Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:02 AM
Ignite Modification Date: 2025-12-25 @ 10:01 PM
NCT ID: NCT01703858
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until 14 days after the last drug administration, up to 42 days.
Study: NCT01703858
Study Brief: Study to Investigate the Relative Bioavailability, Influence of Pantoprazole Coadministration and Food Effect of Different Oral Formulation of BI 113608
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A : BI-113608 Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions. None None 0 15 6 15 View
B : BI-113608 Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally. None None 0 15 6 15 View
C : BI-113608 Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally. None None 0 15 7 15 View
Pantoprazole 40mg Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608. None None 0 15 3 15 View
D : BI-113608 Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608. None None 0 15 4 15 View
E : BI-113608 Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast. None None 0 14 5 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 15.1 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Frequent bowel movements SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 15.1 View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 15.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 15.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 15.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 15.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 15.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 15.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 15.1 View