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NCT00396383 · OUTCOME

Participant Counts of Summarized Adverse Events (AE) During Treatment

Treatment With AMD3100 (Plerixafor) in MM Patients to Mobilize PBCs For Collection and for Transplantation · Source last updated 2014-03-13

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
1 month

What was measured

Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).

Analysis population: All participants who received plerixafor

Groups in this outcome

Participants With Multiple Myeloma (MM)

Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.

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

Analysis denominator · Participants

GroupSource count
Participants With Multiple Myeloma (MM)9

Reported measurements

AE Severity (Mild)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)3Not reportedNot reportedNot reportedNot reported
AE Severity (Moderate)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)6Not reportedNot reportedNot reportedNot reported
AE Severity (Severe)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)0Not reportedNot reportedNot reportedNot reported
Life-threatening AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)0Not reportedNot reportedNot reportedNot reported
AE Relationship to Drug (Not related)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)4Not reportedNot reportedNot reportedNot reported
AE Relationship to Drug (Probably not related)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)1Not reportedNot reportedNot reportedNot reported
AE Relationship to Drug (Possibly related)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)1Not reportedNot reportedNot reportedNot reported
AE Relationship to Drug (Probably related)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)3Not reportedNot reportedNot reportedNot reported
AE Relationship to Drug (Definitely related)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Participants With Multiple Myeloma (MM)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    AE Severity (Mild)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    AE Severity (Moderate)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    AE Severity (Severe)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Life-threatening AE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    AE Relationship to Drug (Not related)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    AE Relationship to Drug (Probably not related)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    AE Relationship to Drug (Possibly related)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    AE Relationship to Drug (Probably related)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    AE Relationship to Drug (Definitely related)
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    units
    Participants
description
Participant counts of summarized adverse events (AEs) which occurred from the first dose of plerixafor up to the day prior to chemotherapy/ablative treatment. Events were graded according to World Health Organization criteria: Mild (awareness of sign or symptom, but easily tolerated), Moderate (discomfort enough to cause interference with usual activity), Severe (incapacitating with inability to work or do usual activity).
groups
  1. description
    Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
    id
    OG000
    title
    Participants With Multiple Myeloma (MM)
param Type
NUMBER
population Description
All participants who received plerixafor
reporting Status
POSTED
time Frame
1 month
title
Participant Counts of Summarized Adverse Events (AE) During Treatment
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice