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 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT00885118
Description: None
Frequency Threshold: 5
Time Frame: Between the first drug administration and the end of the trial after the last drug administration, up to 28 days.
Study: NCT00885118
Study Brief: 4 Weeks Treatment With Empagliflozin (BI 10773) in Japanese Type 2 Diabetic Patients (T2DM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Empa 10 mg Treatment with Empa 10 mg once daily None None 0 20 5 20 View
Placebo Treatment with placebo once daily None None 0 21 1 21 View
Empa 1 mg Treatment with Empa 1 mg once daily None None 1 19 6 19 View
Empa 5 mg Treatment with Empa 5 mg once daily None None 0 21 2 21 View
Empa 25 mg Treatment with Empa 25 mg once daily None None 0 19 7 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry eye SYSTEMATIC_ASSESSMENT Eye disorders MEDDRA 12.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 12.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 12.1 View
Hyperglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MEDDRA 12.1 View
Pollakiuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDDRA 12.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MEDDRA 12.1 View
Alpha 1 microglobulin urine increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA 12.1 View
Beta 2 microglobulin urine increased SYSTEMATIC_ASSESSMENT Investigations MEDDRA 12.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.1 View
Heat illness SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDDRA 12.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 12.1 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 12.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 12.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 12.1 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDDRA 12.1 View