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NCT02545907 · OUTCOME

Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.

A Dose Escalation Study of Carfilzomib Taken With Thalidomide and Dexamethasone in Relapsed AL Amyloidosis · Source last updated 2021-04-15

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
Between informed consent provided and 30 days post last trial treatment administration, up to 7 months

What was measured

The percentage of patients treated who experience any grade 3 or 4 toxicity as assessed by CTCAE v4.0 throughout all treatment cycles will be assessed based on reported data.

Analysis population: All patients that receive at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.

Groups in this outcome

Dose Level 0- Safety Population

All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.

Dose Level 1- Safety Population

All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.

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

Analysis denominator · Participants

GroupSource count
Dose Level 0- Safety Population3
Dose Level 1- Safety Population7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 0- Safety Population2Not reportedNot reportedNot reportedNot reported
Dose Level 1- Safety Population3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      7
    units
    Participants
description
The percentage of patients treated who experience any grade 3 or 4 toxicity as assessed by CTCAE v4.0 throughout all treatment cycles will be assessed based on reported data.
groups
  1. description
    All patients allocated to dose level 0 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
    id
    OG000
    title
    Dose Level 0- Safety Population
  2. description
    All patients allocated to dose level 1 that received at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
    id
    OG001
    title
    Dose Level 1- Safety Population
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients that receive at least one dose of Carfilzomib and with no protocol deviations with relevant impact on safety will be included in the safety analysis set.
reporting Status
POSTED
time Frame
Between informed consent provided and 30 days post last trial treatment administration, up to 7 months
title
Number of Participants Experiencing Grade 3 or 4 Toxicity as Assessed by CTCAE v4.0.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice