NCT00936936 · ADVERSE EVENTS

Adverse events

High-dose Chemotherapy for Poor-Prognosis Relapsed Germ-Cell Tumors · Source last updated 2024-08-26

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: 2 years
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.	7 / 41	41 / 41	22 / 41
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.	2 / 23	23 / 23	12 / 23

Group identifiers: EG000: Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT · EG001: Cohort 2: HD GeM-DMC+ ICE for Refractory GCT

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
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
num Events
7
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
41
num Events
4
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Bleeding (no GI no PUL)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Ejection fraction decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
2
num At Risk
23
num Events
2
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
41
num Events
6
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Fungal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Gastrointestinal bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Oral Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Pneumonitis

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
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
41
num Events
4
group Id
EG001
num Affected
3
num At Risk
23
num Events
3
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
41
num At Risk
41
num Events
70
group Id
EG001
num Affected
22
num At Risk
23
num Events
22
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
41
num Events
6
group Id
EG001
num Affected
2
num At Risk
23
num Events
2
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
37
num At Risk
41
num Events
37
group Id
EG001
num Affected
14
num At Risk
23
num Events
14
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
num Events
7
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Bleeding (no GI no PUL)
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
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
HSCT related microangiopathy (TA-TMA)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
38
num At Risk
41
num Events
63
group Id
EG001
num Affected
23
num At Risk
23
num Events
32
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
41
num Events
9
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Dysrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
num Events
5
group Id
EG001
num Affected
3
num At Risk
23
num Events
3
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
27
num At Risk
41
num Events
27
group Id
EG001
num Affected
16
num At Risk
23
num Events
16
term
Creatinine increased

Complete source fields

event Groups

deaths Num Affected
22
deaths Num At Risk
41
description
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) You will receive 1 dose of Outpatient IV at Bevacizumab 7.5mg/kg. HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
id
EG000
other Num Affected
41
other Num At Risk
41
serious Num Affected
7
serious Num At Risk
41
title
Cohort 1: HD GeM-DMC+ ICE + Bevacizumab for Refractory GCT
deaths Num Affected
12
deaths Num At Risk
23
description
First Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #1: Gemcitabine/Docetaxel/Melphalan/Carboplatin + PBPC Gemcitabine: 1800 mg/m\^2 IV over 3 hours on Days -5 to Day -2. Docetaxel: Docetaxel 300 mg/m\^2 IV over 2 hours on Day -5. Melphalan: 50 mg/m\^2 IV over 15 minutes on Days -4 to Day -2. Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Stem Cell Transplant: Stem cell infusion on Day 0. Second Cycle High-dose (HD) chemotherapy followed by stem-cell infusion (PBPC) HD Cycle #2: Ifosfamide/Carboplatin/Etoposide + PBPC Carboplatin: Cycle 1: 333 mg/m\^2 IV over 2 hours on Days -4 to -2. Cycle #2: 300 mg/m\^2 IV over 2 hours on Days -6 to -3. Mesna: 3,000 mg/m\^2 per day in 96-hour continuous infusion, starting 30 minutes prior to the first dose of ifosfamide, on Days -6 to -4. Ifosfamide: 3,000 mg/m\^2 IV over 6 hours on Days -6 to -3 Etoposide: 200 mg/m\^2 IV over 3 hours, every 12 hours on Days -6 to -4. Stem Cell Transplant: Stem cell infusion on Day 0.
id
EG001
other Num Affected
23
other Num At Risk
23
serious Num Affected
2
serious Num At Risk
23
title
Cohort 2: HD GeM-DMC+ ICE for Refractory GCT

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
41
num Events
4
group Id
EG001
num Affected
3
num At Risk
23
num Events
3
term
ALK increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Immune system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Allergic reaction
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
41
num At Risk
41
num Events
70
group Id
EG001
num Affected
22
num At Risk
23
num Events
22
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
41
num Events
6
group Id
EG001
num Affected
2
num At Risk
23
num Events
2
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
37
num At Risk
41
num Events
37
group Id
EG001
num Affected
14
num At Risk
23
num Events
14
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
num Events
7
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Bleeding (no GI no PUL)
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
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
HSCT related microangiopathy (TA-TMA)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
38
num At Risk
41
num Events
63
group Id
EG001
num Affected
23
num At Risk
23
num Events
32
term
Febrile neutropenia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
9
num At Risk
41
num Events
9
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Dysrhythmia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Chest pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Psychiatric disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
5
num At Risk
41
num Events
5
group Id
EG001
num Affected
3
num At Risk
23
num Events
3
term
Confusion
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
27
num At Risk
41
num Events
27
group Id
EG001
num Affected
16
num At Risk
23
num Events
16
term
Creatinine increased

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
ALT increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
AST increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
7
num At Risk
41
num Events
7
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Bacterial
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
4
num At Risk
41
num Events
4
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Bleeding (no GI no PUL)
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Ejection fraction decreased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
2
num At Risk
23
num Events
2
term
Creatinine increased
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
6
num At Risk
41
num Events
6
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Fungal
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Gastrointestinal bleeding
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Oral Mucositis
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
2
num At Risk
41
num Events
2
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Viral
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Dyspnea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCAE (4.0)
stats
group Id
EG000
num Affected
1
num At Risk
41
num Events
1
group Id
EG001
num Affected
0
num At Risk
23
num Events
0
term
Pneumonitis

time Frame

2 years

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Preserved source evidence · Not medical advice