NCT02234115 · ADVERSE EVENTS

Adverse events

Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma · Source last updated 2019-03-05

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: 336 days
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Leuprolide Mesylate 50mg All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate	20 / 137	114 / 137	3 / 137

Group identifiers: EG000: Leuprolide Mesylate 50mg

Serious adverse events

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

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
2
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Bronchitis bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Clostridium difficile colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Pneumonia

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
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
9
num At Risk
137
num Events
10
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
10
num At Risk
137
num Events
13
term
Injection site pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
7
num At Risk
137
num Events
9
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
9
num At Risk
137
num Events
12
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
7
num At Risk
137
num Events
7
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
13
num At Risk
137
num Events
18
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
8
num At Risk
137
num Events
9
term
Nocturia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
67
num At Risk
137
num Events
69
term
Hot flush
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
20
num At Risk
137
num Events
23
term
Hypertension

Complete source fields

event Groups

deaths Num Affected
3
deaths Num At Risk
137
description
All subjects were males with advanced prostate carcinoma. They were injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects were followed until day 336. Leuprolide Mesylate: Subcutaneous injection of 50mg Leuprolide Mesylate
id
EG000
other Num Affected
114
other Num At Risk
137
serious Num Affected
20
serious Num At Risk
137
title
Leuprolide Mesylate 50mg

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
9
num At Risk
137
num Events
10
term
Fatigue
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
10
num At Risk
137
num Events
13
term
Injection site pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
7
num At Risk
137
num Events
9
term
Nasopharyngitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
9
num At Risk
137
num Events
12
term
Arthralgia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
7
num At Risk
137
num Events
7
term
Back pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Musculoskeletal and connective tissue disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
13
num At Risk
137
num Events
18
term
Pain in extremity
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
8
num At Risk
137
num Events
9
term
Nocturia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
67
num At Risk
137
num Events
69
term
Hot flush
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
20
num At Risk
137
num Events
23
term
Hypertension

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
2
term
Angina pectoris
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Atrial fibrillation
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Myocardial infarction
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Vertigo
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Vision blurred
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Dysphagia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Asthenia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Death
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Non-cardiac chest pain
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Bronchitis bacterial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Clostridium difficile colitis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA (19.1)
stats
group Id
EG000
num Affected
1
num At Risk
137
num Events
1
term
Pneumonia

time Frame

336 days

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Preserved source evidence · Not medical advice