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NCT00765102 · OUTCOME

Participants With Treatment-emergent Adverse Events (TEAEs)

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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
up to 9 months

What was measured

Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.

Analysis population: Safety population of participants who took at least one dose of drug.

Groups in this outcome

Romidepsin + Bortezomib

Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.

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

Analysis denominator · Participants

GroupSource count
Romidepsin + Bortezomib32

Reported measurements

At least 1 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib32Not reportedNot reportedNot reportedNot reported
At least 1 drug-related TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib30Not reportedNot reportedNot reportedNot reported
At least 1 Romidepsin-related TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib28Not reportedNot reportedNot reportedNot reported
At least 1 Bortezomib-related TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib30Not reportedNot reportedNot reportedNot reported
At least 1 >=Grade 3 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib28Not reportedNot reportedNot reportedNot reported
At least 1 Grade 4 TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib5Not reportedNot reportedNot reportedNot reported
At least 1 serious TEAE
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib14Not reportedNot reportedNot reportedNot reported
At least 1 TEAE leading to discontinuation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib6Not reportedNot reportedNot reportedNot reported
At least 1 TEAE leading to death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Romidepsin + Bortezomib2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        32
    title
    At least 1 TEAE
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    At least 1 drug-related TEAE
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    At least 1 Romidepsin-related TEAE
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        30
    title
    At least 1 Bortezomib-related TEAE
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        28
    title
    At least 1 >=Grade 3 TEAE
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
    title
    At least 1 Grade 4 TEAE
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        14
    title
    At least 1 serious TEAE
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    At least 1 TEAE leading to discontinuation
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    At least 1 TEAE leading to death
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Counts of participants with TEAEs, and subset by relation to drug, grade of severity, serious, TEAEs leading to discontinuation or leading to death. AEs were graded for severity according to the National Cancer Institute Common Terminology Criteria (NCI CTCAE), V 3.0: Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe (prevents normal everyday activities); Grade 4: Life-threatening or disabling; Grade 5: Death.
groups
  1. description
    Romidepsin was given as an infusion on Days 1, 8 and 15 of each 28-day cycle. Bortezomib was administered twice a week for two consecutive weeks (Days 1, 4, 8 and 11) followed by a 17-day rest period. Patients were treated to a maximum response plus two additional cycles or a maximum of eight cycles.
    id
    OG000
    title
    Romidepsin + Bortezomib
param Type
NUMBER
population Description
Safety population of participants who took at least one dose of drug.
reporting Status
POSTED
time Frame
up to 9 months
title
Participants With Treatment-emergent Adverse Events (TEAEs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice