Adverse Events Module

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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: 2025-12-24 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT02251704
Description: According to the pre-specified protocol, only serious adverse events were collected. Since no other adverse events were captured in this study, the total number of participants at risk or affected by non-serious adverse events is zero. The analysis was performed on the Total Effective Cohort.
Frequency Threshold: 0
Time Frame: Serious adverse events (SAEs) and all-cause mortality were collected from Year 1 to Year 10
Study: NCT02251704
Study Brief: Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Survey 1 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 1. 0 None 0 4214 0 0 View
Survey 2 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 2. 0 None 0 4204 0 0 View
Survey 3 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 3. 0 None 0 2400 0 0 View
Survey 4 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 4. 0 None 0 3003 0 0 View
Survey 5 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 5. 0 None 0 5417 0 0 View
Survey 6 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 6. 0 None 0 5991 0 0 View
Survey 7 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 7. 0 None 0 7246 0 0 View
Survey 8 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 8. 0 None 0 7220 0 0 View
Survey 9 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 9. 0 None 0 7203 0 0 View
Survey 10 Group Participants aged 6 months to \<10 years, enrolled in the current EPI-MAL-005 study from sites that participated in EPI-MAL-002/-003, during study Year 10. 0 None 0 7202 0 0 View
Serious Events(If Any):
Other Events(If Any):