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 |
|---|---|---|---|---|---|---|---|---|
| Lanthanum Carbonate & Low Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day. | None | None | 0 | 4 | 0 | 4 | View |
| Lanthanum Carbonate & Unrestricted Phosphorous Diet | Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. | None | None | 0 | 4 | 0 | 4 | View |
| Placebo & Low Phosphorous Diet | Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day. | None | None | 0 | 4 | 0 | 4 | View |
| Placebo & Unrestricted Phosphorous Diet | Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. | None | None | 0 | 4 | 0 | 4 | View |