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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT04673851
Description: Since FEP Clinicians were not exposed to the study intervention, adverse events were not collected for this group.
Frequency Threshold: 5
Time Frame: From the time of signing informed consent through the end of post treatment, approximately 3 months for Cohort 1 and 6 months for Cohort 2.
Study: NCT04673851
Study Brief: Horyzons: Implementation in Clinical Practice
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FEP Clients (Cohort 1) Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 3 months as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians. 0 None 1 25 0 25 View
FEP Clients (Cohort 2) Participants with first episode psychosis (FEP) recruited from First Episode Clinics in North Carolina (OASIS, Encompass, Eagle, and SHORE). Participants will use the online platform Horyzons for 6 months (cohort 2) as a part of their care plan. Participants will be encouraged to use both the therapeutic content and the moderated online community throughout their time in the study. Horyzons USA: Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians. 1 None 0 37 0 37 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization for substance abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):