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 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
NCT ID:
NCT01749956
Description:
All patients who received at least one dose of protocol treatment during the trial.
Frequency Threshold:
5
Time Frame:
From Day 1 of treatment thru 30 days after discontinuation or completion of study treatment, an average of 6 months.
Study:
NCT01749956
Study Brief:
5-FU, Aflibercept, and Radiation (RT) for Preoperative and Postoperative Patients With Stage II/III 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 |
|---|---|---|---|---|---|---|---|---|
| FOLFOX6/Aflibercept/Radiation/Surgery | Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15. Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines. Postoperative Chemotherapy and Aflibercept Treatments: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle. Modified FOLFOX6: * Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle. * 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle. Radiation Aflibercept Surgery: Abdominoperineal or low anterior resectio | None | None | 9 | 39 | 38 | 39 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pelvic Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE 4.0 | View |
| Small Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE 4.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE 4.0 | View |
| Device Related Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE 4.0 | View |
| Embolism Venous | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE 4.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Gastrointestinal Fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Mucosal Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE 4.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE 4.0 | View |
| Rectal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE 4.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE 4.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 4.0 | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE 4.0 | View |
| Oropharyngeal Pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 4.0 | View |
| Palmar-Plantar Erythrodysaesthesia Syndrome | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE 4.0 | View |
| Rectal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE 4.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE 4.0 | View |
| Temperature Intolerance | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE 4.0 | View |
| Device Related Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE 4.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 4.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE 4.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE 4.0 | View |
| Pain in Extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE 4.0 | View |
| Peripheral Sensory Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE 4.0 | View |
| Radiation Skin Injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | NCI CTCAE 4.0 | View |
| Upper Respiratory Tract Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | NCI CTCAE 4.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE 4.0 | View |
| Back Pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE 4.0 | View |
| Catheter Site Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE 4.0 | View |
| Dry Skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | NCI CTCAE 4.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | NCI CTCAE 4.0 | View |
| Neutrophil Count Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE 4.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE 4.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE 4.0 | View |
| Nasal Congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 4.0 | View |
| Oral Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Peripheral Neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE 4.0 | View |
| Diarrheoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE 4.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | NCI CTCAE 4.0 | View |
| Muscousal Inflammation | NON_SYSTEMATIC_ASSESSMENT | General disorders | NCI CTCAE 4.0 | View |
| Proteinuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | NCI CTCAE 4.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | NCI CTCAE 4.0 | View |
| Proctalgia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE 4.0 | View |
| Decreased Appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE 4.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | NCI CTCAE 4.0 | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE 4.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | NCI CTCAE 4.0 | View |
| Dysphonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | NCI CTCAE 4.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | NCI CTCAE 4.0 | View |
| Weight Decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | NCI CTCAE 4.0 | View |