NCT00998049 · ADVERSE EVENTS

Adverse events

Plerixafor in Treating Patients With Multiple Myeloma Previously Treated With Lenalidomide and Planning to Undergo Autologous Stem Cell Transplant · Source last updated 2015-05-14

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
Plerixafor Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.	0 / 39	25 / 39	Not reported / Not reported

Group identifiers: EG000: Plerixafor

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

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
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
39
num Events
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
10
num At Risk
39
num Events
10
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
17
num At Risk
39
num Events
17
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
term
Injection site reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
39
num Events
8
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
39
num Events
8
term
Headache

Complete source fields

event Groups

description
Plerixafor 160mg/kg/dose by IV on days 5-8 Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8.
id
EG000
other Num Affected
25
other Num At Risk
39
serious Num Affected
0
serious Num At Risk
39
title
Plerixafor

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
7
num At Risk
39
num Events
7
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
39
num Events
1
term
Bloating
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
10
num At Risk
39
num Events
10
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
17
num At Risk
39
num Events
17
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
term
Injection site reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
39
num Events
2
term
Platelet count decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
39
num Events
8
term
Dizziness
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
8
num At Risk
39
num Events
8
term
Headache

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Preserved source evidence · Not medical advice