NCT00540644 · OUTCOME

Treatment Related Adverse Events Grade 3 or Higher

Phase II Study of Revlimid®, Oral Cyclophosphamide and Prednisone for Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2016-06-21

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: Beginning of treatment up to 5 years

What was measured

Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

Analysis population: All patients enrolled and received treatment.

Groups in this outcome

Original Study - Revlimid, Cyclophosphamide, Prednisone

Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

Extension - Revlimid, Cyclophosphamide, Prednisone

Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.

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
Original Study - Revlimid, Cyclophosphamide, Prednisone	48
Extension - Revlimid, Cyclophosphamide, Prednisone	22

Reported measurements

Source class 1

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Original Study - Revlimid, Cyclophosphamide, Prednisone	21	Not reported	Not reported	Not reported	Not reported
Extension - Revlimid, Cyclophosphamide, Prednisone	11	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
21
group Id
OG001
value
11

denoms

counts
group Id
OG000
value
48
group Id
OG001
value
22
units
Participants

description

Number of unique patients who had treatment related (possible, probable or definite) adverse events that were graded 3 or greater.

groups

description
Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
id
OG000
title
Original Study - Revlimid, Cyclophosphamide, Prednisone
description
Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
id
OG001
title
Extension - Revlimid, Cyclophosphamide, Prednisone

param Type

NUMBER

population Description

All patients enrolled and received treatment.

reporting Status

POSTED

time Frame

Beginning of treatment up to 5 years

title

Treatment Related Adverse Events Grade 3 or Higher

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice