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:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
NCT ID:
NCT03422718
Description:
Reporting serious adverse events (SAEs) are based on the guidelines of the International Conference on Harmonization (ICH).
Frequency Threshold:
0
Time Frame:
12 months for those who were in the main study; and another 3-6 months for those who opted to continue with the extension study.
Study:
NCT03422718
Study Brief:
Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Arm 5 | No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments | 0 | None | 0 | 58 | 0 | 58 | View |
| Arm 7 | No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments | 1 | None | 0 | 64 | 0 | 64 | View |
| Arm 1 | No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation | 0 | None | 0 | 62 | 0 | 62 | View |
| Arm 2 | Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation | 0 | None | 0 | 60 | 0 | 60 | View |
| Arm 3 | No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling No healthy behavior texts: Participants do not receive healthy behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation | 0 | None | 0 | 63 | 0 | 63 | View |
| Arm 4 | Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff No physician appointment and transportation scheduling: Participants do not receive assistance scheduling physician appointment or transportation | 2 | None | 0 | 61 | 0 | 61 | View |
| Arm 6 | Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Weekly Via Text Messaging: Weekly text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments | 0 | None | 0 | 61 | 0 | 61 | View |
| Arm 8 | Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling Healthy Behavior Texts: Participants receive motivational health behavior texts BP Monitoring Daily Via Text Messaging: Daily text messages will prompt participants for BP by home cuff Physician appointment and transportation scheduling: Participants receive assistance scheduling physician appointment and transportation to those appointments | 0 | None | 0 | 59 | 0 | 59 | View |
Serious Events(If Any):
Other Events(If Any):