NCT00928486 · ADVERSE EVENTS

Adverse events

A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated 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: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Lenalidomide and Dexamethasone Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.	12 / 25	25 / 25	Not reported / Not reported

Group identifiers: EG000: Lenalidomide and 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 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Hepatic function abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Gastric cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Waldenstrom's macroglobulinaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Vertigo positional
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Herpes zoster

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 12.0
stats
group Id
EG000
num Affected
20
num At Risk
25
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
16
num At Risk
25
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
15
num At Risk
25
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
13
num At Risk
25
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
7
num At Risk
25
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
13
num At Risk
25
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
25
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Dental caries
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
12
num At Risk
25
term
Nasopharyngitis

Complete source fields

event Groups

description
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
id
EG000
other Num Affected
25
other Num At Risk
25
serious Num Affected
12
serious Num At Risk
25
title
Lenalidomide and Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
20
num At Risk
25
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
16
num At Risk
25
term
Lymphopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
15
num At Risk
25
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
13
num At Risk
25
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
7
num At Risk
25
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
13
num At Risk
25
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
25
term
Stomatitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Abdominal discomfort
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Dental caries
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
25
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
12
num At Risk
25
term
Nasopharyngitis

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Death
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Cholecystitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Hepatic function abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Gastric cancer
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Waldenstrom's macroglobulinaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Myocardial infarction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Vertigo positional
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Cataract
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Amyloidosis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
25
term
Herpes zoster

time Frame

Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks

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Preserved source evidence · Not medical advice