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 @ 2:50 PM
Ignite Modification Date:
2025-12-25 @ 1:17 PM
NCT ID:
NCT05533359
Description:
This study was a text message based study that had little risk to participants.
Frequency Threshold:
0
Time Frame:
10 months
Study:
NCT05533359
Study Brief:
SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Conversational Agent Study
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Conversational Agent (CA) + No Patient Navigation (NoPN) + 10 Day | Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages. | 0 | None | 0 | 261 | 0 | 261 | View |
| Conversational Agent (CA) + No Patient Navigation (PN) + 30 Day | Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages. | 0 | None | 0 | 264 | 0 | 264 | View |
| Conversational Agent (CA) + Patient Navigation (PN) + 10 Day | Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages. | 0 | None | 0 | 264 | 0 | 264 | View |
| Conversational Agent (CA) + Patient Navigation (PN) + 30 Day | Patients in this group received a link to an automated scripted and interactive conversation agent used to mimic human interaction to: 1) elicit specific hesitancy factors and barriers to testing; 2) provide tailored information to address each individual's hesitancy factors and barriers to testing; and 3) offer access to at-home rapid test kits. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages. | 0 | None | 0 | 262 | 0 | 262 | View |
| Text Message (TM) + No Patient Navigation (NoPN) + 10 Day | Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 10 days for a total of 6 messages. | 0 | None | 0 | 265 | 0 | 265 | View |
| Text Message (TM) + No Patient Navigation (NoPN) + 30 Day | Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group did not receive Patient Navigation, and outreach frequency was intervention message delivered every 30 days for a total of 3 messages. | 0 | None | 0 | 265 | 0 | 265 | View |
| Text Message (TM) + Patient Navigation (PN) + 10 Day | Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 10 days for a total of 6 messages. | 0 | None | 0 | 270 | 0 | 270 | View |
| Text Message (TM) + Patient Navigation (PN) + 30 Day | Patients in this group received a bidirectional text message that included a brief message alerting patients they were eligible to receive a test kit. Participants in this group could receive Patient Navigation. Patient navigation was a phone call from a community health worker that gave practical advice in addressing barriers to testing. Outreach frequency was intervention message delivered every 30 days for a total of 3 messages. | 0 | None | 0 | 266 | 0 | 266 | View |
Serious Events(If Any):
Other Events(If Any):