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NCT01050790 · OUTCOME

Toxicity as Assessed by NCI CTCAE v3.0

Lenalidomide + Azacitidine for Adaptive Immunotherapy -> Auto SCT in Multiple Myeloma · Source last updated 2018-06-26

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 months

What was measured

Time frame includes after stem cell transplant engraftment. Toxicity post ALI infusion: 1 patient grade 1 hypertension 90 min post infusion. Toxicity post Rev maintenance: 1 patient not tolerated, 1 patient dose decreased due to counts.

Groups in this outcome

5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant

azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21

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

Analysis denominator · Participants

GroupSource count
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant17

Reported measurements

Toxicity post ALI infusion
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant1Not reportedNot reportedNot reportedNot reported
Toxicity post Rev maintenance
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Toxicity post ALI infusion
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Toxicity post Rev maintenance
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    units
    Participants
description
Time frame includes after stem cell transplant engraftment. Toxicity post ALI infusion: 1 patient grade 1 hypertension 90 min post infusion. Toxicity post Rev maintenance: 1 patient not tolerated, 1 patient dose decreased due to counts.
groups
  1. description
    azacitidine: 75 mg/sq m daily for 5 days lenalidomide: 10 mg p.o. daily, Days 6-21
    id
    OG000
    title
    5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant
param Type
NUMBER
reporting Status
POSTED
time Frame
6 months
title
Toxicity as Assessed by NCI CTCAE v3.0
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice