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NCT00339183 · OUTCOME

Number of Participants With Adverse Events (AEs)

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone · Source last updated 2022-09-23

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 randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.

What was measured

A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"

Analysis population: Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.

Groups in this outcome

Panitumumab Plus FOLFIRI

Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.

FOLFIRI Alone

Participants received FOLFIRI chemotherapy regimen administered in cycles 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
Panitumumab Plus FOLFIRI587
FOLFIRI Alone594

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panitumumab Plus FOLFIRI584Not reportedNot reportedNot reportedNot reported
FOLFIRI Alone573Not reportedNot reportedNot reportedNot reported
Serious adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panitumumab Plus FOLFIRI232Not reportedNot reportedNot reportedNot reported
FOLFIRI Alone175Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of any study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panitumumab Plus FOLFIRI123Not reportedNot reportedNot reportedNot reported
FOLFIRI Alone64Not reportedNot reportedNot reportedNot reported
Treatment-related adverse event (TRAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panitumumab Plus FOLFIRI577Not reportedNot reportedNot reportedNot reported
FOLFIRI Alone542Not reportedNot reportedNot reportedNot reported
Serious treatment-related adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panitumumab Plus FOLFIRI124Not reportedNot reportedNot reportedNot reported
FOLFIRI Alone90Not reportedNot reportedNot reportedNot reported
TRAE leading to discontinuation of any study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Panitumumab Plus FOLFIRI97Not reportedNot reportedNot reportedNot reported
FOLFIRI Alone34Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        584
      2. group Id
        OG001
        value
        573
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        232
      2. group Id
        OG001
        value
        175
    title
    Serious adverse event
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        123
      2. group Id
        OG001
        value
        64
    title
    Leading to discontinuation of any study drug
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        577
      2. group Id
        OG001
        value
        542
    title
    Treatment-related adverse event (TRAE)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        124
      2. group Id
        OG001
        value
        90
    title
    Serious treatment-related adverse event
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        97
      2. group Id
        OG001
        value
        34
    title
    TRAE leading to discontinuation of any study drug
denoms
  1. counts
    1. group Id
      OG000
      value
      587
    2. group Id
      OG001
      value
      594
    units
    Participants
description
A serious adverse event (SAE) is defined by regulatory authorities as one that • is fatal • is life threatening (places the subject at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • other significant medical hazard. The relationship of the adverse event to the study treatment was assessed by the Investigator by means of the question: "Is there a reasonable possibility that the event may have been caused by the study treatment?"
groups
  1. description
    Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
    id
    OG000
    title
    Panitumumab Plus FOLFIRI
  2. description
    Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
    id
    OG001
    title
    FOLFIRI Alone
param Type
NUMBER
population Description
Safety analysis set: all participants who received at least 1 dose of panitumumab or chemotherapy. One participant was randomized to Panitumumab Plus FOLFIRI, but received FOLFIRI Alone and is included in the FOLFIRI Alone group for safety analyses.
reporting Status
POSTED
time Frame
From randomization until the data cut-off date of 30 April 2009. Maximum follow-up time was 33 months.
title
Number of Participants With Adverse Events (AEs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Independent clinical review pending · Not medical advice