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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT01000493
Description: All subject population was used for the analysis of safety (AE and SAE).
Frequency Threshold: 5
Time Frame: AE and SAE were reported from the start of investigational product and until the follow-up contact (up to 18 weeks).
Study: NCT01000493
Study Brief: Orvepitant (GW823296) in Adult Post Traumatic Stress 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 Participants assigned to take one tablet of matching placebo of orvepitant each day in the evening (once daily) up to 12 weeks. 0 None 1 60 27 60 View
Orvepitant 60 mg Once Daily Participants assigned to take one tablet of orvepitant 60 mg each day in the evening (once daily) up to 12 weeks. 0 None 1 69 34 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View