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 @ 3:15 AM
Ignite Modification Date: 2025-12-26 @ 1:54 AM
NCT ID: NCT05335005
Description: None
Frequency Threshold: 0
Time Frame: Run-in (Clopidogrel 75 mg) arm: Approximately 14 days MK-2060 25 mg IV/Clopidogrel 75 mg arm: Up to approximately 108 days
Study: NCT05335005
Study Brief: MK-2060 and Clopidogrel Co-administration Safety and Tolerability Study in Participants With End-Stage Renal Disease (ESRD) (MK-2060-008)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Run-in (Clopidogrel 75 mg) Participants continued their established background therapy of daily 75 mg clopidogrel for 2 weeks (days -14 to 0). 0 None 0 12 1 12 View
MK-2060 25 mg IV/Clopidogrel 75 mg In addition to standard background therapy of 75 mg clopidogrel, participants received 25 mg MK-2060 intravenous (IV) infusion on days 1, 3, 5, and 8. 0 None 3 12 5 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Staphylococcal sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 26.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 26.0 View
Arteriovenous fistula site complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 26.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cold sweat SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 26.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 26.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 26.0 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 26.0 View
Renal hypertension SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 26.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 26.0 View