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NCT02181738 · OUTCOME

Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase

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 monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)

What was measured

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.

Analysis population: All participants treated in the Cohort D monotherapy phase

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

ALT OR AST > 3XULN
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
ALT OR AST> 5XULN
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
ALT OR AST> 10XULN
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
ALT OR AST > 20XULN
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
TOTAL BILIRUBIN > 2XULN
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
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
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
ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
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
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    ALT OR AST > 3XULN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    ALT OR AST> 5XULN
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ALT OR AST> 10XULN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ALT OR AST > 20XULN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TOTAL BILIRUBIN > 2XULN
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 1 DAY
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN IN 30 DAYS
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    units
    Participants
description
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.
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 participants treated in the Cohort D monotherapy phase
reporting Status
POSTED
time Frame
From first dose of monotherapy to 30 days after last dose of monotherapy phase (up to approximately 3 months)
title
Number of Participants With Laboratory Abnormalities in Specific Liver Tests in Cohort D Monotherapy Phase
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice