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 @ 2:24 AM

Ignite Modification Date: 2025-12-26 @ 12:56 AM

NCT ID: NCT02185534

Description: Adverse events (AEs) were assigned to the treatment after which they occurred: Treatment A: AEs starting at the time of /after dosing of European clopidogrel tablets Treatment B: AEs starting at the time of / after dosing of Japanese clopidogrel tablets Treatment C: AEs starting at the time of / after dosing of US clopidogrel tablets

Frequency Threshold: 1

Time Frame: From screening until follow-up, i.e. up to 7 weeks after the first dose.

Study: NCT02185534

Study Brief: Clopidogrel Bioequivalence Study in Healthy Subjects

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

European Clopidogrel Tablets, 75 mg	Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)	None	None	0	81	19	81	View
Japanese Clopidogrel Tablets, 75 mg	Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)	None	None	0	80	18	80	View
US Clopidogrel Tablets, 75 mg	Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)	None	None	0	82	22	82	View
Total Number of Participants	total number of subjects exposed to any treatment	None	None	0	83	38	83	View

Serious Events(If Any):

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Headache	NON_SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA version 17.0.	View
Dizziness	NON_SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA version 17.0.	View
Presyncope	NON_SYSTEMATIC_ASSESSMENT	Nervous system disorders	MedDRA version 17.0.	View
Abdominal Pain	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA version 17.0.	View
Diarrhoea	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA version 17.0.	View
Nausea	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA version 17.0.	View
Vomiting	NON_SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	MedDRA version 17.0.	View
Catheter Site Pain	NON_SYSTEMATIC_ASSESSMENT	General disorders	MedDRA version 17.0.	View
Catheter Site Inflammation	NON_SYSTEMATIC_ASSESSMENT	General disorders	MedDRA version 17.0.	View
Fatigue	NON_SYSTEMATIC_ASSESSMENT	General disorders	MedDRA version 17.0.	View
Nasopharyngitis	NON_SYSTEMATIC_ASSESSMENT	Infections and infestations	MedDRA version 17.0.	View
Contusion	NON_SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	MedDRA version 17.0.	View
Dysphonia	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA version 17.0.	View
Tinnitus	NON_SYSTEMATIC_ASSESSMENT	Ear and labyrinth disorders	MedDRA version 17.0.	View
Cough	NON_SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	MedDRA version 17.0.	View