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NCT00642954 · OUTCOME

Number of Participants Experiencing Drug-Related Adverse Events (AEs)

Vorinostat (MK-0683, SAHA [Suberoylanilide Hydroxamic Acid]) + Lenalidomide + Dexamethasone in Multiple Myeloma (MM) (MK-0683-074) · Source last updated 2020-11-18

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
Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)

What was measured

An 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 of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug.

Analysis population: All participants who received ≥1 dose of study treatment.

Groups in this outcome

Level 1: Vorinostat 300 mg + Lenalidomide 10 mg

Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

Level 2: Vorinostat 400 mg + Lenalidomide 10 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

Level 3: Vorinostat 400 mg + Lenalidomide 15 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

Level 4: Vorinostat 400 mg + Lenalidomide 20 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.

Level 5: Vorinostat 400 mg + Lenalidomide 25 mg

Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg4
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg4
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg3
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg3
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg17

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Level 1: Vorinostat 300 mg + Lenalidomide 10 mg2Not reportedNot reportedNot reportedNot reported
Level 2: Vorinostat 400 mg + Lenalidomide 10 mg3Not reportedNot reportedNot reportedNot reported
Level 3: Vorinostat 400 mg + Lenalidomide 15 mg3Not reportedNot reportedNot reportedNot reported
Level 4: Vorinostat 400 mg + Lenalidomide 20 mg3Not reportedNot reportedNot reportedNot reported
Level 5: Vorinostat 400 mg + Lenalidomide 25 mg17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        17
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      4
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      17
    units
    Participants
description
An 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 of a pre-existing condition which is temporally associated with the use of the Sponsor's product is also an AE. An AE was considered related to a drug as determined by the investigator based on exposure (evidence of exposure to drug), time course (time of AE onset versus drug-induced effect), likely cause (AE etiology related or un-related to drug), de-challenge (drug dose reduction/discontinuation) or re-challenge (drug re-exposure). Per protocol participants experiencing drug-related AEs were analyzed at the time of the protocol-specified final statistical analysis with a 3-September (Sep)-2012 data cut-off. The number of participants experiencing drug-related AEs is reported here for all participants who got ≥1 dose of study drug.
groups
  1. description
    Participants received vorinostat 300 mg orally once-daily (QD) on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    OG000
    title
    Level 1: Vorinostat 300 mg + Lenalidomide 10 mg
  2. description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 10 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    OG001
    title
    Level 2: Vorinostat 400 mg + Lenalidomide 10 mg
  3. description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 15 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    OG002
    title
    Level 3: Vorinostat 400 mg + Lenalidomide 15 mg
  4. description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 20 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle for up to 8 cycles.
    id
    OG003
    title
    Level 4: Vorinostat 400 mg + Lenalidomide 20 mg
  5. description
    Participants received vorinostat 400 mg orally QD on Days 1-7 and Days 15-21; lenalidomide 25 mg orally QD on Days 1-21 and dexamethasone 40 mg orally QD on Days 1, 8, 15 and 22 of each 28-day cycle. Treatment continued until progressive disease or unacceptable toxicity.
    id
    OG004
    title
    Level 5: Vorinostat 400 mg + Lenalidomide 25 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
All participants who received ≥1 dose of study treatment.
reporting Status
POSTED
time Frame
Up to ~55 months (through pre-specified final statistical analysis cut-off date of 3-Sep-2012)
title
Number of Participants Experiencing Drug-Related Adverse Events (AEs)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice