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 |
|---|---|---|---|---|---|---|---|---|
| Not Pretreated With Rocuronium | Succinylcholine administration with no Rocuronium pre-treatment non-pretreated Succinylcholine: no pretreatment | 0 | None | 0 | 100 | 0 | 100 | View |
| Pre-treated With Rocuronium 1 Minute Before Succinylcholine Administration | Succinylcholine administration 1 minute following Rocuronium pre-treatment succinylcholine 1 minute after rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment | 0 | None | 0 | 100 | 0 | 100 | View |
| Pre-treated With Rocuronium 2 Minutes Before Succinylcholine Administratjion | Succinylcholine administratjion 2 minutes following Rocuronium pre-treatment succinylcholine 2 minutes following rocuronium pretreatment: 0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment. | 0 | None | 0 | 100 | 0 | 100 | View |