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 |
|---|---|---|---|---|---|---|---|---|
| Letter A Intervention | The intervention arm will involve letter A sent to prescribers in Los Angeles County. Letter A: The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking \> 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018. | 0 | None | 0 | 269 | 0 | 269 | View |
| Letter B Intervention | The intervention arm will involve letter B sent to prescribers in Los Angeles County. Letter B: This letter includes all the details in Letter A plus additional text involving an "if/when/then statement" along with an injunction to providers to share safety information with patients so that they identify as a "safe prescriber." Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. "If/when/then" is a form of "pre-suasion" that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation. | 0 | None | 0 | 241 | 0 | 241 | View |