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NCT01720043 · OUTCOME

Efficacy of Velcade

Hemostatic Effects of VELCADE®* Treatment in Multiple Myeloma Patients · Source last updated 2017-09-05

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

Measure
MEAN
Unit
percentage
Interval / dispersion
Standard Deviation
Time frame
48 hours

What was measured

Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.

Analysis population: One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.

Groups in this outcome

All Participants

All participants enrolled Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)

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 Participants7

Reported measurements

Collagen 5.g.ml, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-4.1437.244Not reportedNot reportedNot reported
Collagen 2.g.ml, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-4.4297.390Not reportedNot reportedNot reported
ADP.10.M, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-4.5716.949Not reportedNot reportedNot reported
ADP.5.M, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-6.4297.591Not reportedNot reportedNot reported
ADP.3.M, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-7.57116.400Not reportedNot reportedNot reported
Arach.Acid.0.5.mg.ml, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-11.14315.507Not reportedNot reportedNot reported
Ristocetin1.5.mg.ml, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-1.4297.345Not reportedNot reportedNot reported
Ristocetin.0.5.mg.ml, 24 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-2.4296.803Not reportedNot reportedNot reported
Collagen.5.g.mL, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-2.42910.130Not reportedNot reportedNot reported
Collagen.2.g.mL, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-0.85710.605Not reportedNot reportedNot reported
ADP.10.M, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-3.4297.044Not reportedNot reportedNot reported
ADP.5.M, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-3.57110.845Not reportedNot reportedNot reported
ADP.3.M, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants1.57113.587Not reportedNot reportedNot reported
Arach.Acid.0.5.mg.mL, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-2.28611.368Not reportedNot reportedNot reported
Ristocetin.1.5.mg.mL, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants.01439.353Not reportedNot reportedNot reported
Ristocetin.0.5.mg.mL, 48 hrs
Values in percentage · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
All Participants-2.0004.041Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Collagen.5.g.ml, 24 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.181
    statistical Method
    t-test, 2 sided
  2. group Description
    Collagen.2.g.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .164
    statistical Method
    t-test, 2 sided
  3. group Description
    ADP.10.M, 24 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .132
    statistical Method
    t-test, 2 sided
  4. group Description
    ADP.5.M
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .066
    statistical Method
    t-test, 2 sided
  5. group Description
    ADP.3.M, 24 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.268
    statistical Method
    t-test, 2 sided
  6. group Description
    Arach.Acid.0.5.mg.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.106
    statistical Method
    t-test, 2 sided
  7. group Description
    Ristocetin.1.5.mg.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.625
    statistical Method
    t-test, 2 sided
  8. group Description
    Ristocetin.0.5.mg.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.381
    statistical Method
    t-test, 2 sided
  9. group Description
    Collagen.5.g.ml, 48 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.549
    statistical Method
    t-test, 2 sided
  10. group Description
    Collagen.2.g.ml, 48 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .838
    statistical Method
    t-test, 2 sided
  11. group Description
    ADP.10.M
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.245
    statistical Method
    t-test, 2 sided
  12. group Description
    ADP.5.M
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.417
    statistical Method
    t-test, 2 sided
Complete source fields
analyses
  1. group Description
    Collagen.5.g.ml, 24 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.181
    statistical Method
    t-test, 2 sided
  2. group Description
    Collagen.2.g.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .164
    statistical Method
    t-test, 2 sided
  3. group Description
    ADP.10.M, 24 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .132
    statistical Method
    t-test, 2 sided
  4. group Description
    ADP.5.M
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .066
    statistical Method
    t-test, 2 sided
  5. group Description
    ADP.3.M, 24 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.268
    statistical Method
    t-test, 2 sided
  6. group Description
    Arach.Acid.0.5.mg.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.106
    statistical Method
    t-test, 2 sided
  7. group Description
    Ristocetin.1.5.mg.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.625
    statistical Method
    t-test, 2 sided
  8. group Description
    Ristocetin.0.5.mg.ml
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.381
    statistical Method
    t-test, 2 sided
  9. group Description
    Collagen.5.g.ml, 48 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.549
    statistical Method
    t-test, 2 sided
  10. group Description
    Collagen.2.g.ml, 48 hrs
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    .838
    statistical Method
    t-test, 2 sided
  11. group Description
    ADP.10.M
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.245
    statistical Method
    t-test, 2 sided
  12. group Description
    ADP.5.M
    group Ids
    1. OG000
    non Inferiority Type
    SUPERIORITY
    p Value
    0.417
    statistical Method
    t-test, 2 sided
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.244
        value
        -4.143
    title
    Collagen 5.g.ml, 24 hrs
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.390
        value
        -4.429
    title
    Collagen 2.g.ml, 24 hrs
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.949
        value
        -4.571
    title
    ADP.10.M, 24 hrs
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.591
        value
        -6.429
    title
    ADP.5.M, 24 hrs
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        16.400
        value
        -7.571
    title
    ADP.3.M, 24 hrs
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        15.507
        value
        -11.143
    title
    Arach.Acid.0.5.mg.ml, 24 hrs
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.345
        value
        -1.429
    title
    Ristocetin1.5.mg.ml, 24 hrs
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        6.803
        value
        -2.429
    title
    Ristocetin.0.5.mg.ml, 24 hrs
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.130
        value
        -2.429
    title
    Collagen.5.g.mL, 48 hrs
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.605
        value
        -0.857
    title
    Collagen.2.g.mL, 48 hrs
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        7.044
        value
        -3.429
    title
    ADP.10.M, 48 hrs
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.845
        value
        -3.571
    title
    ADP.5.M, 48 hrs
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    units
    Participants
description
Effect of VELCADE at 1.0-1.3 mg/m2 dose on platelet aggregation at 24 and 48 hour post-infusion in patients with multiple myeloma. The following components of platelet aggregation were evaluated at varying levels: Collagen, Adenine di-Phosphate (ADP), Arachidonic acid, and Ristocetin.
dispersion Type
Standard Deviation
groups
  1. description
    All participants enrolled Velcade: Single dose of Velcade (1.0-1.3 mg/m2 dose)
    id
    OG000
    title
    All Participants
param Type
MEAN
population Description
One patient withdrew before receiving the 24 hour dose, leaving 7 patients evaluable for response.
reporting Status
POSTED
time Frame
48 hours
title
Efficacy of Velcade
type
PRIMARY
unit Of Measure
percentage

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Preserved source evidence · Not medical advice