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NCT00103662 · OUTCOME

Number of Participants With Adverse Events

Mobilization of Stem Cells With AMD3100 (Plerixafor) in Multiple Myeloma Patients · 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
up to Day 38

What was measured

Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.

Analysis population: Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.

Groups in this outcome

G-CSF Plus Plerixafor

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.

G-CSF Plus Placebo

Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.

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

Analysis denominator · Participants

GroupSource count
G-CSF Plus Plerixafor147
G-CSF Plus Placebo151

Reported measurements

Adverse Events (AEs)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor140Not reportedNot reportedNot reportedNot reported
G-CSF Plus Placebo140Not reportedNot reportedNot reportedNot reported
Related AEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor95Not reportedNot reportedNot reportedNot reported
G-CSF Plus Placebo67Not reportedNot reportedNot reportedNot reported
AEs Leading to early treatment termination
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor1Not reportedNot reportedNot reportedNot reported
G-CSF Plus Placebo2Not reportedNot reportedNot reportedNot reported
AEs Leading to early termination
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor3Not reportedNot reportedNot reportedNot reported
G-CSF Plus Placebo0Not reportedNot reportedNot reportedNot reported
Grade 3 (severe) or 4 (life-threatening) AEs
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor11Not reportedNot reportedNot reportedNot reported
G-CSF Plus Placebo11Not reportedNot reportedNot reportedNot reported
Serious Adverse Events (SAEs)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
G-CSF Plus Plerixafor4Not reportedNot reportedNot reportedNot reported
G-CSF Plus Placebo6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        140
      2. group Id
        OG001
        value
        140
    title
    Adverse Events (AEs)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        95
      2. group Id
        OG001
        value
        67
    title
    Related AEs
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        2
    title
    AEs Leading to early treatment termination
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    AEs Leading to early termination
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        11
      2. group Id
        OG001
        value
        11
    title
    Grade 3 (severe) or 4 (life-threatening) AEs
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
    title
    Serious Adverse Events (SAEs)
denoms
  1. counts
    1. group Id
      OG000
      value
      147
    2. group Id
      OG001
      value
      151
    units
    Participants
description
Number of participants with treatment emergent adverse events (AEs). The timeframe for treatment emergent AEs is defined as Day 1 (start of G-CSF Mobilization) to the day before starting chemotherapy (approximately 38 days later). AEs were reported regardless of relationship to study treatment. The investigator graded each AE using the World Health Organization (WHO) Adverse Event Grading Scale. AEs of Grade 3 were considered severe and Grade 4 were considered life-threatening.
groups
  1. description
    Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.
    id
    OG000
    title
    G-CSF Plus Plerixafor
  2. description
    Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6\*10\^6 CD34+ cells/kg were collected.
    id
    OG001
    title
    G-CSF Plus Placebo
param Type
NUMBER
population Description
Primary Safety population of all participants who received at least 1 mobilization dose of G-CSF or study treatment (plerixafor or placebo). Four participants did not receive G-CSF or any study treatment and were excluded from the safety analyses.
reporting Status
POSTED
time Frame
up to Day 38
title
Number of Participants With Adverse Events
type
SECONDARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice