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: 2025-12-25 @ 12:59 AM
Ignite Modification Date: 2025-12-25 @ 11:13 PM
NCT ID: NCT02240693
Description: The treated set (TS) used (all patients who were randomised and treated with at least one dose of trial medication.) for safety assessment.
Frequency Threshold: 5
Time Frame: From the first dose of study medication until 7 days after last administration of BI 409306, up to 16 weeks.
Study: NCT02240693
Study Brief: Alzheimer Disease Proof of Concept Study With BI 409306 Versus Placebo
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 409306 10 Milligram (mg) Once Daily (QD) Patients were administered orally a tablet of 10 mg BI 409306 once daily for 12 weeks. 0 None 0 22 5 22 View
BI 409306 25 mg QD Patients were administered orally a tablet of 25 mg BI 409306 once daily for 12 weeks. 0 None 0 21 8 21 View
BI 409306 50 mg QD Patients were administered orally a tablet of 50 mg BI 409306 once daily for 12 weeks. 0 None 0 21 11 21 View
BI 409306 25 mg Twice Daily (BID) Patients were administered orally a tablet of 25 mg BI 409306 twice daily for 12 weeks. 0 None 1 21 3 21 View
Placebo Matching BI 409306 Patients were administered orally tablet of Placebo matching BI 409306 once daily for 12 weeks. 0 None 1 43 6 43 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 20.1 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 20.1 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 20.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 20.1 View