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 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
NCT ID:
NCT03366220
Description:
None
Frequency Threshold:
0
Time Frame:
30 days
Study:
NCT03366220
Study Brief:
Resuscitation With Plasma in Surgical and Trauma Patients With Septic Shock
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Initial Resuscitation With Plasma | Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids. Plasma: Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids. | 1 | None | 4 | 4 | 0 | 4 | View |
| Initial Resuscitation With Balanced Crystalloids | Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation. Balanced crystalloids: Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation. | 1 | None | 4 | 4 | 0 | 4 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Acute Kidney Injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| atrial fibrillation requiring multiple cardioversions | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| acute renal failure requiring intermittent hemodialysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Enterocutaneous fistula | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| acute renal failure requiring continuous renal replacement therapy/intermittent hemodialysis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| acalculous cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| medication induced blindness | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Deep vein thrombosis with persistent anemia requiring inferior vena cava filter | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| chylothorax | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| multiple episodes of severe sepsis secondary to urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| bacteremia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Gastrointestinal bleed | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Ascending colon perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Congestive heart failure exacerbation/flash pulmonary edema | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Worsening acute kidney injury requiring continuous renal replacement therapy to be restarted | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Traumatic brain injury (tracheostomy & percutaneous endoscopic gastrostomy) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Liver failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | None | View |
| anemia requiring Inferior vena cava filter | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
Other Events(If Any):