Trial Outcomes & Findings for Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP) (NCT NCT00952484)
NCT ID: NCT00952484
Last Updated: 2019-04-01
Results Overview
A 7-point RGI-C (radiographic global impression of change) score was used to rate change in rickets severity. Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2019-04-01
Participant Flow
Patients were recruited to participate in the study from September to December 2009 at investigational sites via posting in clinicaltrials.gov and contact with physicians experienced in the diagnosis and management of HPP. De-identified historical controls were also selected from a natural history database of patients with HPP.
Patients meeting eligibility criteria were randomly assigned to receive 2mg/kg or 3mg/kg of asfotase alfa SC 3 times weekly for 24 weeks.
Participant milestones
| Measure |
2 mg/kg Asfotase Alfa
2 mg/kg subcutaneous (SC) injection three times per week.
|
3 mg/kg Asfotase Alfa
3 mg/kg subcutaneous (SC) injection three times per week.
|
Historical Control
De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner's Hospitals for Children, St. Louis, Missouri.
Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
2 mg/kg Asfotase Alfa
2 mg/kg subcutaneous (SC) injection three times per week.
|
3 mg/kg Asfotase Alfa
3 mg/kg subcutaneous (SC) injection three times per week.
|
Historical Control
De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner's Hospitals for Children, St. Louis, Missouri.
Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Safety and Efficacy of Asfotase Alfa in Juvenile Patients With Hypophosphatasia (HPP)
Baseline characteristics by cohort
| Measure |
Asfotase Alfa 2 mg/kg
n=6 Participants
2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
|
Asfotase Alfa 3 mg/kg
n=7 Participants
3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
|
Historical Control
n=16 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
8.4 years
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.1 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
6.0 years
STANDARD_DEVIATION 1.78 • n=5 Participants
|
7.3 years
STANDARD_DEVIATION 2.4 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
16 participants
n=5 Participants
|
25 participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included randomized patients that received treatment with asfotase alfa, even if discontinued or lost to follow-up. The last assessment prior to Week 24 is used for missing Week 24 data; patients with no post-baseline assessments imputed as having no change. A historical control group is used for comparison.
A 7-point RGI-C (radiographic global impression of change) score was used to rate change in rickets severity. Only those patients with a minimum score of +2 indicating substantial healing of rickets) were considered responders. Three pediatric radiologists not affiliated with the conduct of the study performed the ratings.
Outcome measures
| Measure |
Historical Controls
n=16 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=13 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Rickets Severity on Skeletal Radiographs From Baseline to Week 24 as Measured by the Radiographic Global Impression of Change (RGI-C) Scale
|
0 units on a scale
Interval -1.3 to 2.0
|
2.00 units on a scale
Interval 0.0 to 2.3
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.
Change from Baseline to Week 24 in osteoid thickness.
Outcome measures
| Measure |
Historical Controls
n=12 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Osteomalacia - Osteoid Thickness (as Measured by Trans-iliac Crest Bone Biopsy)
|
-3.858 um
Standard Deviation 4.2784
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.
Change from Baseline to Week 24 in osteoid volume/bone volume (%), calculated as the absolute difference of the Baseline and Week 24 percentages.
Outcome measures
| Measure |
Historical Controls
n=12 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Osteomalacia - Osteoid Volume/Bone Volume (as Measured by Trans-iliac Crest Bone Biopsy)
|
-4.225 percentage points
Standard Deviation 7.5582
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.
Change from Baseline to Week 24 in mineralization lag time.
Outcome measures
| Measure |
Historical Controls
n=12 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Osteomalacia - Mineralization Lag Time (as Measured by Trans-iliac Crest Bone Biopsy)
|
20.392 days
Standard Deviation 208.9814
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.
Change from Baseline to Week 24 in Height Z-Score. Height Z-Scores assigned based on Centers for Disease Control (CDC) growth charts and methodology.
Outcome measures
| Measure |
Historical Controls
n=12 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Height (Z-scores)
|
0.01 Height Z score
Standard Deviation 0.141
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.
Change from Baseline to Week 24 in Plasma PPi
Outcome measures
| Measure |
Historical Controls
n=12 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Biomarkers of Asfotase Alfa Activity as Measured by Plasma Inorganic Pyrophosphate (PPi)
|
-1.883 uM
Standard Deviation 0.7285
|
—
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population, which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly), even if they discontinued or were lost to follow-up during the conduct of the clinical trial. Data imputation was not performed.
Change from Baseline to Week 24 in Plasma PLP
Outcome measures
| Measure |
Historical Controls
n=12 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Change in Biomarkers of Asfotase Alfa Activity as Measured by Pyridoxal-5'-Phosphate (PLP)
|
-164.533 ng/mL
Standard Deviation 121.4840
|
—
|
SECONDARY outcome
Timeframe: Study Week 1 (0 to 48 hours post-dose)Population: ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).
Maximum serum concentration observed following single dose of asfotase alfa.
Outcome measures
| Measure |
Historical Controls
n=6 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=7 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Maximum Serum Concentration of Asfotase Alfa (Cmax).
|
566 U/L
Standard Deviation 120
|
1260 U/L
Standard Deviation 439
|
SECONDARY outcome
Timeframe: Study Week 1 (0 to 48 hours post-dose)Population: ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).
Maximum serum concentration observed following single dose of asfotase alfa.
Outcome measures
| Measure |
Historical Controls
n=6 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=7 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Time at Maximum Serum Concentration of Asfotase Alfa (Tmax)
|
37.2 hours
Standard Deviation 8.1
|
34.3 hours
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Study Week 1 (0 to 48 hours post-dose)Population: ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).
Area under serum concentration-time curve to last measurable concentration following single dose of asfotase alfa.
Outcome measures
| Measure |
Historical Controls
n=6 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=7 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)
|
19700 h*U/L
Standard Deviation 5720
|
45200 h*U/L
Standard Deviation 15100
|
SECONDARY outcome
Timeframe: Study Week 6 (0 to 48 hours post-dose)Population: ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).
Maximum serum concentration observed following multiple doses of asfotase alfa.
Outcome measures
| Measure |
Historical Controls
n=6 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=7 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Maximum Serum Concentration of Asfotase Alfa (Cmax).
|
1780 U/L
Standard Deviation 666
|
2280 U/L
Standard Deviation 875
|
SECONDARY outcome
Timeframe: Study Week 6 (0 to 48 hours post-dose)Population: ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).
Time at maximum serum concentration observed following multiple doses of asfotase alfa.
Outcome measures
| Measure |
Historical Controls
n=6 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=7 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Time at Maximum Serum Concentration of Asfotase Alfa (Tmax).
|
20.8 hours
Standard Deviation 10
|
17.3 hours
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Study Week 6 (0 to 48 hours post-dose).Population: ITT population which included all randomized patients that received any treatment with asfotase alfa (2 mg/kg or 3 mg/kg thrice weekly).
Area under serum concentration-time curve to last measurable concentration following multiple doses of asfotase alfa.
Outcome measures
| Measure |
Historical Controls
n=6 Participants
De-identified historical controls selected from a natural history database of patients with HPP.
|
Asfotase Alfa Combined
n=7 Participants
ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
|
|---|---|---|
|
Area Under Serum Concentration-time Curve to Last Measurable Concentration of Asfotase Alfa (AUCt)
|
76000 h*U/L
Standard Deviation 28100
|
94200 h*U/L
Standard Deviation 44400
|
Adverse Events
Asfotase Alfa 2 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Asfotase Alfa 3 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Asfotase Alfa 2 mg/kg
n=6 participants at risk
2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
|
Asfotase Alfa 3 mg/kg
n=7 participants at risk
3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
|
|---|---|---|
|
General disorders
Injection site erythema
|
83.3%
5/6 • Number of events 13 • 6 months
Adverse event data for the historical control group were not collected.
|
100.0%
7/7 • Number of events 16 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Injection site discoloration
|
66.7%
4/6 • Number of events 4 • 6 months
Adverse event data for the historical control group were not collected.
|
57.1%
4/7 • Number of events 4 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Injection site pruritis
|
66.7%
4/6 • Number of events 8 • 6 months
Adverse event data for the historical control group were not collected.
|
42.9%
3/7 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Injection site pain
|
50.0%
3/6 • Number of events 5 • 6 months
Adverse event data for the historical control group were not collected.
|
42.9%
3/7 • Number of events 5 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Injection site swelling
|
16.7%
1/6 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
28.6%
2/7 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Infusion site pain
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
66.7%
4/6 • Number of events 4 • 6 months
Adverse event data for the historical control group were not collected.
|
42.9%
3/7 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
28.6%
2/7 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Vomiting
|
66.7%
4/6 • Number of events 8 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Dental caries
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
28.6%
2/7 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
33.3%
2/6 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
28.6%
2/7 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 6 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
42.9%
3/7 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Infections and infestations
Otitis media
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
2/6 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Unequal limb length
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Immune system disorders
Seasonal allergy
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Investigations
Blood 1,25-dihydroxycholecaliferol decreased
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 5 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Eye disorders
Scleral hemmorhage
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Eye disorders
Eye Allergy
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Anal Fissure
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Tooth loss
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Injection site hemorrhage
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Injection site nodule
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Irritability
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Edema peripheral
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
General disorders
Pain
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
2/6 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Infections and infestations
Gastroenteritis viral
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Investigations
Blood 25-hydroxycholecalciferol decreased
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Investigations
Vitamin B6 decreased
|
0.00%
0/6 • 6 months
Adverse event data for the historical control group were not collected.
|
14.3%
1/7 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Fall
|
50.0%
3/6 • Number of events 3 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
33.3%
2/6 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Foreign Body
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Injury, poisoning and procedural complications
Laceration
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
2/6 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
16.7%
1/6 • Number of events 2 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Psychiatric disorders
Anxiety
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Number of events 1 • 6 months
Adverse event data for the historical control group were not collected.
|
0.00%
0/7 • 6 months
Adverse event data for the historical control group were not collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60