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 @ 12:32 PM
Ignite Modification Date:
2025-12-25 @ 12:10 PM
NCT ID:
NCT04776161
Description:
None
Frequency Threshold:
0
Time Frame:
Adverse events were collected through the entire trial period of 18 weeks.
Study:
NCT04776161
Study Brief:
Medication Adherence Patterns in Rheumatic Diseases: A Behavioral Trial
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Control | Patients in the control arm will not receive any intervention (but will receive electronic pill bottles to monitor their adherence). | 0 | None | 1 | 18 | 0 | 18 | View |
| Non-adaptive Intervention | Patients in this intervention arm will choose an event-based cue and receive reminder text messages reminding them of their cue. Additionally, a donation will be made to a local charity every time they take their medication. Cue-Reward Intervention: Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf. | 0 | None | 2 | 18 | 0 | 18 | View |
| Adaptive Intervention | Patients in this intervention arm will choose an event-based cue. Additionally, a donation will be made to a local charity every time they take their medication. Those who show no improvement in adherence after 6 weeks will start receiving reminder text messages reminding them of their cue. Cue-Reward Intervention with possible intensification: Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf. After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue. | 0 | None | 3 | 20 | 0 | 20 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization for congestive heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalization for fall-related complications | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Kidney transplant | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Appendectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Hospitalization for secondary hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hospitalization for colostomy leak | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Ileostomy reversal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
Other Events(If Any):