NCT00275262 · ADVERSE EVENTS

Adverse events

A Study to Evaluate the Ability of Lupron Depot to Enhance Immune Function Following Bone Marrow Transplantation · Source last updated 2010-05-06

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: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.	6 / 12	7 / 12	Not reported / Not reported
Placebo Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.	4 / 13	7 / 13	Not reported / Not reported

Group identifiers: EG000: Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month · EG001: Placebo

Serious adverse events

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

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Febrile neutropenia
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Thrombocytopenia
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Pyrexia
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Gastroenteritis
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Pneumonia
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Pneumonia mycoplasmal
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Respiratory tract infection bacterial
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Respiratory tract infection viral
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Staphylococcal bacteremia
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Failure to thrive
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Hypokalemia
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Multiple myeloma

Other reported adverse events

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

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Lymphopenia
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Neutropenia
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Palpitations
organ System
Endocrine disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Hypogonadism
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Constipation
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Diarrhea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Food poisoning
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Gastroesophageal reflux disease
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Axillary pain
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Fatigue
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Injection site swelling
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Mucosal inflammation

Complete source fields

event Groups

description
Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
id
EG000
other Num Affected
7
other Num At Risk
12
serious Num Affected
6
serious Num At Risk
12
title
Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month
description
Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
id
EG001
other Num Affected
7
other Num At Risk
13
serious Num Affected
4
serious Num At Risk
13
title
Placebo

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Lymphopenia
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Neutropenia
organ System
Cardiac disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Palpitations
organ System
Endocrine disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Hypogonadism
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Constipation
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Diarrhea
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Food poisoning
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Gastroesophageal reflux disease
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Axillary pain
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Fatigue
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Injection site swelling
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Mucosal inflammation

serious Events

organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Febrile neutropenia
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA (11.1)
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Thrombocytopenia
organ System
General disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Pyrexia
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Gastroenteritis
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Pneumonia
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Pneumonia mycoplasmal
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
1
num At Risk
12
group Id
EG001
num Affected
0
num At Risk
13
term
Respiratory tract infection bacterial
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Respiratory tract infection viral
organ System
Infections and infestations
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Staphylococcal bacteremia
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Failure to thrive
organ System
Metabolism and nutrition disorders
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Hypokalemia
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA 11.1
stats
group Id
EG000
num Affected
0
num At Risk
12
group Id
EG001
num Affected
1
num At Risk
13
term
Multiple myeloma

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