Trial Outcomes & Findings for Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH) (NCT NCT02750618)
NCT ID: NCT02750618
Last Updated: 2024-05-06
Results Overview
The Generalized Estimation Equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline, Week 40
Results posted on
2024-05-06
Participant Flow
The study enrolled pediatric participants between 1 and 4 years old, inclusive, with clinical findings consistent with XLH including hypophosphatemia and radiographic evidence of rickets, and a confirmed PHEX mutation or variant of uncertain significance.
Participant milestones
| Measure |
Burosumab Q2W
Burosumab subcutaneous (SC) injections every 2 weeks (Q2W) for a total of 160 weeks.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
Completed Week 40
|
13
|
|
Overall Study
Completed Week 64
|
13
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Burosumab Q2W
Burosumab subcutaneous (SC) injections every 2 weeks (Q2W) for a total of 160 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Study of the Safety, Pharmacodynamics (PD) and Efficacy of KRN23 in Children From 1 to 4 Years Old With X-linked Hypophosphatemia (XLH)
Baseline characteristics by cohort
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Age, Continuous
|
2.94 years
STANDARD_DEVIATION 1.146 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
|
Serum Phosphorus
|
2.51 mg/dL
STANDARD_DEVIATION 0.284 • n=5 Participants
|
|
Rickets Severity Score (RSS) Total Score
|
2.92 units on a scale
STANDARD_DEVIATION 1.367 • n=5 Participants
|
|
Recumbent length/Standing height
|
89.15 cm
STANDARD_DEVIATION 7.597 • n=5 Participants
|
|
Recumbent length/Standing height (Z score)
|
-1.378 Z score
STANDARD_DEVIATION 1.1947 • n=5 Participants
|
|
Recumbent length/Standing height (percentile)
|
18.044 percentile
STANDARD_DEVIATION 25.2644 • n=5 Participants
|
|
Serum Alkaline Phosphatase (ALP)
|
548.5 U/L
STANDARD_DEVIATION 193.80 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 40Population: Pharmacokinetic/Pharmacodynamic (PK/PD) Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples.
The Generalized Estimation Equation (GEE) model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline at Week 40 in Serum Phosphorus
|
0.96 mg/dL
Standard Error 0.117
|
PRIMARY outcome
Timeframe: From first dose of study drug through the end of the study (Week 160). Maximum duration of exposure to study drug was 160 weeks.Population: Safety Analysis Set: all participants who received at least one dose of study drug.
An AE was defined as any untoward medical occurrence associated with the use of a drug, whether or not considered drug related. A serious AE was defined as an AE 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 disability, a congenital anomaly/birth defect, or other important medical events (according to the investigator). An AE was considered a TEAE if it occurred on or after the first dose and was not present prior to the first dose, or it was present prior to the first dose but increased in severity during the study. Events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0: grade 1 (mild), grade 2 (moderate), grade 3 (severe), grade 4 (life-threatening), grade 5 (death).
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Adverse Event Starting during Screening Period
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
TEAEs
|
13 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Related TEAEs
|
5 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Serious TEAEs
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Serious Related TEAEs
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
Grade 3 or 4 TEAE
|
2 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
TEAE Leading to Study Discontinuation
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
TEAE Leading to Treatment Discontinuation
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation
TEAE Leading to Death
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 40Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.
Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The Analysis of Covariance (ANCOVA) model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Radiographic Global Impression of Change (RGI-C) Score at Week 40
|
2.21 units on a scale
Standard Error 0.071
|
SECONDARY outcome
Timeframe: Week 64Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.
Changes in the severity of rickets and bowing were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
RGI-C Score at Week 64
|
2.23 units on a scale
Standard Error 0.111
|
SECONDARY outcome
Timeframe: Baseline, Week 40Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.
The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points and the minimum score is 0, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity.The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline in Rickets at Week 40 as Assessed by the RSS Total Score
|
-1.75 units on a scale
Standard Error 0.116
|
SECONDARY outcome
Timeframe: Baseline, Week 64Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.
The RSS system is a 10-point radiographic scoring method that was developed to assess the severity of nutritional rickets in the wrists and knees based on the degree of metaphyseal fraying, cupping, and the proportion of the growth plate affected. Scores are assigned for the unilateral wrist and knee X-rays deemed by the rater to be the more severe of the bilateral images. The maximum total score on the RSS is 10 points, with a total possible score of 4 points for the wrists and 6 points for the knees. Higher scores indicate greater rickets severity. The GEE model includes the change from baseline in RSS as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline in Rickets at Week 64 as Assessed by the RSS Total Score
|
-2.02 units on a scale
Standard Error 0.115
|
SECONDARY outcome
Timeframe: Week 40Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.
Changes in the severity of lower extremity skeletal abnormalities were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The ANCOVA model includes the RGI-C score as the dependent variable, age and RSS at baseline as covariates.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
RGI-C Lower Limb Deformity Score at Week 40
|
1.21 units on a scale
Standard Error 0.155
|
SECONDARY outcome
Timeframe: Week 64Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement.
Changes in the severity of lower extremity skeletal abnormalities were assessed centrally by three independent pediatric radiologists contracted by a central imaging facility using a disease specific qualitative RGI-C scoring system. The RGI-C is a seven point ordinal scale with possible values: +3 = very much better (complete or near complete healing of rickets), +2 = much better (substantial healing of rickets), +1 = minimally better (i.e., minimal healing of rickets), 0 = unchanged, -1 = minimally worse (minimal worsening of rickets), -2 = much worse (moderate worsening of rickets), -3 = very much worse (severe worsening of rickets). The GEE model includes the RGI-C score as the dependent variable, visit as a factor, age and RSS at baseline as covariates, with exchangeable covariance structure.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
RGI-C Lower Limb Deformity Score at Week 64
|
1.51 units on a scale
Standard Error 0.123
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 40, 64, 88, 112, 136, 160Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement at given time point.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 12
|
1.44 cm
Standard Deviation 2.009
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 24
|
2.52 cm
Standard Deviation 1.518
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 40
|
4.29 cm
Standard Deviation 2.451
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 64
|
7.22 cm
Standard Deviation 3.157
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 88
|
10.30 cm
Standard Deviation 3.400
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 112
|
13.25 cm
Standard Deviation 3.724
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 136
|
15.41 cm
Standard Deviation 3.699
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height
Week 160
|
18.96 cm
Standard Deviation 4.206
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 40, 64, 88, 112, 136, 160Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement at given time point.
Recumbent length/Standing height z scores are measures of height adjusted for a child's age and sex. The Z-score indicates the number of standard deviations away from a reference population (from the CDC growth charts) in the same age range and with the same sex. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z-scores indicate a better outcome.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 12
|
-0.082 Z score
Standard Deviation 0.4964
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 24
|
-0.208 Z score
Standard Deviation 0.4540
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 40
|
-0.276 Z score
Standard Deviation 0.6647
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 64
|
-0.264 Z score
Standard Deviation 0.8755
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 88
|
-0.212 Z score
Standard Deviation 0.9115
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 112
|
-0.174 Z score
Standard Deviation 0.9273
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 136
|
-0.321 Z score
Standard Deviation 0.9123
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Height-for-Age Z-Scores
Week 160
|
-0.172 Z score
Standard Deviation 0.9048
|
SECONDARY outcome
Timeframe: Baseline, Weeks 12, 24, 40, 64, 88, 112, 136, 160Population: Efficacy Analysis Set: all participants who received at least one dose of study drug and had at least one post-study drug measurement at given time point.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 12
|
-0.006 percentiles
Standard Deviation 11.6149
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 24
|
-4.940 percentiles
Standard Deviation 13.1323
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 40
|
-5.283 percentiles
Standard Deviation 20.1675
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 64
|
-4.980 percentiles
Standard Deviation 23.4412
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 88
|
-4.155 percentiles
Standard Deviation 23.9126
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 112
|
-3.000 percentiles
Standard Deviation 24.7569
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 136
|
-7.026 percentiles
Standard Deviation 24.8583
|
|
Change From Baseline Over Time in Recumbent Length/Standing Height as Assessed by Percentiles
Week 160
|
-3.628 percentiles
Standard Deviation 25.5113
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 20, 40, 48, 56, 64, 76, 88, 100, 112, 124, 136, 148, 160Population: PK/PD Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples at given time point.
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with exchangeable covariance structure.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 4
|
-82.91 U/L
Standard Error 23.348
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 12
|
-83.84 U/L
Standard Error 45.263
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 20
|
-161.38 U/L
Standard Error 12.924
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 40
|
-214.99 U/L
Standard Error 13.628
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 48
|
-226.58 U/L
Standard Error 11.491
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 56
|
-216.45 U/L
Standard Error 16.165
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 64
|
-216.76 U/L
Standard Error 12.705
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 76
|
-231.22 U/L
Standard Error 15.964
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 88
|
-237.78 U/L
Standard Error 12.837
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 100
|
-218.14 U/L
Standard Error 15.340
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 112
|
-233.91 U/L
Standard Error 11.098
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 124
|
-252.22 U/L
Standard Error 8.312
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 136
|
-267.89 U/L
Standard Error 13.124
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 148
|
-248.05 U/L
Standard Error 12.653
|
|
Change From Baseline Over Time in Serum Alkaline Phosphatase (ALP)
Week 160
|
-248.47 U/L
Standard Error 10.990
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 20, 40, 48, 56, 64, 76, 88, 100, 112, 124, 136, 148, 160Population: PK/PD Analysis Set: all participants who received at least one dose of study drug and had evaluable blood samples at given time point.
Outcome measures
| Measure |
Burosumab Q2W
n=13 Participants
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Percent Change From Baseline Over Time in Serum ALP
Week 4
|
-12.47 percent change
Standard Deviation 16.620
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 12
|
-5.00 percent change
Standard Deviation 60.124
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 20
|
-24.76 percent change
Standard Deviation 18.883
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 40
|
-36.25 percent change
Standard Deviation 12.787
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 48
|
-37.29 percent change
Standard Deviation 13.936
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 56
|
-35.80 percent change
Standard Deviation 16.568
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 64
|
-35.95 percent change
Standard Deviation 14.851
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 76
|
-38.36 percent change
Standard Deviation 15.621
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 88
|
-39.08 percent change
Standard Deviation 12.987
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 100
|
-37.42 percent change
Standard Deviation 12.466
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 112
|
-39.05 percent change
Standard Deviation 13.808
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 124
|
-43.11 percent change
Standard Deviation 12.493
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 136
|
-47.01 percent change
Standard Deviation 11.752
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 148
|
-43.47 percent change
Standard Deviation 11.321
|
|
Percent Change From Baseline Over Time in Serum ALP
Week 160
|
-42.35 percent change
Standard Deviation 13.574
|
Adverse Events
Burosumab Q2W
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Burosumab Q2W
n=13 participants at risk
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Infections and infestations
Tooth Abscess
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
Other adverse events
| Measure |
Burosumab Q2W
n=13 participants at risk
Burosumab SC injections Q2W for a total of 160 weeks.
|
|---|---|
|
Congenital, familial and genetic disorders
Skull Malformation
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Congenital, familial and genetic disorders
Syringomyelia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Deafness Unilateral
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Ear Haemorrhage
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Ear Pain
|
30.8%
4/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Excessive Cerumen Production
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Hypoacusis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Motion Sickness
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Otorrhoea
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Eye disorders
Ocular Hyperaemia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
38.5%
5/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Aphthous Ulcer
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Constipation
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Dental Caries
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
46.2%
6/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Epigastric Discomfort
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Gingival Blister
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Gingival Erythema
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Gingival Pain
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Loose Tooth
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Oral Pain
|
30.8%
4/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Post-Tussive Vomiting
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Teething
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Toothache
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
53.8%
7/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Gastrointestinal disorders
Vomiting Projectile
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Fatigue
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Injection Site Bruising
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Injection Site Erythema
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Injection Site Pain
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Injection Site Pruritus
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Injection Site Reaction
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Non-Cardiac Chest Pain
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Pain
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Pyrexia
|
84.6%
11/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
General disorders
Vaccination Site Reaction
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Immune system disorders
Food Allergy
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Immune system disorders
Hypersensitivity
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Atypical Pneumonia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Conjunctivitis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Croup Infectious
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Ear Infection
|
46.2%
6/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Enterobiasis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Eye Infection
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Gastroenteritis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Gastrointestinal Viral Infection
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Genital Candidiasis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Gingival Abscess
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Hand-Foot-And-Mouth Disease
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Hordeolum
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Impetigo
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Influenza
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Molluscum Contagiosum
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Otitis Media
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
61.5%
8/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Sinusitis
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Tooth Abscess
|
76.9%
10/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
69.2%
9/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Urinary Tract Infection
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Viral Infection
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
30.8%
4/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Lip Injury
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Skin Abrasion
|
30.8%
4/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Tooth Injury
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Injury, poisoning and procedural complications
Traumatic Tooth Displacement
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Amylase Increased
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Blood 25-Hydroxycholecalciferol Decreased
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Blood Parathyroid Hormone Increased
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Blood Phosphorus Decreased
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Heart Rate Abnormal
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Lipase Increased
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
Vitamin D Decreased
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Investigations
White Blood Cell Count Increased
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Metabolism and nutrition disorders
Polydipsia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
30.8%
4/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Knee Deformity
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
69.2%
9/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Nervous system disorders
Dysarthria
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Nervous system disorders
Headache
|
46.2%
6/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Nervous system disorders
Hypersomnia
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Nervous system disorders
Lethargy
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Nervous system disorders
Periodic Limb Movement Disorder
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Renal and urinary disorders
Dysuria
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Renal and urinary disorders
Polyuria
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Renal and urinary disorders
Urinary Incontinence
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Reproductive system and breast disorders
Penile Erythema
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Reproductive system and breast disorders
Penile Pain
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal Disorder
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Throat Clearing
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
84.6%
11/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
61.5%
8/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discharge Discolouration
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
23.1%
3/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
53.8%
7/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Throat Irritation
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.4%
2/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
30.8%
4/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria Papular
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
|
Vascular disorders
Haematoma
|
7.7%
1/13 • From first dose of study drug through the end of the study (at Week 160). Maximum duration of exposure to study drug was 160 weeks.
|
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