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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT02915705
Description: None
Frequency Threshold: 5
Time Frame: Up to Week 64 in the Treatment Period and up to Week 140 in the Long Term Extension Period, plus up to 12 weeks ±1 week after the last dose of study drug.
Study: NCT02915705
Study Brief: Efficacy and Safety of Burosumab Versus Oral Phosphate and Active Vitamin D Treatment in Pediatric Patients With 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
Oral Phosphate/Active Vitamin D (Treatment Period) Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). 0 None 3 32 23 32 View
Burosumab (Treatment Period) Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). 0 None 3 29 21 29 View
Oral Phosphate/Active Vitamin D->Burosumab (Extension Period) Multiple daily doses of oral phosphate and one or more daily doses of active vitamin D therapy, titrated and individualized by the investigator based on published recommendations during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants crossed over to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period. 0 None 0 26 9 26 View
Total Burosumab (Treatment Period and Extension Period) Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection at any time during the study. 0 None 4 55 34 55 View
Burosumab->Burosumab (Treatment Period and Extension Period) Burosumab 0.8 mg/kg starting dose, administered Q2W by SC injection during the Treatment Period (up to Week 64). During the Treatment Extension Period (Week 64 to Week 140), participants continued to receive a starting dose of SC burosumab 0.8 mg/kg Q2W. Participants in Japan and Korea did not enter the Treatment Extension Period. 0 None 4 29 25 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Craniosynostosis SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Papilloedema SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 18.1 View
Viral Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Knee Deformity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tooth Hypoplasia SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 18.1 View
Ear Discomfort SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 18.1 View
Abdominal Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Constipation 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
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Teething SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Tooth Loss 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
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Erosion 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 Rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Reaction SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Injection Site Urticaria 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
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Seasonal Allergy SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 18.1 View
Ear Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Gastroenteritis Viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Otitis Externa 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
Rhinitis 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
Varicella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Viral Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations 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
Procedural Pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 18.1 View
Vitamin D Decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Decreased Appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Vitamin D Deficiency 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
Pain In Extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Attention Deficit/Hyperactivity Disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 18.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinitis Allergic SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 18.1 View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View
Swelling Face SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 18.1 View