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 @ 2:13 PM
Ignite Modification Date: 2025-12-25 @ 12:52 PM
NCT ID: NCT02650895
Description: The analysis population included all participants who received at least one dose of study medication.
Frequency Threshold: 0
Time Frame: Up to 42 days after treatment
Study: NCT02650895
Study Brief: Safety Study of Efprezimod Alfa (CD24Fc, MK-7110) When Administered Intravenously in Healthy Adult Subjects (MK-7110-001)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CD24Fc 30 mg Single dose of 30 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain 0 None 0 6 3 6 View
CD24Fc 60 mg Single dose of 60 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain 0 None 1 6 2 6 View
CD24Fc 120 mg Single dose of 120 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain 0 None 0 6 3 6 View
CD24Fc 240 mg Single dose of 240 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain 0 None 0 6 2 6 View
Saline Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride 0 None 0 10 6 10 View
CD24Fc 10 mg Single dose of 10 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain 0 None 0 6 2 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness postural SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Upper Respiratory tract infections SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16.1 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Gastroesophageal reflux disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16.1 View
Burns second degree SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16.1 View
Skin rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 16.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View