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NCT01949532 · OUTCOME

Number of Participants With Adverse Events (AEs)

Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease · Source last updated 2017-05-02

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
From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.

What was measured

Determination of the severity of all adverse events was assessed following the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal. A Serious AE is an AE that meets one or more of the following criteria: * Death, * Life-threatening experience; * Requires in-patient hospitalization or prolongation of an existing hospitalization, * Results in persistent or significant disability/incapacity, * Is a congenital anomaly/birth defect, * Important medical events that may not result in death, be life-threatening, or require hospitalization. Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.

Analysis population: All treated participants

Groups in this outcome

Normal Renal Function

Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.

End Stage Renal Disease

Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent 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
Normal Renal Function15
End Stage Renal Disease11

Reported measurements

Any adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function15Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease11Not reportedNot reportedNot reportedNot reported
Adverse event ≥ Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function12Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease9Not reportedNot reportedNot reportedNot reported
Serious adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function10Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease9Not reportedNot reportedNot reportedNot reported
AE leading to discontinuation of carfilzomib
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function6Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease0Not reportedNot reportedNot reportedNot reported
Fatal adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function2Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease1Not reportedNot reportedNot reportedNot reported
Treatment-related adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function12Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease8Not reportedNot reportedNot reportedNot reported
Treatment-related adverse event ≥ Grade 3
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function7Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease6Not reportedNot reportedNot reportedNot reported
Serious treatment-related adverse event
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function5Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease2Not reportedNot reportedNot reportedNot reported
TRAE leading to discontinuation of carfilzomib
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function4Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease0Not reportedNot reportedNot reportedNot reported
Treatment-related fatal adverse events
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Normal Renal Function0Not reportedNot reportedNot reportedNot reported
End Stage Renal Disease0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        11
    title
    Any adverse event
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        9
    title
    Adverse event ≥ Grade 3
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        9
    title
    Serious adverse event
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        0
    title
    AE leading to discontinuation of carfilzomib
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Fatal adverse events
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        8
    title
    Treatment-related adverse events
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        6
    title
    Treatment-related adverse event ≥ Grade 3
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    Serious treatment-related adverse event
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    TRAE leading to discontinuation of carfilzomib
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Treatment-related fatal adverse events
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      11
    units
    Participants
description
Determination of the severity of all adverse events was assessed following the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 4.03, where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Fatal. A Serious AE is an AE that meets one or more of the following criteria: * Death, * Life-threatening experience; * Requires in-patient hospitalization or prolongation of an existing hospitalization, * Results in persistent or significant disability/incapacity, * Is a congenital anomaly/birth defect, * Important medical events that may not result in death, be life-threatening, or require hospitalization. Treatment-related adverse events (TRAEs) are adverse events considered related to carfilzomib by the investigator, including those with unknown relationship.
groups
  1. description
    Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
    id
    OG000
    title
    Normal Renal Function
  2. description
    Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
    id
    OG001
    title
    End Stage Renal Disease
param Type
NUMBER
population Description
All treated participants
reporting Status
POSTED
time Frame
From the first dose of study drug up to 30 days after the last dose of study drug as of the data cut-off date of 12 October 2015; median duration of treatment was 14 weeks in the normal renal function group and 12 weeks in the ESRD group.
title
Number of Participants With Adverse Events (AEs)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice