Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00395967 · OUTCOME

Overall Participants Counts of Adverse Events

AMD3100 (Plerixafor) in Multiple Myeloma (MM) or Non-Hodgkin's Lymphoma (NHL) Patients Predicted to be Unable to Mobilize With G-CSF Alone · Source last updated 2015-05-01

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
up to 13 months

What was measured

Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.

Analysis population: Safety Population defined as all participants who received G-CSF and/or plerixafor.

Groups in this outcome

All Patients

Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.

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

Analysis denominator · Participants

GroupSource count
All Patients5

Reported measurements

Participants Reporting At Least One AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients5Not reportedNot reportedNot reportedNot reported
Participants Reporting a Severe AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients4Not reportedNot reportedNot reportedNot reported
Participants Reporting a Life-threatening AE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients2Not reportedNot reportedNot reportedNot reported
AE Relation to Drug: Not Related or Probably Not
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients3Not reportedNot reportedNot reportedNot reported
AE Relation to Drug: Possibly Related
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients2Not reportedNot reportedNot reportedNot reported
AE Relation to Drug: Probably or Definitely Relate
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients0Not reportedNot reportedNot reportedNot reported
Serious Adverse Events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients4Not reportedNot reportedNot reportedNot reported
AEs Leading to Discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
All Patients0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    Participants Reporting At Least One AE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Participants Reporting a Severe AE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Participants Reporting a Life-threatening AE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    AE Relation to Drug: Not Related or Probably Not
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    AE Relation to Drug: Possibly Related
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    AE Relation to Drug: Probably or Definitely Relate
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Serious Adverse Events
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    AEs Leading to Discontinuation
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Numbers of participants with adverse events (AEs) collected from Day 1 (start of G-CSF Mobilization) to 12 months after transplantation. AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale and provided assessments of seriousness and relatedness to study treatment.
groups
  1. description
    Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
    id
    OG000
    title
    All Patients
param Type
NUMBER
population Description
Safety Population defined as all participants who received G-CSF and/or plerixafor.
reporting Status
POSTED
time Frame
up to 13 months
title
Overall Participants Counts of Adverse Events
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice