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 |
|---|---|---|---|---|---|---|---|---|
| Ghanaian Men | Men in the Ghana cohort are located at or near the the village of Nkwantakese which is approximately 20 kilometers outside of Kwame Nkrumah University of Science and Technology in Kumasi. | 0 | None | 0 | 207 | 0 | 207 | View |
| South African Men | Men in the South Africa cohort are located at or near Khayelitsha, the 3rd largest township in South Africa, which is an adjacent town to the city of Cape Town. The population of Khayelitsha is about 500,000 people. | 0 | None | 0 | 236 | 0 | 236 | View |
| Jamaican Men | Men in the Jamaica cohort are located at or near Spanish Town, Jamaica which is an urban area 25 km from the center of Kingston. The population of Spanish Town in 1991 was estimated at 92,000 people. | 0 | None | 0 | 249 | 0 | 249 | View |
| Seychelles Men | Men in the Seychelles cohort are located at or near The Republic of Seychelles, which is an archipelago with 81,000 inhabitants located approximately 1,500 km east of Kenya in the Indian Ocean and approximately 2,000 km north of the island of Mauritius. | 0 | None | 0 | 230 | 0 | 230 | View |
| United States Men | Men in the United States cohort are located at or near Maywood, IL, which is an African-American working class community adjacent to the western border of Chicago, IL. The population of Maywood in 2010 was estimated at 24,090 people. | 0 | None | 0 | 245 | 0 | 245 | View |
| Ghanaian Women | Women in the Ghana cohort are located at or near the the village of Nkwantakese which is approximately 20 kilometers outside of Kwame Nkrumah University of Science and Technology in Kumasi. | 0 | None | 0 | 293 | 0 | 293 | View |
| South African Women | Women in the South Africa cohort are located at or near Khayelitsha, the 3rd largest township in South Africa, which is an adjacent town to the city of Cape Town. The population of Khayelitsha is about 500,000 people. | 0 | None | 0 | 268 | 0 | 268 | View |
| Jamaican Women | Women in the Jamaica cohort are located at or near Spanish Town, Jamaica which is an urban area 25 km from the center of Kingston. The population of Spanish Town in 1991 was estimated at 92,000 people. | 0 | None | 0 | 251 | 0 | 251 | View |
| Seychelles Women | Women in the Seychelles cohort are located at or near The Republic of Seychelles, which is an archipelago with 81,000 inhabitants located approximately 1,500 km east of Kenya in the Indian Ocean and approximately 2,000 km north of the island of Mauritius. | 0 | None | 0 | 270 | 0 | 270 | View |
| United States Women | Women in the United States cohort are located at or near Maywood, IL, which is an African-American working class community adjacent to the western border of Chicago, IL. The population of Maywood in 2010 was estimated at 24,090 people. | 0 | None | 0 | 257 | 0 | 257 | View |