NCT00069121 · ADVERSE EVENTS

Adverse events

A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer · Source last updated 2020-03-06

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 time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
Other-event reporting threshold: 5%

AE reporting is based on the Safety Analysis Population; the patients who were randomized and received at least one dose of capecitabine, 5-FU, or oxaliplatin. Safety Population 5-FU/LV (n = 926); XELOX (n = 938)

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
5-FU/LV MAYO CLINIC 5-fluorouracil/leucovorin	134 / 657	622 / 657	215 / 664
5-FU/LV ROSWELL PARK 5-fluorouracil/leucovorin	88 / 269	262 / 269	71 / 278
XELOX Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)	208 / 938	926 / 938	242 / 944

Group identifiers: EG000: 5-FU/LV MAYO CLINIC · EG001: 5-FU/LV ROSWELL PARK · EG002: XELOX

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 12.0
stats
group Id
EG000
num Affected
39
num At Risk
657
group Id
EG001
num Affected
24
num At Risk
269
group Id
EG002
num Affected
55
num At Risk
938
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
657
group Id
EG001
num Affected
0
num At Risk
269
group Id
EG002
num Affected
2
num At Risk
938
term
STOMATITIS ALL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
6
num At Risk
657
group Id
EG001
num Affected
3
num At Risk
269
group Id
EG002
num Affected
15
num At Risk
938
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
657
group Id
EG001
num Affected
3
num At Risk
269
group Id
EG002
num Affected
13
num At Risk
938
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
657
group Id
EG001
num Affected
2
num At Risk
269
group Id
EG002
num Affected
7
num At Risk
938
term
INTESTINAL OBSTRUCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
657
group Id
EG001
num Affected
3
num At Risk
269
group Id
EG002
num Affected
8
num At Risk
938
term
SMALL INTESTINAL OBSTRUCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
657
group Id
EG001
num Affected
4
num At Risk
269
group Id
EG002
num Affected
3
num At Risk
938
term
ILEUS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
657
group Id
EG001
num Affected
1
num At Risk
269
group Id
EG002
num Affected
4
num At Risk
938
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
657
group Id
EG001
num Affected
1
num At Risk
269
group Id
EG002
num Affected
3
num At Risk
938
term
COLITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
657
group Id
EG001
num Affected
2
num At Risk
269
group Id
EG002
num Affected
1
num At Risk
938
term
ENTERITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
657
group Id
EG001
num Affected
0
num At Risk
269
group Id
EG002
num Affected
4
num At Risk
938
term
GASTROINTESTINAL HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
657
group Id
EG001
num Affected
0
num At Risk
269
group Id
EG002
num Affected
3
num At Risk
938
term
SUBILEUS

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 12.0
stats
group Id
EG000
num Affected
449
num At Risk
657
group Id
EG001
num Affected
219
num At Risk
269
group Id
EG002
num Affected
577
num At Risk
938
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
350
num At Risk
657
group Id
EG001
num Affected
190
num At Risk
269
group Id
EG002
num Affected
625
num At Risk
938
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
419
num At Risk
657
group Id
EG001
num Affected
57
num At Risk
269
group Id
EG002
num Affected
195
num At Risk
938
term
STOMATITIS ALL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
142
num At Risk
657
group Id
EG001
num Affected
103
num At Risk
269
group Id
EG002
num Affected
415
num At Risk
938
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
118
num At Risk
657
group Id
EG001
num Affected
92
num At Risk
269
group Id
EG002
num Affected
204
num At Risk
938
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
82
num At Risk
657
group Id
EG001
num Affected
48
num At Risk
269
group Id
EG002
num Affected
187
num At Risk
938
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
38
num At Risk
657
group Id
EG001
num Affected
37
num At Risk
269
group Id
EG002
num Affected
87
num At Risk
938
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
44
num At Risk
657
group Id
EG001
num Affected
21
num At Risk
269
group Id
EG002
num Affected
77
num At Risk
938
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
21
num At Risk
657
group Id
EG001
num Affected
29
num At Risk
269
group Id
EG002
num Affected
47
num At Risk
938
term
FLATULENCE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
23
num At Risk
657
group Id
EG001
num Affected
14
num At Risk
269
group Id
EG002
num Affected
26
num At Risk
938
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
16
num At Risk
657
group Id
EG001
num Affected
10
num At Risk
269
group Id
EG002
num Affected
339
num At Risk
938
term
PARAESTHESIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
8
num At Risk
657
group Id
EG001
num Affected
12
num At Risk
269
group Id
EG002
num Affected
279
num At Risk
938
term
NEUROPATHY PERIPHERAL

Complete source fields

description

event Groups

deaths Num Affected
215
deaths Num At Risk
664
description
5-fluorouracil/leucovorin
id
EG000
other Num Affected
622
other Num At Risk
657
serious Num Affected
134
serious Num At Risk
657
title
5-FU/LV MAYO CLINIC
deaths Num Affected
71
deaths Num At Risk
278
description
5-fluorouracil/leucovorin
id
EG001
other Num Affected
262
other Num At Risk
269
serious Num Affected
88
serious Num At Risk
269
title
5-FU/LV ROSWELL PARK
deaths Num Affected
242
deaths Num At Risk
944
description
Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
id
EG002
other Num Affected
926
other Num At Risk
938
serious Num Affected
208
serious Num At Risk
938
title
XELOX

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
449
num At Risk
657
group Id
EG001
num Affected
219
num At Risk
269
group Id
EG002
num Affected
577
num At Risk
938
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
350
num At Risk
657
group Id
EG001
num Affected
190
num At Risk
269
group Id
EG002
num Affected
625
num At Risk
938
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
419
num At Risk
657
group Id
EG001
num Affected
57
num At Risk
269
group Id
EG002
num Affected
195
num At Risk
938
term
STOMATITIS ALL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
142
num At Risk
657
group Id
EG001
num Affected
103
num At Risk
269
group Id
EG002
num Affected
415
num At Risk
938
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
118
num At Risk
657
group Id
EG001
num Affected
92
num At Risk
269
group Id
EG002
num Affected
204
num At Risk
938
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
82
num At Risk
657
group Id
EG001
num Affected
48
num At Risk
269
group Id
EG002
num Affected
187
num At Risk
938
term
CONSTIPATION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
38
num At Risk
657
group Id
EG001
num Affected
37
num At Risk
269
group Id
EG002
num Affected
87
num At Risk
938
term
DYSPEPSIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
44
num At Risk
657
group Id
EG001
num Affected
21
num At Risk
269
group Id
EG002
num Affected
77
num At Risk
938
term
ABDOMINAL PAIN UPPER
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
21
num At Risk
657
group Id
EG001
num Affected
29
num At Risk
269
group Id
EG002
num Affected
47
num At Risk
938
term
FLATULENCE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
23
num At Risk
657
group Id
EG001
num Affected
14
num At Risk
269
group Id
EG002
num Affected
26
num At Risk
938
term
DRY MOUTH
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
16
num At Risk
657
group Id
EG001
num Affected
10
num At Risk
269
group Id
EG002
num Affected
339
num At Risk
938
term
PARAESTHESIA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
8
num At Risk
657
group Id
EG001
num Affected
12
num At Risk
269
group Id
EG002
num Affected
279
num At Risk
938
term
NEUROPATHY PERIPHERAL

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
39
num At Risk
657
group Id
EG001
num Affected
24
num At Risk
269
group Id
EG002
num Affected
55
num At Risk
938
term
DIARRHOEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
22
num At Risk
657
group Id
EG001
num Affected
0
num At Risk
269
group Id
EG002
num Affected
2
num At Risk
938
term
STOMATITIS ALL
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
6
num At Risk
657
group Id
EG001
num Affected
3
num At Risk
269
group Id
EG002
num Affected
15
num At Risk
938
term
VOMITING
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
657
group Id
EG001
num Affected
3
num At Risk
269
group Id
EG002
num Affected
13
num At Risk
938
term
ABDOMINAL PAIN
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
5
num At Risk
657
group Id
EG001
num Affected
2
num At Risk
269
group Id
EG002
num Affected
7
num At Risk
938
term
INTESTINAL OBSTRUCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
657
group Id
EG001
num Affected
3
num At Risk
269
group Id
EG002
num Affected
8
num At Risk
938
term
SMALL INTESTINAL OBSTRUCTION
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
657
group Id
EG001
num Affected
4
num At Risk
269
group Id
EG002
num Affected
3
num At Risk
938
term
ILEUS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
3
num At Risk
657
group Id
EG001
num Affected
1
num At Risk
269
group Id
EG002
num Affected
4
num At Risk
938
term
NAUSEA
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
657
group Id
EG001
num Affected
1
num At Risk
269
group Id
EG002
num Affected
3
num At Risk
938
term
COLITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
2
num At Risk
657
group Id
EG001
num Affected
2
num At Risk
269
group Id
EG002
num Affected
1
num At Risk
938
term
ENTERITIS
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
0
num At Risk
657
group Id
EG001
num Affected
0
num At Risk
269
group Id
EG002
num Affected
4
num At Risk
938
term
GASTROINTESTINAL HAEMORRHAGE
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12.0
stats
group Id
EG000
num Affected
1
num At Risk
657
group Id
EG001
num Affected
0
num At Risk
269
group Id
EG002
num Affected
3
num At Risk
938
term
SUBILEUS

time Frame

From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).

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