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NCT03512353 · OUTCOME

Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12

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
MEAN
Unit
percentage of expected dose
Interval / dispersion
Standard Deviation
Time frame
Cycles 1-6 and 7-12 (each cycle is 28 days)

What was measured

Percentage of expected dose of carfilzomib is defined as the percentage of actual cumulative dose (mg/m²) received by the participant relative to the full intended cumulative dose (mg/m²).

Analysis population: All enrolled and treated participants with available data in each time period

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

Cycles 1 - 6

Analysis denominator · Participants

GroupSource count
Carfilzomib Plus Dexamethasone6
Values in percentage of expected dose · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone92.078.70Not reportedNot reportedNot reported
Cycles 7 - 12

Analysis denominator · Participants

GroupSource count
Carfilzomib Plus Dexamethasone5
Values in percentage of expected dose · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib Plus Dexamethasone85.9612.98Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        8.70
        value
        92.07
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      units
      Participants
    title
    Cycles 1 - 6
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        12.98
        value
        85.96
    denoms
    1. counts
      1. group Id
        OG000
        value
        5
      units
      Participants
    title
    Cycles 7 - 12
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    units
    Participants
description
Percentage of expected dose of carfilzomib is defined as the percentage of actual cumulative dose (mg/m²) received by the participant relative to the full intended cumulative dose (mg/m²).
dispersion Type
Standard Deviation
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
MEAN
population Description
All enrolled and treated participants with available data in each time period
reporting Status
POSTED
time Frame
Cycles 1-6 and 7-12 (each cycle is 28 days)
title
Percentage of Expected Dose of Carfilzomib Received in Cycles 1 to 6 and 7 to 12
type
SECONDARY
unit Of Measure
percentage of expected dose

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

Preserved source evidence · Not medical advice