Trial Outcomes & Findings for Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP) (NCT NCT01203826)

NCT ID: NCT01203826

Last Updated: 2019-03-13

Results Overview

Evaluation of radiographic change in rickets severity (as assessed by skeletal radiographs of the hands/wrists and knees) from the Baseline of Study ENB-006-09 (NCT00952484) to the End of Study (EOS) visit in Study ENB-008-10 using an ordinal RGI-C scale score. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP associated rickets) to +3 (indicative of complete or near complete healing of HPP associated rickets). The time points will be pre-treatment (Baseline from Study ENB-006-09) to the last radiographic assessment in Study ENB-008-10, which represents at least 72 months of treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: At least 72 months of treatment with asfotase alfa
• Results posted on: 2019-03-13

Participant Flow

The main criteria for inclusion in Study ENB-006-09 were patients ages 5 to 12 years inclusive, with open growth plates at time of study entry and a documented diagnosis of HPP. To enter the extension, Study ENB-008-10, patients had to successfully complete Study ENB-006-09 and provide consent.

Participant milestones

Measure	2 mg/kg Asfotase Alfa The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.	3 mg/kg Asfotase Alfa The starting dose of asfotase alfa was 3 mg/kg/week for all patients in Study ENB-008-10 and was subsequently increased per study-wide dose adjustment to a total dose of 6 mg/kg/week. Results are shown by the patient's dose group assignment from Study ENB-006-09.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Extension Study of Protocol ENB-006-09 - Study of Asfotase Alfa in Children With Hypophosphatasia (HPP)

Baseline characteristics by cohort

Measure	2 mg/kg Asfotase Alfa n=6 Participants Dose group shown is as per patient's randomization in Study ENB-006-09	3 mg/kg Asfotase Alfa n=6 Participants Dose group shown is as per patient's randomization in Study ENB-006-09	Total n=12 Participants Total of all reporting groups
Age, Continuous	8.4 years STANDARD_DEVIATION 2.21 • n=5 Participants	9.0 years STANDARD_DEVIATION 2.51 • n=7 Participants	8.7 years STANDARD_DEVIATION 2.27 • n=5 Participants
Age, Customized Age Group at Enrollment: 2 to 11 Years; %	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Customized Age Group at Enrollment: 12 to 17 Years; %	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Hypophosphatasia Phenotype Infantile (< 6 months)	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Hypophosphatasia Phenotype Juvenile (≥ 6 months to < 18 yrs)	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Age at Onset of Hypophosphatasia Symptoms	10.8 Months STANDARD_DEVIATION 8.66 • n=5 Participants	11.5 Months STANDARD_DEVIATION 5.54 • n=7 Participants	11.2 Months STANDARD_DEVIATION 6.94 • n=5 Participants
Tanner Stage 1	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: At least 72 months of treatment with asfotase alfa

Population: Each visit in Study ENB-008-10 was calculated relative to the start of exposure to asfotase alfa in Study ENB-006-09 (NCT00952484); 24 weeks are added to each visit in Study ENB-008-10. Results shown are for the last assessment in Study ENB-008-10 and represent at least 72 months of treatment with asfotase alfa.

Evaluation of radiographic change in rickets severity (as assessed by skeletal radiographs of the hands/wrists and knees) from the Baseline of Study ENB-006-09 (NCT00952484) to the End of Study (EOS) visit in Study ENB-008-10 using an ordinal RGI-C scale score. The RGI-C is a 7-point rating scale that ranges from -3 (indicative of severe worsening of HPP associated rickets) to +3 (indicative of complete or near complete healing of HPP associated rickets).

The time points will be pre-treatment (Baseline from Study ENB-006-09) to the last radiographic assessment in Study ENB-008-10, which represents at least 72 months of treatment.

Outcome measures

Measure	Asfotase Alfa Combined n=12 Participants ITT population for Study ENB-008-10, which included all patients that received treatment with asfotase alfa.
Skeletal Radiograph Evaluation Using a Qualitative Radiographic Global Impression of Change (RGI-C) Scale Compared to Baseline (Pre-treatment) in Study ENB-006-09.	2.83 units on a scale Interval 2.0 to 3.0

Adverse Events

2 mg/kg Asfotase Alfa

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

3 mg/kg Asfotase Alfa

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Combined Asfotase Alfa Group

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	2 mg/kg Asfotase Alfa n=6 participants at risk Dose group shown is as per patient's randomization in Study ENB-006-09.	3 mg/kg Asfotase Alfa n=6 participants at risk Dose group shown is as per patient's randomization in Study ENB-006-09.	Combined Asfotase Alfa Group n=12 participants at risk All patients treated with asfotase alfa during Study ENB-008-10
Psychiatric disorders Acute stress disorder	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site erythema	66.7% 4/6 • Number of events 18 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	100.0% 6/6 • Number of events 27 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	83.3% 10/12 • Number of events 45 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site macule	66.7% 4/6 • Number of events 28 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	83.3% 5/6 • Number of events 31 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	75.0% 9/12 • Number of events 59 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site hypertrophy	66.7% 4/6 • Number of events 14 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	66.7% 4/6 • Number of events 13 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	66.7% 8/12 • Number of events 27 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site atrophy	50.0% 3/6 • Number of events 10 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 3/6 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 6/12 • Number of events 18 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site discolouration	33.3% 2/6 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 4/12 • Number of events 16 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Fatigue	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 4 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Gait disturbance	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 3/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site pain	33.3% 2/6 • Number of events 6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Pyrexia	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site pruritis	33.3% 2/6 • Number of events 12 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 12 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Discomfort	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site hypersensitivity	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site induration	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site papule	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site reaction	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site swelling	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 7 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 7 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Upper respiratory tract infection	83.3% 5/6 • Number of events 24 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	66.7% 4/6 • Number of events 20 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	75.0% 9/12 • Number of events 44 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Gastroenteritis	33.3% 2/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 3/6 • Number of events 5 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	41.7% 5/12 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Pneumonia	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 3/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Bronchitis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Gastroenteritis viral	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Viral infection	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Ear infection	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Enterobiasis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Influenza	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Otitis media	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Pharyngitis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Pharyngitis streptococcal	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Sinusitis	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Staphylococcal skin infection	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Tinea cruris	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Infections and infestations Tonsillitis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Contusion	50.0% 3/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Joint sprain	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Arthropod bite	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Limb injury	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Procedural pain	33.3% 2/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Accidental exposure	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Ankle fracture	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Arthropod sting	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Burns second degree	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Drug administration error	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Joint injury	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Muscle strain	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Periorbital haematoma	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Post-traumatic pain	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Radius fracture	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Injury, poisoning and procedural complications Testicular injury	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 4/6 • Number of events 6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	41.7% 5/12 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 4 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Pain in extremity	50.0% 3/6 • Number of events 6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Joint swelling	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Epiphyses premature fusion	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Joint hyperextension	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Neck pain	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Musculoskeletal and connective tissue disorders Tendonitis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Diarrhoea	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Oral pain	16.7% 1/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 4 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Dental discomfort	16.7% 1/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Food poisoning	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Tooth crowding	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Toothache	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Conjunctival deposit	50.0% 3/6 • Number of events 5 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 3/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 6/12 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Conjunctivitis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Conjunctivitis allergic	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Corneal deposits	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Optic atrophy	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Optic disc drusen	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Eye disorders Retinal vascular disorder	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • Number of events 5 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 5 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Allergic sinusitis	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Nervous system disorders Headache	50.0% 3/6 • Number of events 15 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 3/6 • Number of events 4 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	50.0% 6/12 • Number of events 19 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Hair colour changes	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Skin discolouration	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Psychiatric disorders Anxiety	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 2 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Psychiatric disorders Attention deficit/hyperactivity disorder	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Psychiatric disorders Initial insomnia	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Immune system disorders Seasonal allergy	16.7% 1/6 • Number of events 7 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 7 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Immune system disorders Hypersensitivity	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Investigations Blood 25-hydroxycholecalciferol decreased	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	33.3% 2/6 • Number of events 7 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	25.0% 3/12 • Number of events 8 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	16.7% 1/6 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 3 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Renal and urinary disorders Nephrolithiasis	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	33.3% 2/6 • Number of events 6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 2/12 • Number of events 6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Renal and urinary disorders Nephrocalcinosis	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Ear and labyrinth disorders Ear pain	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Ear and labyrinth disorders Middle ear inflammation	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Congenital, familial and genetic disorders Phimosis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Endocrine disorders Growth hormone deficiency	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
Reproductive system and breast disorders Balanitis	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).
General disorders Injection site urticaria	16.7% 1/6 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	0.00% 0/6 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).	8.3% 1/12 • Number of events 1 • Treatment emergent AEs are events starting on or after the day of first dose of asfotase alfa and recorded in Study ENB-008-10 (at least 66 months of treatment in Study ENB-008-10).

Additional Information

Director of Clinical Trials

Alexion Pharmaceuticals, Inc.

Phone: 475-230-2596

Email: ClinicalTrials@alexion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60