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 @ 4:46 AM
Ignite Modification Date: 2025-12-26 @ 3:48 AM
NCT ID: NCT02750618
Description: None
Frequency Threshold: 5
Time Frame: From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
Study: NCT02750618
Study Brief: Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Burosumab Q2W Burosumab SC injections Q2W for a total of 160 weeks. 0 None 1 13 13 13 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Oral Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Injection Site Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Hordeolum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Chronic Throat Clearing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Skin Disorder SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Swelling Face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Urticaria SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skull Malformation SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Syringomyelia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Deafness Unilateral SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Ear Haemorrhage SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Excessive Cerumen Production SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Motion Sickness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Otorrhoea SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Tinnitus SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Ocular Hyperaemia SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Aphthous Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Dental Caries SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Epigastric Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gingival Blister SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gingival Erythema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Gingival Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Loose Tooth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Post-Tussive Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Stomatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Toothache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting Projectile SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Vaccination Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Food Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Atypical Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Conjunctivitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Croup Infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Enterobiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Eye Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastrointestinal Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Genital Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gingival Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Hand-Foot-And-Mouth Disease SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Impetigo SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Molluscum Contagiosum SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis Media SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pharyngitis Streptococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Tooth Abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Arthropod Bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Lip Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Skin Abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Tooth Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Tooth Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Traumatic Tooth Displacement SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Amylase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood 25-Hydroxycholecalciferol Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Parathyroid Hormone Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Blood Phosphorus Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Heart Rate Abnormal SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Lipase Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Vitamin D Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
White Blood Cell Count Increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Increased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Polydipsia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Bone Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Foot Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Knee Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Dysarthria SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Hypersomnia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Periodic Limb Movement Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Polyuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Penile Erythema SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Penile Pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 18.1 View
Adenoidal Disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal Discharge Discolouration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Respiratory Tract Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sinus Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Throat Irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Dermatitis Contact SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Pruritus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Urticaria Papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Flushing SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 18.1 View