NCT00622336 · ADVERSE EVENTS

Adverse events

A Companion Study for Studies THAL-MM-003, CC-5013-MM-009, and CC-5013-MM-010 for Subjects With Multiple Myeloma · Source last updated 2019-11-20

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle	177 / 330	0 / 330	Not reported / Not reported
Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013 Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle	5 / 21	6 / 21	Not reported / Not reported

Group identifiers: EG000: Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009 · EG001: Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
38
num At Risk
330
group Id
EG001
num Affected
2
num At Risk
21
term
Pneumonia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
6
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Respiratory tract infection NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
4
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Lobar pneumonia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
4
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Sepsis NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
3
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
3
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Bronchitis acute NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Bronchopneumonia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Lung infection NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Pyelonephritis NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Abscess NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Arthritis infective NOS

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
330
group Id
EG001
num Affected
2
num At Risk
21
term
Anaemia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
330
group Id
EG001
num Affected
3
num At Risk
21
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
330
group Id
EG001
num Affected
3
num At Risk
21
term
Headache

Complete source fields

event Groups

description
Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
id
EG000
other Num Affected
0
other Num At Risk
330
serious Num Affected
177
serious Num At Risk
330
title
Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009
description
Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
id
EG001
other Num Affected
6
other Num At Risk
21
serious Num Affected
5
serious Num At Risk
21
title
Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
330
group Id
EG001
num Affected
2
num At Risk
21
term
Anaemia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
330
group Id
EG001
num Affected
3
num At Risk
21
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
0
num At Risk
330
group Id
EG001
num Affected
3
num At Risk
21
term
Headache

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
38
num At Risk
330
group Id
EG001
num Affected
2
num At Risk
21
term
Pneumonia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
6
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Respiratory tract infection NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
4
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Lobar pneumonia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
4
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Sepsis NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
3
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Bacteraemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
3
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Bronchitis acute NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Bronchopneumonia NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Cellulitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Lung infection NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
2
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Pyelonephritis NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Abscess NOS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 5.1
stats
group Id
EG000
num Affected
1
num At Risk
330
group Id
EG001
num Affected
0
num At Risk
21
term
Arthritis infective NOS

time Frame

From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 11 November 2013. Maximum time on Lenalidomide treatment was 1260 days.

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

Preserved source evidence · Not medical advice