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 |
|---|---|---|---|---|---|---|---|---|
| SRP and Amoxicillin, MET, Local Tetracycline NonSmokers | In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects. Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally. | None | None | 3 | 27 | 6 | 27 | View |
| SRP and Amoxicillin, MET, Local Tetracycline Smokers | In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets \> 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects. Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally. | None | None | 1 | 20 | 5 | 20 | View |
| Scaling and Root Planing (SRP) Only NonSmokers | Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects. | None | None | 1 | 27 | 8 | 27 | View |
| SRP Only Smokers | Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects. | None | None | 0 | 22 | 4 | 22 | View |
| SRP and Metronidazole (MET) NonSmokers | In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects. Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species. | None | None | 2 | 30 | 10 | 30 | View |
| SRP and Metronidazole (MET) Smokers | In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects. Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species. | None | None | 2 | 20 | 3 | 20 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal Upset | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |