NCT00467051 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors · Source last updated 2018-08-29

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%

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Treatment (Chemotherapy, Biological Therapy) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies	0 / 20	18 / 20	Not reported / Not reported

Group identifiers: EG000: Treatment (Chemotherapy, Biological Therapy)

Serious adverse events

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

Other reported adverse events

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

organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Alanine aminotransferase increased
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
20
term
Anemia
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Aspartate aminotransferase increased
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Ataxia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Bladder infection
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Blood and lymphatic system disorders - Other
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cardiac disorders - Other
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Confusion
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Febrile neutropenia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hyperglycemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
20
term
Hypokalemia

Complete source fields

description

SAE field contains NCI CTCAEs submitted via expedited reporting (NCI AdEERs / CAeRs). The AE field contains grade 3 and higher CTCAEs reported on study excluding those that were reported as SAEs.

event Groups

description
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. paclitaxel: Given IV dosage 135 mg/m2/dose carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x \[(0.93 x GFR mL/min/m2) + 15\]= 6.5 x \[(0.93 x GFR mL/min/m2) + 15\]. (BSA = body surface area in square meters). GFR is reported in institutions as "uncorrected" or "raw" (not normalized to BSA) or "corrected." This number needs to be converted to GFR in mL/min/m2. ifosfamide: Given IV dosage 1800 mg/m2/dose filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2 laboratory biomarker analysis: Optional correlative studies
id
EG000
other Num Affected
18
other Num At Risk
20
serious Num Affected
0
serious Num At Risk
20
title
Treatment (Chemotherapy, Biological Therapy)

frequency Threshold

other Events

organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Agitation
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
20
term
Alanine aminotransferase increased
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
8
num At Risk
20
term
Anemia
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Aspartate aminotransferase increased
organ System
Nervous system disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Ataxia
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Bladder infection
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Blood and lymphatic system disorders - Other
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Cardiac disorders - Other
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Confusion
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
5
num At Risk
20
term
Febrile neutropenia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
20
term
Hyperglycemia
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
3
num At Risk
20
term
Hypokalemia

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Preserved source evidence · Not medical advice