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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT02854527
Description: The treated set (TS) included all randomized subjects who were documented to have taken at least 1 dose of study drug.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) occurring up to 192 hours after intake of trial drug administration in each treatment period were assigned to treatment.
Study: NCT02854527
Study Brief: Transporter Cocktail Mutual Interaction
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Digoxin (R1) Subjects were administered a single dose of 0.25 milligram (mg) tablet of Digoxin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours. None None 1 28 0 28 View
Furosemide (R2) Subjects were administered a single dose of 0.1 milliliter (mL) or 1 mg oral solution of Furosemide orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours. None None 0 30 0 30 View
Metformin Hydrochloride (R3) Subjects were administered a single dose of 0.1 mL (10 mg) oral solution of Metformin hydrochloride orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours. None None 0 29 1 29 View
Rosuvastatin (R4) Subjects were administered a single dose of 10 mg film-coated tablet of Rosuvastatin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours. None None 0 29 1 29 View
Test Cocktail (T) Subjects were administered a single dose of test cocktail (T) comprised of 0.25 mg tablet of Digoxin, 0.1 mL (1 mg) oral solution of Furosemide, 0.1 mL (10 mg) oral solution of Metformin hydrochloride and 10 mg film-coated tablet of Rosuvastatin orally with 320 mL of non-sparkling drinking water after overnight fasting of 10 hours. None None 0 28 3 28 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Exposure to toxic agent SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 19.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 19.1 View