NCT00075582 · ADVERSE EVENTS

Adverse events

Vincristine, Dactinomycin, and Cyclophosphamide With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Low-Risk Rhabdomyosarcoma · Source last updated 2021-11-19

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%

Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Regimen I (Chemotherapy, Radiotherapy) Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy	1 / 272	74 / 272	Not reported / Not reported
Regimen II (Chemotherapy, Radiotherapy, Surgery) Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy	1 / 70	27 / 70	Not reported / Not reported

Group identifiers: EG000: Regimen I (Chemotherapy, Radiotherapy) · EG001: Regimen II (Chemotherapy, Radiotherapy, Surgery)

Serious adverse events

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

organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
272
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Neutrophil count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
White blood cell decreased

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
14
num At Risk
272
num Events
14
group Id
EG001
num Affected
9
num At Risk
70
num Events
9
term
Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
14
num At Risk
272
num Events
14
group Id
EG001
num Affected
7
num At Risk
70
num Events
7
term
Febrile neutropenia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Sinus tachycardia
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Photophobia
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Watering eyes
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Abdominal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
272
num Events
3
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Flatulence
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Ileus
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
2
num At Risk
70
num Events
2
term
Mucositis oral

Complete source fields

description

Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.

event Groups

description
Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010) dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
id
EG000
other Num Affected
74
other Num At Risk
272
serious Num Affected
1
serious Num At Risk
272
title
Regimen I (Chemotherapy, Radiotherapy)
description
Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011). conventional surgery: Some patients may undergo second-look surgery dactinomycin: Given IV cyclophosphamide: Given IV vincristine sulfate: Given IV radiation therapy: Undergo radiotherapy
id
EG001
other Num Affected
27
other Num At Risk
70
serious Num Affected
1
serious Num At Risk
70
title
Regimen II (Chemotherapy, Radiotherapy, Surgery)

frequency Threshold

other Events

organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
14
num At Risk
272
num Events
14
group Id
EG001
num Affected
9
num At Risk
70
num Events
9
term
Anemia
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Disseminated intravascular coagulation
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
14
num At Risk
272
num Events
14
group Id
EG001
num Affected
7
num At Risk
70
num Events
7
term
Febrile neutropenia
organ System
Cardiac disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Sinus tachycardia
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Photophobia
organ System
Eye disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Watering eyes
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Abdominal pain
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
3
num At Risk
272
num Events
3
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Constipation
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Diarrhea
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Flatulence
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
Ileus
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
272
num Events
2
group Id
EG001
num Affected
2
num At Risk
70
num Events
2
term
Mucositis oral

serious Events

organ System
Investigations
stats
group Id
EG000
num Affected
0
num At Risk
272
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Neutrophil count decreased
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
272
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
term
White blood cell decreased

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice