NCT00061893 · ADVERSE EVENTS

Adverse events

Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors · Source last updated 2019-02-15

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%

By protocol design, all eligible patients who received any protocol therapy were considered in the evaluation of study outcome measures, including the occurence of Adverse Events. Three (3) patients were considered ineligible. The remaining eligible 35 patients started protocol therapy and are included in the valuation of Adverse Event experience.

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
Combination Chemotherapy Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.	33 / 35	34 / 35	Not reported / Not reported

Group identifiers: EG000: Combination Chemotherapy

Serious adverse events

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

notes
Grades 3-5
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Abdominal pain
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Activated partial thromboplastin time prolonged
notes
Grades 3-5
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Adult respiratory distress syndrome
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Alanine aminotransferase increased
notes
Grades 3-5
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
12
num At Risk
35
term
Anemia
notes
Grades 3-5
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
6
num At Risk
35
term
Anorexia
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Aspartate aminotransferase increased
notes
Grades 3-5
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Back pain
notes
Grades 3-5
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bladder infection
notes
Grades 3-5
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bladder spasm
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
35
term
Blood bilirubin increased
notes
Grades 3-5
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bronchial infection

Other reported adverse events

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

notes
Grades 1-2
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
9
num At Risk
35
term
Acidosis
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Activated partial thromboplastin time prolonged
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
35
term
Alanine aminotransferase increased
notes
Grades 1-2
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Anemia
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Aspartate aminotransferase increased
notes
Grades 1-2
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bladder spasm
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Blood bilirubin increased
notes
Grades 1-2
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Burn
notes
Grades 1-2
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Catheter related infection
notes
Grades 1-2
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Constipation
notes
Grades 1-2
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Depression
notes
Grades 1-2
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
35
term
Gastritis

Complete source fields

description

event Groups

description
Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
id
EG000
other Num Affected
34
other Num At Risk
35
serious Num Affected
33
serious Num At Risk
35
title
Combination Chemotherapy

frequency Threshold

other Events

notes
Grades 1-2
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
9
num At Risk
35
term
Acidosis
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Activated partial thromboplastin time prolonged
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
35
term
Alanine aminotransferase increased
notes
Grades 1-2
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Anemia
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Aspartate aminotransferase increased
notes
Grades 1-2
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bladder spasm
notes
Grades 1-2
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Blood bilirubin increased
notes
Grades 1-2
organ System
Injury, poisoning and procedural complications
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Burn
notes
Grades 1-2
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Catheter related infection
notes
Grades 1-2
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Constipation
notes
Grades 1-2
organ System
Psychiatric disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Depression
notes
Grades 1-2
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
8
num At Risk
35
term
Gastritis

serious Events

notes
Grades 3-5
organ System
Gastrointestinal disorders
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Abdominal pain
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Activated partial thromboplastin time prolonged
notes
Grades 3-5
organ System
Respiratory, thoracic and mediastinal disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Adult respiratory distress syndrome
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Alanine aminotransferase increased
notes
Grades 3-5
organ System
Blood and lymphatic system disorders
stats
group Id
EG000
num Affected
12
num At Risk
35
term
Anemia
notes
Grades 3-5
organ System
Metabolism and nutrition disorders
stats
group Id
EG000
num Affected
6
num At Risk
35
term
Anorexia
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
2
num At Risk
35
term
Aspartate aminotransferase increased
notes
Grades 3-5
organ System
Musculoskeletal and connective tissue disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Back pain
notes
Grades 3-5
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bladder infection
notes
Grades 3-5
organ System
Renal and urinary disorders
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bladder spasm
notes
Grades 3-5
organ System
Investigations
stats
group Id
EG000
num Affected
3
num At Risk
35
term
Blood bilirubin increased
notes
Grades 3-5
organ System
Infections and infestations
stats
group Id
EG000
num Affected
1
num At Risk
35
term
Bronchial infection

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Preserved source evidence · Not medical advice