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 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 12:03 AM
NCT ID:
NCT05525494
Description:
We did not collect adverse event information. We monitored whether reminder recall through the portal and text was effective at increased influenza vaccination rates. Because influenza vaccination is recommended by the Advisory Committee on Immunization Practices and is part of the U.S. recommended vaccine schedule, we did not collect adverse event data.
Frequency Threshold:
0
Time Frame:
We did not collect information regarding adverse events.
Study:
NCT05525494
Study Brief:
Patient Portal Flu Vaccine Reminders (5)
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 Fixed R/R Messages With Direct Appointment Schedule Link + Text Pre-Appointment Reminders | Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period. Text Fixed R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Text Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period. | 0 | None | 0 | 0 | 0 | 0 | View |
| Text Fixed R/R Messages With Direct Appointment Schedule Link | Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Text Fixed R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by text. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. | 0 | None | 0 | 0 | 0 | 0 | View |
| Portal Pre-Commitment Prompt, Tailored R/R Messages w/ Direct Scheduling + Pre-Appointment Reminders | Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period. Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period. | 0 | None | 0 | 0 | 0 | 0 | View |
| Portal Pre-Commitment Prompt With Tailored R/R Messages With Direct Appointment Schedule Link | Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Pre-Commitment Prompt with Tailored R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive a pre-commitment prompt message by portal in September. Tailored R/R messages will be sent monthly by portal based on time and place selected by patients (up to 3). R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. | 0 | None | 0 | 0 | 0 | 0 | View |
| Portal Fixed R/R Messages With Direct Appointment Schedule Link + Portal Pre-Appointment Reminder | Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period. Portal Fixed R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Pre-Appointment Reminder: Participants will receive a Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment via portal when they schedule a visit during the study period. | 0 | None | 0 | 0 | 0 | 0 | View |
| Portal Fixed R/R Messages With Direct Appointment Schedule Link | Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. Portal Fixed R/R Messages with Direct Appointment Schedule Link: Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment. | 0 | None | 0 | 0 | 0 | 0 | View |
| No R/R Message or Pre-Appointment Reminder | Participants do not receive any flu vaccine R/R message or Pre-Appointment Reminder advising them to ask their doctor for the flu vaccine at their upcoming appointment during the specified flu season. | 0 | None | 0 | 0 | 0 | 0 | View |
Serious Events(If Any):
Other Events(If Any):