NCT00387348 · ADVERSE EVENTS

Adverse events

Escitalopram in Treating Depression in Patients With Advanced Lung or Gastrointestinal Cancer · Source last updated 2012-12-03

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
Placebo-Placebo Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks	1 / 8	1 / 8	Not reported / Not reported
Placebo-Escitalopram Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks	1 / 5	0 / 5	Not reported / Not reported
Escitalopram-Placebo Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks	0 / 11	1 / 11	Not reported / Not reported

Group identifiers: EG000: Placebo-Placebo · EG001: Placebo-Escitalopram · EG002: Escitalopram-Placebo

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
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
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
term
HAM-D score increased by at least 25%

Complete source fields

event Groups

description
Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
id
EG000
other Num Affected
1
other Num At Risk
8
serious Num Affected
1
serious Num At Risk
8
title
Placebo-Placebo
description
Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
id
EG001
other Num Affected
0
other Num At Risk
5
serious Num Affected
1
serious Num At Risk
5
title
Placebo-Escitalopram
description
Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
id
EG002
other Num Affected
1
other Num At Risk
11
serious Num Affected
0
serious Num At Risk
11
title
Escitalopram-Placebo

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
group Id
EG001
num Affected
0
num At Risk
5
num Events
0
group Id
EG002
num Affected
1
num At Risk
11
num Events
1
term
HAM-D score increased by at least 25%

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
stats
group Id
EG000
num Affected
1
num At Risk
8
num Events
1
group Id
EG001
num Affected
1
num At Risk
5
num Events
1
group Id
EG002
num Affected
0
num At Risk
11
num Events
0
term
death

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

Preserved source evidence · Not medical advice