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 @ 6:25 PM
Ignite Modification Date:
2025-12-25 @ 3:55 PM
NCT ID:
NCT01990768
Description:
Chart reviews were made daily. Events prespecified as possibly related to study drug were categorized for seriousness by site PIs and are listed in both the "Serious" and "Other" AE sections below. Other events (marked with "\^") were monitored and reported but not considered adverse events of the study drug. These are listed in the "Other" AE section since they were not assessed for seriousness. One Bolus Only arm subject who was mistakenly enrolled while in police custody is excluded.
Frequency Threshold:
0
Time Frame:
Adverse events data were captured from the beginning of study drug infusion on day 0 through day 28. While follow-up time varies by patient due to withdrawals, transfers to non-participating hospitals, deaths, and participants lost to follow-up, all analysis patients were "at risk" for adverse events during at least some period of time and are thus included in all adverse event denominators.
Study:
NCT01990768
Study Brief:
Prehospital Tranexamic Acid Use for Traumatic Brain Injury
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Placebo IV bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours. | 50 | None | 25 | 309 | 81 | 309 | View |
| Bolus-Maintenance | 1 gram IV TXA bolus in the prehospital setting followed by a 1 gram IV maintenance infusion initiated on hospital arrival and infused over 8 hours. | 53 | None | 13 | 312 | 74 | 312 | View |
| Bolus Only | 2 grams IV TXA bolus in the prehospital setting followed by a placebo maintenance infusion initiated on hospital arrival and infused over 8 hours. | 40 | None | 24 | 345 | 92 | 345 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cerebral venus sinus thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Myocardial infarction (MI) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cerebrovascular accident - hemorrhagic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebrovascular accident - thrombotic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Pulmonary embolism (PE) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cerebral vascular emboli | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Deep vein thrombosis (DVT) | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Embolic infarcts | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Inferior vena cava thrombus | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Internal jugular vein thrombus | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Left ventricular thrombus | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cardiac arrest (non-fatal)^ | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac failure^ | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Myocardial infarction (MI) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pseudomembranous colitis^ | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Abdominal Compartment Syndrome^ | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Central diabetes insipidus^ | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cerebral vasospams^ | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Extremity Compartment Syndrome^ | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Cholecystitis^ | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Liver failure^ | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| Bloodstream infection^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Empyema^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Intra-abdominal abscess^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Meningitis^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Sepsis^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Urinary tract infection (UTI)^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound infection^ | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hypernatremia^ | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Cerebrovascular accident - hemorrhagic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cerebrovascular accident - thrombotic | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Acute kidney injury (AKI)^ | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Renal failure^ | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Acute Respiratory Distress Syndrome (ARDS)^ | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Pulmonary embolism (PE) | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Cerebral venus sinus thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Deep vein throbosis (DVT) | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Superficial venus thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |