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 @ 10:51 PM
Ignite Modification Date: 2025-12-25 @ 8:20 PM
NCT ID: NCT04772469
Description: Same definition
Frequency Threshold: 0
Time Frame: Adverse event data were collected among each participant over a period of 6 months, from baseline to follow up.
Study: NCT04772469
Study Brief: Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Promoter Training, Multiple Self-test Kits, and Incentives Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks. Provision of multiple self-tests: Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks. Small monetary incentives: Use of small incentive voucher (\~$5) to encourage linkage to confirmatory testing. Use of SMS/text reminders to motivate adherence to ART or PrEP: Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support. 14 None 14 374 1 374 View
Short Training and Referral for Testing Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available. 0 None 0 359 0 359 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fracture NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View