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NCT01001377 · OUTCOME

Number of Participants With Adverse Events (AEs)

ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer · Source last updated 2022-09-21

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 day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.

What was measured

Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.

Analysis population: Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.

Groups in this outcome

Cetuximab

Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.

Panitumumab

Panitumumab 6 mg/kg IV every 14 days.

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

Analysis denominator · Participants

GroupSource count
Cetuximab503
Panitumumab496

Reported measurements

Any adverse event (AE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab494Not reportedNot reportedNot reportedNot reported
Panitumumab485Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab169Not reportedNot reportedNot reportedNot reported
Panitumumab151Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab61Not reportedNot reportedNot reportedNot reported
Panitumumab69Not reportedNot reportedNot reportedNot reported
Any treatment-related adverse event (TRAE)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab459Not reportedNot reportedNot reportedNot reported
Panitumumab437Not reportedNot reportedNot reportedNot reported
Treatment-related serious adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab22Not reportedNot reportedNot reportedNot reported
Panitumumab25Not reportedNot reportedNot reportedNot reported
TRAE leading to discontinuation of study drug
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cetuximab15Not reportedNot reportedNot reportedNot reported
Panitumumab14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        494
      2. group Id
        OG001
        value
        485
    title
    Any adverse event (AE)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        169
      2. group Id
        OG001
        value
        151
    title
    Serious adverse events
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        61
      2. group Id
        OG001
        value
        69
    title
    Leading to discontinuation of study drug
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        459
      2. group Id
        OG001
        value
        437
    title
    Any treatment-related adverse event (TRAE)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        22
      2. group Id
        OG001
        value
        25
    title
    Treatment-related serious adverse event
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        14
    title
    TRAE leading to discontinuation of study drug
denoms
  1. counts
    1. group Id
      OG000
      value
      503
    2. group Id
      OG001
      value
      496
    units
    Participants
description
Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.
groups
  1. description
    Cetuximab 400 mg/m\^2 as an initial dose, followed by 250 mg/m\^2 intravenously (IV) every 7 days.
    id
    OG000
    title
    Cetuximab
  2. description
    Panitumumab 6 mg/kg IV every 14 days.
    id
    OG001
    title
    Panitumumab
param Type
NUMBER
population Description
Safety Analysis Set (randomized participants who received at least 1 dose of study medication). Five participants who received the incorrect study medication (4 assigned to panitumumab but received cetuximab and 1 assigned to cetuximab but received panitumumab) were included in different treatment arms for safety analyses.
reporting Status
POSTED
time Frame
From the day of the first dose of study therapy through 30 days since the last dose. Maximum time on study treatment was 130 weeks.
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 · Not medical advice