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 |
|---|---|---|---|---|---|---|---|---|
| Overall Study Group (Survey 1) | Subjects at least 6 months of age at the time of Survey 1, conducted at Year 1 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. | 0 | None | 0 | 6404 | 0 | 0 | View |
| Overall Study Group (Survey 4) | Subjects at least 6 months of age at the time of Survey 4, conducted at Year 4 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. | 0 | None | 0 | 2400 | 0 | 0 | View |
| Overall Study Group (Survey 2) | Subjects at least 6 months of age at the time of Survey 2, conducted at Year 2 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. | 0 | None | 0 | 6414 | 0 | 0 | View |
| Overall Study Group (Survey 3) | Subjects at least 6 months of age at the time of Survey 3, conducted at Year 3 of the 4 annual cross sectional surveys performed preferably at peak transmission (end of rainy season), infected with P. falciparum parasite. Infection determined using a blood smear slide and determined using microscopy. Subjects were enrolled from the catchment areas of study 110021 (NCT00866619) but those who previously participated in study 110021 were excluded from this epidemiological study. | 0 | None | 0 | 6400 | 0 | 0 | View |