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 |
|---|---|---|---|---|---|---|---|---|
| Diabetics: L+C Maxillary Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml) | None | None | 0 | 29 | 0 | 29 | View |
| Diabetics: L+C Mandibular Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml) | None | None | 0 | 30 | 0 | 30 | View |
| Diabetics: L+E Maxillary Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000) | None | None | 0 | 32 | 0 | 32 | View |
| Diabetics: L+E Mandibular Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000) | None | None | 0 | 31 | 0 | 31 | View |
| Healthy: L+C Maxillary Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml) | None | None | 0 | 24 | 0 | 24 | View |
| Healthy: L+C Mandibular Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml) | None | None | 0 | 25 | 0 | 25 | View |
| Healthy: L+E Maxillary Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000) | None | None | 0 | 25 | 0 | 25 | View |
| Healthy: L+E Mandibular Anesthesia | Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000) | None | None | 0 | 24 | 0 | 24 | View |