NCT01794039 · OUTCOME

Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Pomalidomide or Lenalidomide and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide · Source last updated 2018-08-21

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: Up to 30 days after last day of study drug treatment

What was measured

Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.

Analysis population: All treated patients are evaluable for Adverse Events

Groups in this outcome

Arm A (Lenalidomide, Dexamethasone)

Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. \> \> Dexamethasone: Given PO \> \> Lenalidomide: Given PO

Arm B (Pomalidomide, Dexamethasone)

Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Dexamethasone: Given PO \> \> Pomalidomide: Given PO

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
Arm A (Lenalidomide, Dexamethasone)	5
Arm B (Pomalidomide, Dexamethasone)	4

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Arm A (Lenalidomide, Dexamethasone)	5	Not reported	Not reported	Not reported	Not reported
Arm B (Pomalidomide, Dexamethasone)	4	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
4
units
Participants

description

Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report.

groups

description
Patients receive lenalidomide PO daily on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients experiencing progressive disease may crossover to arm B. \> \> Dexamethasone: Given PO \> \> Lenalidomide: Given PO
id
OG000
title
Arm A (Lenalidomide, Dexamethasone)
description
Patients receive pomalidomide PO daily on days 1-21 and dexamethasone as in arm A. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. \> \> Dexamethasone: Given PO \> \> Pomalidomide: Given PO
id
OG001
title
Arm B (Pomalidomide, Dexamethasone)

param Type

COUNT_OF_PARTICIPANTS

population Description

All treated patients are evaluable for Adverse Events

reporting Status

POSTED

time Frame

Up to 30 days after last day of study drug treatment

title

Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

type

SECONDARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice