NCT00396266 · ADVERSE EVENTS

Adverse events

AMD3100 (Plerixafor) Given to NHL and MM Patients to Increase the Number of PBSCs When Given a Mobilizing Regimen of G-CSF · Source last updated 2014-03-07

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: Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).
Other-event reporting threshold: 0%

In the event a single participant has experienced both a serious and a non-serious form of the same adverse event term, the individual has been included in the numerator ("number of affected participants") of both adverse event tables. Each AE table includes events, regardless of reported relationship to study treatment or grade.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Non-Hodgkin's Lymphoma (NHL) Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	1 / 8	8 / 8	Not reported / Not reported
Multiple Myeloma (MM) Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.	2 / 14	14 / 14	Not reported / Not reported

Group identifiers: EG000: Non-Hodgkin's Lymphoma (NHL) · EG001: Multiple Myeloma (MM)

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 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Catheter site haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Catheter site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Catheter bacteraemia

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 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
14
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
14
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
7
num At Risk
14
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Hypoaesthesia oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
8
group Id
EG001
num Affected
4
num At Risk
14
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
14
term
Retching
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Toothache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Asthenia

Complete source fields

description

event Groups

description
Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
id
EG000
other Num Affected
8
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Non-Hodgkin's Lymphoma (NHL)
description
Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5\*10\^6 CD34+ cells/kg were collected.
id
EG001
other Num Affected
14
other Num At Risk
14
serious Num Affected
2
serious Num At Risk
14
title
Multiple Myeloma (MM)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
14
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Abdominal distension
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
2
num At Risk
14
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
14
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
7
num At Risk
14
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Flatulence
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Hypoaesthesia oral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
3
num At Risk
8
group Id
EG001
num Affected
4
num At Risk
14
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
0
num At Risk
14
term
Retching
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Toothache
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Asthenia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Catheter site haemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Catheter site pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
8
group Id
EG001
num Affected
1
num At Risk
14
term
Catheter bacteraemia

time Frame

Treatment emergent AEs covering Day 1 (start of G-CSF Mobilization to the day before starting chemotherapy (approximately Day 38).

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Preserved source evidence · Not medical advice