NCT00478777 · ADVERSE EVENTS

Adverse events

A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma · Source last updated 2011-11-03

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: Up to 8 months
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.	79 / 144	129 / 144	Not reported / Not reported

Group identifiers: EG000: Lenalidomide Plus Dexamethasone

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
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
14
num At Risk
144
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
6
num At Risk
144
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Orthostatic intolerance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
6
num At Risk
144
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
term
Upper respiratory tract infection

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
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
35
num At Risk
144
term
Muscle spasms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
13
num At Risk
144
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
12
num At Risk
144
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
11
num At Risk
144
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
9
num At Risk
144
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
33
num At Risk
144
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
19
num At Risk
144
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
18
num At Risk
144
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
17
num At Risk
144
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
15
num At Risk
144
term
Tremor
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
14
num At Risk
144
term
Polyneuropathy

Complete source fields

event 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), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
id
EG000
other Num Affected
129
other Num At Risk
144
serious Num Affected
79
serious Num At Risk
144
title
Lenalidomide Plus Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
35
num At Risk
144
term
Muscle spasms
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
13
num At Risk
144
term
Back pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
12
num At Risk
144
term
Arthralgia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
11
num At Risk
144
term
Pain in extremity
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
9
num At Risk
144
term
Muscular weakness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
term
Bone pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
33
num At Risk
144
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
19
num At Risk
144
term
Oedema peripheral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
18
num At Risk
144
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
17
num At Risk
144
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
15
num At Risk
144
term
Tremor
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
14
num At Risk
144
term
Polyneuropathy

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
14
num At Risk
144
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
6
num At Risk
144
term
General physical health deterioration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
term
Multi-organ failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Chills
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Gait disturbance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Orthostatic intolerance
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
1
num At Risk
144
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
8
num At Risk
144
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
6
num At Risk
144
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (10.0)
stats
group Id
EG000
num Affected
2
num At Risk
144
term
Upper respiratory tract infection

time Frame

Up to 8 months

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Preserved source evidence · Not medical advice