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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
NCT ID:
NCT01888367
Description:
Subjects queried at each visit for any potential adverse events. The safety analysis was "as treated". For 4 patients the actual treatment given could not be assigned due to conflicting data excluding them from the analysis leaving 441 subjects out of the 445 randomized. The DFA-02 Gel and Placebo Gel groups were decreased as the surgeon did not administer the gel to all patients randomized to gel. Those patients were counted in the SOC group.
Frequency Threshold:
5
Time Frame:
From time of surgery until 30 days post-op.
Study:
NCT01888367
Study Brief:
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| DFA-02 Antibiotic Gel | Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Antibiotic Gel | None | None | 59 | 284 | 267 | 284 | View |
| DFA-02 Placebo Gel | Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. DFA-02 Placebo Gel | None | None | 14 | 64 | 61 | 64 | View |
| Standard of Care | Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied. | None | None | 21 | 93 | 86 | 93 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pelvic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Pneuomia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Abdominal Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Abdominal Wall Hematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Pneumonia Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Systemic Inflammatory Response Syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Rectal Cancer Metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Renal Cell Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.0) | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Pelvic Pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (18.0) | View |
| Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Abdominal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Abdominal Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Clostridium difficile Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Hematoma Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Incision Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Postoperative Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Septic Shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Splenic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Subdiaphragmatic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Small Intestine Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Enterocutaneous Fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Gastrointestinal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Intra-abdominal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Localized Abdominal Fluid Collection | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Pneumoperitoneum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Rectal Hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Small Intestinal Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Postoperative Ileus | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Anastomotic Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Abdominal Wound Dehiscence | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Anastomotic Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Bladder Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Hip Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Postoperative Renal Failure | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Procedural Vomiting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Splenic Rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Wound Secretion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Acute Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Failure to Thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Ventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Device Dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypomagnesemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Abdominal Distention | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypokalemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypophosphatemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypocalcemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (18.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (18.0) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Procedural Nausea | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Anemia Postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Incision Site Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Postoperative Ileus | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Seroma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (18.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Diarrhea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (18.0) | View |
| Hypoproteinemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypoalbuminemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hyponatremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Hypochloremia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (18.0) | View |
| Urine Output Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Oxygen Saturation Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Amylase Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (18.0) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (18.0) | View |
| Incision Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Pelvic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (18.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (18.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (18.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (18.0) | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Anemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (18.0) | View |
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Urinary Retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (18.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (18.0) | View |