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NCT03512353 · OUTCOME

Number of Participants With Treatment-emergent Adverse Events

A Study of Carfilzomib Plus Dexamethasone in Adults With Relapsed or Refractory Multiple Myeloma at US Community Oncology Centers · Source last updated 2021-01-08

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
From the first dose of study drug until 30 days after the last dose (12 months)

What was measured

Treatment-emergent adverse events are defined as any adverse event with an onset date from the first dose through 30 days after the last dose of any study drug. Treatment-emergent related adverse events are adverse events considered related to at least one study drug by the investigator. Adverse events were graded using Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, where Grade 1: Mild (asymptomatic or mild symptoms) Grade 2: Moderate (minimal, local or noninvasive intervention indicated) Grade 3: Severe (severe) or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated) Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

Analysis population: All enrolled and treated participants

Groups in this outcome

Carfilzomib Plus Dexamethasone

Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib Plus Dexamethasone6

Reported measurements

Any adverse event
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone6Not reportedNot reportedNot reportedNot reported
Adverse events ≥ Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Serious adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone3Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of carfilzomib
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Leading to discontinuation of dexamethasone
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone0Not reportedNot reportedNot reportedNot reported
Fatal adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone1Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone6Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events ≥ Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone4Not reportedNot reportedNot reportedNot reported
Treatment-related serious adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone3Not reportedNot reportedNot reportedNot reported
Treatment-related fatal adverse events
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Adverse events ≥ Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Serious adverse events
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Leading to discontinuation of carfilzomib
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Leading to discontinuation of dexamethasone
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Fatal adverse events
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Treatment-related adverse events
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        4
    title
    Treatment-related adverse events ≥ Grade 3
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Treatment-related serious adverse events
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Treatment-related fatal adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Treatment-emergent adverse events are defined as any adverse event with an onset date from the first dose through 30 days after the last dose of any study drug. Treatment-emergent related adverse events are adverse events considered related to at least one study drug by the investigator. Adverse events were graded using Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03, where Grade 1: Mild (asymptomatic or mild symptoms) Grade 2: Moderate (minimal, local or noninvasive intervention indicated) Grade 3: Severe (severe) or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated) Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.
groups
  1. description
    Participants received carfilzomib administered as an intravenous (IV) infusion twice-weekly for up to six 28-day cycles followed by once-weekly for another six 28-day cycles. The carfilzomib dose was 20 mg/m² on days 1 and 2 of cycle 1, 56 mg/m² for the remaining days of cycle 1 (days 8, 9, 15, and 16) and then on days 1, 2, 8, 9, 15, and 16 of each cycle for cycles 2 to 6, and 70 mg/m² on days 1, 8, and 15 of each cycle for cycles 7 to 12. Participants also received dexamethasone either orally or by IV infusion at a dose of 20 mg once daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1 to 6 and at a dose 40 mg once daily on days 1, 8, 15 of cycles 7 to 12.
    id
    OG000
    title
    Carfilzomib Plus Dexamethasone
param Type
COUNT_OF_PARTICIPANTS
population Description
All enrolled and treated participants
reporting Status
POSTED
time Frame
From the first dose of study drug until 30 days after the last dose (12 months)
title
Number of Participants With Treatment-emergent Adverse Events
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice