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 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
NCT ID:
NCT05533918
Description:
This study was a text message based study that had little risk to participants.
Frequency Threshold:
0
Time Frame:
10 months
Study:
NCT05533918
Study Brief:
SCALE-UP Utah II: Community-Academic Partnership to Address COVID-19 Text Message 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 |
|---|---|---|---|---|---|---|---|---|
| Text Messaging (TM) + No Patient Navigation (NoPN) + 10 Day | Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed. Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 10 days for a total of 6 messages. | 0 | None | 0 | 7861 | 0 | 7861 | View |
| Text Messaging (TM) + No Patient Navigation (NoPN) + 30 Day | Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed. Patients will not receive patient navigation. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Intervention message frequency is every 30 days for a total of 3 messages. | 0 | None | 0 | 7860 | 0 | 7860 | View |
| Text Messaging (TM) + Patient Navigation (PN) + 10 Day | Bidirectional text messaging with a one-touch response to connect patients to mailed at-home rapid test kits for use as needed. RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy. There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 10 days for a total of 6 messages. | 0 | None | 0 | 7856 | 0 | 7856 | View |
| Text Messaging (TM) + Patient Navigation (PN) + 30 Day | Bidirectional text messaging with a one-touch response to connect patients at-home rapid test kits for use as needed. RPN will provide patients the opportunity to reply PERSON (for connection to a PN) in response to a TM offering connection to testing and/or vaccination. Text-Messaging (TM): Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive a test kit and asking participants if they would like to receive a test kit. Participants who reply "yes" will receive an additional message with information about how to receive a test kit. Patient Navigation (PN): Patient navigation from the Community Health Worker includes practical advice in addressing barriers to testing such as logistics, as well as fear, skepticism, and hesitancy. There are two distinct different types of patient navigation, Request PN and No PN. Each person will be randomly assigned between the two types. Intervention message frequency is every 30 days for a total of 3 messages. | 0 | None | 0 | 7862 | 0 | 7862 | View |
Serious Events(If Any):
Other Events(If Any):