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 @ 10:53 PM
Ignite Modification Date: 2025-12-25 @ 8:22 PM
NCT ID: NCT02100969
Description: None
Frequency Threshold: 0
Time Frame: 23 weeks
Study: NCT02100969
Study Brief: Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Privigen/Hizentra Experimental Treatment arm: Privigen/Hizentra assigned to subjects who are stable in the screening phase of the study. 0 None 6 23 17 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Thromboembolic event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Generalized muscle weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Psychiatric Disorders- Other SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Injection Site Reactions SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paresthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Gastroesophageal Reflux Disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blood and Lymphatic System Disorder SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hyperhydrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Neck edema SYSTEMATIC_ASSESSMENT General disorders None View
Bruising SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Bronchial Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Edema Limbs SYSTEMATIC_ASSESSMENT General disorders None View
Eye Disorders SYSTEMATIC_ASSESSMENT Eye disorders None View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Generalized Muscle Weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash Acneiform SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
Spasticity SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blurred Vision SYSTEMATIC_ASSESSMENT Eye disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Musculoskeletal and Connective Tissue Disorder Other SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Flu like symptoms SYSTEMATIC_ASSESSMENT General disorders None View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Increased Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View