Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-25 @ 12:42 PM
NCT ID:
NCT00516295
Description:
Patients found not to meet the eligibility requirements are by group policy not followed for adverse events or outcome.
Frequency Threshold:
0
Time Frame:
None
Study:
NCT00516295
Study Brief:
Vincristine Sulfate, Topotecan Hydrochloride, and Cyclophosphamide With or Without Bevacizumab in Treating Young Patients With Refractory or First Recurrent Extracranial Ewing Sarcoma
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm I (Feasibility Assessment of VTCB) | Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 \[course 5\], 17, 18 \[course 6\], 26, 27 \[course 9\], 29, and 30 \[course 10\] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity. topotecan hydrochloride: Given IV vincristine sulfate: Given IV cyclophosphamide: Given IV bevacizumab: Given IV | None | None | 5 | 6 | 6 | 6 | View |
| Arm III (VTC) | Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I. | None | None | 0 | 0 | 0 | 0 | View |
| Arm II (VTCB) | Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I. | None | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Burn | None | Injury, poisoning and procedural complications | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Infections and infestations - Other, specify | None | Infections and infestations | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Vomiting | None | Gastrointestinal disorders | None | View |
| Esophageal stenosis | None | Gastrointestinal disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Alanine aminotransferase increased | None | Investigations | None | View |
| Allergic reaction | None | Immune system disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Anorexia | None | Metabolism and nutrition disorders | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Bone pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Catheter related infection | None | Infections and infestations | None | View |
| Creatinine increased | None | Investigations | None | View |
| Dry skin | None | Skin and subcutaneous tissue disorders | None | View |
| Dysgeusia | None | Nervous system disorders | None | View |
| Epistaxis | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Esophageal infection | None | Infections and infestations | None | View |
| Febrile neutropenia | None | Blood and lymphatic system disorders | None | View |
| Gastritis | None | Gastrointestinal disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hyperkalemia | None | Metabolism and nutrition disorders | None | View |
| Hypoalbuminemia | None | Metabolism and nutrition disorders | None | View |
| Infections and infestations - Other, specify | None | Infections and infestations | None | View |
| Lymphocyte count decreased | None | Investigations | None | View |
| Middle ear inflammation | None | Ear and labyrinth disorders | None | View |
| Mucositis oral | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Neutrophil count decreased | None | Investigations | None | View |
| Oral hemorrhage | None | Gastrointestinal disorders | None | View |
| Platelet count decreased | None | Investigations | None | View |
| Rash maculo-papular | None | Skin and subcutaneous tissue disorders | None | View |
| Upper respiratory infection | None | Infections and infestations | None | View |
| White blood cell decreased | None | Investigations | None | View |
| Abdominal pain | None | Gastrointestinal disorders | None | View |
| Arthralgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Aspartate aminotransferase increased | None | Investigations | None | View |
| Peripheral motor neuropathy | None | Nervous system disorders | None | View |