NCT02234115 · OUTCOME

Number of Participants With Adverse Events (AEs)

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.

Measure: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: 336 days

What was measured

Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.

Analysis population: Safety population

Groups in this outcome

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Leuprolide Mesylate 50mg	137

Reported measurements

TEAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Leuprolide Mesylate 50mg	114	Not reported	Not reported	Not reported	Not reported

Drug-related AEs

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Leuprolide Mesylate 50mg	85	Not reported	Not reported	Not reported	Not reported

SAE

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Leuprolide Mesylate 50mg	20	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
114
title
TEAE
categories
measurements
group Id
OG000
value
85
title
Drug-related AEs
categories
measurements
group Id
OG000
value
20
title
SAE

denoms

counts
group Id
OG000
value
137
units
Participants

description

Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.

groups

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
OG000
title
Leuprolide Mesylate 50mg

param Type

COUNT_OF_PARTICIPANTS

population Description

Safety population

reporting Status

POSTED

time Frame

336 days

title

Number of Participants With Adverse Events (AEs)

type

SECONDARY

unit Of Measure

Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice