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:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
NCT ID:
NCT01372202
Description:
None
Frequency Threshold:
0
Time Frame:
Up to 3 years
Study:
NCT01372202
Study Brief:
CHFR Methylation Status Esophageal Cancer Study
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 A | Paclitaxel with Cisplatin along with Radiotherapy and followed by Esophagectomy Paclitaxel: Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin: Paclitaxel and cisplatin: * Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. * Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32. * Cisplatin 75 mg/m² days 1, 29. Radiotherapy: Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. Esophagectomy: The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56). | 7 | None | 4 | 13 | 4 | 13 | View |
| Arm B | Oxaliplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy Cisplatin: Paclitaxel and cisplatin: * Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. * Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Cisplatin and 5-fluorouracil: * 5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32. * Cisplatin 75 mg/m² days 1, 29. Oxaliplatin: Oxaliplatin 85 mg/m2 days 1, 15, 29. 5-Fu: Oxaliplatin \& 5-fu: * Oxaliplatin 85 mg/m2 days 1, 15, 29. * 5-Fu 180 mg/m2 prolonged infusion day 1 of radiation \& completing on the final day of radiation Cisplatin/5-fluorouracil: * 5-Fu 1000 mg/m2 per day over 24 hours days 1-4 and 29-32. * Cisplatin 75 mg/m² days 1, 29. Radiotherapy: Treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy. | 4 | None | 6 | 9 | 1 | 9 | View |
| Arm C | Cisplatin with 5-Fluorouracil along with Radiotherapy and followed by Esophagectomy | 3 | None | 5 | 9 | 7 | 9 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Failure to thrive | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Non-responsive | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Orthostatic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Bacteremia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Thrombus | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Atrial Fibrliation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Shortness of Breath | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Neutropenic Fever | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperglycemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Low Potassium | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Anorexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Renal Calculi | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Lymphopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |