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 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
NCT ID:
NCT01977456
Description:
None
Frequency Threshold:
4
Time Frame:
Serious adverse events are monitored through 90 days. Non-serious adverse events are monitored through day 3 or discharge
Study:
NCT01977456
Study Brief:
Study of the Combination Therapy of Rt-PA and Eptifibatide to Treat Acute Ischemic Stroke (CLEAR-FDR)
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Eptifibatide | All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours. Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen. | None | None | 4 | 27 | 17 | 27 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diabetic complications | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (12.0) | View |
| Glucose metabolism disorders (incl diabetes mellitus) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA (12.0) | View |
| Anaemias nonhaemolytic and marrow depression | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Cardiac arrhythmias | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Heart failures | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| General system disorders NEC | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (12.0) | View |
| Diabetic complications | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Glucose metabolism disorders (incl diabetes mellitus) | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Neurological disorders NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Coagulopathies and bleeding diatheses (excl thrombocytopenic) | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| White blood cell disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (12.0) | View |
| Cardiac arrhythmias | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (12.0) | View |
| Gastrointestinal motility and defaecation conditions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Gastrointestinal signs and symptoms | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (12.0) | View |
| Infections - pathogen unspecified | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (12.0) | View |
| Electrolyte and fluid balance conditions | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (12.0) | View |
| Musculoskeletal and connective tissue disorders NEC | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | View |
| Neurological disorders NEC | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (12.0) | View |
| Anxiety disorders and symptoms | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (12.0) | View |
| Genitourinary tract disorders NEC | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Urinary tract signs and symptoms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (12.0) | View |
| Epidermal and dermal conditions | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Skin vascular abnormalities | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (12.0) | View |
| Decreased and nonspecific blood pressure disorders and shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |
| Vascular haemorrhagic disorders | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (12.0) | View |