NCT00354835 · ADVERSE EVENTS

Adverse events

Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma · Source last updated 2023-01-31

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%

All eligible patients were considered in the evaluation of adverse events.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Vincristine, Dactinomycin, Cyclophosphamide (VAC) Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	4 / 222	209 / 222	Not reported / Not reported
VAC Alternating With VI Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Irinotecan Hydrochloride: Given IV Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies	11 / 226	213 / 226	Not reported / Not reported

Group identifiers: EG000: Vincristine, Dactinomycin, Cyclophosphamide (VAC) · EG001: VAC Alternating With VI

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
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Alanine aminotransferase increased
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Anemia
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Ascites
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Aspartate aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Blood bilirubin increased
organ System
General disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
2
num At Risk
226
num Events
2
term
Death NOS
organ System
Nervous system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Encephalopathy
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Esophagitis
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Gastritis
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Gastrointestinal disorders - Other, specify
organ System
Hepatobiliary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Hepatic pain
organ System
Hepatobiliary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Hepatobiliary disorders - Other, specify

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
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
2
num At Risk
226
num Events
2
term
Abdominal distension
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
2
num At Risk
226
num Events
2
term
Abdominal infection
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
9
num At Risk
222
num Events
11
group Id
EG001
num Affected
12
num At Risk
226
num Events
14
term
Abdominal pain
organ System
Nervous system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Abducens nerve disorder
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Activated partial thromboplastin time prolonged
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
19
num At Risk
222
num Events
21
group Id
EG001
num Affected
16
num At Risk
226
num Events
22
term
Alanine aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Alkaline phosphatase increased
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Anal mucositis
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Anal pain
organ System
Immune system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
222
num Events
4
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
102
num At Risk
222
num Events
183
group Id
EG001
num Affected
57
num At Risk
226
num Events
89
term
Anemia
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
2
term
Anorectal infection

Complete source fields

description

All eligible patients were considered in the evaluation of adverse events.

event Groups

description
Patients receive VAC chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 19-25, 28, 31-37, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 4, 13, 16, 19, 22, 25, 28, 31, 34, 37,and 40; and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, and 40. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies
id
EG000
other Num Affected
209
other Num At Risk
222
serious Num Affected
4
serious Num At Risk
222
title
Vincristine, Dactinomycin, Cyclophosphamide (VAC)
description
Patients receive VAC chemotherapy alternating with VI chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-13, 16, 17, 19, 20, 22-26, 28, 31-34, 37, 38, and 40; dactinomycin IV over 1-5 minutes on day 1 of weeks 1, 13, 22, 28, 34, and 40; cyclophosphamide IV over 1 hour on day 1 of weeks 1,10, 13, 22, 28, 34, and 40; and irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 4, 7, 16, 19, 25, 31, and 37. Patients may also undergo radiotherapy 5 days a week for 4-6 weeks beginning in week 4. Irinotecan Hydrochloride: Given IV Dactinomycin: Given IV Cyclophosphamide: Given IV Vincristine Sulfate: Given IV Radiation Therapy: Undergo radiotherapy Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies
id
EG001
other Num Affected
213
other Num At Risk
226
serious Num Affected
11
serious Num At Risk
226
title
VAC Alternating With VI

frequency Threshold

other Events

organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
2
num At Risk
226
num Events
2
term
Abdominal distension
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
2
num At Risk
226
num Events
2
term
Abdominal infection
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
9
num At Risk
222
num Events
11
group Id
EG001
num Affected
12
num At Risk
226
num Events
14
term
Abdominal pain
organ System
Nervous system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Abducens nerve disorder
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Activated partial thromboplastin time prolonged
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
19
num At Risk
222
num Events
21
group Id
EG001
num Affected
16
num At Risk
226
num Events
22
term
Alanine aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Alkaline phosphatase increased
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Anal mucositis
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Anal pain
organ System
Immune system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
222
num Events
4
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Anaphylaxis
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
102
num At Risk
222
num Events
183
group Id
EG001
num Affected
57
num At Risk
226
num Events
89
term
Anemia
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
2
term
Anorectal infection

serious Events

organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Alanine aminotransferase increased
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Anemia
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Ascites
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Aspartate aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Blood bilirubin increased
organ System
General disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
2
num At Risk
226
num Events
2
term
Death NOS
organ System
Nervous system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Encephalopathy
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Esophagitis
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Gastritis
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
222
num Events
0
group Id
EG001
num Affected
1
num At Risk
226
num Events
1
term
Gastrointestinal disorders - Other, specify
organ System
Hepatobiliary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Hepatic pain
organ System
Hepatobiliary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
222
num Events
1
group Id
EG001
num Affected
0
num At Risk
226
num Events
0
term
Hepatobiliary disorders - Other, specify

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