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: 2025-12-25 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT01624194
Description: None
Frequency Threshold: 0
Time Frame: 4 weeks
Study: NCT01624194
Study Brief: Intranasal Oxytocin Treatment for Social Deficits in Children With Autism
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Nasal Spray Placebo: 3 x 0.1 mL sprays per nostril twice daily for 4-weeks. 0 None 0 18 12 18 View
Oxytocin Nasal Spray Oxytocin nasal spray: 24IU BID (3 x 0.1 mL \[4IU\] sprays per nostril twice for 4-weeks. 0 None 0 14 11 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold Symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Cough SYSTEMATIC_ASSESSMENT General disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Excitement/Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depressive Affect SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Labile Mood SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Silly Behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
More Distractible SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nasal Congestion SYSTEMATIC_ASSESSMENT General disorders None View
Epistaxis SYSTEMATIC_ASSESSMENT General disorders None View
Sneezing SYSTEMATIC_ASSESSMENT General disorders None View
Mouth Pain SYSTEMATIC_ASSESSMENT General disorders None View
Intranasal Swelling SYSTEMATIC_ASSESSMENT General disorders None View
Runny Nose SYSTEMATIC_ASSESSMENT General disorders None View
Blinking Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Earache SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Nasal Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Loose Stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Skin Cut SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View