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NCT01087970 · OUTCOME

Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)

A Study for Participants With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2014-05-19

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From enrollment to 30 days post-treatment discontinuation up to 26.4 months

What was measured

Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.

Analysis population: All enrolled participants who received at least 1 dose of any study drug.

Groups in this outcome

Cetuximab + Pemetrexed + Carboplatin/Cisplatin

Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.

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

Analysis denominator · Participants

GroupSource count
Cetuximab + Pemetrexed + Carboplatin/Cisplatin69

Reported measurements

Due to AE while on treatment
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin3Not reportedNot reportedNot reportedNot reported
Due to PD during 30-day FU
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab + Pemetrexed + Carboplatin/Cisplatin5Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Due to AE while on treatment
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Due to PD during 30-day FU
denoms
  1. counts
    1. group Id
      OG000
      value
      69
    units
    Participants
description
Presented are the number of participants who died due to adverse events (AEs) while on treatment and participants who died due to progressive disease (PD) during the 30-day post-treatment discontinuation FU.
groups
  1. description
    Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly. Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab. Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed. Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression.
    id
    OG000
    title
    Cetuximab + Pemetrexed + Carboplatin/Cisplatin
param Type
NUMBER
population Description
All enrolled participants who received at least 1 dose of any study drug.
reporting Status
POSTED
time Frame
From enrollment to 30 days post-treatment discontinuation up to 26.4 months
title
Number of Participants Who Died While on Treatment and Died During 30-Day Post-Treatment Discontinuation Follow-Up (FU)
type
OTHER_PRE_SPECIFIED
unit Of Measure
participants

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

Preserved source evidence · Not medical advice