NCT02837042 · ADVERSE EVENTS

Adverse events

Trial of Pembrolizumab for Advanced Penile Squamous Cell Carcinoma · Source last updated 2022-06-21

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: From baseline through one year after the end of the study, up to 2 years.
Other-event reporting threshold: 5%

The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Pembrolizumab 200 mg Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.	2 / 6	2 / 6	0 / 6

Group identifiers: EG000: Pembrolizumab 200 mg

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
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hypoalbuminemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Constipation

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
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hyponatremia

Complete source fields

description

The study was closed prematurely due to poor accrual and substantial loss to follow-up of patients.

event Groups

deaths Num Affected
0
deaths Num At Risk
6
description
Once eligibility is confirmed, the patient will start treatment cycles with Pembrolizumab at 200 mg given intravenously on the first day of each cycle. Each cycle corresponds to a duration of 3 weeks. Pembrolizumab: Pembrolizumab will be administered intravenously every 3 weeks.
id
EG000
other Num Affected
2
other Num At Risk
6
serious Num Affected
2
serious Num At Risk
6
title
Pembrolizumab 200 mg

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hyponatremia

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Hypoalbuminemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
6
num Events
1
term
Constipation

time Frame

From baseline through one year after the end of the study, up to 2 years.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice