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NCT02181738 · OUTCOME

Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy 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 the combination therapy to 30 days after last dose of combination therapy (an average of 8 months and a maximum of 11 months)

What was measured

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

Analysis population: 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

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)48

Reported measurements

TSH > ULN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)12Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH TSH <= ULN AT BASELINE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)8Not reportedNot reportedNot reportedNot reported
TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
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
TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
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
TSH > ULN WITH FT3/FT4 TEST MISSING
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)8Not reportedNot reportedNot reportedNot reported
TSH < LLN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)5Not reportedNot reportedNot reportedNot reported
TSH <LLN WITH TSH >= LLN AT BASELINE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort D: Newly Diagnosed, Previously Untreated Advanced Stage cHL (Stage IIB, III and IV)5Not reportedNot reportedNot reportedNot reported
TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
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
TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
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
TSH < LLN WITH FT3/FT4 TEST MISSING
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
        12
    title
    TSH > ULN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    TSH > ULN WITH TSH <= ULN AT BASELINE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    TSH >ULN WITH ATLEAST ONE FT3/FT4 TEST VALUE <LLN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    TSH >ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    TSH > ULN WITH FT3/FT4 TEST MISSING
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    TSH < LLN
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    TSH <LLN WITH TSH >= LLN AT BASELINE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    TSH <LLN WITH ATLEAST ONE FT3/FT4 TEST VALUE > ULN
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TSH <LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    TSH < LLN WITH FT3/FT4 TEST MISSING
denoms
  1. counts
    1. group Id
      OG000
      value
      48
    units
    Participants
description
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
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 combination therapy phase who had at least one on-treatment AST, ALT and/or bilirubin test measurement during the combination therapy phase
reporting Status
POSTED
time Frame
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)
title
Number of Participants Laboratory Abnormalities in Specific Thyroid Tests in Cohort D Combination Therapy Phase
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice