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 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT04013932
Description: Adverse event data was not collected on caregivers. Death and temporary missing person experiences were identified during follow-up data collection timepoints (review of medical records and contacts with caregivers).
Frequency Threshold: 0
Time Frame: From baseline to endline data collection (~1 year)
Study: NCT04013932
Study Brief: Family Psychoeducation for Adults With Psychotic Disorders in Tanzania
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
KUPAA Intervention + Standard of Care Patients will be assigned to a KUPAA group composed of approximately 6 patients per group (with matched caregivers also attending). Patients first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (\~1.5-2 hours) for 12 weeks. KUPAA Intervention Group (Culturally Tailored Family Psychoeducation): KUPAA is composed of 3 key components: 1-2 Joining sessions \[\~30 to 45 minutes each\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions. Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses. 12 Family psychoeducation group sessions \[\~1.5 hours each session\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided. 0 None 0 33 0 33 View
Control - Standard of Care Patients will receive the standard of care. 1 None 2 33 0 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Patient who left home temporarily/missing (relapse related) NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):