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 @ 11:44 PM
Ignite Modification Date: 2025-12-25 @ 9:37 PM
NCT ID: NCT05365451
Description: None
Frequency Threshold: 0
Time Frame: 10 months
Study: NCT05365451
Study Brief: Pharmacokinetic Drug-Drug Interaction Study to Identify Biomarkers of Kidney Transporters
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Metformin Alone 16 subjects were administered 50 mg metformin as a solution for Part 1 Arm A. 0 None 0 16 1 16 View
Cimetidine + Metformin The same 16 subjects were administered 400 mg cimetidine as a tablet, then 50 mg metformin as a solution for Part 1 Arm B. 0 None 0 16 1 16 View
Furosemide Alone The same 16 subjects were administered 5 mg furosemide as a tablet for Part 2 Arm A. 0 None 0 16 3 16 View
Probenecid + Furosemide The same 16 subjects were administered 1000 mg probenecid as a tablet, then 5 mg furosemide as a tablet for Part 2 Arm B. 0 None 0 16 4 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
nausea/vomiting SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
IV site tenderness SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Neck discomfort SYSTEMATIC_ASSESSMENT Nervous system disorders None View