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 @ 3:45 PM
Ignite Modification Date: 2025-12-25 @ 1:53 PM
NCT ID: NCT05934292
Description: All-Cause Mortality reported for all allocated participants. Serious and non-serious adverse events (AEs) were reported on all allocated participants who received a dose of study treatment. Per protocol, All-cause mortality, serious and non-serious AEs were not collected separately for Panel C ESRD - Enlicitide Decanoate pre-hemodialysis and Panel C ESRD Enlicitide Decanoate post-hemodialysis arms.
Frequency Threshold: 0
Time Frame: Up to approximately 30 days
Study: NCT05934292
Study Brief: Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) Renal Impairment Study (MK-0616-020)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Panel A: Moderate Renal Impairment (RI) Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. 0 None 0 8 2 8 View
Panel B: Severe RI Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. 0 None 0 8 2 8 View
Panel C: End-Stage Renal Disease (ESRD) on Hemodialysis (HD) Participants received Enlicitide Decanoate 20 mg tablet orally on Day 1 and Day 16. 0 None 1 9 0 9 View
Panel D: Healthy Controls Participants received Enlicitide Decanoate 20 mg tablet single dose orally on Day 1. 0 None 0 8 0 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypervolaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.0 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 27.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.0 View