Trial Outcomes & Findings for Long-Term Extension Study of KRN23 in Adult Subjects With X-Linked Hypophosphatemia (XLH) (NCT NCT02312687)
NCT ID: NCT02312687
Last Updated: 2024-05-06
Results Overview
An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
Results posted on
2024-05-06
Participant Flow
Participant milestones
| Measure |
KRN23
KRN23 subcutaneous (SC) injections every 4 weeks
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
KRN23
KRN23 subcutaneous (SC) injections every 4 weeks
|
|---|---|
|
Overall Study
Other, Not Specified
|
1
|
Baseline Characteristics
participants with an assessment
Baseline characteristics by cohort
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Age, Continuous
|
49.8 years
STANDARD_DEVIATION 12.87 • n=20 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=20 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=20 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=20 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
|
Serum Phosphorus
|
1.89 mg/dL
STANDARD_DEVIATION 0.301 • n=20 Participants
|
|
Serum Intact Parathyroid Hormone (iPTH)
|
110.8 pg/mL
STANDARD_DEVIATION 43.70 • n=20 Participants
|
|
Serum Total Fibroblast Growth Factor 23 (FGF23)
|
262.9 pg/mL
STANDARD_DEVIATION 227.02 • n=20 Participants
|
|
Serum Free FGF23
|
81.9 pg/mL
STANDARD_DEVIATION 42.33 • n=20 Participants
|
|
Serum 1,25-dihydroxy vitamin D [1,25(OH)2D]
|
31.7 pg/mL
STANDARD_DEVIATION 12.61 • n=20 Participants
|
|
2-hour Urine TmP/GFR
|
1.583 mg/dL
STANDARD_DEVIATION 0.2566 • n=20 Participants
|
|
2-hour Urine Tubular Reabsorption of Phosphate (TRP)
|
0.783 fraction of phosphorus reabsorbed
STANDARD_DEVIATION 0.0792 • n=20 Participants
|
|
Fractional Excretion of Phosphorus (FEP)
|
0.217 fraction of phosphorus excreted
STANDARD_DEVIATION 0.0792 • n=20 Participants
|
|
24-hour Urine Phosphorus
|
0.74 g/24hr
STANDARD_DEVIATION 0.322 • n=20 Participants
|
|
24-Hour Urine Calcium
|
96.118 mg/24hr
STANDARD_DEVIATION 75.9530 • n=17 Participants • participants with an assessment
|
|
24-Hour Urine Creatinine
|
1058.150 mg/24hr
STANDARD_DEVIATION 444.3073 • n=20 Participants
|
|
24-Hour Urine Calcium/Creatinine Ratio
|
0.0881 mg/mg
STANDARD_DEVIATION 0.05034 • n=17 Participants • participants with an assessment
|
|
Total Alkaline Phosphatase (ALP)
|
131.1 U/L
STANDARD_DEVIATION 50.50 • n=20 Participants
|
|
Bone-Specific Alkaline Phosphatase (BALP)
|
31.26 mcg/L
STANDARD_DEVIATION 18.528 • n=20 Participants
|
|
Carboxy Terminal Cross-Linked Telopeptide of Type I Collagen (CTx)
|
732.4 pg/mL
STANDARD_DEVIATION 404.01 • n=20 Participants
|
|
Procollagen Type N-Propeptide (P1NP)
|
76.5 ng/mL
STANDARD_DEVIATION 41.58 • n=20 Participants
|
PRIMARY outcome
Timeframe: Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).Population: Safety Analysis Set
An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
All AEs
|
20 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
TEAEs
|
20 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
Related AEs
|
12 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
SAEs
|
9 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
Related SAEs
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
Grade 3 and 4 AEs
|
10 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
AEs Leading to Discontinuation
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death
AEs Leading to Death
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Clinically significant changes from baseline reported as adverse events are presented.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Hypertension
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs
Decreased blood pressure
|
1 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Clinically significant changes from baseline reported as adverse events are presented.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated eosinophils
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hypercholesterolemia
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hyperkalemia
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hyperglycemia
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated alanine aminotransferase
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated aspartate aminotransferase
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated gamma-glutamyl transferase
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Proteinuria
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated amylase
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated alkaline phosphatase
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated lipase
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hypercalciuria
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Worsening hypercholesterolemia
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Decreased hemoglobin
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hypocalcemia (intermittent)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hypovitaminosis D
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Elevated cholesterol
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Hyperparathyroidism
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category
Urine electrophoresis abnormal
|
1 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Clinically significant changes from baseline reported as adverse events are presented.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Bone pain
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Conjunctival haemorrhage
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Hypoacusis
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Dermal cyst
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Osteoarthritis
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Gravitational oedema
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Hypoaesthesia
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Neuropathy peripheral
|
2 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Arthralgia
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Peroneal nerve palsy
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Spinal pain
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Bone lesion
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Femur fracture
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Scrotal oedema
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Synovial cyst
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Testicular swelling
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Thermal burn
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category
Weight decreased
|
1 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Clinically significant changes from baseline reported as adverse events are presented.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Clinically significant changes from baseline reported as adverse events are presented.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in ECGs
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Clinically significant changes from baseline reported as adverse events are presented.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category
Kidney stone(s)
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category
Nephrocalcinosis
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category
Right renal mass
|
1 Participants
|
|
Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category
Nephrolithiasis
|
2 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Population: Participants tested for neutralizing antibodies (n=4) are those who were positive for anti-KRN23 antibodies at any time during the study.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline
Baseline: Anti-KRN23 Antibodies
|
2 Participants
|
|
Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline
Post Baseline:Anti-KRN23 Antibodies
|
4 Participants
|
|
Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline
Baseline: Neutralizing Antibodies
|
0 Participants
|
|
Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline
Postbaseline: Neutralizing Antibodies
|
0 Participants
|
PRIMARY outcome
Timeframe: Through Week 184Population: Pharmacodynamic (PD) Analysis Set: all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing
|
100 percentage of participants
Interval 83.9 to 100.0
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in Serum Phosphorus
Change at Week 24
|
0.68 mg/dL
Standard Error 0.103
|
|
Change From Baseline Over Time in Serum Phosphorus
Change at Week 48
|
0.68 mg/dL
Standard Error 0.055
|
|
Change From Baseline Over Time in Serum Phosphorus
Change at Week 72
|
0.59 mg/dL
Standard Error 0.077
|
|
Change From Baseline Over Time in Serum Phosphorus
Change at Week 96
|
0.47 mg/dL
Standard Error 0.081
|
|
Change From Baseline Over Time in Serum Phosphorus
Change at Week 120
|
0.57 mg/dL
Standard Error 0.082
|
|
Change From Baseline Over Time in Serum Phosphorus
Change at Week 144
|
0.59 mg/dL
Standard Error 0.084
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in Serum iPTH
Change at Week 24
|
-9.75 pg/mL
Standard Error 6.551
|
|
Change From Baseline Over Time in Serum iPTH
Change at Week 48
|
-11.17 pg/mL
Standard Error 7.444
|
|
Change From Baseline Over Time in Serum iPTH
Change at Week 72
|
-18.12 pg/mL
Standard Error 4.567
|
|
Change From Baseline Over Time in Serum iPTH
Change at Week 96
|
-25.28 pg/mL
Standard Error 5.577
|
|
Change From Baseline Over Time in Serum iPTH
Change at Week 120
|
-22.39 pg/mL
Standard Error 4.655
|
|
Change From Baseline Over Time in Serum iPTH
Change at Week 144
|
-28.33 pg/mL
Standard Error 6.007
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in Serum Total FGF23
Change at Week 24
|
215493.38 pg/mL
Standard Error 10634.172
|
|
Change From Baseline Over Time in Serum Total FGF23
Change at Week 48
|
202525.38 pg/mL
Standard Error 17429.124
|
|
Change From Baseline Over Time in Serum Total FGF23
Change at Week 72
|
221481.03 pg/mL
Standard Error 21353.941
|
|
Change From Baseline Over Time in Serum Total FGF23
Change at Week 96
|
221674.07 pg/mL
Standard Error 20592.592
|
|
Change From Baseline Over Time in Serum Total FGF23
Change at Week 120
|
208270.02 pg/mL
Standard Error 20945.303
|
|
Change From Baseline Over Time in Serum Total FGF23
Change at Week 144
|
235953.55 pg/mL
Standard Error 35634.821
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in Serum Free FGF23
Change at Week 24
|
1277.84 pg/mL
Standard Error 38.521
|
|
Change From Baseline Over Time in Serum Free FGF23
Change at Week 48
|
1244.99 pg/mL
Standard Error 40.250
|
|
Change From Baseline Over Time in Serum Free FGF23
Change at Week 72
|
1298.49 pg/mL
Standard Error 33.129
|
|
Change From Baseline Over Time in Serum Free FGF23
Change at Week 96
|
1311.05 pg/mL
Standard Error 37.119
|
|
Change From Baseline Over Time in Serum Free FGF23
Change at Week 120
|
1368.68 pg/mL
Standard Error 21.063
|
|
Change From Baseline Over Time in Serum Free FGF23
Change at Week 144
|
1298.41 pg/mL
Standard Error 45.972
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in Serum 1,25(OH)2D
Change at Week 24
|
7.87 pg/mL
Standard Error 2.403
|
|
Change From Baseline Over Time in Serum 1,25(OH)2D
Change at Week 48
|
2.70 pg/mL
Standard Error 2.653
|
|
Change From Baseline Over Time in Serum 1,25(OH)2D
Change at Week 72
|
2.62 pg/mL
Standard Error 2.505
|
|
Change From Baseline Over Time in Serum 1,25(OH)2D
Change at Week 96
|
0.31 pg/mL
Standard Error 2.052
|
|
Change From Baseline Over Time in Serum 1,25(OH)2D
Change at Week 120
|
-0.48 pg/mL
Standard Error 2.365
|
|
Change From Baseline Over Time in Serum 1,25(OH)2D
Change at Week 144
|
-3.43 pg/mL
Standard Error 2.844
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
Change at Week 24
|
0.57 mg/dL
Standard Error 0.128
|
|
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
Change at Week 48
|
0.47 mg/dL
Standard Error 0.047
|
|
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
Change at Week 72
|
0.42 mg/dL
Standard Error 0.072
|
|
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
Change at Week 96
|
0.44 mg/dL
Standard Error 0.084
|
|
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
Change at Week 120
|
0.36 mg/dL
Standard Error 0.066
|
|
Change From Baseline Ovr Time in 2-hour Urine TmP/GFR
Change at Week 144
|
0.47 mg/dL
Standard Error 0.078
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in in 2-hour Urine TRP
Change at Week 24
|
0.04 fraction of phosphorus reabsorbed
Standard Error 0.015
|
|
Change From Baseline Over Time in in 2-hour Urine TRP
Change at Week 48
|
0.01 fraction of phosphorus reabsorbed
Standard Error 0.011
|
|
Change From Baseline Over Time in in 2-hour Urine TRP
Change at Week 72
|
0.01 fraction of phosphorus reabsorbed
Standard Error 0.011
|
|
Change From Baseline Over Time in in 2-hour Urine TRP
Change at Week 96
|
0.05 fraction of phosphorus reabsorbed
Standard Error 0.012
|
|
Change From Baseline Over Time in in 2-hour Urine TRP
Change at Week 120
|
0.01 fraction of phosphorus reabsorbed
Standard Error 0.012
|
|
Change From Baseline Over Time in in 2-hour Urine TRP
Change at Week 144
|
0.02 fraction of phosphorus reabsorbed
Standard Error 0.017
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in FEP
Change at Week 24
|
-0.04 fraction of phosphorus excreted
Standard Error 0.015
|
|
Change From Baseline Over Time in FEP
Change at Week 48
|
-0.01 fraction of phosphorus excreted
Standard Error 0.011
|
|
Change From Baseline Over Time in FEP
Change at Week 72
|
-0.01 fraction of phosphorus excreted
Standard Error 0.011
|
|
Change From Baseline Over Time in FEP
Change at Week 96
|
-0.05 fraction of phosphorus excreted
Standard Error 0.012
|
|
Change From Baseline Over Time in FEP
Change at Week 120
|
-0.01 fraction of phosphorus excreted
Standard Error 0.012
|
|
Change From Baseline Over Time in FEP
Change at Week 144
|
-0.02 fraction of phosphorus excreted
Standard Error 0.017
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in 24-hour Urine Phosphorus
Change at Week 24
|
-0.01 g/24hr
Standard Error 0.045
|
|
Change From Baseline Over Time in 24-hour Urine Phosphorus
Change at Week 48
|
0.02 g/24hr
Standard Error 0.044
|
|
Change From Baseline Over Time in 24-hour Urine Phosphorus
Change at Week 72
|
0.08 g/24hr
Standard Error 0.044
|
|
Change From Baseline Over Time in 24-hour Urine Phosphorus
Change at Week 96
|
-0.01 g/24hr
Standard Error 0.040
|
|
Change From Baseline Over Time in 24-hour Urine Phosphorus
Change at Week 120
|
-0.01 g/24hr
Standard Error 0.058
|
|
Change From Baseline Over Time in 24-hour Urine Phosphorus
Change at Week 144
|
-0.05 g/24hr
Standard Error 0.054
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in 24-Hour Urine Calcium
Change at Week 24
|
22.89 mg/24hr
Standard Error 12.605
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium
Change at Week 48
|
15.15 mg/24hr
Standard Error 8.914
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium
Change at Week 72
|
11.10 mg/24hr
Standard Error 12.975
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium
Change at Week 96
|
-16.65 mg/24hr
Standard Error 10.637
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium
Change at Week 120
|
3.48 mg/24hr
Standard Error 18.375
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium
Change at Week 144
|
28.55 mg/24hr
Standard Error 20.239
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in 24-Hour Urine Creatinine
Change at Week 24
|
-14.77 mg/24hr
Standard Error 37.170
|
|
Change From Baseline Over Time in 24-Hour Urine Creatinine
Change at Week 48
|
-70.79 mg/24hr
Standard Error 46.186
|
|
Change From Baseline Over Time in 24-Hour Urine Creatinine
Change at Week 72
|
-16.11 mg/24hr
Standard Error 48.389
|
|
Change From Baseline Over Time in 24-Hour Urine Creatinine
Change at Week 96
|
-41.74 mg/24hr
Standard Error 55.546
|
|
Change From Baseline Over Time in 24-Hour Urine Creatinine
Change at Week 120
|
-76.11 mg/24hr
Standard Error 82.239
|
|
Change From Baseline Over Time in 24-Hour Urine Creatinine
Change at Week 144
|
-96.06 mg/24hr
Standard Error 56.389
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Change at Week 24
|
0.01 mg/mg
Standard Error 0.010
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Change at Week 48
|
0.01 mg/mg
Standard Error 0.011
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Change at Week 72
|
0.00 mg/mg
Standard Error 0.011
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Change at Week 96
|
-0.01 mg/mg
Standard Error 0.013
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Change at Week 120
|
0.00 mg/mg
Standard Error 0.013
|
|
Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio
Change at Week 144
|
0.03 mg/mg
Standard Error 0.023
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in Total ALP
Change at Week 24
|
14.92 U/L
Standard Error 6.935
|
|
Change From Baseline Over Time in Total ALP
Change at Week 48
|
-1.73 U/L
Standard Error 5.752
|
|
Change From Baseline Over Time in Total ALP
Change at Week 72
|
-22.28 U/L
Standard Error 4.044
|
|
Change From Baseline Over Time in Total ALP
Change at Week 96
|
-20.93 U/L
Standard Error 3.567
|
|
Change From Baseline Over Time in Total ALP
Change at Week 120
|
-18.77 U/L
Standard Error 7.228
|
|
Change From Baseline Over Time in Total ALP
Change at Week 144
|
-25.72 U/L
Standard Error 5.701
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in BALP
Change at Week 24
|
4.68 mcg/L
Standard Error 3.389
|
|
Change From Baseline Over Time in BALP
Change at Week 48
|
-2.68 mcg/L
Standard Error 2.247
|
|
Change From Baseline Over Time in BALP
Change at Week 72
|
-7.45 mcg/L
Standard Error 1.067
|
|
Change From Baseline Over Time in BALP
Change at Week 96
|
-8.08 mcg/L
Standard Error 0.910
|
|
Change From Baseline Over Time in BALP
Change at Week 120
|
-10.01 mcg/L
Standard Error 1.561
|
|
Change From Baseline Over Time in BALP
Change at Week 144
|
-10.89 mcg/L
Standard Error 1.979
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in CTx
Change at Week 24
|
343.38 pg/mL
Standard Error 135.575
|
|
Change From Baseline Over Time in CTx
Change at Week 48
|
41.45 pg/mL
Standard Error 61.062
|
|
Change From Baseline Over Time in CTx
Change at Week 72
|
-61.96 pg/mL
Standard Error 63.458
|
|
Change From Baseline Over Time in CTx
Change at Week 96
|
-68.62 pg/mL
Standard Error 63.152
|
|
Change From Baseline Over Time in CTx
Change at Week 120
|
-53.41 pg/mL
Standard Error 50.545
|
|
Change From Baseline Over Time in CTx
Change at Week 144
|
-97.46 pg/mL
Standard Error 55.670
|
PRIMARY outcome
Timeframe: Baseline, Weeks 24, 48, 72, 96, 120, 144Population: PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point.
Outcome measures
| Measure |
KRN23
n=20 Participants
KRN23 SC injections every 4 weeks
|
|---|---|
|
Change From Baseline Over Time in P1NP
Change at Week 24
|
72.45 ng/mL
Standard Error 16.962
|
|
Change From Baseline Over Time in P1NP
Change at Week 48
|
44.40 ng/mL
Standard Error 7.175
|
|
Change From Baseline Over Time in P1NP
Change at Week 72
|
28.30 ng/mL
Standard Error 7.684
|
|
Change From Baseline Over Time in P1NP
Change at Week 96
|
27.02 ng/mL
Standard Error 6.739
|
|
Change From Baseline Over Time in P1NP
Change at Week 120
|
13.02 ng/mL
Standard Error 8.359
|
|
Change From Baseline Over Time in P1NP
Change at Week 144
|
43.12 ng/mL
Standard Error 33.717
|
Adverse Events
KRN23
Serious events: 9 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KRN23
n=20 participants at risk
KRN23 SC injections every 4 weeks
|
|---|---|
|
Congenital, familial and genetic disorders
Hereditary Non-Polyposis Colorectal Cancer Syndrome
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Medical Device Site Joint Infection
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Of Colon
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chordoma
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Hemianaesthesia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Hemiparesis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
Other adverse events
| Measure |
KRN23
n=20 participants at risk
KRN23 SC injections every 4 weeks
|
|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Ear and labyrinth disorders
Hypoacusis
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Ear and labyrinth disorders
Tinnitus
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Ear and labyrinth disorders
Vertigo
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Ear and labyrinth disorders
Vertigo Positional
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Endocrine disorders
Hyperparathyroidism
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Cataract
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Conjunctival Haemorrhage
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Diplopia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Dry Eye
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Vision Blurred
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Visual Impairment
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Eye disorders
Vitreous Floaters
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Abdominal Distension
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Constipation
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Dyspepsia
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Faecal Incontinence
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Gastritis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Ileus
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Intestinal Dilatation
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Large Intestinal Stenosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Nausea
|
30.0%
6/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Pancreatic Calcification
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Pancreatic Duct Dilatation
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
5/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Asthenia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Cyst
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Fatigue
|
20.0%
4/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Gravitational Oedema
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Injection Site Erythema
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Injection Site Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Injection Site Reaction
|
20.0%
4/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Medical Device Site Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Pain
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
General disorders
Tenderness
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Hepatobiliary disorders
Ampulla Of Vater Stenosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Hepatobiliary disorders
Biliary Dilatation
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Immune system disorders
Seasonal Allergy
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Arthritis Infective
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Breast Abscess
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Bronchitis
|
20.0%
4/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Cystitis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Ear Infection
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Gingivitis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Herpes Zoster
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Hordeolum
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Incision Site Infection
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Infected Bite
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Localised Infection
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Lyme Disease
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
35.0%
7/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Otitis Externa
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Pharyngitis Streptococcal
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Pneumonia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Respiratory Tract Infection
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Sinusitis
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Sinusitis Bacterial
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Tooth Abscess
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Tooth Infection
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
25.0%
5/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Urinary Tract Infection
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Infections and infestations
Urinary Tract Infection Enterococcal
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Contusion
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
30.0%
6/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Procedural Hypertension
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Procedural Nausea
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Seroma
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Sunburn
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Alanine Aminotransferase Increased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Amylase Increased
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Aspartate Aminotransferase Increased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Blood Cholesterol Increased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Blood Iron Decreased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Blood Pressure Decreased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Eosinophil Count Increased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Haemoglobin Decreased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Lipase Increased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Oxygen Saturation Decreased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Smear Cervix Abnormal
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Urine Electrophoresis Abnormal
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Investigations
Weight Decreased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Fluid Overload
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Metabolism and nutrition disorders
Vitamin D Deficiency
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
60.0%
12/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
40.0%
8/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bone Lesion
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint Effusion
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint Range Of Motion Decreased
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
4/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
20.0%
4/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
40.0%
8/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Pain In Jaw
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma Of Liver
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Aphasia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Cervical Radiculopathy
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Cubital Tunnel Syndrome
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Disturbance In Attention
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Dizziness
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Fine Motor Skill Dysfunction
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Headache
|
30.0%
6/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
5/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Migraine
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Nerve Compression
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Neuropathy Peripheral
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Paraesthesia
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Peroneal Nerve Palsy
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Restless Legs Syndrome
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Sciatica
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Nervous system disorders
Sinus Headache
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Psychiatric disorders
Delirium
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Psychiatric disorders
Depression
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Psychiatric disorders
Insomnia
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Psychiatric disorders
Mental Status Changes
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Bladder Prolapse
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Dysuria
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Haematuria
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Hypercalciuria
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Nephrocalcinosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Nephrolithiasis
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Proteinuria
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Renal Mass
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Urethral Stenosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Urinary Hesitation
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Renal and urinary disorders
Urinary Retention
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Endometrial Hyperplasia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Menopausal Symptoms
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Pelvic Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Postmenopausal Haemorrhage
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Prostatitis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Scrotal Oedema
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Testicular Swelling
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Uterine Cervical Squamous Metaplasia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Vulvovaginal Dryness
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Reproductive system and breast disorders
Vulvovaginal Pain
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
15.0%
3/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Leukoplakia
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Papule
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Surgical and medical procedures
Ophthalmic Fluid Drainage
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Vascular disorders
Hypotension
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
|
Vascular disorders
Pallor
|
5.0%
1/20 • Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER