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 @ 9:18 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT04505904
Description: All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.
Frequency Threshold: 0
Time Frame: 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection.
Study: NCT04505904
Study Brief: Oxytocin and Approach-avoid in Grief
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Syntocinon Participants with adverse event during syntocinon condition 0 None 0 39 2 39 View
Placebo Participants with adverse events during placebo condition 0 None 0 39 1 39 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Back pain SYSTEMATIC_ASSESSMENT General disorders None View
Incidental Finding SYSTEMATIC_ASSESSMENT General disorders None View