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: 2025-12-26 @ 4:00 PM
Ignite Modification Date: 2025-12-26 @ 4:00 PM
NCT ID: NCT01694706
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until the end of trial visit, up until 20 days
Study: NCT01694706
Study Brief: Investigation of Food Effect and Gastric ph Increase on the Bioavailability of Faldapravir
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Faldaprevir in Fasting Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment) None None 0 15 4 15 View
Faldaprevir After a High-fat Meal Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less None None 0 14 4 14 View
Faldaprevir and Omeprazole Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast None None 0 14 4 14 View
Omeprazole 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir None None 0 15 0 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.1 View
Arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 15.1 View