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NCT01380145 · OUTCOME

Assessment of Safety of recMAGE-A3 + AS15

MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation · Source last updated 2022-10-25

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
Continuously for up to 14 months

What was measured

Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.

Analysis population: The Safety Analysis Set comprises all subjects who received at least 1 immunization with study drug.

Groups in this outcome

Safety Analysis Set

Includes all subjects who received at least 1 immunization with study drug.

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

Analysis denominator · Participants

GroupSource count
Safety Analysis Set13

Reported measurements

Any TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set13Not reportedNot reportedNot reportedNot reported
Grade 3 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set8Not reportedNot reportedNot reportedNot reported
Grade 4 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set4Not reportedNot reportedNot reportedNot reported
Grade 5 TEAE (Death)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set0Not reportedNot reportedNot reportedNot reported
Treatment-related TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set10Not reportedNot reportedNot reportedNot reported
SAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set4Not reportedNot reportedNot reportedNot reported
TEAE leading to withdrawal
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Safety Analysis Set0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        13
    title
    Any TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Grade 3 TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Grade 4 TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Grade 5 TEAE (Death)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Treatment-related TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    SAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    TEAE leading to withdrawal
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    units
    Participants
description
Analysis of treatment-emergent adverse events (TEAEs) reported from clinical laboratory tests, physical examinations, and vital signs, with severity graded according to the NCI CTCAE, Version 4.0.
groups
  1. description
    Includes all subjects who received at least 1 immunization with study drug.
    id
    OG000
    title
    Safety Analysis Set
param Type
NUMBER
population Description
The Safety Analysis Set comprises all subjects who received at least 1 immunization with study drug.
reporting Status
POSTED
time Frame
Continuously for up to 14 months
title
Assessment of Safety of recMAGE-A3 + AS15
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice