NCT02545907 · OUTCOME

Number of Patients Experiencing Dose Delays Based on Reported Data.

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: Within 6 months

What was measured

The number of patients experiencing dose delays will be assessed based on reported data.

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

Group	Source count
Dose Level 0- Safety Population	3
Dose Level 1- Safety Population	7

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Dose Level 0- Safety Population	2	Not reported	Not reported	Not reported	Not reported
Dose Level 1- Safety Population	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
1

denoms

counts
group Id
OG000
value
3
group Id
OG001
value
7
units
Participants

description

The number of patients experiencing dose delays will be assessed based on reported data.

groups

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
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

reporting Status

POSTED

time Frame

Within 6 months

title

Number of Patients Experiencing Dose Delays Based on Reported Data.

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice