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 @ 5:03 PM
Ignite Modification Date: 2025-12-25 @ 2:43 PM
NCT ID: NCT05030350
Description: None
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT05030350
Study Brief: Open-label Safety Trial of PH94B in Social Anxiety Disorder (SAD)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
PH94B PH94B Nasal Spray - administration of 3.2 micrograms PH94B, as needed, up to four times per day. 1 None 6 481 137 481 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ruptured ectopic pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Diverticulitis intestinal perforated SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gallbladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Pelvic abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View