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NCT00111813 · OUTCOME

Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug

Phase 1 Study of Vorinostat and Bortezomib in Multiple Myeloma (MK-0683-015 EXT 1 (AM1)) · Source last updated 2015-05-21

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 to disease progression, toxicity, or death, assessed up to 29 months

What was measured

An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.

Groups in this outcome

Vorinostat 200 mg + Bortezomib 0.7 mg/m^2

Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).

Vorinostat 200 mg + Bortezomib 0.9 mg/m^2

Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).

Vorinostat 300 mg + Bortezomib 1.3 mg/m^2

Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

Vorinostat 400 mg + Bortezomib 0.9 mg/m^2

Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

Vorinostat 400 mg + Bortezomib 1.1 mg/m^2

Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

Vorinostat 400 mg + Bortezomib 1.3 mg/m^2

Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).

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

Analysis denominator · Participants

GroupSource count
Vorinostat 200 mg + Bortezomib 0.7 mg/m^23
Vorinostat 200 mg + Bortezomib 0.9 mg/m^23
Vorinostat 300 mg + Bortezomib 1.3 mg/m^210
Vorinostat 400 mg + Bortezomib 0.9 mg/m^26
Vorinostat 400 mg + Bortezomib 1.1 mg/m^26
Vorinostat 400 mg + Bortezomib 1.3 mg/m^26

Reported measurements

No dose modification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vorinostat 200 mg + Bortezomib 0.7 mg/m^23Not reportedNot reportedNot reportedNot reported
Vorinostat 200 mg + Bortezomib 0.9 mg/m^23Not reportedNot reportedNot reportedNot reported
Vorinostat 300 mg + Bortezomib 1.3 mg/m^28Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 0.9 mg/m^24Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 1.1 mg/m^23Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 1.3 mg/m^23Not reportedNot reportedNot reportedNot reported
One dose modification
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vorinostat 200 mg + Bortezomib 0.7 mg/m^20Not reportedNot reportedNot reportedNot reported
Vorinostat 200 mg + Bortezomib 0.9 mg/m^20Not reportedNot reportedNot reportedNot reported
Vorinostat 300 mg + Bortezomib 1.3 mg/m^22Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 0.9 mg/m^22Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 1.1 mg/m^21Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 1.3 mg/m^20Not reportedNot reportedNot reportedNot reported
Two or more dose modifications
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Vorinostat 200 mg + Bortezomib 0.7 mg/m^20Not reportedNot reportedNot reportedNot reported
Vorinostat 200 mg + Bortezomib 0.9 mg/m^20Not reportedNot reportedNot reportedNot reported
Vorinostat 300 mg + Bortezomib 1.3 mg/m^20Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 0.9 mg/m^20Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 1.1 mg/m^22Not reportedNot reportedNot reportedNot reported
Vorinostat 400 mg + Bortezomib 1.3 mg/m^23Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        8
      4. group Id
        OG003
        value
        4
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        3
    title
    No dose modification
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
    title
    One dose modification
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        3
    title
    Two or more dose modifications
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    units
    Participants
description
An adverse experience (AE) was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which was temporally associated with the use of the sponsor's product, was also an adverse experience.
groups
  1. description
    Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
    id
    OG000
    title
    Vorinostat 200 mg + Bortezomib 0.7 mg/m^2
  2. description
    Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle).
    id
    OG001
    title
    Vorinostat 200 mg + Bortezomib 0.9 mg/m^2
  3. description
    Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
    id
    OG002
    title
    Vorinostat 300 mg + Bortezomib 1.3 mg/m^2
  4. description
    Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
    id
    OG003
    title
    Vorinostat 400 mg + Bortezomib 0.9 mg/m^2
  5. description
    Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
    id
    OG004
    title
    Vorinostat 400 mg + Bortezomib 1.1 mg/m^2
  6. description
    Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break). Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle).
    id
    OG005
    title
    Vorinostat 400 mg + Bortezomib 1.3 mg/m^2
param Type
NUMBER
reporting Status
POSTED
time Frame
Day 1 to disease progression, toxicity, or death, assessed up to 29 months
title
Number of Participants With Dose Modifications of Either Vorinostat or Bortezomib Due to Adverse Experiences (AEs) After Treatment With Study Drug
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice