVD
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00349 subjects
N-AVD Combination Therapy Phase
Received only AVD
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
COMPLETED
Completed = completed treatment as per protocol
FG0000 subjects
FG0010 subjects
FG00213 subjects
FG00345 subjects
NOT COMPLETED
FG00063 subjects
FG00180 subjects
FG00287 subjects
FG0036 subjects
Type
Comment
Reasons
Participant Withdrew Consent
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
Participant no Longer Meets Study Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Poor/Non-Compliance
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0031 subjects
Disease Progression
FG00028 subjects
FG00135 subjects
FG00240 subjects
FG0030 subjects
Participant Request to Discontinue Study Treatment
FG0005 subjects
FG00112 subjects
FG0025 subjects
FG0031 subjects
Study Drug Toxicity
FG0006 subjects
FG00111 subjects
FG0028 subjects
FG0031 subjects
Other Reasons
FG00014 subjects
FG00116 subjects
FG00228 subjects
FG0030 subjects
Maximum Clinical Benefit
FG0003 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
Adverse Event Unrelated to Study Drug
FG0003 subjects
FG0013 subjects
FG0021 subjects
FG0030 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
BG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
BG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
BG003
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00063
BG00180
BG002100
BG00351
BG004294
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
All treated participants
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00036.3± 12.54
BG00138.7± 13.00
BG00236.1± 12.41
BG003
Sex: Female, Male
All treated participants
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00029
BG00129
BG002
Ethnicity (NIH/OMB)
All treated participants
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0003
BG0011
BG002
Race/Ethnicity, Customized
All treated particpants
Number
Participants
Title
Denominators
Categories
White
Title
Measurements
BG00054
BG00171
BG002
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) Based on IRRC Assessments in Cohorts A, B, and C
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
All treated Cohort A, B and C participants
Posted
Number
95% Confidence Interval
Percentage of Particpants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 28 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00063
OG00180
OG002100
Title
Denominators
Categories
Title
Measurements
OG00065.1(52.0 to 76.7)
OG00167.5(56.1 to 77.6)
OG00273.0(63.2 to 81.4)
Primary
Number of Participants Who Experienced at Least One Treatment Related Grade 3-5 AE in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation subject administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
All Cohort D participants treated in the monotherapy and combination therapy phases.
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Secondary
Duration of Objective Response Based on IRRC Assessments in Cohorts A, B, and C
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Computed using Kaplan-Meier method.
All treated Cohort A, B and C participants with objective response of CR or PR.
Posted
Median
95% Confidence Interval
Months
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months).
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Secondary
Complete Remission (CR) Rate Based on IRRC Assessments in Cohorts A, B, and C
The CR rate was defined as the percent of participants with a BOR of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
All treated Cohort A, B and C participants
Posted
Number
95% Confidence Interval
Percentage of Participants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Secondary
Duration of Complete Remission (CR) Based on IRRC Assessments for Cohorts A, B, and C
The duration of CR was only evaluated in participants with BOR of CR and was defined as the time from first documentation of CR (the date of first negative FDG-PET scan or the date of first documentation of no disease involvement in the bone marrow (if required), whichever occurred later) to the date of initial objectively documented progression (Any new lesion or increase by >=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Computed using Kaplan-Meier method.
All treated Cohort A, B and C participants who had a BOR of CR.
Posted
Median
95% Confidence Interval
Months
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Secondary
Partial Remission (PR) Rate Based on IRRC Assessments in Cohorts A, B, and C
The PR rate was defined as the percent of participants with a BOR of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
All treated Cohort A, B and C participants
Posted
Number
95% Confidence Interval
Percentage of Participants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Secondary
Duration of PR Based on IRRC Assessments in Cohorts A, B, and C
The duration of PR was only evaluated in participants with BOR of PR and was defined as the time from first documentation of PR (regression of measurable disease and no new sites) to the date of initial objectively documented progression (any new lesion or increase by >=50% of previously involved sites from nadir) as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. Censoring was applied as per DOR definition.
Computed using Kaplan-Meier method.
All treated Cohort A, B and C participants who had a BOR of PR.
Posted
Median
95% Confidence Interval
Months
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Secondary
Objective Response Rates (ORR) Based on Investigator Assessments for Cohorts A, B, and C
ORR is the percent of participants achieving either a complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. Analyses of efficacy endpoints were performed separately for each cohort, according to IWG 2007. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all participants in lieu of bone marrow aspirate/ biopsy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Confidence interval based on Clopper-Pearson method.
All treated Cohort A, B and C participants
Posted
Number
95% Confidence Interval
Percentage of Participants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Secondary
Duration of Objective Response (DOR) Based on Investigator Assessments in Cohorts A, B, and C
DOR is the time from first response (complete remission (CR) or partial remission (PR)) to the date of initial objectively documented progression as determined using the 2007 IWG criteria or death due to any cause, whichever occurred first. For participants who neither progressed nor died, the DOR was censored on the date of their last tumor assessment. Participants who started subsequent therapy without a prior reported progression were censored at the last tumor assessments prior to initiation of the subsequent anticancer therapy.
CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria, based on IRRC assessment.
PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria, based on IRRC assessment.
Computed using Kaplan-Meier method.
All treated Cohort A, B and C participants who had a BOR of CR or PR.
Posted
Median
95% Confidence Interval
Months
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Secondary
Treatment Discontinuation Rate in Cohort D
Treatment discontinuation rate (TDR) is the number of treated participants who received <4 doses of monotherapy or <12 doses of their assigned combination regimen. A participant is considered as having received an AVD/NAVD dose as soon as they received at least one drug of AVD/NAVD for the considered dose. Participants must have received at least one dose of Nivolumab during the combination therapy phase to be included in participants treated with NAVD. If a participant subsequently met Criteria to Resume Nivolumab Dosing, the combination of nivolumab and AVD could be used. Participants who underwent treatment beyond progression during the Monotherapy phase could use the combination of nivolumab and AVD if all 4 doses of nivolumab monotherapy are completed.
Discontinuation can be due to any reason including, but not limited to, drug-related toxicity, diseases progression, or death.
All Cohort D participants treated in the monotherapy and combination therapy phases.
Posted
Count of Participants
Participants
From first dose up until the date of treatment discontinuation (up to approximately 100 months).
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Secondary
Number of Participants Who Died in Cohort D
Number of participants who died in Cohort D within 100 days after last dose of study therapy.
All Cohort D participants treated in the monotherapy and combination therapy phases.
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 100 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 10 months up to a maximum of 13 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
OG000
Secondary
Number of Participants With Adverse Events (AEs) in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
All treated participants in Cohort D
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Secondary
Number of Participants With Serious Adverse Events (SAEs) in Cohort D
A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe), requires inpatient hospitalization or causes prolongation of existing hospitalization. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
All treated participants in Cohort D
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
Secondary
Number of Participants With AEs Leading to Discontinuation in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
All treated participants in Cohort D
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Secondary
Number of Participants With AEs Leading to Dose Delay in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
All treated participants in Cohort D
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Secondary
Number of Participants With Select AEs in Cohort D
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Toxicities were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Select AEs have been categorized into seven areas: pulmonary toxicity, gastrointestinal toxicity, hepatotoxicity, endocrinopathy, skin toxicity, neurological toxicity and renal toxicity. Select AEs, in particular pneumonitis, are considered clinically meaningful as they require greater vigilance and for early recognition and prompt intervention.
All treated participants in Cohort D
Posted
Count of Participants
Participants
From first dose of the considered therapy phase to 30 days after last dose of study therapy phase (or up to first dose of combination if any when considering the monotherapy period) (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Secondary
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Monotherapy Phase
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
All participants treated in the Cohort D monotherapy phase who had at least one on-treatment TSH measurement during the monotherapy phase
Posted
Count of Participants
Participants
From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
OG000
Secondary
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
The number of participants with laboratory abnormalities in specific thyroid tests based on SI conventional units. TSH = Thyroid Stimulating Hormone LLN = Lower Limit of Normal ULN = Upper Limit of Normal
All participants treated in the Cohort D combination therapy phase who had at least one on-treatment AST, ALT and/or bilirubin test measurement during the combination therapy phase
Posted
Count of Participants
Participants
From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
OG000
Secondary
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
All participants treated in the Cohort D monotherapy phase
Posted
Count of Participants
Participants
From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
OG000
Secondary
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Combination Therapy Phase
The number of participants with laboratory abnormalities in specific liver tests based on SI conventional units. ALT = Alanine Aminotransferase, AST = Aspartate Aminotransferase, ULN = Upper Limit of Normal.
All participants treated in the Cohort D combination therapy phase with at least one on-treatment laboratory measurement
Posted
Count of Participants
Participants
From first dose of the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
OG000
Secondary
Complete Response (CR) Rate at Planned End of Therapy Based on IRRC Assessments in Cohort D
CR rate is the percent of participants who show CR (disappearance of all evidence of disease) according to the 2007 IWG criteria at the planned end of study therapy radiographic tumor assessment.
Confidence interval based on the Klopper and Pearson method.
All Cohort D participants treated in the monotherapy and combination therapy phases.
Posted
Number
95% Confidence Interval
Percent of Participants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, or death whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
Units
Counts
Participants
OG000
Post-Hoc
Objective Response Rate (ORR) Based on IRRC Assessments in Cohorts A, B, and C Extended Collection
Represents an updated version of the primary endpoint to include additional data collection that occurred after the primary completion date. (Assessments were made until 30 Nov 2022). Clinical benefit of nivolumab, as measured by ORR per IRRC assessment, and defined as percent of participants achieving either complete remission (CR) or partial remission (PR) according to the 2007 IWG criteria. For cohort A and B, if the bone marrow was involved by lymphoma before treatment, the infiltrate must have cleared on repeat bone marrow biopsy. For cohort C, no evidence of FDG-avid disease in bone marrow was required in all patients in lieu of bone marrow aspirate/ biopsy. CR is the percent of participants with a best overall response (BOR) of CR (disappearance of all evidence of disease) according to the 2007 IWG criteria. PR is the percent of participants with a best overall response (BOR) of PR (regression of measurable disease and no new sites) according to the 2007 IWG criteria.
All treated Cohort A, B and C participants
Posted
Number
95% Confidence Interval
Percentage of Participants
From first dose to the date of initial objectively documented progression or the date of subsequent therapy, whichever occurred first (up to approximately 100 months)
ID
Title
Description
OG000
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Time Frame
Participants were assessed for All-Cause Mortality from first dose until study completion (assessed up to approximately 100 months). SAEs and Other AEs were assessed from first dose to 100 days after last dose of study therapy (assessed for an average of 32 months up to maximum of 98 months).
Description
All-Cause Mortality and Serious and Other (Not Including Serious) Adverse Events is represented per dosage, per arm for Cohorts A, B, and C. This is to account for these events after the dosage and administration changes for nivolumab were implemented per revised protocol version 04c (dated 22-Aug-2019).
Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
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
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin- Nivolumab 3 mg/kg
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
14
46
10
46
46
46
EG001
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 240 mg
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
3
9
3
9
9
9
EG002
Cohort A: Post-Transplant, Never Taken Brentuximab Vedotin-Nivolumab 480 mg
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
0
8
1
8
8
8
EG003
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 3 mg/kg
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
25
75
30
75
75
75
EG004
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant-Nivolumab 240 mg
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
0
3
0
3
3
3
EG005
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Stem Cell Transplant- Nivolumab 480 mg
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
0
3
3
3
3
3
EG009
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
Four doses of nivolumab flat dose 240 mg IV were administered every 2 weeks (monotherapy phase), followed by 12 doses of the combination of AVD (adriamycin/ doxorubicin 25 mg/m2, vinblastine 6 mg/m2, dacarbazine 375 mg/m2) chemotherapy and nivolumab flat dose 240 mg IV for 6 cycles (combination phase).
5
51
12
51
50
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG0030 affected75 at risk
EG0040 affected3 at risk
EG0050 affected2 at risk
EG0061 affected84 at risk
EG0070 affected13 at risk
EG0080 affected3 at risk
EG0090 affected51 at risk
Febrile neutropenia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Acute myocardial infarction
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Angina pectoris
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Arrhythmia
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cardiac arrest
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cardiac failure
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cardiac failure congestive
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Myocardial infarction
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Palpitations
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Pericardial effusion
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Tracheo-oesophageal fistula
Congenital, familial and genetic disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hyperthyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Colitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Enteritis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gastritis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Immune-mediated enterocolitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pancreatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Stomatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Fatigue
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Generalised oedema
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Multiple organ dysfunction syndrome
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pyrexia
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Systemic inflammatory response syndrome
General disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Autoimmune hepatitis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hyperbilirubinaemia
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Acute graft versus host disease
Immune system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Graft versus host disease
Immune system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Appendicitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Atypical pneumonia
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Bacteraemia
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Bacterial sepsis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cellulitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cystitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Device related sepsis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Encephalitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Erysipelas
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Febrile infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gastroenteritis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hepatitis A
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Influenza
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Lower respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Lyme disease
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Meningitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Parainfluenzae virus infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pharyngitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pneumonia
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pyelonephritis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Sepsis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Blood creatine phosphokinase increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Blood creatinine increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Lipase increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Platelet count decreased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Respirovirus test positive
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Glucose tolerance impaired
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypercalcaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Bursitis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Osteonecrosis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Soft tissue disorder
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Basal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Follicular lymphoma stage III
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Malignant neoplasm progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Neuroendocrine carcinoma of the skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Peripheral T-cell lymphoma unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Squamous cell carcinoma of the tongue
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Carotid artery stenosis
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Headache
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Polyneuropathy
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Posterior reversible encephalopathy syndrome
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Seizure
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Syncope
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Suicide attempt
Psychiatric disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Acute kidney injury
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Tubulointerstitial nephritis
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Ovarian cyst
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pneumothorax
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Tracheomalacia
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Embolism
Vascular disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Peripheral ischaemia
Vascular disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG00312 affected75 at risk
EG0040 affected3 at risk
EG0050 affected2 at risk
EG00618 affected84 at risk
EG0072 affected13 at risk
EG0080 affected3 at risk
EG0099 affected51 at risk
Eosinophilia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Febrile neutropenia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Palpitations
Cardiac disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Tachycardia
Cardiac disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Ear pain
Ear and labyrinth disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Tinnitus
Ear and labyrinth disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Vertigo
Ear and labyrinth disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Hyperthyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypothyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0007 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Primary hypothyroidism
Endocrine disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Dry eye
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Eye disorder
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Eye pruritus
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Mydriasis
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Swelling of eyelid
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Vision blurred
Eye disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Visual field defect
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Vitreous floaters
Eye disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Abdominal distension
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Abdominal hernia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Abdominal pain
Gastrointestinal disorders
25.1
Systematic Assessment
EG0007 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
25.1
Systematic Assessment
EG0006 affected46 at risk
EG0013 affected9 at risk
EG0020 affected8 at risk
EG003
Anorectal discomfort
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Constipation
Gastrointestinal disorders
25.1
Systematic Assessment
EG0007 affected46 at risk
EG0012 affected9 at risk
EG0021 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
25.1
Systematic Assessment
EG00026 affected46 at risk
EG0013 affected9 at risk
EG0025 affected8 at risk
EG003
Dry mouth
Gastrointestinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Dysphagia
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Flatulence
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gastritis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
25.1
Systematic Assessment
EG00014 affected46 at risk
EG0011 affected9 at risk
EG0025 affected8 at risk
EG003
Pancreatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Periodontal disease
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Steatorrhoea
Gastrointestinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Stomatitis
Gastrointestinal disorders
25.1
Systematic Assessment
EG0005 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Toothache
Gastrointestinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Vomiting
Gastrointestinal disorders
25.1
Systematic Assessment
EG00011 affected46 at risk
EG0012 affected9 at risk
EG0025 affected8 at risk
EG003
Asthenia
General disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0022 affected8 at risk
EG003
Chest discomfort
General disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Chest pain
General disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Chills
General disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0013 affected9 at risk
EG0021 affected8 at risk
EG003
Fatigue
General disorders
25.1
Systematic Assessment
EG00019 affected46 at risk
EG0015 affected9 at risk
EG0023 affected8 at risk
EG003
Feeling cold
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0012 affected9 at risk
EG0020 affected8 at risk
EG003
Illness
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Inflammation
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Influenza like illness
General disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0023 affected8 at risk
EG003
Malaise
General disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0012 affected9 at risk
EG0020 affected8 at risk
EG003
Mucosal dryness
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Mucosal inflammation
General disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Non-cardiac chest pain
General disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Oedema peripheral
General disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pain
General disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Peripheral swelling
General disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Pyrexia
General disorders
25.1
Systematic Assessment
EG00012 affected46 at risk
EG0015 affected9 at risk
EG0023 affected8 at risk
EG003
Thirst
General disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Venoocclusive liver disease
Hepatobiliary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Anaphylactic reaction
Immune system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cytokine release syndrome
Immune system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypersensitivity
Immune system disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0022 affected8 at risk
EG003
Seasonal allergy
Immune system disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Aeromonas infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Atypical mycobacterial infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Bacterial infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Bronchitis
Infections and infestations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected9 at risk
EG0023 affected8 at risk
EG003
COVID-19
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Cellulitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Conjunctivitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cystitis
Infections and infestations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Folliculitis
Infections and infestations
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gastric infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Gastroenteritis
Infections and infestations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Gastrointestinal infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Gingivitis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Herpes simplex
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Herpes zoster
Infections and infestations
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Hordeolum
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Infected skin ulcer
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Influenza
Infections and infestations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0013 affected9 at risk
EG0020 affected8 at risk
EG003
Lip infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Lymph gland infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Nasopharyngitis
Infections and infestations
25.1
Systematic Assessment
EG00010 affected46 at risk
EG0015 affected9 at risk
EG0026 affected8 at risk
EG003
Oral herpes
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Pharyngitis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pharyngitis bacterial
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pneumonia
Infections and infestations
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Pyelonephritis
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Rhinitis
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0013 affected9 at risk
EG0021 affected8 at risk
EG003
Septic shock
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Sinusitis
Infections and infestations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0013 affected9 at risk
EG0021 affected8 at risk
EG003
Skin infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Tooth abscess
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Tooth infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG00011 affected46 at risk
EG0011 affected9 at risk
EG0023 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Viral infection
Infections and infestations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Compression fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Fall
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Infusion related reaction
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0006 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Post-traumatic pain
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Skin procedural complication
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Sunburn
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Alanine aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0006 affected46 at risk
EG0012 affected9 at risk
EG0022 affected8 at risk
EG003
Amylase increased
Investigations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Aspartate aminotransferase increased
Investigations
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0022 affected8 at risk
EG003
Blood alkaline phosphatase increased
Investigations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Blood bilirubin increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Blood creatinine increased
Investigations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Lipase increased
Investigations
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Liver function test increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Lymphocyte count decreased
Investigations
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Neutrophil count decreased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Platelet count decreased
Investigations
25.1
Systematic Assessment
EG0005 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
SARS-CoV-2 test positive
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Sputum abnormal
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Transaminases increased
Investigations
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Weight decreased
Investigations
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0023 affected8 at risk
EG003
Weight increased
Investigations
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
White blood cell count decreased
Investigations
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0005 affected46 at risk
EG0013 affected9 at risk
EG0022 affected8 at risk
EG003
Dehydration
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hyponatraemia
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Vitamin B12 deficiency
Metabolism and nutrition disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0009 affected46 at risk
EG0014 affected9 at risk
EG0022 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0008 affected46 at risk
EG0011 affected9 at risk
EG0022 affected8 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Flank pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0012 affected9 at risk
EG0020 affected8 at risk
EG003
Joint effusion
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Muscle contracture
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Muscle swelling
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0007 affected46 at risk
EG0011 affected9 at risk
EG0022 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Osteoporosis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Plantar fasciitis
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Tumour pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Cerebrospinal fluid leakage
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Convulsions local
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Dizziness
Nervous system disorders
25.1
Systematic Assessment
EG0006 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Dysaesthesia
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Headache
Nervous system disorders
25.1
Systematic Assessment
EG00014 affected46 at risk
EG0013 affected9 at risk
EG0022 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Lethargy
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Memory impairment
Nervous system disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Migraine
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Migraine with aura
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Neuropathy peripheral
Nervous system disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Peripheral sensory neuropathy
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Polyneuropathy
Nervous system disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Syncope
Nervous system disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Tremor
Nervous system disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Anxiety
Psychiatric disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Anxiety disorder
Psychiatric disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Depressed mood
Psychiatric disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Depression
Psychiatric disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Generalised anxiety disorder
Psychiatric disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Insomnia
Psychiatric disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Cystitis haemorrhagic
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Dysuria
Renal and urinary disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Pollakiuria
Renal and urinary disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Urinary tract pain
Renal and urinary disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Amenorrhoea
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Balanoposthitis
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Menopausal symptoms
Reproductive system and breast disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG00021 affected46 at risk
EG0015 affected9 at risk
EG0024 affected8 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0023 affected8 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0012 affected9 at risk
EG0021 affected8 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Haemoptysis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Increased viscosity of upper respiratory secretion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0009 affected46 at risk
EG0010 affected9 at risk
EG0025 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0006 affected46 at risk
EG0013 affected9 at risk
EG0022 affected8 at risk
EG003
Painful respiration
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Paranasal sinus inflammation
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Pneumonitis
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0004 affected46 at risk
EG0012 affected9 at risk
EG0023 affected8 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0010 affected9 at risk
EG0023 affected8 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Sinus pain
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Sneezing
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Upper-airway cough syndrome
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0012 affected9 at risk
EG0021 affected8 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0024 affected8 at risk
EG003
Dermatitis allergic
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0005 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Hyperhidrosis
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0003 affected46 at risk
EG0013 affected9 at risk
EG0021 affected8 at risk
EG003
Pityriasis rosea
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG00011 affected46 at risk
EG0013 affected9 at risk
EG0021 affected8 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG00012 affected46 at risk
EG0010 affected9 at risk
EG0022 affected8 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0005 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0011 affected9 at risk
EG0021 affected8 at risk
EG003
Flushing
Vascular disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hot flush
Vascular disorders
25.1
Systematic Assessment
EG0001 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Hypertension
Vascular disorders
25.1
Systematic Assessment
EG0002 affected46 at risk
EG0010 affected9 at risk
EG0020 affected8 at risk
EG003
Lymphoedema
Vascular disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0010 affected9 at risk
EG0021 affected8 at risk
EG003
Peripheral venous disease
Vascular disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Superficial vein thrombosis
Vascular disorders
25.1
Systematic Assessment
EG0000 affected46 at risk
EG0011 affected9 at risk
EG0020 affected8 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00041
OG00157
OG00275
Title
Denominators
Categories
Title
Measurements
OG00026.18(15.21 to NA)The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
OG00116.59(9.26 to 25.72)
OG00218.17(11.63 to 30.85)
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00063
OG00180
OG002100
Title
Denominators
Categories
Title
Measurements
OG00031.7(20.6 to 44.7)
OG00113.8(7.1 to 23.3)
OG00221(13.5 to 30.3)
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00020
OG00111
OG00221
Title
Denominators
Categories
Title
Measurements
OG00043.47(18.00 to NA)The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
OG00130.32(2.4 to NA)The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
OG00226.41(7.13 to NA)The upper 95% confidence interval was not reached due to Insufficient number of participants with events to reach the threshold according to Kaplan-Meier methodology.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00063
OG00180
OG002100
Title
Denominators
Categories
Title
Measurements
OG00033.3(22.0 to 46.3)
OG00157.5(45.9 to 68.5)
OG00254.0(43.7 to 64.0)
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00021
OG00146
OG00254
Title
Denominators
Categories
Title
Measurements
OG00012.78(4.17 to 27.17)
OG00110.58(7.46 to 25.26)
OG00214.65(9.36 to 30.36)
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00063
OG00180
OG002100
Title
Denominators
Categories
Title
Measurements
OG00069.8(57.0 to 80.8)
OG00173.8(62.7 to 83.0)
OG00270.0(60.0 to 78.8)
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
Units
Counts
Participants
OG00044
OG00159
OG00270
Title
Denominators
Categories
Title
Measurements
OG00039.10(16.59 to 78.29)
OG00125.26(10.09 to 41.72)
OG00228.85(12.02 to 34.53)
Units
Counts
Participants
OG00051
Title
Denominators
Categories
Monotherapy
ParticipantsOG00051
Title
Measurements
OG0002
Combination Therapy (receiving AVD or NAVD)
ParticipantsOG00050
Title
Measurements
OG0005
Combination Therapy (NAVD receivers only)
ParticipantsOG00049
Title
Measurements
OG0005
Overall Therapy
ParticipantsOG00051
Title
Measurements
OG0006
51
Title
Denominators
Categories
Monotherapy
ParticipantsOG00051
Title
Measurements
OG0000
Combination Therapy (receiving AVD or NAVD)
ParticipantsOG00050
Title
Measurements
OG0001
Participants
OG00051
Title
Denominators
Categories
Monotherapy
ParticipantsOG00051
Title
Measurements
OG00048
Combination Therapy (receiving AVD or NAVD)
ParticipantsOG00050
Title
Measurements
OG00049
OG00051
Title
Denominators
Categories
Monotherapy
ParticipantsOG00051
Title
Measurements
OG0002
Combination Therapy (receiving AVD or NAVD)
ParticipantsOG00050
Title
Measurements
OG00010
Participants
OG00051
Title
Denominators
Categories
Monotherapy
ParticipantsOG00051
Title
Measurements
OG0001
Combination Therapy (receiving AVD or NAVD)
ParticipantsOG00050
Title
Measurements
OG0003
Participants
OG00051
Title
Denominators
Categories
Monotherapy
ParticipantsOG00051
Title
Measurements
OG0003
Combination Therapy (receiving AVD or NAVD)
ParticipantsOG00050
Title
Measurements
OG00029
Units
Counts
Participants
OG00051
Title
Denominators
Categories
Gastrointestinal Monotherapy
Title
Measurements
OG0006
Gastrointestinal Combination Therapy
Title
Measurements
OG00013
Hepatic Monotherapy
Title
Measurements
OG0002
Hepatic Combination Therapy
Title
Measurements
OG0003
Pulmonary Monotherapy
Title
Measurements
OG0000
Pulmonary Combination Therapy
Title
Measurements
OG0003
Renal Monotherapy
Title
Measurements
OG0001
Renal Combination Therapy
Title
Measurements
OG0000
Skin Monotherapy
Title
Measurements
OG00017
Skin Combination Therapy
Title
Measurements
OG0009
Hypersensitivity/Infusion Reactions Monotherapy
Title
Measurements
OG00016
Hypersensitivity/Infusion Reactions Combination
Title
Measurements
OG0004
42
Title
Denominators
Categories
TSH > ULN
Title
Measurements
OG0001
TSH > ULN WITH TSH <= ULN AT BASELINE
Title
Measurements
OG0001
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
Title
Measurements
OG0000
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
Title
Measurements
OG0000
TSH > ULN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0001
TSH < LLN
Title
Measurements
OG0005
TSH <LLN WITH TSH >= LLN AT BASELINE
Title
Measurements
OG0005
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
Title
Measurements
OG0001
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
Title
Measurements
OG0000
TSH < LLN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0004
48
Title
Denominators
Categories
TSH > ULN
Title
Measurements
OG00012
TSH > ULN WITH TSH <= ULN AT BASELINE
Title
Measurements
OG0008
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
Title
Measurements
OG0003
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
Title
Measurements
OG0001
TSH > ULN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0008
TSH < LLN
Title
Measurements
OG0005
TSH <LLN WITH TSH >= LLN AT BASELINE
Title
Measurements
OG0005
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
Title
Measurements
OG0001
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
Title
Measurements
OG0000
TSH < LLN WITH FT3/FT4 TEST MISSING
Title
Measurements
OG0004
51
Title
Denominators
Categories
ALT OR AST > 3XULN
Title
Measurements
OG0002
ALT OR AST> 5XULN
Title
Measurements
OG0001
ALT OR AST> 10XULN
Title
Measurements
OG0000
ALT OR AST > 20XULN
Title
Measurements
OG0000
TOTAL BILIRUBIN > 2XULN
Title
Measurements
OG0000
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
Title
Measurements
OG0000
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
Title
Measurements
OG0000
49
Title
Denominators
Categories
ALT OR AST > 3XULN
Title
Measurements
OG0004
ALT OR AST> 5XULN
Title
Measurements
OG0001
ALT OR AST> 10XULN
Title
Measurements
OG0001
ALT OR AST > 20XULN
Title
Measurements
OG0000
TOTAL BILIRUBIN > 2XULN
Title
Measurements
OG0000
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
Title
Measurements
OG0000
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
Title
Measurements
OG0000
51
Title
Denominators
Categories
Title
Measurements
OG00066.7(52.1 to 79.2)
OG001
Cohort B: Post Transplant, Brentuximab Vedotin Taken Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.
OG002
Cohort C: Post Transplant, Brentuximab Vedotin Taken Pre-and/or Post-Autologous Stem Cell Transplant
Nivolumab was administered at 3 mg/kg IV over 60 minutes on the first day of each 2-week cycle. Upon the implementation of revised protocol version 04c (dated 22-Aug-2019), participants were switched from a body weight-based dose of 3 mg/kg every 2 weeks to a flat dose of 480 mg every 4 weeks or a flat dose of 240 mg every 2 weeks. Nivolumab treatment was continued until unacceptable toxicity or disease progression.