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NCT00675428 · OUTCOME

Number of Participants With Adverse Events (AEs)

Study of Natalizumab in Relapsed/Refractory Multiple Myeloma · Source last updated 2014-09-19

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
Day 1 up to Month 6

What was measured

An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.

Groups in this outcome

Natalizumab 300 mg

Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.

Natalizumab 450 mg

Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.

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

Analysis denominator · Participants

GroupSource count
Natalizumab 300 mg3
Natalizumab 450 mg3

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Natalizumab 300 mg3Not reportedNot reportedNot reportedNot reported
Natalizumab 450 mg3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    units
    Participants
description
An AE was defined as any untoward medical occurrence in a participant administered medicinal (investigational) product and that does not necessarily have a causal relationship with this product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. See the adverse events section of the record for more details.
groups
  1. description
    Intravenous (IV) infusions of natalizumab 300 mg once every 28 days for 6 months.
    id
    OG000
    title
    Natalizumab 300 mg
  2. description
    Intravenous (IV) infusions of natalizumab 450 mg once every 28 days for 6 months.
    id
    OG001
    title
    Natalizumab 450 mg
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 1 up to Month 6
title
Number of Participants With Adverse Events (AEs)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice