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 |
|---|---|---|---|---|---|---|---|---|
| Experience of Another Member | This group will receive a message that includes a quote from the perspective of a Vitality member with diabetes who uses the HealthyFood benefit. Given the need to standardise message content across study arms, the quote was written by the study team and not an actual member. The quote emphasizes the positive impact the benefit has had for the member-both the financial benefit, as well as the two specific diabetes health benefits. Email message regarding the HealthyFood benefit | None | None | 0 | 766 | 0 | 766 | View |
| Control Arm | This arm will represent current practice. This group will receive no contact from the research team. They may receive information regarding the benefit from the Vitality marketing team during the intervention period and can enroll in the benefit at any time during the study period. | None | None | 0 | 737 | 0 | 737 | View |
| Diabetes-specific | This group will receive a message which simply cites the two specific benefits of the eating more healthy foods for individuals with diabetes. This message contains a link to start the enrolment process. Email message regarding the HealthyFood benefit | None | None | 0 | 753 | 0 | 753 | View |
| Input From a Diabetes Expert | This group will receive a message that includes a quote from a South African physician who specializes in diabetes. The quote emphasises the financial benefit and the two specific diabetes health benefits of the HealthyFood program included in the other messages. It concludes with the doctor's recommendation of the benefit for all individuals with diabetes. Email message regarding the HealthyFood benefit | None | None | 0 | 701 | 0 | 701 | View |
| Enhanced Active Choice | This group will receive a message whose first portion is identical to those in the diabetes-specific message group. The second portion of the message differs in that instead of just asking recipients to click on the provided link if interested, the message asks people to choose and click on one of following possible responses: 1. Yes! I want to active the HealthyFood benefit and get up to 25% cash back on the healthy food I buy at Pick n Pay or Woolworths 2. No, I'd prefer not to activate and continue paying full price for my healthy food purchases Email message regarding the HealthyFood benefit | None | None | 0 | 708 | 0 | 708 | View |