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 @ 11:45 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT02732951
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until 4 days after last drug administration, up to 89 days.
Study: NCT02732951
Study Brief: Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
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 1026706 Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks. 0 None 7 52 14 52 View
Placebo Matching to BI 1026706 Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks. 0 None 2 53 12 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders 20.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders 20.1 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations 20.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations 20.1 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 20.1 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations 20.1 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations 20.1 View
Red blood cell count decreased SYSTEMATIC_ASSESSMENT Investigations 20.1 View
Generalised tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders 20.1 View
Glycosuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders 20.1 View
Reactive perforating collagenosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Visual acuity reduced SYSTEMATIC_ASSESSMENT Eye disorders 20.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations 20.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders 20.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders 20.1 View