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 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
NCT ID:
NCT02526160
Description:
None
Frequency Threshold:
5
Time Frame:
From first dose of study drug through the end of study plus 4 weeks (+ 5 days). Mean (SE) duration of exposure to burosumab for all periods combined through EOS II was 771.3 (21.97) days (range: 167 - 957) in the burosumab->burosumab group and 625.7 (19.40) days (range: 165 - 844) in the placebo->burosumab group.
Study:
NCT02526160
Study Brief:
Study of KRN23 in Adults 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 -> Burosumab (Combined DB and OL Period) | SC injection of 1.0 mg/kg burosumab Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open-label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II \[US only\]). | 1 | None | 12 | 68 | 68 | 68 | View |
| Total Burosumab (Combined DB and OL Period) | SC injection of 1.0 mg/kg burosumab at any time during the study. | 1 | None | 22 | 134 | 131 | 134 | View |
| Placebo (DB Period) | SC injection of placebo Q4W for 24 weeks (double-blind placebo-controlled Treatment Period) | 0 | None | 1 | 66 | 57 | 66 | View |
| Placebo -> Burosumab (OL Period) | SC injection of placebo Q4W for 24 weeks (double-blind placebo-controlled Treatment Period), SC injection of burosumab 1 mg/kg Q4W for 24 weeks (open-label Treatment Continuation Period), SC injection of burosumab 1 mg/kg Q4W for 48 weeks (open label Treatment Extension Period I), and SC injection of burosumab 1 mg/kg Q4W up to 53 weeks (open-label Treatment Extension Period II \[US only\]). | 0 | None | 10 | 66 | 63 | 66 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 18.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Duodenal Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Irritable Bowel Syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Periodontal Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Peritoneal Adhesions | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 18.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Medical Device Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Procedural Nausea | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Procedural Vomiting | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Road Traffic Accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Subdural Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 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 |
| Cervical Spinal Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Joint Range Of Motion Decreased | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Knee Deformity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Pseudarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Spinal Column Stenosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Spondylolisthesis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Invasive Ductal Breast Carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Parathyroid Tumour Benign | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | View |
| Cerebrospinal Fluid Leakage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Cervical Radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Myelopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Neuralgia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Partial Seizures | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hyperphosphataemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 18.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 18.1 | View |
| Hyperparathyroidism Secondary | SYSTEMATIC_ASSESSMENT | Endocrine 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 |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 18.1 | View |
| Nausea | 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 |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Fatigue | 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 |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 18.1 | View |
| Seasonal Allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 18.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Gastroenteritis | 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 |
| Oral Herpes | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 18.1 | View |
| Rhinitis | 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 |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Ligament Sprain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 18.1 | View |
| Blood 25-Hydroxycholecalciferol Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood Glucose Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood Parathyroid Hormone Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 18.1 | View |
| Blood Pressure Increased | 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 |
| 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 |
| Bone Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Joint Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Joint Swelling | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Muscle Spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Muscular Weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal Chest Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Musculoskeletal Stiffness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | View |
| Neck 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 |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Migraine | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Restless Legs Syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 18.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 18.1 | View |
| Nephrocalcinosis | 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 |
| Rhinorrhoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal 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 |
| Hot Flush | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 18.1 | View |