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 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:57 PM
NCT ID:
NCT04104256
Description:
An adverse event is defined as an Emergency Department visit that did not require hospitalization.
Serious adverse events include hospitalization or death.
Providers were not assessed for adverse events
Frequency Threshold:
0
Time Frame:
Post-Intervention (3 Months) Patients were monitored for the completion of their cataract surgery following their pre-op visit. Adverse events were then monitored/assessed for 12 weeks following the completion of their cataract surgery.
Study:
NCT04104256
Study Brief:
Using Behavioral Economics to Reduce Low-Value Care
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Alert 1 | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #1 group Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests: Nudge 1: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" | 1 | None | 11 | 269 | 9 | 269 | View |
| Alert 2 | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #2 group Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests: Nudge #2: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines * Nudge includes "hard stop" before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" | 3 | None | 4 | 267 | 7 | 267 | View |
| Alert 3 | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Nudge #3 group Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests: Nudge 3: * UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing. * UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery. * Routine pre-op tests are inappropriate. * Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines * Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: "EXPLAIN WHY GOING AGAINST GUIDELINES" | 0 | None | 4 | 272 | 12 | 272 | View |
| Control | Patients with a pre-op encounter in which the physician attempts to place an order for a pre-op test. Physician has been assigned to the Control group Usual Care: Patients will receive usual care from their physicians. | 2 | None | 12 | 237 | 12 | 237 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Inpatient Admission | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Emergency Department visits that did not require admissions | SYSTEMATIC_ASSESSMENT | General disorders | None | View |