NCT00606944 · ADVERSE EVENTS

Adverse events

Fast-track Rehabilitation After Elective Colorectal and Small Bowel Resection · Source last updated 2012-08-21

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: Not reported
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Control Group traditional, conventional care group	0 / 100	16 / 100	Not reported / Not reported
ERP Group Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation	1 / 98	28 / 98	Not reported / Not reported

Group identifiers: EG000: Control Group · EG001: ERP Group

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
notes
1 patient in ERP group who underwent low anterior resection for rectal cancer died due to aspiration pneumonia at postoperative 3day
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
100
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Death

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
notes
defined by patient's symptom and X-ray
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
100
num Events
7
group Id
EG001
num Affected
17
num At Risk
98
num Events
17
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
num Events
5
group Id
EG001
num Affected
9
num At Risk
98
num Events
9
term
Urinary retention
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
num Events
5
group Id
EG001
num Affected
6
num At Risk
98
num Events
6
term
Chylous ascites

Complete source fields

event Groups

description
traditional, conventional care group
id
EG000
other Num Affected
16
other Num At Risk
100
serious Num Affected
0
serious Num At Risk
100
title
Control Group
description
Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
id
EG001
other Num Affected
28
other Num At Risk
98
serious Num Affected
1
serious Num At Risk
98
title
ERP Group

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
defined by patient's symptom and X-ray
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
7
num At Risk
100
num Events
7
group Id
EG001
num Affected
17
num At Risk
98
num Events
17
term
Ileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
num Events
5
group Id
EG001
num Affected
9
num At Risk
98
num Events
9
term
Urinary retention
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
5
num At Risk
100
num Events
5
group Id
EG001
num Affected
6
num At Risk
98
num Events
6
term
Chylous ascites

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
notes
1 patient in ERP group who underwent low anterior resection for rectal cancer died due to aspiration pneumonia at postoperative 3day
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
0
num At Risk
100
num Events
0
group Id
EG001
num Affected
1
num At Risk
98
num Events
1
term
Death

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

Preserved source evidence · Not medical advice