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NCT01121588 · OUTCOME

Number of Participants With All-Causality TEAEs in the Pediatric Population

Studying An Investigational Drug Crizotinib (PF-02341066) In Non Non-Small Cell Lung Cancer Tumors That Are Positive For Anaplastic Lymphoma Kinase (ALK) · Source last updated 2025-01-23

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)

What was measured

An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication.Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.

Analysis population: Enrolled pediatric (\<18 years old) participants who received at least 1 dose of study treatment.

Groups in this outcome

ALCL Arm

In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

IMT Arm

In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

Other Tumors

In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.

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

Analysis denominator · Participants

GroupSource count
ALCL Arm3
IMT Arm2
Other Tumors0

Reported measurements

AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm3Not reportedNot reportedNot reportedNot reported
IMT Arm2Not reportedNot reportedNot reportedNot reported
SAEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm2Not reportedNot reportedNot reportedNot reported
IMT Arm1Not reportedNot reportedNot reportedNot reported
Maximum Grade 3 or 4 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm3Not reportedNot reportedNot reportedNot reported
IMT Arm2Not reportedNot reportedNot reportedNot reported
Maximum Grade 5 AEs
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm0Not reportedNot reportedNot reportedNot reported
IMT Arm0Not reportedNot reportedNot reportedNot reported
AEs resulting in study treatment discontinuation (participant continued study)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm0Not reportedNot reportedNot reportedNot reported
IMT Arm0Not reportedNot reportedNot reportedNot reported
AEs resulting in dose reduction
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm1Not reportedNot reportedNot reportedNot reported
IMT Arm0Not reportedNot reportedNot reportedNot reported
AEs resulting in temporary discontinuation of study treatment
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
ALCL Arm2Not reportedNot reportedNot reportedNot reported
IMT Arm2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    AEs
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    SAEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
    title
    Maximum Grade 3 or 4 AEs
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Maximum Grade 5 AEs
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    AEs resulting in study treatment discontinuation (participant continued study)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    AEs resulting in dose reduction
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    AEs resulting in temporary discontinuation of study treatment
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      0
    units
    Participants
description
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. Serious AE was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly. Treatment-emergent AEs were those with initial onset or that worsened in severity after the first dose of study medication.Grades of AEs were defined by NCI CTCAE version 4.03. Grade 3=severe or medically significant but not immediately life-threatening, hospitalization of prolongation of hospitalization indicated; disabling limiting self-care ADL; Grade 4=events with life-threatening consequences, urgent intervention indicated; Grade 5=death related to AE.
groups
  1. description
    In ALK genetic event positive participants with ALCL, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG000
    title
    ALCL Arm
  2. description
    In ALK genetic event positive participants with IMT, crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG001
    title
    IMT Arm
  3. description
    In ALK genetic event positive participants with other tumors (excluding non-small cell lung cancer), crizotinib 250 mg twice daily (BID) was administered orally at approximately the same time each day on a continuous daily dosing schedule. Crizotinib was allowed to be taken without regard to meals. Cycles were defined in 21 day periods. Participants could have continued treatment with crizotinib on this study as long as there was evidence of clinical benefit in the judgment of the Investigator.
    id
    OG002
    title
    Other Tumors
param Type
COUNT_OF_PARTICIPANTS
population Description
Enrolled pediatric (\<18 years old) participants who received at least 1 dose of study treatment.
reporting Status
POSTED
time Frame
From the first dose of study treatment up to 28 days after the last dose of study treatment (maximum 342 weeks)
title
Number of Participants With All-Causality TEAEs in the Pediatric Population
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice