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 |
|---|---|---|---|---|---|---|---|---|
| Cohort 1 (12-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 12 Travoprost Intracameral Implant exchanged at Month 12: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 12 | 1 | None | 1 | 30 | 4 | 30 | View |
| Cohort 2 (3-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 3 Travoprost Intracameral Implant exchanged at Month 3: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 3 | 0 | None | 0 | 30 | 0 | 30 | View |
| Cohort 3 (6-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 6 Travoprost Intracameral Implant exchanged at Month 6: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 6 | 0 | None | 0 | 30 | 5 | 30 | View |
| Cohort 4 (24-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 24 Travoprost Intracameral Implant exchanged at Month 24: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 24 | 0 | None | 0 | 30 | 3 | 30 | View |
| Cohort 5 (21-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 21 Travoprost Intracameral Implant exchanged at Month 21: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 21 | 1 | None | 1 | 30 | 0 | 30 | View |
| Cohort 6 (18-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 18 Travoprost Intracameral Implant exchanged at Month 18: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 18 | 0 | None | 0 | 30 | 1 | 30 | View |
| Cohort 7 (15-month Exchange) | Travoprost Intracameral Implant Exchanged at Month 15 Travoprost Intracameral Implant exchanged at Month 15: intracameral implant containing travoprost 75 mcg implanted on Day 1 and exchanged at Month 15 | 0 | None | 0 | 30 | 1 | 30 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 21.0 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Corona virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 21.0 | View |
| Iridodialysis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 21.0 | View |
| Hyphaema | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 21.0 | View |
| Intraocular pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 21.0 | View |