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 @ 7:45 PM
Ignite Modification Date: 2025-12-25 @ 5:22 PM
NCT ID: NCT02508103
Description: For systematic assessment of adverse events during administration of nasal sprays, we reviewed various symptoms with participants over the phone; response options for each symptom were "yes/no". If participants endorsed a symptom (e.g., headache), we collected information on severity, whether or not it might be related to the study, whether the symptom resolved, and whether the symptom led to drop out.
Frequency Threshold: 5
Time Frame: Systematic assessment of adverse events occurred during intranasal oxytocin and placebo administration; each assessment occurred on the 3rd day of at-home administration. Participants were asked to report any other adverse events throughout their enrollment in the study (minimally: 2 months, maximally: 5mos).
Study: NCT02508103
Study Brief: Emotional Processing and Oxytocin Mechanisms in Premenstrual Dysphoric Disorder: A Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oxytocin Intranasal Oxytocin spray (40 IU, 3x/day) for 4-5 days 0 None 0 10 4 10 View
Placebo Intranasal Placebo spray (3x/day) for 4-5 days 0 None 0 10 1 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Uterine cramps SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Clogged nostril SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View