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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT03503669
Description: Adverse events were assessed by asking participants whether they experienced any negative side effects
Frequency Threshold: 0
Time Frame: Adverse event data were collected from baseline through study completion, up to six months.
Study: NCT03503669
Study Brief: Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Memory Training Group memory training will be administered for amnestic mild cognitive impairment (MCI) Memory Training: Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks. 0 None 0 39 3 39 View
Kundalini Yoga and Meditation Participants will engage in weekly yoga classes and daily 12 minute meditation Kundalini yoga and meditation: Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks. 0 None 0 40 3 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flu NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Steroid Injection NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Food Poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vaccine side effect NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View