NCT01055314 · ADVERSE EVENTS

Adverse events

Temozolomide, Cixutumumab, and Combination Chemotherapy in Treating Patients With Metastatic Rhabdomyosarcoma · Source last updated 2017-08-29

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. Nine participants who were ineligible or did not receive treatment were excluded (both serious and other).

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50 \& 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47 \& 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, \& 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28 \& 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 \& 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41 \& 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24. Cixutumumab: Given IV Cyclophosphamide: Given IV Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Vincristine Sulfate	79 / 96	85 / 96	Not reported / Not reported
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide) Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50. Cyclophosphamide: Given IV Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO Vincristine Sulfate Liposome: Given IV	40 / 70	63 / 70	Not reported / Not reported

Group identifiers: EG000: Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab) · EG001: Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

Serious 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
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Abdominal distension
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
5
num At Risk
96
num Events
7
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Abdominal pain
organ System
Renal and urinary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Acute kidney injury
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Adult respiratory distress syndrome
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
9
num At Risk
96
num Events
10
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Alanine aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Alkaline phosphatase increased
organ System
Immune system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Allergic reaction
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Anal ulcer
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
96
num Events
5
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Anemia
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
96
num Events
4
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Anorexia
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Apnea
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Appendicitis

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
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Abdominal distension
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Abdominal infection
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
7
num At Risk
96
num Events
8
group Id
EG001
num Affected
8
num At Risk
70
num Events
10
term
Abdominal pain
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
3
group Id
EG001
num Affected
2
num At Risk
70
num Events
3
term
Acidosis
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Activated partial thromboplastin time prolonged
organ System
Renal and urinary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Acute kidney injury
organ System
Psychiatric disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
2
num At Risk
70
num Events
2
term
Agitation
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
15
num At Risk
96
num Events
22
group Id
EG001
num Affected
15
num At Risk
70
num Events
22
term
Alanine aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
2
term
Alkaline phosphatase increased
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
2
term
Alkalosis
organ System
Immune system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Allergic reaction
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
2
num At Risk
70
num Events
2
term
Anal fistula

Complete source fields

description

event Groups

description
Patients receive vincristine sulfate IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50 \& 51; irinotecan hydrochloride IV over 90 minutes on days 1-5 of weeks 1, 4, 20, 23, 47 \& 50; ifosfamide IV over 1 hour and etoposide IV over 1-2 hours on days 1-5 of weeks 9, 13, 17, 26, \& 30; doxorubicin hydrochloride IV over 1-15 minutes on days 1 and 2 of weeks 7, 11, 15, 28 \& 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 \& 44; dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41 \& 44; and cixutumumab IV over 1 hour on day 1 of weeks 1-51. Patients also undergo radiation therapy on days 1-5 of weeks 20-24. Cixutumumab: Given IV Cyclophosphamide: Given IV Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Vincristine Sulfate
id
EG000
other Num Affected
85
other Num At Risk
96
serious Num Affected
79
serious Num At Risk
96
title
Group 1 (Chemotherapy, Radiation Therapy, Cixutumumab)
description
Patients receive vincristine sulfate, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin and undergo radiation therapy as in group 1. Patients also receive temozolomide PO on days 1-5 of weeks 1, 4, 20, 23, 47, and 50. Cyclophosphamide: Given IV Dactinomycin: Given IV Doxorubicin Hydrochloride: Given IV Etoposide: Given IV Ifosfamide: Given IV Irinotecan Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Temozolomide: Given PO Vincristine Sulfate Liposome: Given IV
id
EG001
other Num Affected
63
other Num At Risk
70
serious Num Affected
40
serious Num At Risk
70
title
Group 2 (Chemotherapy, Radiation Therapy, Temozolomide)

frequency Threshold

other Events

organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Abdominal distension
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Abdominal infection
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
7
num At Risk
96
num Events
8
group Id
EG001
num Affected
8
num At Risk
70
num Events
10
term
Abdominal pain
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
3
group Id
EG001
num Affected
2
num At Risk
70
num Events
3
term
Acidosis
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Activated partial thromboplastin time prolonged
organ System
Renal and urinary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Acute kidney injury
organ System
Psychiatric disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
2
num At Risk
70
num Events
2
term
Agitation
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
15
num At Risk
96
num Events
22
group Id
EG001
num Affected
15
num At Risk
70
num Events
22
term
Alanine aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
2
term
Alkaline phosphatase increased
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
2
term
Alkalosis
organ System
Immune system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Allergic reaction
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
2
num At Risk
70
num Events
2
term
Anal fistula

serious Events

organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Abdominal distension
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
5
num At Risk
96
num Events
7
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Abdominal pain
organ System
Renal and urinary disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Acute kidney injury
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
0
num At Risk
96
num Events
0
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Adult respiratory distress syndrome
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
9
num At Risk
96
num Events
10
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Alanine aminotransferase increased
organ System
Investigations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Alkaline phosphatase increased
organ System
Immune system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Allergic reaction
organ System
Gastrointestinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Anal ulcer
organ System
Blood and lymphatic system disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
96
num Events
5
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Anemia
organ System
Metabolism and nutrition disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
4
num At Risk
96
num Events
4
group Id
EG001
num Affected
1
num At Risk
70
num Events
1
term
Anorexia
organ System
Respiratory, thoracic and mediastinal disorders
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
2
num At Risk
96
num Events
2
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Apnea
organ System
Infections and infestations
source Vocabulary
CTCv4
stats
group Id
EG000
num Affected
1
num At Risk
96
num Events
1
group Id
EG001
num Affected
0
num At Risk
70
num Events
0
term
Appendicitis

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

Preserved source evidence · Not medical advice