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NCT02181738 · OUTCOME

Number of Participants With Select AEs in Cohort D

Study of Nivolumab in Patients With Classical Hodgkin's Lymphoma (Registrational) · 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
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)

What was measured

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.

Analysis population: All treated participants in Cohort D

Groups in this outcome

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).

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 D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)51

Reported measurements

Gastrointestinal Monotherapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)6Not reportedNot reportedNot reportedNot reported
Gastrointestinal Combination Therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)13Not reportedNot reportedNot reportedNot reported
Hepatic Monotherapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)2Not reportedNot reportedNot reportedNot reported
Hepatic Combination Therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)3Not reportedNot reportedNot reportedNot reported
Pulmonary Monotherapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)0Not reportedNot reportedNot reportedNot reported
Pulmonary Combination Therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)3Not reportedNot reportedNot reportedNot reported
Renal Monotherapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)1Not reportedNot reportedNot reportedNot reported
Renal Combination Therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)0Not reportedNot reportedNot reportedNot reported
Skin Monotherapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)17Not reportedNot reportedNot reportedNot reported
Skin Combination Therapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)9Not reportedNot reportedNot reportedNot reported
Hypersensitivity/Infusion Reactions Monotherapy
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)16Not reportedNot reportedNot reportedNot reported
Hypersensitivity/Infusion Reactions Combination
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Gastrointestinal Monotherapy
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Gastrointestinal Combination Therapy
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Hepatic Monotherapy
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Hepatic Combination Therapy
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Pulmonary Monotherapy
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Pulmonary Combination Therapy
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Renal Monotherapy
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Renal Combination Therapy
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Skin Monotherapy
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        9
    title
    Skin Combination Therapy
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        16
    title
    Hypersensitivity/Infusion Reactions Monotherapy
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Hypersensitivity/Infusion Reactions Combination
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
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.
groups
  1. description
    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).
    id
    OG000
    title
    Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants in Cohort D
reporting Status
POSTED
time Frame
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)
title
Number of Participants With Select AEs in Cohort D
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice