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NCT02837042 · OUTCOME

Overall Survival

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma · Source last updated 2022-06-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
days
Interval / dispersion
Inter-Quartile Range
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months

What was measured

Length of subject survival after starting study treatment

Analysis population: Due to poor accrual, low sample size, and higher number of patients censored, the 95% CI for median OS and PFS could not be determined.

Groups in this outcome

Pembrolizumab 200 mg

Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Pembrolizumab 200 mg6

Reported measurements

Source class 1
Values in days · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Pembrolizumab 200 mg307Not reportedNANAThe study was ended prematurely due to poor accrual and only two patients progressed while the rest were lost to follow up. The statistical analysis will not give a reliable range except median based on two findings
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The study was ended prematurely due to poor accrual and only two patients progressed while the rest were lost to follow up. The statistical analysis will not give a reliable range except median based on two findings
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        307
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Length of subject survival after starting study treatment
dispersion Type
Inter-Quartile Range
groups
  1. description
    Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
    id
    OG000
    title
    Pembrolizumab 200 mg
param Type
MEDIAN
population Description
Due to poor accrual, low sample size, and higher number of patients censored, the 95% CI for median OS and PFS could not be determined.
reporting Status
POSTED
time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 100 months
title
Overall Survival
type
SECONDARY
unit Of Measure
days

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

Preserved source evidence · Not medical advice