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NCT00966693 · OUTCOME

Progression Free Survival

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
MEAN
Unit
Months
Interval / dispersion
Standard Deviation
Time frame
Up to 9 years

What was measured

Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.

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)3
RTD (Cohort 2, Phase 1)3
RTD (Cohort 3, Phase 1)9
RTD (Cohort 2, Phase 2)49

Reported measurements

Source class 1
Values in Months · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
RTD (Cohort 1, Phase 1)32.7427Not reportedNot reportedNot reported
RTD (Cohort 2, Phase 1)9.047.49Not reportedNot reportedNot reported
RTD (Cohort 3, Phase 1)14.6116.41Not reportedNot reportedNot reported
RTD (Cohort 2, Phase 2)10.0217.61Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27
        value
        32.74
      2. group Id
        OG001
        spread
        7.49
        value
        9.04
      3. group Id
        OG002
        spread
        16.41
        value
        14.61
      4. group Id
        OG003
        spread
        17.61
        value
        10.02
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      49
    units
    Participants
description
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
dispersion Type
Standard Deviation
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
MEAN
reporting Status
POSTED
time Frame
Up to 9 years
title
Progression Free Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice