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 @ 1:28 PM
Ignite Modification Date: 2025-12-25 @ 12:32 PM
NCT ID: NCT05961995
Description: Participants were thoroughly briefed on potential risks and provided with contact information for study coordinators who can offer support and guidance. During each in-person visit and follow up phone calls, adverse events are reviewed and documented in the participant's binder. The study team including the principal investigator assess/grade the findings and take the necessary steps to resolve them. A serious adverse event is promptly reported to the local IRB as per protocol.
Frequency Threshold: 0
Time Frame: Adverse event were collected at Baseline (week 1) and Week 6
Study: NCT05961995
Study Brief: Heartfulness Meditation (HFM) in Cyclic Vomiting Syndrome (CVS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Single Arm Study We conducted a 6-week single-arm pilot study to assess the effects of Heartfulness meditation (HFM) in CVS using a custom-designed meditation app. Primary outcomes included state and trait anxiety and mood state changes pre- vs. post-meditation, and secondary outcomes were psychological distress, coping, sleep quality and Health-Related Quality of Life at baseline and weeks 3 and 6. Serum concentration of endocannabinoids N-arachidonylethanolamine (AEA) and 2-arachidonoylglycerol (2-AG) and related lipids were measured pre-and-post HFM at baseline and week 6. 0 None 0 45 0 45 View
Serious Events(If Any):
Other Events(If Any):