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NCT00966693 · OUTCOME

Incidence of Adverse Events

Lenalidomide, Thalidomide and Dexamethasone in Treating Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2020-11-04

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
Up to 9 years

What was measured

Linear regression was utilized to assess the effect of patient prognostic factors on the toxicity rate.

Analysis population: The Number in each of the arms was insufficient to conduct regression analyses, therefore regression analyses was conducted overall. Participants who were Thalidomide incompatible.

Groups in this outcome

RTD (Cohort 1, Phase 1)

Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle

RTD (Cohort 2, Phase 1)

Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle

RTD (Cohort 3, Phase 1)

Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle

RTD (Cohort 2, Phase 2)

Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle

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

Analysis denominator · Participants

GroupSource count
RTD (Cohort 1, Phase 1)2
RTD (Cohort 2, Phase 1)3
RTD (Cohort 3, Phase 1)6
RTD (Cohort 2, Phase 2)49

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)0Not reportedNot reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)2Not reportedNot reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)10Not 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
        2
      4. group Id
        OG003
        value
        10
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      49
    units
    Participants
description
Linear regression was utilized to assess the effect of patient prognostic factors on the toxicity rate.
groups
  1. description
    Oral Revlimid 15mg, Thalidomide 100mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG000
    title
    RTD (Cohort 1, Phase 1)
  2. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG001
    title
    RTD (Cohort 2, Phase 1)
  3. description
    Oral Revlimid 25mg, Thalidomide 200mg, Dexamethasone 40mg\*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG002
    title
    RTD (Cohort 3, Phase 1)
  4. description
    Oral Revlimid 25mg, Thalidomide 100mg, Dexamethasone \*21 days+ 7 days rest and reevaluation=28 day cycle
    id
    OG003
    title
    RTD (Cohort 2, Phase 2)
param Type
COUNT_OF_PARTICIPANTS
population Description
The Number in each of the arms was insufficient to conduct regression analyses, therefore regression analyses was conducted overall. Participants who were Thalidomide incompatible.
reporting Status
POSTED
time Frame
Up to 9 years
title
Incidence of Adverse Events
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice