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NCT00561470 · OUTCOME

Number of Participants With Adverse Events (AE)

Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen · Source last updated 2012-09-28

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 the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized

What was measured

All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.

Analysis population: The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).

Groups in this outcome

Placebo/FOLFIRI

Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks

Aflibercept/FOLFIRI

Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two 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
Placebo/FOLFIRI605
Aflibercept/FOLFIRI611

Reported measurements

Treatment-Emergent Adverse Event (TEAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI592Not reportedNot reportedNot reportedNot reported
Aflibercept/FOLFIRI606Not reportedNot reportedNot reportedNot reported
Serious TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI198Not reportedNot reportedNot reportedNot reported
Aflibercept/FOLFIRI294Not reportedNot reportedNot reportedNot reported
TEAE leading to Death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI29Not reportedNot reportedNot reportedNot reported
Aflibercept/FOLFIRI37Not reportedNot reportedNot reportedNot reported
TEAE causing permanent treatment discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo/FOLFIRI73Not reportedNot reportedNot reportedNot reported
Aflibercept/FOLFIRI164Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        592
      2. group Id
        OG001
        value
        606
    title
    Treatment-Emergent Adverse Event (TEAE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        198
      2. group Id
        OG001
        value
        294
    title
    Serious TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        29
      2. group Id
        OG001
        value
        37
    title
    TEAE leading to Death
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        73
      2. group Id
        OG001
        value
        164
    title
    TEAE causing permanent treatment discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      605
    2. group Id
      OG001
      value
      611
    units
    Participants
description
All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization. The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
groups
  1. description
    Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
    id
    OG000
    title
    Placebo/FOLFIRI
  2. description
    Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
    id
    OG001
    title
    Aflibercept/FOLFIRI
param Type
NUMBER
population Description
The safety population was the subset of the ITT population that took at least one dose of study treatment. Analyses was based on the treatment actually received (any participant who received at least one dose of aflibercept, even when receiving the rest of study treatment with placebo, was counted in the aflibercept treatment arm).
reporting Status
POSTED
time Frame
From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
title
Number of Participants With Adverse Events (AE)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice