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 @ 4:14 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT02671266
Description: Adverse events data were collected by a nurse using a symptom checklist.
Frequency Threshold: 5
Time Frame: Adverse event data was collected during an approximately two hour period after participant inhaled the nasal spray until completion of the experimental tasks.
Study: NCT02671266
Study Brief: Oxytocin Administration in BDD and OCD
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 Participants will first receive a nasal spray containing the hormone oxytocin (24 IU, 3 puffs per nostril). After a one-week washout period, participants will come back to the clinic and receive a placebo nasal spray (containing all of the same ingredients as the oxytocin spray minus the active oxytocin ingredient). Oxytocin: Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray. 0 None 0 34 15 34 View
Placebo Participants will first receive a placebo nasal spray containing a matching formulation as the oxytocin spray (without the active oxytocin ingredient). After a one-week washout period, participants will come back to the clinic and receive an oxytocin nasal spray (24 IU, 3 puffs per nostril). Placebo: Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient. 0 None 0 33 17 33 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Trouble concentrating SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Blurred vision SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety or depression SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth/throat SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasal irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Poor memory SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Tremors or shakiness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling of calmness or euphoria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Difficulty sitting still SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Feeling drowsy or sleepy SYSTEMATIC_ASSESSMENT Nervous system disorders None View