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 @ 9:46 PM
Ignite Modification Date: 2025-12-25 @ 7:26 PM
NCT ID: NCT05355532
Description: a standard definition of adverse events was used
Frequency Threshold: 5
Time Frame: up to 7-15 days after PCI
Study: NCT05355532
Study Brief: Genetic Determinants of the Coronary Microvascular Obstruction in PCI
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
"CMVO+" (Patients Has Presented CMVO in PCI) Patients with 1 type MI that has presented CMVO in emergency PCI. different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes. 6 None 0 40 0 40 View
"CMVO-" (Patients Hasn't Presented CMVO in PCI) Patients with 1 type MI that hasn't presented CMVO in emergency PCI. different variants of SNPs that may be associated with the coronary microvascular obstruction development: Some variants of SNPs determine endothelial function, microcirculation, hemostasis, and inflammation in MI patients. They may be associated with the development of coronary microvascular obstruction during emergency PCI. A link between the different SNPs and the CMVO development will be established. SNP will be determined by real-time polymerase chain reaction with high-resolution melting curve analysis using TaqMan fluorescent probes. 2 None 0 40 0 40 View
Serious Events(If Any):
Other Events(If Any):