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: 2025-12-25 @ 1:16 AM
Ignite Modification Date: 2025-12-25 @ 11:25 PM
NCT ID: NCT01581593
Description: None
Frequency Threshold: 5
Time Frame: 13 months
Study: NCT01581593
Study Brief: Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Kedrion IVIG 10% Kedrion IVIG 10% treatment. Kedrion IVIG 10%: Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Duration - 12 months None None 4 45 44 45 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infective exacerbation of bronchiectasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Bipolar disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
Humerus Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA SOC View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Bacterial pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Viral Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Acute Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA SOC View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA SOC View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA SOC View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA SOC View
Adverse drug reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA SOC View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Sinus Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA SOC View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA SOC View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA SOC View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA SOC View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA SOC View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA SOC View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA SOC View
Investigations SYSTEMATIC_ASSESSMENT Investigations MedDRA SOC View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA SOC View
Skin and subcutaneous tissue disorders SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA SOC View
Lymphadenopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA SOC View
Eye Disorders SYSTEMATIC_ASSESSMENT Eye disorders MedDRA SOC View
Metabolism and nutrition disorders SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA SOC View
Immune System Disorders SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA SOC View
Vascular Disorders SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA SOC View