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 @ 3:53 PM
Ignite Modification Date: 2025-12-25 @ 1:59 PM
NCT ID: NCT04183192
Description: None
Frequency Threshold: 0
Time Frame: 63 days for subjects in treatment groups A,B,E,F and 123 days for subjects in treatment groups C,D,G, H.
Study: NCT04183192
Study Brief: Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm G: Reslizumab High Intermediate Dose Single dose of reslizumab 0.4 mg/kg IV Reslizumab: Reslizumab 0.4 mg/kg administered IV 0 None 0 8 4 8 View
Arm A: Mepolizumab Low Dose Single dose of mepolizumab 3 mg SC Mepolizumab: Mepolizumab 3 mg administered SC 0 None 0 8 4 8 View
Arm H: Reslizumab High Dose Single dose of reslizumab 0.8 mg/kg IV Reslizumab: Reslizumab 0.8 mg/kg administered IV 0 None 0 8 6 8 View
Arm B: Mepolizumab Low Intermediate Dose Single dose of mepolizumab 6 mg SC Mepolizumab: Mepolizumab 6 mg administered SC 0 None 0 8 3 8 View
Arm C: Mepolizumab High Intermediate Dose Single dose of mepolizumab 12 mg SC Mepolizumab: Mepolizumab 12 mg administered SC 0 None 0 8 3 8 View
Arm I: Placebo Single dose of placebo Placebo: Placebo (administered either IV or SC) 0 None 0 8 3 8 View
Arm D: Mepolizumab High Dose Single dose of mepolizumab 24 mg SC Mepolizumab: Mepolizumab 24 mg administered SC 0 None 0 8 1 8 View
Arm E: Reslizumab Low Dose Single dose of reslizumab 0.1 mg/kg IV Reslizumab: Reslizumab 0.1 mg/kg administered IV 0 None 0 8 3 8 View
Arm F: Reslizumab Intermediate Low Dose Single dose of reslizumab 0.2 mg/kg IV Reslizumab: Reslizumab 0.2 mg/kg administered IV 0 None 0 8 2 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Eye irritation SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.23.0 View
Photophobia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA v.23.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA v.23.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Medical device site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Vessel puncture site bruise SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Vessel puncture site irritation SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Vessel puncture site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Vessel puncture site paresthesia SYSTEMATIC_ASSESSMENT General disorders MedDRA v.23.0 View
Arthropod bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA v.23.0 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.23.0 View
Musculoskeletal stiffness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.23.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.23.0 View
Neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA v.23.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View
Euphoric mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA v.23.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Paranasal sinus discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Pharyngitis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA v.23.0 View
Dry skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.23.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.23.0 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.23.0 View
Xerosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA v.23.0 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA v.23.0 View