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 |
|---|---|---|---|---|---|---|---|---|
| DIAGNOdent Patients (Pre-intervention and Post-intervention) | The total number of patients in these two phases is 1057 and 0/1057 were affected. These were 2 different sets of patients. | 0 | None | 0 | 1057 | 0 | 1057 | View |
| No Device Clinicians | The practitioners will not receive any additional training. | 0 | None | 0 | 28 | 0 | 28 | View |
| Spectra Device Clinicians | The practitioners in the Spectra Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients. Spectra Device: Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment. | 0 | None | 0 | 28 | 0 | 28 | View |
| No Device Patients (Pre-intervention and Post-intervention) | The total number of patients in these two phases is 1000 and 0/1000 were affected. These were 2 different sets of patients. | 0 | None | 0 | 1000 | 0 | 1000 | View |
| Spectra Patients (Pre-intervention and Post-intervention) | The total number of patients in these two phases is 918 and 0/918 were affected. These were 2 different sets of patients. | 0 | None | 0 | 918 | 0 | 918 | View |
| DIAGNOdent Device Clinicians | The practitioners in the DIAGNOdent Device Arm will be trained to the device according to the manufacturers' usual care for training. The training will consist of viewing the manufacturer's instructions for the device. Training will also consist of practitioners familiarizing themselves with the device through unsupervised clinical use with patients. DIAGNOdent: DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment. | 0 | None | 0 | 29 | 0 | 29 | View |