NCT00420849 · OUTCOME

Participants With Adverse Events of Special Interest: Venous Thromboembolic Events

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2012-05-21

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: up to 124 weeks

What was measured

Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.

Analysis population: Safety population

Groups in this outcome

Lenalidomide Plus Dexamethasone

Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.

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
Lenalidomide Plus Dexamethasone	587

Reported measurements

At least one venous thromboembolic event

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide Plus Dexamethasone	60	Not reported	Not reported	Not reported	Not reported

Deep vein thrombosis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide Plus Dexamethasone	38	Not reported	Not reported	Not reported	Not reported

Pulmonary embolism

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide Plus Dexamethasone	23	Not reported	Not reported	Not reported	Not reported

Thrombophlebitis

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide Plus Dexamethasone	7	Not reported	Not reported	Not reported	Not reported

Venous thrombosis limb

Values in participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Lenalidomide Plus Dexamethasone	1	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
60
title
At least one venous thromboembolic event
categories
measurements
group Id
OG000
value
38
title
Deep vein thrombosis
categories
measurements
group Id
OG000
value
23
title
Pulmonary embolism
categories
measurements
group Id
OG000
value
7
title
Thrombophlebitis
categories
measurements
group Id
OG000
value
1
title
Venous thrombosis limb

denoms

counts
group Id
OG000
value
587
units
Participants

description

groups

description
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
id
OG000
title
Lenalidomide Plus Dexamethasone

param Type

NUMBER

population Description

Safety population

reporting Status

POSTED

time Frame

up to 124 weeks

title

Participants With Adverse Events of Special Interest: Venous Thromboembolic Events

type

SECONDARY

unit Of Measure

participants

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

Preserved source evidence · Not medical advice