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 @ 9:27 PM
Ignite Modification Date: 2025-12-25 @ 7:13 PM
NCT ID: NCT02102932
Description: None
Frequency Threshold: 5
Time Frame: First drug administration until 7 days after last drug administration, up to 8 days
Study: NCT02102932
Study Brief: Bioavailability of Empagliflozin/Metformin Fixed Dose Combinations (FDCs) in Healthy Chinese Volunteers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
T1 (FDC) Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin None None 0 24 8 24 View
R1 (FC) Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg None None 0 24 8 24 View
T2 (FDC) Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin None None 0 24 9 24 View
R2 (FC) Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg None None 0 24 11 24 View
T3 (FDC) Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin None None 0 24 12 24 View
R3 (FC) Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg None None 0 24 11 24 View
T4 (FDC) Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin None None 0 24 7 24 View
R4 (FC) Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg None None 0 24 9 24 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 17.0 View
Bilirubin conjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Blood bilirubin unconjugated increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Glucose urine present SYSTEMATIC_ASSESSMENT Investigations MedDRA 17.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 17.0 View