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 @ 12:46 AM
Ignite Modification Date: 2025-12-25 @ 10:59 PM
NCT ID: NCT01924767
Description: None
Frequency Threshold: 5
Time Frame: day1 to day21
Study: NCT01924767
Study Brief: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Doses of BI 10773 Tablets
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 were treated with matching placebo as tablet once daily in the morning. None None 0 12 5 12 View
Empagliflozin 2.5 mg qd Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning. None None 0 9 6 9 View
Empagliflozin 10 mg qd Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning. None None 0 9 5 9 View
Empagliflozin 25 mg qd Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning. None None 0 9 5 9 View
Empagliflozin 100 mg qd Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning. None None 0 9 3 9 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 10.1 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 10.1 View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 10.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 10.1 View
Eye pruritus SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA 10.1 View
Circulatory collapse SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 10.1 View
Thrombophlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MEDDRA 10.1 View
Pharyngolaryngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDDRA 10.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 10.1 View
Gastric disorder SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 10.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 10.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 10.1 View
Rash pruritic SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 10.1 View
Dermatitis contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 10.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 10.1 View
Joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MEDDRA 10.1 View
Injection site thrombosis SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA 10.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 10.1 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 10.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 10.1 View
Sciatica SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 10.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 10.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 10.1 View
Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 10.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MEDDRA 10.1 View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 10.1 View