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NCT02320058 · OUTCOME

Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests

An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself · Source last updated 2021-10-05

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 to 30 days post last dose (Up to 66 months)

What was measured

Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized: * TSH value \> ULN and * with baseline TSH value \<= ULN * with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test. * TSH \< LLN and * with baseline TSH value \>= LLN * with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test

Analysis population: All treated participants with at least one on-treatment TSH measurement

Groups in this outcome

Cohort A

Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.

Cohort B

Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.

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 A101
Cohort B18

Reported measurements

TSH > ULN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A33Not reportedNot reportedNot reportedNot reported
Cohort B2Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH TSH <= ULN AT BASELINE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A26Not reportedNot reportedNot reportedNot reported
Cohort B2Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A10Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A4Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
TSH > ULN WITH FT3/FT4 TEST MISSING
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A23Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
TSH < LLN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A38Not reportedNot reportedNot reportedNot reported
Cohort B5Not reportedNot reportedNot reportedNot reported
TSH < LLN WITH TSH >= LLN AT BASELINE
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A37Not reportedNot reportedNot reportedNot reported
Cohort B4Not reportedNot reportedNot reportedNot reported
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A7Not reportedNot reportedNot reportedNot reported
Cohort B0Not reportedNot reportedNot reportedNot reported
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A2Not reportedNot reportedNot reportedNot reported
Cohort B1Not reportedNot reportedNot reportedNot reported
TSH < LLN WITH FT3/FT4 TEST MISSING
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort A15Not reportedNot reportedNot reportedNot reported
Cohort B2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        33
      2. group Id
        OG001
        value
        2
    title
    TSH > ULN
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      2. group Id
        OG001
        value
        2
    title
    TSH > ULN WITH TSH <= ULN AT BASELINE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        0
    title
    TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        23
      2. group Id
        OG001
        value
        0
    title
    TSH > ULN WITH FT3/FT4 TEST MISSING
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        38
      2. group Id
        OG001
        value
        5
    title
    TSH < LLN
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        37
      2. group Id
        OG001
        value
        4
    title
    TSH < LLN WITH TSH >= LLN AT BASELINE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        0
    title
    TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        2
    title
    TSH < LLN WITH FT3/FT4 TEST MISSING
denoms
  1. counts
    1. group Id
      OG000
      value
      101
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized: * TSH value \> ULN and * with baseline TSH value \<= ULN * with at least one FT3/FT4 test value \< LLN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \>= LLN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test. * TSH \< LLN and * with baseline TSH value \>= LLN * with at least one FT3/FT4 test value \> ULN within 2-week window after the abnormal TSH test * with all FT3/FT4 test values \<= ULN within 2-week window after the abnormal TSH test * with FT3/FT4 missing within 2-week window after the abnormal TSH test
groups
  1. description
    Asymptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
    id
    OG000
    title
    Cohort A
  2. description
    Symptomatic patients treated with Nivolumab IV 1 mg/kg Q3W + Ipilimumab IV 3 mg/kg Q3W for a total of 4 doses of the combination therapy followed by Nivolumab IV 3 mg/kg BID for a maximum of 24 months or until progression or until unacceptable toxicity.
    id
    OG001
    title
    Cohort B
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated participants with at least one on-treatment TSH measurement
reporting Status
POSTED
time Frame
From first dose to 30 days post last dose (Up to 66 months)
title
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice