NCT02595424 · ADVERSE EVENTS

Adverse events

Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas · Source last updated 2026-07-27

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: Assessed every cycle (1 cycle=21 days) while on treatment and for 30 days after the end of treatment, up to 5 years
Other-event reporting threshold: 5%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm A (Capecitabine, Temozolomide) Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.	9 / 28	27 / 28	23 / 31
Arm B (Cisplatin, Carboplatin, Etoposide) Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.	20 / 29	28 / 29	25 / 32

Group identifiers: EG000: Arm A (Capecitabine, Temozolomide) · EG001: Arm B (Cisplatin, Carboplatin, Etoposide)

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
8
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
29
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Allergic reaction

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
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
10
num At Risk
28
group Id
EG001
num Affected
23
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
18
num At Risk
28
group Id
EG001
num Affected
18
num At Risk
29
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
18
num At Risk
29
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Palmar-plantar erythrodysesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
28
group Id
EG001
num Affected
6
num At Risk
29
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
28
group Id
EG001
num Affected
5
num At Risk
29
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Mucositis oral

Complete source fields

event Groups

deaths Num Affected
23
deaths Num At Risk
31
description
Patients receive capecitabine PO BID on days 1-14 and temozolomide PO QD on days 10-14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
27
other Num At Risk
28
serious Num Affected
9
serious Num At Risk
28
title
Arm A (Capecitabine, Temozolomide)
deaths Num Affected
25
deaths Num At Risk
32
description
Patients receive cisplatin IV on days 1-3 or carboplatin IV on day 1. Patients also receive etoposide IV on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
28
other Num At Risk
29
serious Num Affected
20
serious Num At Risk
29
title
Arm B (Cisplatin, Carboplatin, Etoposide)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
10
num At Risk
28
group Id
EG001
num Affected
23
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
18
num At Risk
28
group Id
EG001
num Affected
18
num At Risk
29
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Fever
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
18
num At Risk
29
term
Alopecia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Palmar-plantar erythrodysesthesia syndrome
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
4
num At Risk
28
group Id
EG001
num Affected
6
num At Risk
29
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
7
num At Risk
28
group Id
EG001
num Affected
5
num At Risk
29
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Dyspepsia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Gastroesophageal reflux disease
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
3
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Mucositis oral

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
8
num At Risk
29
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
3
num At Risk
29
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
2
num At Risk
29
term
Fatigue
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Rash maculo-papular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Colitis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Constipation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Dysphagia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
2
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
1
num At Risk
28
group Id
EG001
num Affected
0
num At Risk
29
term
Vomiting
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE 4.0
stats
group Id
EG000
num Affected
0
num At Risk
28
group Id
EG001
num Affected
1
num At Risk
29
term
Allergic reaction

time Frame

Assessed every cycle (1 cycle=21 days) while on treatment and for 30 days after the end of treatment, up to 5 years

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Preserved source evidence · Not medical advice