NCT00002931 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Germ Cell Cancer · Source last updated 2017-02-23

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: Adverse events occurred over a period of 10 years and 6 months.
Other-event reporting threshold: 0%

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
HD Chemo and Auto Stem Cells Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.	1 / 48	46 / 48	Not reported / Not reported

Group identifiers: EG000: HD Chemo and Auto Stem Cells

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
48
num Events
1
term
Renal failure

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
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
15
num At Risk
48
num Events
21
term
Cerebellar
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
13
num At Risk
48
num Events
20
term
Clinical (Physical Exam)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
9
num At Risk
48
num Events
13
term
Dysrhythmias
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Fluid Retention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
3
num At Risk
48
num Events
4
term
Hematemesis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
9
num At Risk
48
num Events
13
term
Ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
14
num At Risk
48
num Events
57
term
Other Misc
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
9
num At Risk
48
num Events
13
term
Pericardial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Pulmonary
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
4
num At Risk
48
num Events
5
term
Rash/desquamation associated with GVHD for BMT studies

Complete source fields

description

"Other Adverse Events" include all events that were not severe adverse events regardless of grade or relation to treatment.

event Groups

description
Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
id
EG000
other Num Affected
46
other Num At Risk
48
serious Num Affected
1
serious Num At Risk
48
title
HD Chemo and Auto Stem Cells

frequency Threshold

other Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Nervous system disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
15
num At Risk
48
num Events
21
term
Cerebellar
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
13
num At Risk
48
num Events
20
term
Clinical (Physical Exam)
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
9
num At Risk
48
num Events
13
term
Dysrhythmias
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Fluid Retention
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
3
num At Risk
48
num Events
4
term
Hematemesis
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Vascular disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Hemorrhage
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Infection
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
9
num At Risk
48
num Events
13
term
Ischemia
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
General disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
14
num At Risk
48
num Events
57
term
Other Misc
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
9
num At Risk
48
num Events
13
term
Pericardial
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
COH
stats
group Id
EG000
num Affected
16
num At Risk
48
num Events
25
term
Pulmonary
assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Skin and subcutaneous tissue disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
4
num At Risk
48
num Events
5
term
Rash/desquamation associated with GVHD for BMT studies

serious Events

assessment Type
NON_SYSTEMATIC_ASSESSMENT
organ System
Renal and urinary disorders
source Vocabulary
meddra9.0
stats
group Id
EG000
num Affected
1
num At Risk
48
num Events
1
term
Renal failure

time Frame

Adverse events occurred over a period of 10 years and 6 months.

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Preserved source evidence · Not medical advice