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 @ 4:43 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT03928418
Description: The definition of adverse event and/or serious adverse event did not differ from the clinicaltrials.gov definitions. Adverse events were recorded during routine study visits when self reported by participants.
Frequency Threshold: 0
Time Frame: 9 months
Study: NCT03928418
Study Brief: Mobile Technology to Extend Clinic-based Counseling for HIV+s in Uganda
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Live Phone Call Booster Arm The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions. 0 None 1 90 0 90 View
Technology Booster Arm The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim. In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart. Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions. 0 None 0 90 0 90 View
Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention). 0 None 0 89 0 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):