NCT00687674 · ADVERSE EVENTS

Adverse events

Sorafenib, Lenalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2019-08-20

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Sorafenib + Lenalidomide + Dexamethasone Not reported	3 / 13	12 / 13	Not reported / Not reported

Group identifiers: EG000: Sorafenib + Lenalidomide + 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
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Rash

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 10
stats
group Id
EG000
num Affected
11
num At Risk
13
num Events
53
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
9
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
3
term
Oral cavity Mucositis/stomatitis (clinical exam)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
9
num At Risk
13
num Events
63
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
6
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Infection without neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
5
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Bilirubin

Complete source fields

event Groups

id
EG000
other Num Affected
12
other Num At Risk
13
serious Num Affected
3
serious Num At Risk
13
title
Sorafenib + Lenalidomide + Dexamethasone

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
11
num At Risk
13
num Events
53
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
4
num At Risk
13
num Events
9
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
2
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
2
num At Risk
13
num Events
3
term
Oral cavity Mucositis/stomatitis (clinical exam)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
9
num At Risk
13
num Events
63
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
6
term
Pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Infection without neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
2
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Urinary tract infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Injury, poisoning and procedural complications
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
5
term
Bruising
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Bilirubin

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Pneumonia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Leukopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA 10
stats
group Id
EG000
num Affected
1
num At Risk
13
num Events
1
term
Rash

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

Preserved source evidence · Not medical advice