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NCT01055314 · OUTCOME

Response Rate (CR + PR)

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
Proportion of Participants
Interval / dispersion
95% Confidence Interval
Time frame
From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities

What was measured

Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \> 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.

Analysis population: 20 participants were excluded because of ineligibility or absence in overall response evaluation.

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-A1290
Temozolomide65

Reported measurements

Source class 1
Values in Proportion of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
IMC-A120.7667Not reported0.67930.8540Not reported
Temozolomide0.7846Not reported0.68470.8846Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.6793
        upper Limit
        0.8540
        value
        0.7667
      2. group Id
        OG001
        lower Limit
        0.6847
        upper Limit
        0.8846
        value
        0.7846
denoms
  1. counts
    1. group Id
      OG000
      value
      90
    2. group Id
      OG001
      value
      65
    units
    Participants
description
Proportion of patients with complete or partial response. Complete Response (CR): Complete disappearance of the tumor confirmed at \> 4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment; Overall Response (OR) = CR + PR.
dispersion Type
95% Confidence Interval
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
20 participants were excluded because of ineligibility or absence in overall response evaluation.
reporting Status
POSTED
time Frame
From the start of treatment until a maximum of 2 cycles (21 days per cycle) of treatment in the absence of disease progression or unacceptable toxicities
title
Response Rate (CR + PR)
type
SECONDARY
unit Of Measure
Proportion of Participants

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

Preserved source evidence · Not medical advice