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 |
|---|---|---|---|---|---|---|---|---|
| Pantoprazole | Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years. | None | None | 0 | 0 | 0 | 0 | View |
| Other Proton Pump Inhibitors (PPI) | Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years. | None | None | 0 | 0 | 0 | 0 | View |