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 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT01988233
Description: All adverse events or unanticipated problems were to be reported in writing to the University Institutional Review Board within 5 days of the discovery. Serious or unexpected adverse events were to be verbally reported within 24 to 48 h.
Frequency Threshold: 0
Time Frame: The specific period of time over which adverse event data were collected was 1 year for each participant.
Study: NCT01988233
Study Brief: BAILA: Being Active, Increasing Latinos Healthy Aging
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BAILAMOS© Dance Program BAILAMOS© Dance Program + Maintenance Program: includes a 4-month twice-weekly adoption phase and a 4-month twice-weekly maintenance phase. Each month during adoption a new dance style is introduced by a professional dance instructor. During the 4-month maintenance phase an indigenous dance leader, trained by the professional dance instructor, will lead dance with participants twice per week BAILAMOS© Dance Program 0 None 0 167 0 167 View
Health Education Control Group Health Education Control Group: Sedentary older Latinos randomly assigned to the health education control group will participate in classes developed for older adults and offered by the University of Illinois Extension. All classes are conducted in Spanish by extension staff using Spanish-language materials. Classes will meet one day per week for two hours, to provide equitable social contact as the treatment group. Health Education Control Group 0 None 0 166 0 166 View
Serious Events(If Any):
Other Events(If Any):