NCT00322842 · ADVERSE EVENTS

Adverse events

Treatment With AMD3100 (Plerixafor) in Non-Hodgkin's Lymphoma and Multiple Myeloma Patients · Source last updated 2014-03-13

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: First day of G-CSF administration to the day prior to chemotherapy/ablative treatment in preparation of first transplant. This period includes the G-CSF, plerixafor treatment and rest period.
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.	2 / 4	4 / 4	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.	0 / 31	20 / 31	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
4
group Id
EG001
num Affected
0
num At Risk
31
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
31
term
Diabetes mellitus non-insulin-dependent

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
0
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Leukopenia
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
4
group Id
EG001
num Affected
0
num At Risk
31
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
31
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
31
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
31
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
31
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
31
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Catheter site pain

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
4
other Num At Risk
4
serious Num Affected
2
serious Num At Risk
4
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
20
other Num At Risk
31
serious Num Affected
0
serious Num At Risk
31
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
0
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
31
term
Anaemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Leukopenia
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
4
group Id
EG001
num Affected
0
num At Risk
31
term
Lymphadenopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
31
term
Thrombocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
2
num At Risk
31
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
31
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
3
num At Risk
31
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
31
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
0
num At Risk
4
group Id
EG001
num Affected
1
num At Risk
31
term
Catheter site pain

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
4
group Id
EG001
num Affected
0
num At Risk
31
term
Pyrexia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 10.0
stats
group Id
EG000
num Affected
1
num At Risk
4
group Id
EG001
num Affected
0
num At Risk
31
term
Diabetes mellitus non-insulin-dependent

time Frame

First day of G-CSF administration to the day prior to chemotherapy/ablative treatment in preparation of first transplant. This period includes the G-CSF, plerixafor treatment and rest period.

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Preserved source evidence · Not medical advice