NCT00564889 · OUTCOME

Number of Participants With Severe Adverse Events

Lenalidomide, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Amyloidosis · Source last updated 2013-05-14

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: Duration of study (up to 3 years)

What was measured

Severe adverse events were defined as grade 3 or higher, at least possibly related to study drugs. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.

Groups in this outcome

Len/Cyc/Dex

Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m\^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly

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
Len/Cyc/Dex	35

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Len/Cyc/Dex	26	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
26

denoms

counts
group Id
OG000
value
35
units
Participants

description

groups

description
Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m\^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
id
OG000
title
Len/Cyc/Dex

param Type

NUMBER

reporting Status

POSTED

time Frame

Duration of study (up to 3 years)

title

Number of Participants With Severe Adverse Events

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice