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 @ 5:06 AM
Ignite Modification Date: 2025-12-26 @ 4:09 AM
NCT ID: NCT01276327
Description: Treated set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of any study drug. Drug administrations were separated by washout periods of at least 35 days.
Frequency Threshold: 5
Time Frame: 4 days treatment period (one day for every single dose), 35 days washout between drug administrations
Study: NCT01276327
Study Brief: Bioequivalence of a Fixed Dose Combination Tablet Linagliptin/Pioglitazone Compared With Its Mono-components
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
FDC L5P30 (Test) Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast None None 0 62 13 62 View
L5+P30 (Ref) Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast None None 1 63 7 63 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastrointestinal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MEDDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MEDDRA 14.0 View