NCT00104676 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors · Source last updated 2025-02-06

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: Not reported
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Arm I Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered	37 / 98	98 / 98	61 / 98
Arm II Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion	58 / 105	105 / 105	66 / 105

Group identifiers: EG000: Arm I · EG001: Arm II

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
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Acute leukemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
98
group Id
EG001
num Affected
7
num At Risk
105
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
98
group Id
EG001
num Affected
2
num At Risk
105
term
Aplasia bone marrow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Bicytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
98
group Id
EG001
num Affected
5
num At Risk
105
term
Febrile aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
98
group Id
EG001
num Affected
9
num At Risk
105
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
98
group Id
EG001
num Affected
0
num At Risk
105
term
Myeloid leukemia, acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
2
num At Risk
105
term
Myelodysplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
26
num At Risk
98
group Id
EG001
num Affected
17
num At Risk
105
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
98
group Id
EG001
num Affected
2
num At Risk
105
term
Neutropenia aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Neutropenia malignany

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
Skin and subcutaneous tissue disorders
source Vocabulary
MedRRA
stats
group Id
EG000
num Affected
18
num At Risk
98
group Id
EG001
num Affected
27
num At Risk
105
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
72
num At Risk
98
group Id
EG001
num Affected
91
num At Risk
105
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
20
num At Risk
98
group Id
EG001
num Affected
52
num At Risk
105
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
18
num At Risk
98
group Id
EG001
num Affected
45
num At Risk
105
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
43
num At Risk
98
group Id
EG001
num Affected
36
num At Risk
105
term
Liver function test increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
21
num At Risk
98
group Id
EG001
num Affected
82
num At Risk
105
term
Neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
28
num At Risk
98
group Id
EG001
num Affected
52
num At Risk
105
term
Auditory disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
34
num At Risk
98
group Id
EG001
num Affected
43
num At Risk
105
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
9
num At Risk
98
group Id
EG001
num Affected
29
num At Risk
105
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
76
num At Risk
98
group Id
EG001
num Affected
90
num At Risk
105
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
23
num At Risk
98
group Id
EG001
num Affected
33
num At Risk
105
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
98
num At Risk
98
group Id
EG001
num Affected
105
num At Risk
105
term
Hemoglobin

Complete source fields

event Groups

deaths Num Affected
61
deaths Num At Risk
98
description
Patients receive 4 courses of bleomycin, etoposide, and cisplatin (BEP). bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered
id
EG000
other Num Affected
98
other Num At Risk
98
serious Num Affected
37
serious Num At Risk
98
title
Arm I
deaths Num Affected
66
deaths Num At Risk
105
description
Patients receive 1 course of bleomycin, etoposide, and cisplatin (BEP). Patients then receive dose-dense sequential combination chemotherapy comprising cisplatin, etoposide, bleomycin, paclitaxel, oxaliplatin, and ifosfamide. bleomycin sulfate: At least one course administered cisplatin: At least one course administered etoposide: At least one course administered ifosfamide: Given in a dose-dense sequential fashion oxaliplatin: Given in a dose-dense sequential fashion paclitaxel: Given in a dose-dense sequential fashion
id
EG001
other Num Affected
105
other Num At Risk
105
serious Num Affected
58
serious Num At Risk
105
title
Arm II

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
MedRRA
stats
group Id
EG000
num Affected
18
num At Risk
98
group Id
EG001
num Affected
27
num At Risk
105
term
Rash
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
72
num At Risk
98
group Id
EG001
num Affected
91
num At Risk
105
term
Nausea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
20
num At Risk
98
group Id
EG001
num Affected
52
num At Risk
105
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
18
num At Risk
98
group Id
EG001
num Affected
45
num At Risk
105
term
Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
43
num At Risk
98
group Id
EG001
num Affected
36
num At Risk
105
term
Liver function test increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
21
num At Risk
98
group Id
EG001
num Affected
82
num At Risk
105
term
Neuropathy
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
28
num At Risk
98
group Id
EG001
num Affected
52
num At Risk
105
term
Auditory disorder
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
34
num At Risk
98
group Id
EG001
num Affected
43
num At Risk
105
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Hepatobiliary disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
9
num At Risk
98
group Id
EG001
num Affected
29
num At Risk
105
term
Creatinine
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
76
num At Risk
98
group Id
EG001
num Affected
90
num At Risk
105
term
Asthenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
23
num At Risk
98
group Id
EG001
num Affected
33
num At Risk
105
term
Infection
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
98
num At Risk
98
group Id
EG001
num Affected
105
num At Risk
105
term
Hemoglobin

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Acute leukemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
98
group Id
EG001
num Affected
7
num At Risk
105
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
3
num At Risk
98
group Id
EG001
num Affected
2
num At Risk
105
term
Aplasia bone marrow
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Bicytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
1
num At Risk
98
group Id
EG001
num Affected
5
num At Risk
105
term
Febrile aplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
5
num At Risk
98
group Id
EG001
num Affected
9
num At Risk
105
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
4
num At Risk
98
group Id
EG001
num Affected
0
num At Risk
105
term
Myeloid leukemia, acute
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Granulocytopenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
2
num At Risk
105
term
Myelodysplasia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
26
num At Risk
98
group Id
EG001
num Affected
17
num At Risk
105
term
Neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
2
num At Risk
98
group Id
EG001
num Affected
2
num At Risk
105
term
Neutropenia aggravated
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA
stats
group Id
EG000
num Affected
0
num At Risk
98
group Id
EG001
num Affected
1
num At Risk
105
term
Neutropenia malignany

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