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 @ 1:18 AM
Ignite Modification Date: 2025-12-25 @ 11:26 PM
NCT ID: NCT04567693
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected on participants during their participation in the study (12 months)
Study: NCT04567693
Study Brief: Reducing Time to Spaced-out Appointments for Newly-diagnosed People Living With HIV
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Early 1 Advance to spaced-out appointments at month 6 after a single viral load is measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits. 0 None 0 31 3 31 View
Early 2 Advance to spaced-out appointments at month 6 after two viral loads are measured. Early spaced-out appointments: Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits. 0 None 0 31 1 31 View
Usual Care Do not advance to spaced-out appointments during study period 2 None 0 28 2 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Became pregnant during study NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions MEDDra View
Incarcerated during study NON_SYSTEMATIC_ASSESSMENT Social circumstances MEDDra View
Developed tuberculosis during study NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDDra View