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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT03843957
Description:
None
Frequency Threshold:
0
Time Frame:
2 years
Study:
NCT03843957
Study Brief:
Effectiveness and Implementation of mPATH-CRC
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities * Clinic champion identified. * Study team meeting with clinic champion * Implementation adaptations as needed for clinic flow Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard * Monthly program usage report sent to clinic champions * Scheduled phone-calls with clinic champion to review QA data and explore potential barriers. * Implementation adaptations as needed for clinic flow * Goal-triggered follow-up on-site trainings * Additional on-site trainings as requested. Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 7933 | 0 | 7933 | View |
| Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 5159 | 0 | 5159 | View |
| All Adult Clinic Patients on "High Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities * Clinic champion identified. * Study team meeting with clinic champion * Implementation adaptations as needed for clinic flow Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard * Monthly program usage report sent to clinic champions * Scheduled phone-calls with clinic champion to review QA data and explore potential barriers. * Implementation adaptations as needed for clinic flow * Goal-triggered follow-up on-site trainings * Additional on-site trainings as requested. Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 43775 | 0 | 43775 | View |
| All Adult Clinic Patients on "Low Touch" Strategy (Post-Implementation) | English or Spanish-speaking patients aged 18 or older who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 23359 | 0 | 23359 | View |
| Clinic Personnel on "High Touch" Strategy (Post-Implementation) | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities * Clinic champion identified. * Study team meeting with clinic champion * Implementation adaptations as needed for clinic flow Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard * Monthly program usage report sent to clinic champions * Scheduled phone-calls with clinic champion to review QA data and explore potential barriers. * Implementation adaptations as needed for clinic flow * Goal-triggered follow-up on-site trainings * Additional on-site trainings as requested. Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 282 | 0 | 282 | View |
| Clinic Personnel on "Low Touch" Strategy (Post-Implementation) | Clinic personnel (e.g., administrators, nurses, providers) who are involved with the implementation of mPATH-CRC, in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy in the 12 months after implementation. mPATH-CRC: mPATH-CRC is a self-administered iPad program that patients eligible for CRC screening use in primary care clinics to help them receive CRC screening. mPATH-Checkin: The mPATH-CheckIn program includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 232 | 0 | 232 | View |
| Clinic Patients Eligible for CRC Screening on "High Touch" Strategy (Pre-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "high touch" implementation strategy but in 8 months before implementation. "high touch" Implementation strategy: The "high touch" strategy consists of pre-implementation activities, training, and ongoing support. Pre-Implementation Activities * Clinic champion identified. * Study team meeting with clinic champion * Implementation adaptations as needed for clinic flow Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard * Monthly program usage report sent to clinic champions * Scheduled phone-calls with clinic champion to review QA data and explore potential barriers. * Implementation adaptations as needed for clinic flow * Goal-triggered follow-up on-site trainings * Additional on-site trainings as requested. Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 5526 | 0 | 5526 | View |
| Clinic Patients Eligible for CRC Screening on "Low Touch" Strategy (Pre-Implementation) | English or Spanish-speaking patients aged 50-74 who are eligible for CRC screening who are seen in the study clinics randomized to mPATH utilizing the "low touch" implementation strategy but in 8 months before implementation. "low touch" Implementation Strategy: Clinics randomized to receive the low touch implementation strategy will receive: Pre-Implementation Activities • N/A Implementation Kick-Off (Day 1) • On-site training with key clinic personnel Months 1 - 6 * Phone/email technical support, as needed. * Access to web-based QA dashboard Months 7 - 12 * Phone/email technical support, as needed * Access to web-based QA dashboard | 0 | None | 0 | 3971 | 0 | 3971 | View |
Serious Events(If Any):
Other Events(If Any):