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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Phase I (IntePro, US Only) | AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | None | None | 10 | 141 | 30 | 141 | View |
| Phase I (Intexen LP, US Only) | AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | None | None | 1 | 26 | 3 | 26 | View |
| Phase II (France Only) | AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse. Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV | None | None | 11 | 81 | 30 | 81 | View |
| Phase III/IV (Perigee IntePro Lite, US Only) | AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | None | None | 3 | 56 | 20 | 56 | View |
| Phase III/IV (Apogee IntePro Lite, US Only) | AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | None | None | 3 | 55 | 20 | 55 | View |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse | None | None | 8 | 139 | 30 | 139 | View |
| Phase V (Elevate Posterior InteXen LP, US Only) | AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse | None | None | 1 | 23 | 3 | 23 | View |
| Phase VI (Elevate Anterior Gen 1, EU Only) | AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII | None | None | 8 | 35 | 7 | 35 | View |
| Phase VII (Elevate Anterior Gen 2, US & EU) | AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2) | None | None | 11 | 142 | 62 | 142 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| any Serious Adverse Event | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Dyspareunia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Infection- Vaginal | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Device Malfunction | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Any non-serious adverse events | SYSTEMATIC_ASSESSMENT | General disorders | None | View |