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 @ 2:05 AM
Ignite Modification Date: 2025-12-26 @ 12:30 AM
NCT ID: NCT01392560
Description: All adverse events, serious and non-serious, occurring during the course of the clinical trial were to be collected, documented and reported to the sponsor by the investigator on the appropriate case reporting forms. Reporting was performed according to the specific definitions and instructions.
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT01392560
Study Brief: Safety and Efficacy of Empagliflozin (BI 10773) in Type 1 Diabetes Mellitus Patients With or Without Renal Hyperfiltration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Empagliflozin 25 mg Oral once daily Empagliflozin 25 mg: Oral once daily None None 3 42 42 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 16.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 16.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.0 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 16.0 View
Thirst SYSTEMATIC_ASSESSMENT General disorders MEDDRA 16.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 16.0 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 16.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 16.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 16.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 16.0 View
Genitourinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 16.0 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 16.0 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 16.0 View