NCT00179647 · ADVERSE EVENTS

Adverse events

Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma · Source last updated 2010-03-16

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: Median time-on-study=18.3 weeks
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenalidomide This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.	878 / 1913	1877 / 1913	Not reported / Not reported

Group identifiers: EG000: Lenalidomide

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
1
num At Risk
1913
num Events
1
term
ABDOMINAL ABSCESS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL HAEMATOMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
7
num At Risk
1913
num Events
7
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL STRANGULATED HERNIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
3
term
ACUTE CORONARY SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
ACUTE DIVERTICULITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ACUTE RESPIRATORY DISTRESS SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
ACUTE RESPIRATORY FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
3
num At Risk
1913
num Events
3
term
ADRENAL INSUFFICIENCY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
AGITATION

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
423
num At Risk
1913
num Events
606
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
195
num At Risk
1913
num Events
221
term
ANOREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
111
num At Risk
1913
num Events
118
term
APPETITE DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
218
num At Risk
1913
num Events
267
term
ARTHRALGIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
277
num At Risk
1913
num Events
338
term
ASTHENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
276
num At Risk
1913
num Events
322
term
BACK PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
100
num At Risk
1913
num Events
116
term
CONFUSIONAL STATE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
471
num At Risk
1913
num Events
540
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
123
num At Risk
1913
num Events
154
term
CONTUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
301
num At Risk
1913
num Events
349
term
COUGH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
430
num At Risk
1913
num Events
572
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
261
num At Risk
1913
num Events
321
term
DIZZINESS

Complete source fields

event Groups

description
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
id
EG000
other Num Affected
1877
other Num At Risk
1913
serious Num Affected
878
serious Num At Risk
1913
title
Lenalidomide

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
423
num At Risk
1913
num Events
606
term
ANAEMIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
195
num At Risk
1913
num Events
221
term
ANOREXIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
111
num At Risk
1913
num Events
118
term
APPETITE DECREASED
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
218
num At Risk
1913
num Events
267
term
ARTHRALGIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
277
num At Risk
1913
num Events
338
term
ASTHENIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
276
num At Risk
1913
num Events
322
term
BACK PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
100
num At Risk
1913
num Events
116
term
CONFUSIONAL STATE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
471
num At Risk
1913
num Events
540
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
123
num At Risk
1913
num Events
154
term
CONTUSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
301
num At Risk
1913
num Events
349
term
COUGH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
430
num At Risk
1913
num Events
572
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
261
num At Risk
1913
num Events
321
term
DIZZINESS

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL ABSCESS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL DISTENSION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL HAEMATOMA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
7
num At Risk
1913
num Events
7
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ABDOMINAL STRANGULATED HERNIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
3
term
ACUTE CORONARY SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
ACUTE DIVERTICULITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
ACUTE MYOCARDIAL INFARCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
1
num At Risk
1913
num Events
1
term
ACUTE RESPIRATORY DISTRESS SYNDROME
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
ACUTE RESPIRATORY FAILURE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
3
num At Risk
1913
num Events
3
term
ADRENAL INSUFFICIENCY
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
MedDRA (5.1)
stats
group Id
EG000
num Affected
2
num At Risk
1913
num Events
2
term
AGITATION

time Frame

Median time-on-study=18.3 weeks

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Preserved source evidence · Not medical advice