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 @ 10:04 PM
Ignite Modification Date: 2025-12-25 @ 7:41 PM
NCT ID: NCT00789035
Description: None
Frequency Threshold: 5
Time Frame: From first drug administration until 7 days after last intake of study medication, up to 121 days
Study: NCT00789035
Study Brief: 12 Weeks Treatment With 3 Different Doses of BI 10773 in Type 2 Diabetic Patients
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 Patients receive Placebo in tablets matching the Empagliflozin tablets in appearance once daily. None None 0 82 1 82 View
Empagliflozin 5 mg Patients receive 5 mg Empagliflozin in tablets once daily. None None 2 81 3 81 View
Empagliflozin 10 mg qd Patients receive 10 mg Empagliflozin in tablets once daily. None None 0 81 5 81 View
Empagliflozin 25 mg qd Patients receive 25 mg Empagliflozin in tablets once daily. None None 1 82 1 82 View
Metformin OL Patients were to take a dose of 500 mg Metformin (open-label) twice daily for the first 4 weeks. For the remaining 8 weeks, if the fasted blood glucose values were above 110 mg/dL (6.1 mmol/L), the dose was to be increased to 2 x 500 mg tablets twice daily or up to the maximum tolerated. None None 3 80 7 80 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Meniscus lesion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 12.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 12.0 View
Prinzmetal angina SYSTEMATIC_ASSESSMENT Cardiac disorders MEDDRA 12.0 View
Intestinal functional disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 12.0 View
Hand fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.0 View
Ligament rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.0 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.0 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 12.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MEDDRA 12.0 View