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 |
|---|---|---|---|---|---|---|---|---|
| Sodium Zirconium Cyclosilicate (ZS) 10g Tid | Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase. | 0 | None | 0 | 267 | 0 | 267 | View |
| Sodium Zirconium Cyclosilicate (ZS) 10g | Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase. | 0 | None | 3 | 99 | 21 | 99 | View |
| Placebo | Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase. | 0 | None | 1 | 50 | 0 | 50 | View |
| Sodium Zirconium Cyclosilicate (ZS) 5g | Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase. | 0 | None | 4 | 99 | 6 | 99 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Infectious colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |