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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Placebo | Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock. Placebo: One time dose of placebo. | None | None | 7 | 25 | 0 | 25 | View |
| Premarin IV | Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV. Premarin IV: One time dose of Premarin IV | None | None | 5 | 23 | 0 | 23 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pulmonary embolus | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Intra-abdominal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pseudomembranous colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Bloodstream | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |