NCT00942331 · ADVERSE EVENTS

Adverse events

Gemcitabine Hydrochloride and Cisplatin With or Without Bevacizumab in Treating Patients With Advanced Urinary Tract Cancer · Source last updated 2026-06-24

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 7 years
Other-event reporting threshold: 0%

All participants are followed for overall survival and this summarized/included in the All-cause Mortality table. Participants who started treatment are evaluable for adverse events (summarized in the Serious and Other(Not Serious) AE tables).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm II (GCB) Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	95 / 237	215 / 237	207 / 252
Arm I (GCP) Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.	87 / 232	205 / 232	216 / 254

Group identifiers: EG000: Arm II (GCB) · EG001: Arm I (GCP)

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 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
2
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
237
num Events
5
group Id
EG001
num Affected
5
num At Risk
232
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
72
num At Risk
237
num Events
92
group Id
EG001
num Affected
63
num At Risk
232
num Events
78
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
2
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
3
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Ventricular fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Hearing impaired

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 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
237
num Events
9
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
184
num At Risk
237
num Events
1066
group Id
EG001
num Affected
176
num At Risk
232
num Events
1079
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
2
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Ear disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
7
num At Risk
232
num Events
55
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
237
num Events
9
group Id
EG001
num Affected
5
num At Risk
232
num Events
8
term
Tinnitus

Complete source fields

description

event Groups

deaths Num Affected
207
deaths Num At Risk
252
description
Patients receive gemcitabine hydrochloride and cisplatin as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive bevacizumab IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG000
other Num Affected
215
other Num At Risk
237
serious Num Affected
95
serious Num At Risk
237
title
Arm II (GCB)
deaths Num Affected
216
deaths Num At Risk
254
description
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV and placebo IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive placebo IV over 30-90 minutes every 21 days in the absence of disease progression or unacceptable toxicity.
id
EG001
other Num Affected
205
other Num At Risk
232
serious Num Affected
87
serious Num At Risk
232
title
Arm I (GCP)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
4
num At Risk
237
num Events
9
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
184
num At Risk
237
num Events
1066
group Id
EG001
num Affected
176
num At Risk
232
num Events
1079
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Hemolysis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Lymphatic disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Atrial tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
2
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Ear disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
7
num At Risk
232
num Events
55
term
Hearing impaired
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
237
num Events
9
group Id
EG001
num Affected
5
num At Risk
232
num Events
8
term
Tinnitus

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
2
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Blood disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
237
num Events
5
group Id
EG001
num Affected
5
num At Risk
232
num Events
5
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
72
num At Risk
237
num Events
92
group Id
EG001
num Affected
63
num At Risk
232
num Events
78
term
Hemoglobin decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
2
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Atrial fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
237
num Events
3
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Cardiac disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Cardiac pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Conduction disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Left ventricular failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Myocardial ischemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
1
num At Risk
232
num Events
1
term
Pericardial effusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
237
num Events
1
group Id
EG001
num Affected
0
num At Risk
232
num Events
0
term
Ventricular fibrillation
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
237
num Events
0
group Id
EG001
num Affected
2
num At Risk
232
num Events
2
term
Hearing impaired

time Frame

Up to 7 years

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Preserved source evidence · Not medical advice