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 |
|---|---|---|---|---|---|---|---|---|
| Comparison | The comparison condition is designed as a minimal intervention, and allows for blinding of the patients to randomization group. Comparison: Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention. | 1 | None | 1 | 378 | 0 | 378 | View |
| Intervention | The intervention is designed to encourage and remind smokers of the availability of the Quitline services. In addition to the one-way motivational messages, the investigators will use two-way assessments. Two-way automated texting is the ability to push out a question, have the user respond with a brief, numeric or one-word answer, and based on that answer, provide immediate feedback. The goal of these brief assessments is two-fold: 1) to assess behavior (abstinence) and motivation to use services, and 2) to return feedback tailored to each individual smoker based on the answers of the user. Intervention: Participants randomized to the intervention arm will receive: 1. Motivational Messages 2. Abstinence and Motivation to Use Services Assessments 3. Encouragement to access the Quitline 4. Encouragement to use Nicotine Replacement Therapy (NRT) 5. Provision of NRT, if requested Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT. | 1 | None | 1 | 372 | 0 | 372 | View |