NCT00302003 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Lymphoma · Source last updated 2021-03-30

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
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 \[max 2.8 mg\]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy. radiation therapy: Undergo radiation therapy doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given orally cyclophosphamide: Given IV ifosfamide: Given IV vinorelbine tartrate: Given IV dexamethasone: Given IV etoposide phosphate: Given IV cisplatin: Given IV cytarabine: Given IV filgrastim: Given IV or subcutaneously	2 / 278	80 / 278	Not reported / Not reported

Group identifiers: EG000: Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim

Serious adverse events

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

organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Infections and infestations - Other, specify
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
CPK increased
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Acidosis
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Thromboembolic event

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
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
18
num At Risk
278
num Events
18
term
Febrile neutropenia
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
2
num At Risk
278
num Events
2
term
Hearing impaired
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
2
num At Risk
278
num Events
2
term
Tinnitus
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Delayed puberty
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Hypothyroidism
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Eye pain
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Optic nerve disorder
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
278
num Events
3
term
Abdominal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
278
num Events
3
term
Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Enterocolitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Esophageal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Esophagitis

Complete source fields

event Groups

description
Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 \& 2, Vincristine sulfate IV (1.4 mg/m2 \[max 2.8 mg\]) Days 1 \& 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 \& 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy. radiation therapy: Undergo radiation therapy doxorubicin hydrochloride: Given IV vincristine sulfate: Given IV prednisone: Given orally cyclophosphamide: Given IV ifosfamide: Given IV vinorelbine tartrate: Given IV dexamethasone: Given IV etoposide phosphate: Given IV cisplatin: Given IV cytarabine: Given IV filgrastim: Given IV or subcutaneously
id
EG000
other Num Affected
80
other Num At Risk
278
serious Num Affected
2
serious Num At Risk
278
title
Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
18
num At Risk
278
num Events
18
term
Febrile neutropenia
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
2
num At Risk
278
num Events
2
term
Hearing impaired
organ System
Ear and labyrinth disorders
stats
group Id
EG000
num Affected
2
num At Risk
278
num Events
2
term
Tinnitus
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Delayed puberty
organ System
Endocrine disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Hypothyroidism
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Eye pain
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Optic nerve disorder
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
278
num Events
3
term
Abdominal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
278
num Events
3
term
Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Enterocolitis
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Esophageal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Esophagitis

serious Events

organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Infections and infestations - Other, specify
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
CPK increased
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Acidosis
organ System
Vascular disorders
stats
group Id
EG000
num Affected
1
num At Risk
278
num Events
1
term
Thromboembolic event

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Preserved source evidence · Not medical advice