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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:29 AM
NCT ID: NCT01955720
Description: None
Frequency Threshold: 5
Time Frame: From the study drug administration up to start of follow-up period (from Day 1 to Day 35).
Study: NCT01955720
Study Brief: Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dabigatran Etexilate (DE) subjects with Dabigatran etexilate (DE) treatment None None 0 46 13 46 View
Low (1g) Idarucizumab Dose Subjects with low 1g idarucizumab dose treatment None None 0 14 4 14 View
Medium (2.5g) Idarucizumab Dose Subjects with medium (2.5g) idarucizumab dose treatment None None 0 12 1 12 View
High (5g) Idarucizumab Dose Subjects with high (5g) idarucizumab dose treatment None None 0 26 2 26 View
Low (1g) Placebo Dose Subjects with low (1g) placebo dose treatment None None 0 14 3 14 View
Medium (2.5g) Placebo Dose Subjects with medium (2.5g) placebo dose treatment None None 0 12 3 12 View
High (5g) Placebo Dose Subjects with high (5g) placebo dose treatment None None 0 26 0 26 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 17.0 View
Application site dermatitis SYSTEMATIC_ASSESSMENT General disorders MEDDRA 17.0 View
Post procedural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 17.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 17.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 17.0 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 17.0 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 17.0 View
Abdominal discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Abdominal distension SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 17.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 17.0 View
Infusion related reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 17.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 17.0 View