NCT00052910 · ADVERSE EVENTS

Adverse events

Chemotherapy and Radiation Therapy After Surgery in Treating Patients With Stomach or Esophageal Cancer · Source last updated 2020-05-07

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: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I (5-FU/LV) Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.	62 / 272	258 / 272	11 / 272
Arm II (ECF) Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.	42 / 251	234 / 251	5 / 251

Group identifiers: EG000: Arm I (5-FU/LV) · EG001: Arm II (ECF)

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
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
272
num Events
8
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
272
num Events
7
group Id
EG001
num Affected
8
num At Risk
251
num Events
10
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Transfusion: Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
2
num At Risk
251
num Events
2
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Pericardial effusion

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
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
4
group Id
EG001
num Affected
1
num At Risk
251
num Events
2
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
10
num At Risk
272
num Events
11
group Id
EG001
num Affected
8
num At Risk
251
num Events
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
80
num At Risk
272
num Events
165
group Id
EG001
num Affected
81
num At Risk
251
num Events
180
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
2
num At Risk
251
num Events
2
term
Hemoglobin for leukemia studies
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Transfusion: pRBCs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
6
num At Risk
251
num Events
6
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Cardiac pain

Complete source fields

event Groups

deaths Num Affected
11
deaths Num At Risk
272
description
Patients receive leucovorin calcium (LV) IV (20 mg/m\^2 per day) and fluorouracil (5-FU) IV (425 mg/m\^2 per day) on days 1-5 of courses 1, 3, and 4. Courses repeat every 28 days. During course 2, patients undergo radiotherapy 5 days a week and receive 5-FU IV continuously for 5 to 6 weeks. Patients rest for 28-35 days between course 2 and 3.
id
EG000
other Num Affected
258
other Num At Risk
272
serious Num Affected
62
serious Num At Risk
272
title
Arm I (5-FU/LV)
deaths Num Affected
5
deaths Num At Risk
251
description
Patients receive epirubicin IV (50 mg/m\^2) over 3-15 minutes and cisplatin IV (60 mg/m\^2) over 1 hour on day 1 and 5-FU IV (200 mg/m\^2 per day) continuously on days 1-21 during course 1. Beginning 1 week later, patients undergo radiotherapy 5 days a week and 5-FU IV continuously for 5 weeks. Patients rest for 28-35 days before beginning course 2 of chemotherapy. Patients then receive epirubicin, cisplatin, and 5-FU as in course 1. Treatment repeats every 21 days for 2 courses.
id
EG001
other Num Affected
234
other Num At Risk
251
serious Num Affected
42
serious Num At Risk
251
title
Arm II (ECF)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
4
group Id
EG001
num Affected
1
num At Risk
251
num Events
2
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
10
num At Risk
272
num Events
11
group Id
EG001
num Affected
8
num At Risk
251
num Events
10
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
80
num At Risk
272
num Events
165
group Id
EG001
num Affected
81
num At Risk
251
num Events
180
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
2
num At Risk
251
num Events
2
term
Hemoglobin for leukemia studies
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Thrombotic microangiopathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Transfusion: pRBCs
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Arrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
6
num At Risk
251
num Events
6
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Cardiac pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
272
num Events
8
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
7
num At Risk
272
num Events
7
group Id
EG001
num Affected
8
num At Risk
251
num Events
10
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Transfusion: Platelets
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
2
num At Risk
251
num Events
2
term
Arrhythmia supraventricular
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Edema
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
0
num At Risk
272
num Events
0
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
1
num At Risk
251
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 6
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
251
num Events
0
term
Pericardial effusion

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