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NCT02958969 · OUTCOME

Frequency of Major and Clinically Relevant Non-major Bleeding

Apixaban for Primary Prevention of Venous Thromboembolism in Patients With Multiple Myeloma · Source last updated 2019-12-17

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
6 months

What was measured

Major and clinically relevant non-major bleeding. Using the ISTH classification, bleeding is defined as major if it is overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, requires the transfusion of 2 or more units of blood, occurs into a critical site, or contributes to death (12). Using the ISTH classification, clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.

Groups in this outcome

Apixaban

apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 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
Apixaban50

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Apixaban3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    units
    Participants
description
Major and clinically relevant non-major bleeding. Using the ISTH classification, bleeding is defined as major if it is overt and associated with a decrease in the hemoglobin level of 2 g/dL or more, requires the transfusion of 2 or more units of blood, occurs into a critical site, or contributes to death (12). Using the ISTH classification, clinically relevant nonmajor bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, surgical intervention, or interruption of the study drug.
groups
  1. description
    apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months Apixaban: apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
    id
    OG000
    title
    Apixaban
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
6 months
title
Frequency of Major and Clinically Relevant Non-major Bleeding
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice