Trial Outcomes & Findings for Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP) (NCT NCT01205152)
NCT ID: NCT01205152
Last Updated: 2019-03-13
Results Overview
Outcome measure is the number of patients with 1 or more treatment-emergent adverse event. The time period is from Baseline in the ENB-003-08 study to the end of the ENB-003-08 study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
84 months
Results posted on
2019-03-13
Participant Flow
The main criteria for inclusion in Study ENB-002-08 were male and female patients \</= 36 months of age, with severe infantile-onset HPP (symptom onset before 6 months of age) who were medically stable (ventilator support was allowed). To enter extension Study ENB-003-08, parent/guardian had to consent and patient had to complete Study ENB-002-08.
Participant milestones
| Measure |
Asfotase Alfa
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Asfotase Alfa
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Extension Study of Protocol ENB-002-08 - Study of Asfotase Alfa in Infants and Young Children With Hypophosphatasia (HPP)
Baseline characteristics by cohort
| Measure |
Asfotase Alfa
n=10 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
|---|---|
|
Age, Continuous
|
56.44 weeks
STANDARD_DEVIATION 61.888 • n=93 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 84 monthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)
Outcome measure is the number of patients with 1 or more treatment-emergent adverse event. The time period is from Baseline in the ENB-003-08 study to the end of the ENB-003-08 study.
Outcome measures
| Measure |
Asfotase Alfa
n=10 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Long-term Tolerability of Subcutaneous (SC) Asfotase Alfa
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: Up to 90 MonthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)
Outcome measure is the evaluation of radiographic change in rickets severity using a qualitative Radiographic Global Impression of Change (RGI-C) Scale. Skeletal radiographs obtained at the patient's last assessment were compared with skeletal radiographs obtained before initiation of treatment (Baseline in Study ENB-002-08 \[NCT00744042\]). 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 period is pre-dose (Baseline from ENB-002-08 study) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.
Outcome measures
| Measure |
Asfotase Alfa
n=10 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Long-term Efficacy of Asfotase Alfa in Treating Rickets in Infants and Young Children With Hypophosphatasia (HPP).
|
2.00 scores on a scale
Interval 2.0 to 3.0
|
—
|
SECONDARY outcome
Timeframe: Up to 90 MonthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08). Change from Baseline could not be calculated for 3 patients due to non-evaluable samples at Baseline.
Outcome measure is the change from Baseline in plasma inorganic pyrophosphate (PPi) levels. The time period is pre-dose (Baseline from the ENB-002-08 study \[NCT00744042\]) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.
Outcome measures
| Measure |
Asfotase Alfa
n=7 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Long-term Pharmacodynamics (PD) of SC Asfotase Alfa: Plasma Inorganic Pyrophosphate (PPi) Levels
|
-2.460 uM
Interval -9.73 to 2.72
|
—
|
SECONDARY outcome
Timeframe: Up to 90 MonthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08). Change from Baseline could not be calculated for 2 patients because of non-evaluable samples at Baseline.
Outcome measure is the change from Baseline in pyridoxal-5-phosphate (PLP) levels. The time period is pre-dose (Baseline from the ENB-002-08 study \[NCT00744042\]) to the last assessment for each patient in the ENB-003-08 study, which represents up to 90 months of exposure for the combined studies.
Outcome measures
| Measure |
Asfotase Alfa
n=8 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Long-term Pharmacodynamics (PD) of SC Asfotase Alfa: Pyridoxal-5-phosphate (PLP) Levels
|
-266.200 ng/mL
Interval -844.3 to 184.0
|
—
|
SECONDARY outcome
Timeframe: Up to 90 MonthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)
Outcome measure is the change from Baseline in Z-scores for weight. The time period is pre-dose (Baseline from the ENB-002-08 study \[NCT00744042\]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.
Outcome measures
| Measure |
Asfotase Alfa
n=10 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Effect of SC Asfotase Alfa on Growth: Weight Z-scores
|
2.43 Z-score
Interval -2.9 to 5.2
|
—
|
SECONDARY outcome
Timeframe: Up to 90 MonthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)
Outcome measure is the change from Baseline in Z-scores for height/length. The time period is pre-dose (Baseline from the ENB-002-08 study \[NCT00744042\]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.
Outcome measures
| Measure |
Asfotase Alfa
n=10 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Effect of SC Asfotase Alfa on Growth: Height/Length Z-scores
|
1.93 Z-score
Interval -3.2 to 4.6
|
—
|
SECONDARY outcome
Timeframe: Up to 90 MonthsPopulation: Full Analysis Set (All 10 patients enrolled in Study ENB-003-08)
Outcome measure is the shift in the proportion of patients requiring respiratory support at their last assessment in Study ENB-003-08 compared with Baseline. The time period is pre-dose (Baseline from the ENB-002-08 study \[NCT00744042\]) to the last assessment in the ENB-003-08 study, which represents up to 90 months of exposure in the combined studies.
Outcome measures
| Measure |
Asfotase Alfa
n=11 Participants
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
Asfotase Alfa (Last Assessment)
n=10 Participants
Results at the last assessment in the ENB-003-08 study.
|
|---|---|---|
|
Effect of SC Asfotase Alfa on Respiratory Function
No respiratory support
|
6 Participants
|
9 Participants
|
|
Effect of SC Asfotase Alfa on Respiratory Function
Supplemental oxygen
|
0 Participants
|
0 Participants
|
|
Effect of SC Asfotase Alfa on Respiratory Function
Continuous positive airway pressure
|
1 Participants
|
0 Participants
|
|
Effect of SC Asfotase Alfa on Respiratory Function
Mechanical ventilation
|
3 Participants
|
1 Participants
|
|
Effect of SC Asfotase Alfa on Respiratory Function
Biphasic positive airway pressure
|
0 Participants
|
0 Participants
|
|
Effect of SC Asfotase Alfa on Respiratory Function
Other
|
1 Participants
|
0 Participants
|
Adverse Events
Asfotase Alfa
Serious events: 9 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Asfotase Alfa
n=10 participants at risk
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Surgical and medical procedures
Central venous catheter removal
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Surgical and medical procedures
Tracheal fistula repair
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Surgical and medical procedures
Tracheostomy tube removal
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Vascular disorders
Deep vein thrombosis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Cardiac disorders
Cyanosis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Congenital, familial and genetic disorders
Congenital bowing of long bones
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
40.0%
4/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Congenital, familial and genetic disorders
Talipes
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Conductive deafness
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Papilloedema
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Immediate post-injection reaction
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Medical device complication
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Hepatobiliary disorders
Chronic hepatitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Bacterial tracheitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Croup infectious
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Pneumonia
|
30.0%
3/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Septic shock
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Tracheitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Blood urea increased
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
CSF pressure
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Investigation
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Metabolism and nutrition disorders
Feeding disorder of infancy or early childhood
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Nervous system disorders
Intracranial pressure increased
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Nephrolithiasis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoeic attack
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
Other adverse events
| Measure |
Asfotase Alfa
n=10 participants at risk
An initial single intravenous (IV) infusion of 2 mg/kg asfotase alfa, followed by subcutaneous (SC) injections of 1 mg/kg asfotase alfa 3 times per week
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Blood and lymphatic system disorders
Microcytosis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Blood and lymphatic system disorders
Neutropenia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Congenital, familial and genetic disorders
Craniosynostosis
|
20.0%
2/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Deafness
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Middle ear disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Otorrhoea
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Ear and labyrinth disorders
Vertigo
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Endocrine disorders
Precocious puberty
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Astigmatism
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Conjunctival deposit
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Conjunctival hyperaemia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Conjunctivitis
|
20.0%
2/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Lacrimation increased
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Myopia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Optic disc drusen
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Optic nerve disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Papilloedema
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Eye disorders
Visual impairment
|
20.0%
2/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10 • Number of events 9 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Constipation
|
20.0%
2/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Dental caries
|
40.0%
4/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Diarrhoea
|
30.0%
3/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Dysphagia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Gingival swelling
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Gingivitis
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Ileus
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Mouth ulceration
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Stomatitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Teething
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Tooth loss
|
40.0%
4/10 • Number of events 8 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Toothache
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10 • Number of events 14 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Catheter site rash
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site atrophy
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site calcification
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site discolouration
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site erythema
|
40.0%
4/10 • Number of events 18 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site haematoma
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site hypertrophy
|
20.0%
2/10 • Number of events 8 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site inflammation
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site nodule
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site reaction
|
20.0%
2/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site swelling
|
20.0%
2/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Injection site warmth
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Pain
|
30.0%
3/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Pyrexia
|
70.0%
7/10 • Number of events 21 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
General disorders
Vaccination site inflammation
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Hepatobiliary disorders
Cholelithiasis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Immune system disorders
Drug hypersensitivity
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Immune system disorders
Immunisation reaction
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Immune system disorders
Seasonal allergy
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Abscess jaw
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Acute sinusitis
|
30.0%
3/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Bronchitis
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Cellulitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Conjunctivitis infective
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Croup infectious
|
10.0%
1/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Cystitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Gastroenteritis
|
30.0%
3/10 • Number of events 9 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Gastroenteritis viral
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
H1N1 influenza
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Hordeolum
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Influenza
|
30.0%
3/10 • Number of events 7 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Injection site cellulitis
|
10.0%
1/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Laryngitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Lice infestation
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Lower respiratory tract infection
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Molluscum contagiosum
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Nasopharyngitis
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Otitis externa
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Otitis media
|
60.0%
6/10 • Number of events 23 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Otitis media acute
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Otitis media chronic
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Pharyngitis
|
30.0%
3/10 • Number of events 8 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Pneumonia
|
50.0%
5/10 • Number of events 7 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Pneumonia bacterial
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Pneumonia primary atypical
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Rhinitis
|
20.0%
2/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Sinusitis
|
20.0%
2/10 • Number of events 8 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Skin infection
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Tonsillitis
|
20.0%
2/10 • Number of events 6 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Tooth abscess
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Tracheitis
|
20.0%
2/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Upper respiratory tract infection
|
80.0%
8/10 • Number of events 77 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Varicella
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Viral infection
|
30.0%
3/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Viral pharyngitis
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
20.0%
2/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Adverse event following immunisation
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Face injury
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Foreign body
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Head injury
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Limb injury
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Alanine aminotransferase increased
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Blood alkaline phosphatase abnormal
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Oxygen saturation decreased
|
20.0%
2/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Staphylococcus test positive
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Urine calcium/creatinine ratio increased
|
20.0%
2/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Vitamin D decreased
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Investigations
Vitamin D increased
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Metabolism and nutrition disorders
Fluid overload
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Metabolism and nutrition disorders
Hypophosphataemic rickets
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Metabolism and nutrition disorders
Weight gain poor
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Foot deformity
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
40.0%
4/10 • Number of events 19 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Nervous system disorders
Headache
|
50.0%
5/10 • Number of events 14 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Nervous system disorders
Speech disorder developmental
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Psychiatric disorders
Abnormal behaviour
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Psychiatric disorders
Agitation
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Psychiatric disorders
Anticipatory anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Psychiatric disorders
Fear of needles
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Psychiatric disorders
Sleep disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Dysuria
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Haematuria
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Hydronephrosis
|
20.0%
2/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Nephrocalcinosis
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Renal cyst
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Renal pain
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Reproductive system and breast disorders
Breast enlargement
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
2/10 • Number of events 6 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
30.0%
3/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.0%
1/10 • Number of events 4 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea syndrome
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar disorder
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
30.0%
3/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Acne
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.0%
4/10 • Number of events 5 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
10.0%
1/10 • Number of events 3 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
10.0%
1/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Skin and subcutaneous tissue disorders
Urticaria contact
|
10.0%
1/10 • Number of events 1 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
|
Renal and urinary disorders
Nephrolithiasis
|
20.0%
2/10 • Number of events 2 • Adverse events were recorded from the time the parents/legal guardians signed the ICF for study ENB-003-08 through completion of the patient's participation in the study ENB-003-08.
|
Additional Information
Director of Clinical Trials
Alexion Pharmaceuticals, Inc.
Phone: 475-230-2596
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60