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 |
|---|---|---|---|---|---|---|---|---|
| AG200-15 on Lower Abdomen | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. | 0 | None | 0 | 22 | 19 | 22 | View |
| AG200-15 on Buttock | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. | 0 | None | 0 | 23 | 23 | 23 | View |
| AG200-15 on Upper Torso Excluding Breast | Subjects will be randomly assigned to one of six treatment (site of application) sequences. Each sequence will include three patch application sites: abdomen, buttock, or upper torso excluding breasts. AG200-15: A transdermal contraceptive delivery system for LNG and EE. A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week. | 0 | None | 0 | 23 | 21 | 23 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal disorders | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| General disorders and adminstration site conditions | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Musculoskeletal and connective tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Psychiatric disorders | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Vascular disorders | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Metabolism and nutrition disorders | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Nervous system disorders | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Reproductive system and breast disorders | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |
| Skin and subcutaneous tissue disorders | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |