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
Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-25 @ 7:43 PM
NCT ID:
NCT02173535
Description:
None
Frequency Threshold:
5
Time Frame:
Throughout the duration of the study. Approximately 2 hours per subject
Study:
NCT02173535
Study Brief:
Quantitative Study of New Limbal Ring Prototypes
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| AP-CS-LA-JG-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| AP-JG-CS-VC-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| AP-LA-VC-CS-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| AP-VC-JG-LA-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| CS-AP-VC-JG-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| CS-JG-AP-LA-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| CS-VC-LA-AP-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| CS-LA-JG-VC-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| JG-AP-LA-VC-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| JG-CS-VC-LA-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| JG-LA-CS-AP-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| JG-VC-AP-CS-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| LA-AP-JG-CS-VC | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| LA-CS-AP-VC-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| LA-JG-VC-AP-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| LA-VC-CS-JG-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| VC-AP-CS-LA-JG | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| VC-CS-JG-AP-LA | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| VC-JG-LA-CS-AP | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
| VC-LA-AP-JG-CS | All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants | None | None | 0 | 12 | 0 | 12 | View |
Serious Events(If Any):
Other Events(If Any):