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 @ 2:17 PM
Ignite Modification Date: 2025-12-25 @ 12:54 PM
NCT ID: NCT01456195
Description: At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Frequency Threshold: 5
Time Frame: First dose of study drug to 30 days past last dose of study drug (Up to 28 Weeks)
Study: NCT01456195
Study Brief: Comparison of TAK-875 (Fasiglifam) With Placebo in Participants With Type 2 Diabetes
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 Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks. None None 3 143 9 143 View
Fasiglifam 25 mg Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks. None None 3 137 6 137 View
Fasiglifam 50 mg Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks. None None 3 141 7 141 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (16.0) View
Abdominal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (16.0) View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (16.0) View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (16.0) View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA (16.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA (16.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (16.0) View