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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:06 AM
NCT ID: NCT01370005
Description: None
Frequency Threshold: 5
Time Frame: From drug administration until last drug administration plus seven days, up to 171 days
Study: NCT01370005
Study Brief: 12 Week Efficacy and Safety Study of Empagliflozin (BI 10773) in Hypertensive Patients With Type 2 Diabetes Mellitus
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks. None None 7 272 43 272 View
Empa 10mg Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks. None None 3 276 42 276 View
Empa 25mg Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks. None None 4 276 55 276 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Carotid artery thrombosis SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Acute vestibular syndrome SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MEDDRA 15.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 15.0 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA 15.0 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDDRA 15.0 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View
Traumatic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 15.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 15.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 15.0 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Electrocardiogram T wave inversion SYSTEMATIC_ASSESSMENT Investigations MEDDRA 15.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 15.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 15.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 15.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MEDDRA 15.0 View