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NCT01055314 · OUTCOME

Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma · Source last updated 2017-08-29

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
Up to 54 weeks

What was measured

Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.

Analysis population: 9 participants who were ineligible or did not receive treatment were excluded.

Groups in this outcome

IMC-A12

IMC-A12 + Multi-agent intensive chemotherapy regimen.

Temozolomide

Add temozolomide to vincristine/irinotecan cycles.

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

Analysis denominator · Participants

GroupSource count
IMC-A1296
Temozolomide70

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IMC-A1289Not reportedNot reportedNot reportedNot reported
Temozolomide61Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        89
      2. group Id
        OG001
        value
        61
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      70
    units
    Participants
description
Number of patients with grade 3+ adverse events (AE) during therapy. (Grade 3+) = (Grade 3 + Grade 4 + Grade 5) . Grade 3: Severe and undesirable AE; Grade 4: Life threatening or disabling AE; Grade 5: Death related to AE.
groups
  1. description
    IMC-A12 + Multi-agent intensive chemotherapy regimen.
    id
    OG000
    title
    IMC-A12
  2. description
    Add temozolomide to vincristine/irinotecan cycles.
    id
    OG001
    title
    Temozolomide
param Type
NUMBER
population Description
9 participants who were ineligible or did not receive treatment were excluded.
reporting Status
POSTED
time Frame
Up to 54 weeks
title
Incidence of Adverse Events Assessed by Common Terminology Criteria for Adverse Events Version 4.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice