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NCT00483262 · OUTCOME

Toxicity. Number of Patients With Specific Toxicities Are Reported.

Combination CCI-779 (Temsirolimus) and Bortezomib (Velcade) in Relapsed and/or Relapsed/Refractory Multiple Myeloma · Source last updated 2013-11-11

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

Measure
NUMBER
Unit
percentage of patients
Interval / dispersion
95% Confidence Interval
Time frame
10 months

What was measured

Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.

Analysis population: Any patient who was treated was included in the analysis.

Groups in this outcome

CCI779 Toxicity Phase I

Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.

CCI779 Toxicity Phase II

Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used

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

Analysis denominator · Participants

GroupSource count
CCI779 Toxicity Phase I20
CCI779 Toxicity Phase II43

Reported measurements

Source class 1
Values in percentage of patients · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
CCI779 Toxicity Phase I90Not reported7298Not reported
CCI779 Toxicity Phase II79Not reported6689Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    .72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    .98
    estimate Comment
    Estimated proportion of patients with a adverse event of grade 3 or higher.
    group Description
    Single Arm Study
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    >= grade 3 adverse event proportion
    param Value
    .90
    tested Non Inferiority
    false
  2. ci Lower Limit
    .66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    .89
    estimate Comment
    No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.
    group Description
    Phase II toxicity
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    toxicity grade >=3 proportion
    param Value
    .79
    tested Non Inferiority
    false
Complete source fields
analyses
  1. ci Lower Limit
    .72
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    .98
    estimate Comment
    Estimated proportion of patients with a adverse event of grade 3 or higher.
    group Description
    Single Arm Study
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    >= grade 3 adverse event proportion
    param Value
    .90
    tested Non Inferiority
    false
  2. ci Lower Limit
    .66
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    90
    ci Upper Limit
    .89
    estimate Comment
    No comparison. Estimate the proportion of patients with grade 3 or higher toxicity.
    group Description
    Phase II toxicity
    group Ids
    1. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    param Type
    toxicity grade >=3 proportion
    param Value
    .79
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        72
        upper Limit
        98
        value
        90
      2. group Id
        OG001
        lower Limit
        66
        upper Limit
        89
        value
        79
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      43
    units
    Participants
description
Toxicity of CCI-779 (Temsirolimus) and bortezomib (Velcade) in patients with multiple myeloma.
dispersion Type
95% Confidence Interval
groups
  1. description
    Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
    id
    OG000
    title
    CCI779 Toxicity Phase I
  2. description
    Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
    id
    OG001
    title
    CCI779 Toxicity Phase II
param Type
NUMBER
population Description
Any patient who was treated was included in the analysis.
reporting Status
POSTED
time Frame
10 months
title
Toxicity. Number of Patients With Specific Toxicities Are Reported.
type
PRIMARY
unit Of Measure
percentage of patients

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice