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 |
|---|---|---|---|---|---|---|---|---|
| Suggamadex or Treatment Group | Sugammadex will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg will be used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade. | 0 | None | 0 | 25 | 5 | 25 | View |
| Neostigime/Glycopyrrolate or Standard of Care Group | Neostigmine/Glycopyrrolate will be administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. Once T1 is at 10% or greater, a dose of 70mcg/kg of neostigmine with 14 mcg/kg glycopyrrolate will be administered simultaneously over a period of one minute up to 5 mg. | 1 | None | 1 | 25 | 6 | 25 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | CTCAE (4.0) | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Uncontrolled Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | CTCAE (4.0) | View |
| Laceration of penis' skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Hematuria with Clot retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | CTCAE (4.0) | View |
| IV infiltration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | CTCAE (4.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | CTCAE (4.0) | View |