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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT01465958
Description: None
Frequency Threshold: 0
Time Frame: Eligible subjects entered into a 3-month Run-in Phase to receive GAMUNEX-C intravenous infusions. Subjects who completed the Run-in Phase then entered the Intravenous (IV) phase (4 - 5 weeks) followed by the subcutaneous (SC) phase (12 weeks).
Study: NCT01465958
Study Brief: Pharmacokinetics, Safety, and Tolerability of Subcutaneous GAMUNEX-C in Pediatric Subjects With Primary Immunodeficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravenous GAMUNEX-C GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. None None 0 12 10 12 View
Subcutaneous GAMUNEX-C GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks. None None 1 11 11 11 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infusion site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
infusion site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site discomfort SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site haematoma SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Infusion site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Pyrexia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.0 View
Autoimmune thyroiditis SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 14.0 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Drug hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 14.0 View
Joint sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Learning disability SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 14.0 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.0 View
Molluscum contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Rheumatoid arthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Seasonal allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 14.0 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Soft tissue disorder SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Viral pharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Gastrostomy tube insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 14.0 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Infusion site extravasation SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site haemorrhage SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site induration SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site inflammation SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Infusion site warmth SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.0 View
Muscle strain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 14.0 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 14.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 14.0 View
Pharyngitis streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Rhinovirus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Skin chapped SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 14.0 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View
Viral upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 14.0 View