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 @ 9:13 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
NCT ID:
NCT02017704
Description:
None
Frequency Threshold:
0
Time Frame:
60 months
Study:
NCT02017704
Study Brief:
Chemoradiation or Brachytherapy for Rectal Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| IMRT and Capecitabine | Patients will receive IMRT along with capecitabine. Followed by: * Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion * 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions * 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles Then: Surgical Resection capecitabine and IMRT (if randomized to this arm): Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy IMRT (intensity modulated radiation therapy): Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion * Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions * 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. | 0 | None | 1 | 4 | 4 | 4 | View |
| Endo-HDR | Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy Followed by: * Oxaliplatin: 85 mg/m² in 500ml glucose 5% solution, 2-h infusion * 5-Fluorouracil (5-FU) bolus 400mg/m² following the oxaliplatin/FA infusions * 5-FU continuous infusion 2400 mg/m², 46-h infusion following the 5-FU bolus Cycle length: 14 days (2 weeks); Duration of treatment: 12 cycles Then: Surgical Resection: Endo-HDR: Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy FOLFOX6: \* Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion * Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions * 5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus; Surgery: After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine: Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam; Mobility of tumor as assessed if possible by rectal exam; Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis. | 0 | None | 2 | 5 | 5 | 5 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| sacral decubitis ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| pain (NOS) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| rectovaginal fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| ANC elevated | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| alanine amino transferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | CTCAE (4.0) | View |
| aspartate amino transferase increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| bilirubin increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| creatinine decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| dermatitis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| dyspareunia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| fecal incontinence | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| GI hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| pain (NOS) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| WBC decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| anorexia | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| dyspareunia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| erectile dysfunction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| fatigue | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| GI hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| hemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | CTCAE (4.0) | View |
| lymphocytes decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| pain (NOS) | SYSTEMATIC_ASSESSMENT | General disorders | CTCAE (4.0) | View |
| peripheral sensory neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
| proctitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| rectal bleeding | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| rectal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| rectal stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| urinary frequency/urgency | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| vaginal dryness | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| vaginal pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | CTCAE (4.0) | View |
| vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| WBC decreased | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |
| weight loss | SYSTEMATIC_ASSESSMENT | Investigations | CTCAE (4.0) | View |