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 @ 2:24 AM
Ignite Modification Date:
2025-12-26 @ 12:57 AM
NCT ID:
NCT01868334
Description:
For the Tdap and Pneumococcal cohorts: Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015.
For the Influenza cohort: Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015.
Frequency Threshold:
0
Time Frame:
3 years (Baseline, Year 1, Year 2)
Study:
NCT01868334
Study Brief:
SOP Toolkit in Diverse Practices Implemented & Tested With RE-AIM
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Year 1 RCCT Pittsburgh Intervention Sites - Tdap Vaccination | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=10). | 0 | None | 0 | 13186 | 0 | 13186 | View |
| Year 1 RCCT Pittsburgh Control Sites - Tdap Vaccination | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8). | 0 | None | 0 | 17185 | 0 | 17185 | View |
| Year 1 RCCT Pittsburgh Intervention Sites - Pneumococcal Vacc | Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=10). | 0 | None | 0 | 6095 | 0 | 6095 | View |
| Year 1 RCCT Pittsburgh Control Sites - Pneumococcal Vaccine | Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8). | 0 | None | 0 | 6223 | 0 | 6223 | View |
| Year 1 RCCT Pittsburgh Intervention Sites - Influenza Vaccine | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Intervention sites were Pittsburgh practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=10). | 0 | None | 0 | 13186 | 0 | 13186 | View |
| Year 1 RCCT Pittsburgh Control Sites - Influenza Vaccine | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Control sites were Pittsburgh practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=8). | 0 | None | 0 | 17185 | 0 | 17185 | View |
| Year 1 RCCT Houston Intervention Sites - Tdap Vaccination | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult Tdap vaccination (N=3). | 0 | None | 0 | 19274 | 0 | 19274 | View |
| Year 1 RCCT Houston Control Sites - Tdap Vaccination | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3). | 0 | None | 0 | 20904 | 0 | 20904 | View |
| Year 1 RCCT Houston Intervention Sites - Pneumococcal Vaccine | Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult PPSV vaccination (N=3). | 0 | None | 0 | 3010 | 0 | 3010 | View |
| Year 1 RCCT Houston Control Sites - Pneumococcal Vaccine | Adults \>=65 years of age at baseline who were active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 6/1/2012 to 5/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 6/1/2013 to 5/31/2014 and Year 2 (a pre-post study) was 6/1/2014 to 1/31/2015. Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3). | 0 | None | 0 | 2779 | 0 | 2779 | View |
| Year 1 RCCT Houston Intervention Sites - Influenza Vaccination | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Intervention sites were Houston practices who actively utilized the 4 Pillars Practice Transformation Program during Year 1 to promote increases in adult influenza vaccination (N=3). | 0 | None | 0 | 19274 | 0 | 19274 | View |
| Year 1 RCCT Houston Control Sites - Influenza Vaccination | Adults \> 18 years of age who are active patients of 25 diverse practices who were seen \>=1 time each year. Baseline period was 8/1/2012 to 1/31/2013, Year 1 period (which was the randomized controlled cluster trial) was 8/1/2013 to 1/31/2014 and Year 2 (a pre-post study) was 8/1/2014 to 1/31/2015. Control sites were Houston practices who did not receive the 4 Pillars Practice Transformation Program intervention until Year 2 (N=3). | 0 | None | 0 | 20904 | 0 | 20904 | View |
Serious Events(If Any):
Other Events(If Any):