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NCT03255018 · OUTCOME

Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)

Pembrolizumab in Relapsed and Refractory Gray-Zone Lymphoma (GZL), Primary Central Nervous System Lymphoma (PCNSL), and Other Extranodal Diffuse Large B-cell Lymphomas · Source last updated 2023-11-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
adverse events
Interval / dispersion
Not reported
Time frame
Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy, approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.

What was measured

Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

Analysis population: 9/10 participants are analyzed in the DLBCL cohort because 1 participant enrolled in the DLBCL cohort was not evaluable due to withdrawal of consent prior to treatment.

Groups in this outcome

Cohort 1 Gray-Zone Lymphoma (GZL)

Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.

Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)

Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Cohort 1 Gray-Zone Lymphoma (GZL)2
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)9

Reported measurements

Grade 1
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)5Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)35Not reportedNot reportedNot reportedNot reported
Grade 2
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)0Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)20Not reportedNot reportedNot reportedNot reported
Grade 3
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)0Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)8Not reportedNot reportedNot reportedNot reported
Grade 4
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)0Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)2Not reportedNot reportedNot reportedNot reported
Grade 5
Values in adverse events · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 Gray-Zone Lymphoma (GZL)0Not reportedNot reportedNot reportedNot reported
Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        35
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        20
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        8
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Grade 1 is mild. Grade 2 is moderate. Grade 3 is serious. Grade 4 is life-threatening. Grade 5 is death related to adverse event.
groups
  1. description
    Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    id
    OG000
    title
    Cohort 1 Gray-Zone Lymphoma (GZL)
  2. description
    Cohort 2: Extra-nodal diffuse large B-cell lymphoma involving one or more of the specified extra-nodal sites (i.e., extra-nodal DLBCL) Participants will be treated with pembrolizumab 200 mg (flat dose) intravenous (IV) every 3 weeks provided they have clinical benefit and no unacceptable toxicity; participants who achieve a complete response (CR) will have the option to stop after 1 year of therapy.
    id
    OG001
    title
    Cohort 2 Extra-nodal Diffuse Large B-cell Lymphoma (DLBCL)
param Type
NUMBER
population Description
9/10 participants are analyzed in the DLBCL cohort because 1 participant enrolled in the DLBCL cohort was not evaluable due to withdrawal of consent prior to treatment.
reporting Status
POSTED
time Frame
Adverse events are collected from the first dose of therapy through 30 days past the last dose of study drug or start of new anti-cancer therapy, approximately 5 months and 7 days for cohort 1, and 44 months and 25 days for cohort 2.
title
Number of Grades 1-5 Adverse Events in Participant With Gray-zone Lymphomas (GZL) and Extra-nodal Diffuse Large B-cell Lymphomas (DLBCL)
type
SECONDARY
unit Of Measure
adverse events

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice