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 @ 4:16 PM
Ignite Modification Date: 2025-12-24 @ 4:16 PM
NCT ID: NCT01983566
Description: None
Frequency Threshold: 5
Time Frame: From the time of first administration of the respective treatment until start of the next treatment or until the day after the termination date (or until 3 days after administration of last study drug, whichever occurred later), up to 37 days.
Study: NCT01983566
Study Brief: Effect of Food and Increased Gastric pH Value on Bioavailability of a Single Dose of BI 207127 in Healthy Caucasian and Japanese Subjects
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dele Fasted Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h. The tablets were administered oral with 240 mL of water. None None 0 11 2 11 View
Dele High Fat Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h. The tablets were administered oral with 240 mL of water. None None 0 10 1 10 View
Dele Low Fat Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h. The tablets were administered oral with 240 mL of water. None None 0 12 4 12 View
Dele + OMP Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily. All medications were administered oral with 240 mL of water. None None 0 10 7 10 View
OMP Alone One gastro-resistant hard capsule of Omeprazole (OMP) (40 mg) once daily in the evening for 4 days administered oral with 240 mL of water. None None 0 10 0 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MEDDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 17.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 17.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 17.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 17.0 View