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:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT02872012
Description:
None
Frequency Threshold:
0
Time Frame:
7 days after treatment
Study:
NCT02872012
Study Brief:
Cryoanesthesia for Intravitreal Injections
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Cryoanesthesia Device -5 Degrees Celsius for 10 Seconds | All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Their other eye will receive anesthesia via the active comparator, lidocaine. Comment: Cryoanesthesia Device is the name of the device. Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, 0C for 20 seconds, or -10C for 10 seconds. | 0 | None | 0 | 3 | 0 | 3 | View |
| Cryoanesthesia Device -5 Degrees Celsius for 20 Seconds | All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device. Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | None | 0 | 7 | 0 | 7 | View |
| Cryoanesthesia Device -7 Degrees Celsius for 20 Seconds | All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device. Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | None | 0 | 4 | 0 | 4 | View |
| Cryoanesthesia Device -10 Degrees Celsius for 10 Seconds | All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device. Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | None | 0 | 3 | 0 | 3 | View |
| Cryoanesthesia Device -10 Degrees Celsius for 20 Seconds | All patients will have one eye randomized to receiving anesthesia via the cryoanesthesia device which anesthetizes by chilling rather than by use of drug, prior to receiving an intravitreal injection. Comment: Cryoanesthesia Device is the name of the device. Cryoanesthesia device: The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device. Patients will receive the cryoanesthesia at a temperature of -5C for 10 seconds, -5C for 20 seconds, -7C for 20 seconds, -10C for 10 seconds, or -10C for 20 seconds. | 0 | None | 0 | 5 | 0 | 5 | View |
| Standard of Care: Lidocaine Gel | Participants randomized to this arm will have their other eye receive anesthesia via one current standard of care treatment method (lidocaine gel) prior to receiving an intravitreal injection. Lidocaine gel: Lidocaine gel applied to the non-cryoanesthesia eye. | 0 | None | 0 | 22 | 0 | 22 | View |
Serious Events(If Any):
Other Events(If Any):