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: 2025-12-25 @ 4:35 AM
Ignite Modification Date: 2025-12-26 @ 3:37 AM
NCT ID: NCT03694418
Description: There were approximately 453 participants at risk for serious adverse events and all-cause mortality.
Frequency Threshold: 0
Time Frame: Adverse events were assessed at baseline, 3 months, 9 months, and 12 months for participants in NE. Cluster 1 adverse events were assessed September 2019-September 2020; Cluster 2 adverse events were assessed September 2020-September 2021; Cluster 3 & Cluster 4 adverse events were assessed September 2021-September 2022; Cluster 5 adverse events were assessed September 2022-September 2023. No adverse events were reported during NE.
Study: NCT03694418
Study Brief: We Are Here Now: a Multi-level, Multicomponent Sexual and Reproductive Health Intervention for American Indian Youth
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Cluster 1 Cluster 1 adverse event data was collected over a 12 month period between September 2019 - September 2020. 0 None 0 210 0 210 View
Cluster 2 Cluster 2 adverse event data was collected over a 12 month period between September 2020 - September 2021. 0 None 0 41 0 41 View
Cluster 3 Cluster 3 adverse event data was collected over a 12 month period between September 2021 - September 2022. 0 None 0 23 0 23 View
Cluster 4 Cluster 4 adverse event data was collected over a 12 month period between September 2021 - September 2022. 0 None 0 29 0 29 View
Cluster 5 Cluster 5 adverse event data was collected over a 12 month period between September 2022 - September 2023. 0 None 0 150 0 150 View
Serious Events(If Any):
Other Events(If Any):