NCT00477750 · ADVERSE EVENTS

Adverse events

Melphalan, Prednisone, and Lenalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma · Source last updated 2019-10-11

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Lenalidomide, Melphalan, Prednisone) Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression Intervention: Drug: melphalan 5mg/m\^2 orally days 1-4 every 28 days until progression Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days until progression	7 / 26	26 / 26	Not reported / Not reported

Group identifiers: EG000: Treatment (Lenalidomide, Melphalan, Prednisone)

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
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Leukocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Rash desquamating

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 6
stats
group Id
EG000
num Affected
24
num At Risk
26
num Events
103
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
26
num Events
5
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
8
num At Risk
26
num Events
12
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
11
num At Risk
26
num Events
27
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
21
num At Risk
26
num Events
63
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
5
term
Pain

Complete source fields

event Groups

description
Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression Intervention: Drug: melphalan 5mg/m\^2 orally days 1-4 every 28 days until progression Intervention: Drug: prednisone 60mg/m\^2, orally days 1-4 every 28 days until progression
id
EG000
other Num Affected
26
other Num At Risk
26
serious Num Affected
7
serious Num At Risk
26
title
Treatment (Lenalidomide, Melphalan, Prednisone)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
24
num At Risk
26
num Events
103
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
4
num At Risk
26
num Events
5
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Ear, nose and throat examination abnormal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
8
num At Risk
26
num Events
12
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
11
num At Risk
26
num Events
27
term
Edema limbs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
21
num At Risk
26
num Events
63
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
5
term
Pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Sepsis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Skin infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Leukocyte count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Neutrophil count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
26
num Events
2
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Dehydration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
26
num Events
1
term
Rash desquamating

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Preserved source evidence · Not medical advice