NCT00009737 · ADVERSE EVENTS

Adverse events

A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer · Source last updated 2016-06-22

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: Up to Week 29
Other-event reporting threshold: 5%

Adverse event is reported for safety population which consist of all participants who received at least one dose of capecitabine, 5-fluorouracil, or leucovorin and had at least one post baseline safety assessment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Capecitabine Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).	181 / 995	838 / 995	Not reported / Not reported
5-Fluorouracil + Leucovorin Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).	182 / 974	847 / 974	Not reported / Not reported

Group identifiers: EG000: Capecitabine · EG001: 5-Fluorouracil + Leucovorin

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
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
58
num At Risk
995
group Id
EG001
num Affected
34
num At Risk
974
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
\*Monthly Incidence of Hospitalization = (Number of Hospitalizations / (Days on Treatment + 28)) \* 30.5
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
4
num At Risk
995
group Id
EG001
num Affected
25
num At Risk
974
term
*Stomatitis all
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
9
num At Risk
995
group Id
EG001
num Affected
10
num At Risk
974
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
7
num At Risk
995
group Id
EG001
num Affected
10
num At Risk
974
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
9
num At Risk
995
group Id
EG001
num Affected
3
num At Risk
974
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
5
num At Risk
995
group Id
EG001
num Affected
7
num At Risk
974
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
3
num At Risk
974
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
2
num At Risk
974
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
2
num At Risk
974
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
1
num At Risk
974
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
3
num At Risk
995
group Id
EG001
num Affected
0
num At Risk
974
term
Ileus paralytic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
0
num At Risk
995
group Id
EG001
num Affected
3
num At Risk
974
term
Nausea

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
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
437
num At Risk
995
group Id
EG001
num Affected
610
num At Risk
974
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
334
num At Risk
995
group Id
EG001
num Affected
459
num At Risk
974
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
218
num At Risk
995
group Id
EG001
num Affected
574
num At Risk
974
term
Stomatitis all
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
147
num At Risk
995
group Id
EG001
num Affected
199
num At Risk
974
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
133
num At Risk
995
group Id
EG001
num Affected
149
num At Risk
974
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
86
num At Risk
995
group Id
EG001
num Affected
103
num At Risk
974
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
70
num At Risk
995
group Id
EG001
num Affected
65
num At Risk
974
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
59
num At Risk
995
group Id
EG001
num Affected
48
num At Risk
974
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
593
num At Risk
995
group Id
EG001
num Affected
85
num At Risk
974
term
Palmar-plantar
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
63
num At Risk
995
group Id
EG001
num Affected
218
num At Risk
974
term
Erythrodysaesthesia syndrome Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
70
num At Risk
995
group Id
EG001
num Affected
80
num At Risk
974
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
58
num At Risk
995
group Id
EG001
num Affected
51
num At Risk
974
term
Erythema

Complete source fields

description

event Groups

description
Participants received capecitabine 1250 (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
id
EG000
other Num Affected
838
other Num At Risk
995
serious Num Affected
181
serious Num At Risk
995
title
Capecitabine
description
Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
id
EG001
other Num Affected
847
other Num At Risk
974
serious Num Affected
182
serious Num At Risk
974
title
5-Fluorouracil + Leucovorin

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
437
num At Risk
995
group Id
EG001
num Affected
610
num At Risk
974
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
334
num At Risk
995
group Id
EG001
num Affected
459
num At Risk
974
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
218
num At Risk
995
group Id
EG001
num Affected
574
num At Risk
974
term
Stomatitis all
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
147
num At Risk
995
group Id
EG001
num Affected
199
num At Risk
974
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
133
num At Risk
995
group Id
EG001
num Affected
149
num At Risk
974
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
86
num At Risk
995
group Id
EG001
num Affected
103
num At Risk
974
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
70
num At Risk
995
group Id
EG001
num Affected
65
num At Risk
974
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
59
num At Risk
995
group Id
EG001
num Affected
48
num At Risk
974
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
593
num At Risk
995
group Id
EG001
num Affected
85
num At Risk
974
term
Palmar-plantar
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
63
num At Risk
995
group Id
EG001
num Affected
218
num At Risk
974
term
Erythrodysaesthesia syndrome Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
70
num At Risk
995
group Id
EG001
num Affected
80
num At Risk
974
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
58
num At Risk
995
group Id
EG001
num Affected
51
num At Risk
974
term
Erythema

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
58
num At Risk
995
group Id
EG001
num Affected
34
num At Risk
974
term
Diarrhoea
assessment Type
SYSTEMATIC_ASSESSMENT
notes
\*Monthly Incidence of Hospitalization = (Number of Hospitalizations / (Days on Treatment + 28)) \* 30.5
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
4
num At Risk
995
group Id
EG001
num Affected
25
num At Risk
974
term
*Stomatitis all
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
9
num At Risk
995
group Id
EG001
num Affected
10
num At Risk
974
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
7
num At Risk
995
group Id
EG001
num Affected
10
num At Risk
974
term
Small intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
9
num At Risk
995
group Id
EG001
num Affected
3
num At Risk
974
term
Intestinal obstruction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
5
num At Risk
995
group Id
EG001
num Affected
7
num At Risk
974
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
3
num At Risk
974
term
Enteritis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
2
num At Risk
974
term
Abdominal pain upper
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
2
num At Risk
974
term
Subileus
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
2
num At Risk
995
group Id
EG001
num Affected
1
num At Risk
974
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
3
num At Risk
995
group Id
EG001
num Affected
0
num At Risk
974
term
Ileus paralytic
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA (6.1)
stats
group Id
EG000
num Affected
0
num At Risk
995
group Id
EG001
num Affected
3
num At Risk
974
term
Nausea

time Frame

Up to Week 29

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

Preserved source evidence · Not medical advice