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 @ 6:25 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT02310568
Description: The same event may appear as both an adverse event (AE) and an serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
Frequency Threshold: 5
Time Frame: None
Study: NCT02310568
Study Brief: POC Study in Partially Responsive Generalized Anxiety Disorder
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 All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2. None None 1 87 27 87 View
PF-06372865 2.5 mg All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2. None None 0 37 13 37 View
PF-06372865 7.5 mg All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2. None None 0 35 16 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vertigo positional NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View