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: 2025-12-26 @ 1:17 PM
Ignite Modification Date: 2025-12-26 @ 1:17 PM
NCT ID: NCT01580306
Description: Subjects were required to report spontaneously any adverse events (AEs) as well as the time of onset, duration and intensity of these events. In addition, each volunteer was assessed regularly by the medical staff throughout the clinical trial as well as at the end of observation and whenever necessary as deemed by the investigator.
Frequency Threshold: 5
Time Frame: From the time the subject signed the informed consent (21 days before drug administration) through the observational phase to the end of study visit (7 to 14 days after dosing)
Study: NCT01580306
Study Brief: Pharmacokinetics and Safety of BI 201335 in Patients With Mild to Severe Renal Impairment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BI 201335 Relevant Treatment Dose (Normal Renal Function) Capsule for oral administration estimated glomerular filtration rate \>= 90 mL/min/1.73m2 None None 0 8 5 8 View
BI 201335 Relevant Treatment Dose (Mild Renal Impairment) Capsule for oral administration estimated glomerular filtration rate 60-89 mL/min/1.73m2 None None 0 8 8 8 View
BI 201335 Relevant Treatment Dose (Moderate Renal Impairment) Capsule for oral administration estimated glomerular filtration rate 30-59 mL/min/1.73m2 None None 0 8 5 8 View
BI 201335 Relevant Treatment Dose (Severe Renal Impairment) Capsule for oral administration estimated glomerular filtration rate 15-29 mL/min/1.73m2 None None 0 8 7 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Gastrointestinal disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Hyperbilirubinaemia SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA 15.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA 15.0 View
Blood pressure systolic increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA 15.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 15.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View