NCT03500419 · ADVERSE EVENTS

Adverse events

Penile Length Maintenance Post-Prostatectomy · Source last updated 2021-10-20

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: Adverse events were collected from baseline until end of intervention, approximately 6 months.
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Control No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes. No treatment: Control group. No treatment was given for the 6 months post-prostatectomy	0 / 27	0 / 27	0 / 27
PTT 1-2x Daily x 5-7 Days/Week x 5 Months Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months. RestoreX: PTT - Penile traction therapy in the straight position.	0 / 55	17 / 55	0 / 55

Group identifiers: EG000: Control · EG001: PTT 1-2x Daily x 5-7 Days/Week x 5 Months

Serious adverse events

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

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
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
6
num At Risk
55
num Events
6
term
Temporary penile erythema or discoloration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
11
num At Risk
55
num Events
11
term
Temporary mile penile discomfort

Complete source fields

event Groups

deaths Num Affected
0
deaths Num At Risk
27
description
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes. No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
id
EG000
other Num Affected
0
other Num At Risk
27
serious Num Affected
0
serious Num At Risk
27
title
Control
deaths Num Affected
0
deaths Num At Risk
55
description
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months. RestoreX: PTT - Penile traction therapy in the straight position.
id
EG001
other Num Affected
17
other Num At Risk
55
serious Num Affected
0
serious Num At Risk
55
title
PTT 1-2x Daily x 5-7 Days/Week x 5 Months

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
6
num At Risk
55
num Events
6
term
Temporary penile erythema or discoloration
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
stats
group Id
EG000
num Affected
0
num At Risk
27
num Events
0
group Id
EG001
num Affected
11
num At Risk
55
num Events
11
term
Temporary mile penile discomfort

time Frame

Adverse events were collected from baseline until end of intervention, approximately 6 months.

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

Preserved source evidence · Not medical advice