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NCT01154140 · OUTCOME

Percentage of Participants With Adverse Events (AEs) According to Maximum Severity

A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung · Source last updated 2017-11-06

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline up to follow up period (up to 72 months)

What was measured

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.

Analysis population: The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.

Groups in this outcome

Crizotinib

Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.

Chemotherapy

Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.

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

Analysis denominator · Participants

GroupSource count
Crizotinib171
Chemotherapy169

Reported measurements

Grade 1
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib7.0Not reportedNot reportedNot reportedNot reported
Chemotherapy9.5Not reportedNot reportedNot reportedNot reported
Grade 2
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib28.7Not reportedNot reportedNot reportedNot reported
Chemotherapy34.3Not reportedNot reportedNot reportedNot reported
Grade 3
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib41.5Not reportedNot reportedNot reportedNot reported
Chemotherapy44.4Not reportedNot reportedNot reportedNot reported
Grade 4
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib8.8Not reportedNot reportedNot reportedNot reported
Chemotherapy8.9Not reportedNot reportedNot reportedNot reported
Grade 5
Values in percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Crizotinib13.5Not reportedNot reportedNot reportedNot reported
Chemotherapy2.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7.0
      2. group Id
        OG001
        value
        9.5
    title
    Grade 1
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        28.7
      2. group Id
        OG001
        value
        34.3
    title
    Grade 2
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        41.5
      2. group Id
        OG001
        value
        44.4
    title
    Grade 3
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8.8
      2. group Id
        OG001
        value
        8.9
    title
    Grade 4
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        13.5
      2. group Id
        OG001
        value
        2.4
    title
    Grade 5
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      169
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to maximum severity grading based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Grade 1 =mild; Grade 2 =moderate; within normal limits, Grade 3 =severe or medically significant but not immediately life-threatening; Grade 4 =life-threatening or disabling; urgent intervention indicated; Grade 5 =death.
groups
  1. description
    Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
    id
    OG000
    title
    Crizotinib
  2. description
    Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
    id
    OG001
    title
    Chemotherapy
param Type
NUMBER
population Description
The safety analysis population included all randomized subjects who received at least 1 dose of study treatment, with treatment assignments designated according to actual study treatment received during the first cycle.
reporting Status
POSTED
time Frame
Baseline up to follow up period (up to 72 months)
title
Percentage of Participants With Adverse Events (AEs) According to Maximum Severity
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice