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NCT00985959 · OUTCOME

Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) · Source last updated 2013-12-02

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
6 weeks

What was measured

Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1

Analysis population: Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I

Groups in this outcome

Phase I - JNJ-26866138 0.7 mg/m2 Group

JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase I - JNJ-26866138 1.0 mg/m2 Group

JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase I - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 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
Phase I - JNJ-26866138 0.7 mg/m2 Group6
Phase I - JNJ-26866138 1.0 mg/m2 Group6
Phase I - JNJ-26866138 1.3 mg/m2 Group6

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I - JNJ-26866138 0.7 mg/m2 Group0Not reportedNot reportedNot reportedNot reported
Phase I - JNJ-26866138 1.0 mg/m2 Group0Not reportedNot reportedNot reportedNot reported
Phase I - JNJ-26866138 1.3 mg/m2 Group1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      6
    units
    Participants
description
Dose limiting toxicity defined as an adverse event or adverse drug reaction experienced by the participants during 6 weeks of treatment Cycle 1
groups
  1. description
    JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG000
    title
    Phase I - JNJ-26866138 0.7 mg/m2 Group
  2. description
    JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG001
    title
    Phase I - JNJ-26866138 1.0 mg/m2 Group
  3. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG002
    title
    Phase I - JNJ-26866138 1.3 mg/m2 Group
param Type
NUMBER
population Description
Dose Limiting Toxicity set, Which includes all 18 participants in the Phase I
reporting Status
POSTED
time Frame
6 weeks
title
Number of Participants With Dose Limiting Toxicity During the Phase I (Cycle 1)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice