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NCT02499952 · OUTCOME

Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.

Pembrolizumab in Subjects With Incurable Platinum-Refractory Germ Cell Tumors · Source last updated 2022-07-11

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
Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks

What was measured

Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.

Groups in this outcome

Experimental Arm

Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks 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
Experimental Arm12

Reported measurements

Skin and subcutaneous tissue disorders
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental Arm1Not reportedNot reportedNot reportedNot reported
Noncardiac chest pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental Arm1Not reportedNot reportedNot reportedNot reported
Anemia
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental Arm1Not reportedNot reportedNot reportedNot reported
Sciatic pain
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Experimental Arm1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Skin and subcutaneous tissue disorders
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Noncardiac chest pain
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Anemia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Sciatic pain
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    units
    Participants
description
Toxicity and tolerability of pembrolizumab in subjects with refractory GCTs. All grade 3 and higher adverse events are reported.
groups
  1. description
    Pembrolizumab Pembrolizumab: 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
    id
    OG000
    title
    Experimental Arm
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Every week while patient is receiving pembrolizumab, assessed for up to 52 weeks
title
Number of Participants With Adverse Events as a Measure of Safety and Tolerability Using Common Terminology Criteria for Adverse Events (CTCAE) V4.
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice