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 |
|---|---|---|---|---|---|---|---|---|
| Miller Group | In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan. Miller group: Miller blade was used for laryngoscopy | None | None | 0 | 75 | 0 | 75 | View |
| Macintosh Group | In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan. Macintosh group: Macintosh blade was used for laryngoscopy | None | None | 0 | 75 | 0 | 75 | View |