Homozygous Familial Hypercholesterolemia (HoFH)
Conditions
Keywords
LDL-C, HoFH, Hyperlipidemia
Brief summary
The purpose of the study is to evaluate the safety of Rosuvastatin in Children and Adolescents with Homozygous Familial Hypercholesterolemia.
Detailed description
This is a long-term extension (LTE) to the randomized, double-blind, cross-over study of rosuvastatin 20 mg once daily (QD) versus placebo QD in children and adolescents (aged from 6 to \<18 years) with homozygous familial hypercholesterolemia (HoFH) (Study D3561C00004). The study is designed to assess the long-term safety and tolerability of rosuvastatin 20 mg in pediatric patients with HoFH. In this study all patients will receive rosuvastatin 20 mg QD. Investigators will also be permitted to titrate the dose of rosuvastatin from 20 to 40 mg per day if they feel it is warranted to more aggressively treat patients' elevated LDL-C levels. This up-titration will not be permitted in Asian patients. Pharmacokinetic data of the trough plasma exposure of rosuvastatin will also be assessed for the pediatric patients with HoFH taking a daily dose of rosuvastatin 40 mg. The primary outcome measures to be assessed include 1) Adverse events, including: * The frequency and severity of adverse events, * Rate of discontinuations due to adverse events, * Abnormal serum and urine laboratory values, electrocardiograms (ECGs), physical examinations, and vital signs; and 2) Assessments of growth.
Interventions
DRUGRosuvastatin 20mg
Active drug 1 or 2 tablets will be taken taken orally, QD, either in the morning or in the evening
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Prior to any study related procedures being performed, provision of written informed consent from a parent/both parents or guardian and statement of assent from the child or adolescent (if required by Institutional Review Board \[IRB\] or Independent Ethics Committee \[IEC\] according to local regulations and guidelines). Study D3561C00004 participants who have had their 18th birthday (adults) will be required to provide written informed consent. Communication should take place between the Investigator, patient/guardian and child/adolescent to confirm understanding and required compliance with the requirements of the study. 2. Male and female children and adolescents who were aged 6 to \<18 years at the onset of Study D3561C00004 (even if they had their 18th birthday during that study) with: * Documentation of genetic testing confirming 2 mutated alleles of the LDL receptor gene locus; and/or * Documented untreated LDL C \>500 mg/dL (12.9 mmol/L) and TG \<400 mg/dL (4.5 mmol/L) and at least 1 of the following criteria: * Tendinous and/or cutaneous xanthoma prior to 10 years of age; or * Documentation of HeFH in both parents by: * genetic and/or * clinical criteria 3. Negative pregnancy test (b human chorionic gonadotropin analysis) prior to baseline in females of child bearing potential: * Female patients of child bearing potential must adhere to a pregnancy prevention method (abstinence, chemical, or mechanical) during the study and 3 months following the last dose; * Male patients should refrain from fathering a child (including sperm donation) during the study and up to 3 months following the last dose; and 4. Were taking study drug at the end of Study D3561C00004 and are willing to follow all study procedures including adherence to dietary guidelines, study visits, fasting blood draws, and compliance with study treatment regimens.
Exclusion criteria
1. History of statin inducted myopathy or serious hypersensitivity reaction to other HMG CoA reductase inhibitors (statins), including rosuvastatin, at Visit 1 of Study D3561C00004. 2. Fasting serum glucose of \>9.99 mmol/L (180 mg/dL) or glycosylated hemoglobin \>9% during Study D3561C00004 or patients with a history of diabetic ketoacidosis within the past year. 3. Uncontrolled hypothyroidism defined as thyroid stimulating hormone \>1.5 times the upper limit of normal (ULN) at any time during Study D3561C00004. 4. Evidence of active liver disease or hepatic dysfunction (except a confirmed diagnosis of Gilbert's disease) as defined as non-transient elevations of ALT or AST elevations ≥3 times the ULN or non-transient total bilirubin ≥2 times the ULN during the Study D3561C00004. 5. Definite or suspected personal history or family history of clinically significant adverse drug reactions (ADRs), or hypersensitivity to drugs with a similar chemical structure to rosuvastatin as well as other statins.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability in Terms of Abnormal Vital Signs | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | 96 weeks | — |
| The Number of Participants Who Experianced Adverse Events and Serious Adverse Events | 96 weeks | — |
| Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | 96 weeks | — |
| Safety and Tolerability in Terms of Growth, Height | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation | 96 weeks | — |
| Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | 96 weeks | Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean. |
| Safety and Tolerability in Terms of Growth, Weight | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | 96 weeks | — |
| Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | 96 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
| Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg | Up to 22 months |
| Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Up to 22 months |
Countries
Belgium, Canada, Denmark, Israel, Malaysia, Taiwan
Participant flow
Recruitment details
The nine (9) patients recruited were all participants in the D3561C00004 HYDRA study (NCT02226198) four came from Sequence A and five from Sequence B
Participants by arm
| Arm | Count |
|---|---|
| Overall All patients | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 10.6 years STANDARD_DEVIATION 2.83 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Safety and Tolerability in Terms of Abnormal ECG, Abnormalities
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | Final Visit | 0 participants | 25.46 |
| Sequence B | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal ECG, Abnormalities | Final Visit | 0 participants | 12.73 |
Primary
Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation
Time frame: 96 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormalitites in Sexual Maturation | 0 participants |
Primary
Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 84 | 0 participants | 20.43 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Cardiovascular | Week 24 | 0 participants | 15.74 |
Primary
Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 72 | 1 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 84 | 1 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Baseline | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Baseline | 2 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 6 | 2 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 84 | 2 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 18 | 2 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 24 | 2 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 36 | 2 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 48 | 2 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 60 | 2 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, General Appearance | Week 72 | 2 participants | 15.12 |
Primary
Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Head and Neck | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 36 | 0 participants | 24.15 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Musculoskeletal/Extremities | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Physical Exams, Skin
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 18 | 3 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 48 | 3 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 12 | 3 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 60 | 2 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 24 | 3 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 72 | 2 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 6 | 3 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 84 | 2 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 36 | 3 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 96 | 2 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Baseline | 3 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Baseline | 2 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 6 | 2 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 18 | 2 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 24 | 2 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 36 | 2 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 48 | 2 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 60 | 2 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 72 | 2 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Physical Exams, Skin | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Alanine Aminotransferase (U/L) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Albumin (g/dL) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Aspartate Aminotransferase (U/L) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN)
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Basophils/Leukocytes (%) >Upper Limite of Normal (ULN) | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 72 | 2 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 84 | 1 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 36 | 2 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 60 | 3 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) <LLN | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Bicarbonate (Mol/L) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Baseline | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 96 | 0 participants | 25.46 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Blood Urea Nitrogen (mg/dL) <LLN | Week 72 | 0 participants | 15.12 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 18 | 0 participants | 23.56 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Chloride (mmol/L) >ULN | Week 72 | 1 participants | 15.12 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 96 | 1 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Creatine Kinase (U/L) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 12 | 2 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 24 | 2 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 72 | 2 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 84 | 2 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Baseline | 2 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Baseline | 3 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 6 | 2 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 18 | 2 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 24 | 3 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 36 | 3 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 48 | 4 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 60 | 4 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 72 | 3 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB Concentration (g/dL) <LLN | Week 84 | 3 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 96 | 2 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Baseline | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Baseline | 3 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 6 | 2 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 18 | 2 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 24 | 2 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 36 | 2 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 48 | 3 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 60 | 3 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 72 | 3 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular HGB (pg) <LLN | Week 84 | 3 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 96 | 2 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Baseline | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Baseline | 2 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 6 | 2 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 18 | 2 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 24 | 2 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 36 | 2 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 48 | 2 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 60 | 2 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 72 | 3 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) <LLN | Week 84 | 3 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 84 | 1 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 36 | 0 participants | 24.15 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Ery. Mean Corpuscular Volume (fL) >ULN | Week 12 | 0 participants | 14.94 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Baseline | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) <LLN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 24 | 2 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 36 | 2 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 72 | 2 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Erythrocytes (10^12/L) >ULN | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 96 | 0 participants | 25.46 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 84 | 1 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Glucose (mg/dL) >ULN | Week 72 | 0 participants | 15.12 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Baseline | 2 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 6 | 2 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 84 | 0 participants | 20.43 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 84 | 1 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Baseline | 2 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 6 | 3 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 48 | 2 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 18 | 3 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 60 | 2 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hematocrit (%) <LLN | Week 24 | 1 participants | 15.74 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 6 | 2 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Baseline | 2 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 96 | 1 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Baseline | 3 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 6 | 3 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 12 | 3 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 18 | 3 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 24 | 2 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 36 | 3 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 48 | 3 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 60 | 3 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 72 | 3 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Hemoglobin (g/dL) <LLN | Week 84 | 3 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lactate Dehydrogenase (U/L) <LLN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 36 | 0 participants | 24.15 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Leukocytes >ULN | Baseline | 0 participants | 15.02 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) <LLN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Lymphocytes/Leukocytes (%) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Monocytes/Leukocytes (%) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Phosphate (mg/dL) >ULN | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Baseline | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 12 | 0 participants | 23.9 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Platelets (10^9/L) >ULN | Week 72 | 1 participants | 15.12 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Baseline | 0 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Protein (g/dL) >ULN | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Baseline | 2 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 18 | 3 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 6 | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 84 | 0 participants | 17.27 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Sodium (mmol/L) <LLN | Week 48 | 1 participants | 15.21 |
Primary
Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 72 | 1 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 84 | 1 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 96 | 1 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Baseline | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Serum Laboratory Values, Urate (mg/dL) >ULN | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 18 | 0 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 96 | 1 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 24 | 0 participants | 24.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Ketones | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 12 | 1 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 60 | 1 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 24 | 1 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 72 | 2 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 6 | 2 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 84 | 1 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 36 | 1 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Baseline | 1 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 12 | 2 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 18 | 1 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 36 | 1 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Occult Blood | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 18 | 1 participants | 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 48 | 1 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 12 | 2 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 60 | 3 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 24 | 2 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 72 | 3 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 6 | 1 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 84 | 2 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 36 | 2 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 96 | 1 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Baseline | 2 participants | 23.57 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Baseline | 1 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 6 | 1 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 12 | 1 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 24 | 1 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 48 | 1 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 60 | 1 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 72 | 1 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Urine Laboratory Values, Urine Protein | Week 84 | 1 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Abnormal Vital Signs
Time frame: 96 weeks
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 12 | 0 participants | 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 48 | 0 participants | 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 6 | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 60 | 0 participants | 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 24 | 0 participants | 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 72 | 0 participants | 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Baseline | 0 participants | 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 84 | 0 participants | 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 36 | 0 participants | 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 96 | 0 participants | 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 18 | 0 participants | 23.56 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 96 | 0 participants | 12.73 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 18 | 0 participants | 14.83 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Baseline | 0 participants | 15.02 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 6 | 0 participants | 15.32 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 12 | 0 participants | 14.94 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 24 | 0 participants | 15.74 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 36 | 0 participants | 15.61 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 48 | 0 participants | 15.21 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 60 | 0 participants | 16.37 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 72 | 0 participants | 15.12 |
| Sequence B | Safety and Tolerability in Terms of Abnormal Vital Signs | Week 84 | 0 participants | 17.27 |
Primary
Safety and Tolerability in Terms of Growth, Height
Time frame: 96 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 18 | 145.3 cm | Standard Deviation 23.56 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 48 | 148.8 cm | Standard Deviation 24.25 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 12 | 144.0 cm | Standard Deviation 23.9 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 60 | 158.0 cm | Standard Deviation 19.47 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 24 | 145.8 cm | Standard Deviation 24.02 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 72 | 159.0 cm | Standard Deviation 20.22 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 6 | 143.5 cm | Standard Deviation 23.57 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 84 | 159.7 cm | Standard Deviation 20.43 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 36 | 147.0 cm | Standard Deviation 24.15 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Week 96 | 165.0 cm | Standard Deviation 25.46 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height | Baseline | 142.5 cm | Standard Deviation 23.57 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 96 | 138.0 cm | Standard Deviation 12.73 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Baseline | 136.8 cm | Standard Deviation 15.02 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 6 | 136.8 cm | Standard Deviation 15.32 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 12 | 137.6 cm | Standard Deviation 14.94 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 18 | 138.0 cm | Standard Deviation 14.83 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 24 | 139.2 cm | Standard Deviation 15.74 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 36 | 140.6 cm | Standard Deviation 15.61 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 48 | 142.2 cm | Standard Deviation 15.21 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 60 | 144.0 cm | Standard Deviation 16.37 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 72 | 145.0 cm | Standard Deviation 15.12 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height | Week 84 | 148.3 cm | Standard Deviation 17.27 |
Primary
Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score)
Height z-score is a dimensionless quantity derived by subtracting the population mean from the individual raw score, and then deviding the difference by the pouulation SD of the reference population. This indicates how many SDs and observation is above or below the general population mean.
Time frame: 96 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 18 | -0.43 standard deviations | Standard Deviation 1.61 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 48 | -0.16 standard deviations | Standard Deviation 1.781 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 12 | -0.41 standard deviations | Standard Deviation 1.975 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 60 | 0.05 standard deviations | Standard Deviation 1.757 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 24 | -0.60 standard deviations | Standard Deviation 1.73 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 72 | 0.00 standard deviations | Standard Deviation 1.635 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 6 | -0.48 standard deviations | Standard Deviation 1.911 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 84 | 0.08 standard deviations | Standard Deviation 1.734 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 36 | -0.43 standard deviations | Standard Deviation 1.836 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 96 | 1.18 standard deviations | Standard Deviation 0.436 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Baseline | -0.43 standard deviations | Standard Deviation 2.025 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 96 | -0.51 standard deviations | Standard Deviation 0.886 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Baseline | -1.05 standard deviations | Standard Deviation 1.787 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 6 | -1.05 standard deviations | Standard Deviation 1.871 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 12 | -1.19 standard deviations | Standard Deviation 1.709 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 18 | -1.14 standard deviations | Standard Deviation 1.705 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 24 | -0.96 standard deviations | Standard Deviation 1.67 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 36 | -0.76 standard deviations | Standard Deviation 1.727 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 48 | -0.72 standard deviations | Standard Deviation 1.729 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 60 | -1.04 standard deviations | Standard Deviation 1.604 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 72 | -0.87 standard deviations | Standard Deviation 1.604 |
| Sequence B | Safety and Tolerability in Terms of Growth, Height SD-score (or Z-score) | Week 84 | -0.33 standard deviations | Standard Deviation 1.627 |
Primary
Safety and Tolerability in Terms of Growth, Weight
Time frame: 96 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 18 | 38.85 kg | Standard Deviation 17.633 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 48 | 41.00 kg | Standard Deviation 17.579 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 12 | 37.93 kg | Standard Deviation 17.11 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 60 | 48.47 kg | Standard Deviation 16.933 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 24 | 39.15 kg | Standard Deviation 17.521 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 72 | 48.43 kg | Standard Deviation 16.393 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 6 | 37.20 kg | Standard Deviation 16.23 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 84 | 50.17 kg | Standard Deviation 16.737 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 36 | 39.98 kg | Standard Deviation 18.293 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Week 96 | 57.35 kg | Standard Deviation 16.476 |
| Full Analysis Set | Safety and Tolerability in Terms of Growth, Weight | Baseline | 36.25 kg | Standard Deviation 14.719 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 96 | 33.55 kg | Standard Deviation 2.192 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Baseline | 37.42 kg | Standard Deviation 16.089 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 6 | 38.02 kg | Standard Deviation 16.7 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 12 | 38.16 kg | Standard Deviation 17.501 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 18 | 38.40 kg | Standard Deviation 16.688 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 24 | 39.00 kg | Standard Deviation 16.704 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 36 | 39.88 kg | Standard Deviation 15.015 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 48 | 41.16 kg | Standard Deviation 16.045 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 60 | 41.80 kg | Standard Deviation 15.656 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 72 | 42.10 kg | Standard Deviation 17.047 |
| Sequence B | Safety and Tolerability in Terms of Growth, Weight | Week 84 | 45.28 kg | Standard Deviation 19.143 |
Primary
Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events
Time frame: 96 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Set | Safety and Tolerability in Terms of Number of Participants Who Had Adverse Events, Discontinuations Due to Adverse Events | 0 participants |
Primary
The Number of Participants Who Experianced Adverse Events and Serious Adverse Events
Time frame: 96 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Full Analysis Set | The Number of Participants Who Experianced Adverse Events and Serious Adverse Events | 5 participants |
Secondary
Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | 8.0 % change from baseline ApoA-1 |
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | 7.0 % change from baseline ApoA-1 |
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | 5.3 % change from baseline ApoA-1 |
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | 6.5 % change from baseline ApoA-1 |
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | 1.0 % change from baseline ApoA-1 |
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | 10.7 % change from baseline ApoA-1 |
| Full Analysis Set | Percent Change in ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | 1.6 % change from baseline ApoA-1 |
Secondary
Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -23.3 % change from baseline ApoB/ApoA-1 |
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -22.1 % change from baseline ApoB/ApoA-1 |
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -18.9 % change from baseline ApoB/ApoA-1 |
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -15.7 % change from baseline ApoB/ApoA-1 |
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -17.0 % change from baseline ApoB/ApoA-1 |
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -26.0 % change from baseline ApoB/ApoA-1 |
| Full Analysis Set | Percent Change in ApoB/ApoA-1 From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -14.7 % change from baseline ApoB/ApoA-1 |
Secondary
Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -20.5 % change from baseline ApoB |
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -18.7 % change from baseline ApoB |
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -15.2 % change from baseline ApoB |
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -10.5 % change from baseline ApoB |
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -17.2 % change from baseline ApoB |
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -19.2 % change from baseline ApoB |
| Full Analysis Set | Percent Change in ApoB From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -9.5 % change from baseline ApoB |
Secondary
Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | 12.3 % change from baseline HDL-C |
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | 19.0 % change from baseline HDL-C |
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | 5.2 % change from baseline HDL-C |
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | 4.4 % change from baseline HDL-C |
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | 4.4 % change from baseline HDL-C |
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | 9.4 % change from baseline HDL-C |
| Full Analysis Set | Percent Change in HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | 3.8 % change from baseline HDL-C |
Secondary
Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -21.0 % change from baseline LDL-C |
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -18.6 % change from baseline LDL-C |
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -14.7 % change from baseline LDL-C |
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -12.1 % change from baseline LDL-C |
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -21.3 % change from baseline LDL-C |
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -20.5 % change from baseline LDL-C |
| Full Analysis Set | Percent Change in LDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -12.4 % change from baseline LDL-C |
Secondary
Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -39.4 % change from baseline LDL-C/HDL-C |
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -41.2 % change from baseline LDL-C/HDL-C |
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -36.1 % change from baseline LDL-C/HDL-C |
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -35.0 % change from baseline LDL-C/HDL-C |
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -48.6 % change from baseline LDL-C/HDL-C |
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -42.2 % change from baseline LDL-C/HDL-C |
| Full Analysis Set | Percent Change in LDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -27.8 % change from baseline LDL-C/HDL-C |
Secondary
Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -21.7 % change from baseline Non-HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -19.2 % change from baseline Non-HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -15.7 % change from baseline Non-HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -13.3 % change from baseline Non-HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -22.1 % change from baseline Non-HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -21.0 % change from baseline Non-HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -13.2 % change from baseline Non-HDL-C |
Secondary
Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -32.9 % change from baseline Non-HDL-C/HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -31.5 % change from baseline Non-HDL-C/HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -22.3 % change from baseline Non-HDL-C/HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -18.1 % change from baseline Non-HDL-C/HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -26.3 % change from baseline Non-HDL-C/HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -31.8 % change from baseline Non-HDL-C/HDL-C |
| Full Analysis Set | Percent Change in Non-HDL-C/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -17.6 % change from baseline Non-HDL-C/HDL-C |
Secondary
Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -30.6 % change from baseline TC/HDL-C |
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -29.4 % change from baseline TC/HDL-C |
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -20.5 % change from baseline TC/HDL-C |
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -16.6 % change from baseline TC/HDL-C |
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -24.1 % change from baseline TC/HDL-C |
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -29.2 % change from baseline TC/HDL-C |
| Full Analysis Set | Percent Change in TC/HDL-C From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -15.6 % change from baseline TC/HDL-C |
Secondary
Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -19.4 % change from baseline TC |
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -16.8 % change from baseline TC |
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -14.0 % change from baseline TC |
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -11.8 % change from baseline TC |
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -19.9 % change from baseline TC |
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -18.3 % change from baseline TC |
| Full Analysis Set | Percent Change in Total Cholesterol (TC) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -11.9 % change from baseline TC |
Secondary
Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis
Time frame: Up to 22 months
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 1 | -17.3 % change from baseline TG |
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 2 | -17.4 % change from baseline TG |
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 3 | -16.2 % change from baseline TG |
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 4 | -22.0 % change from baseline TG |
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 5 | -23.3 % change from baseline TG |
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 6 | -21.7 % change from baseline TG |
| Full Analysis Set | Percent Change in Triglycerides (TG) From End of Placebo of D3561C00004 to the End of D356NC00001, Repeated Measures Analysis | Visit 7 | -28.5 % change from baseline TG |
Secondary
Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg
Time frame: Up to 22 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Full Analysis Set | Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg | Day 292 | 9.00 ng/mL |
| Full Analysis Set | Pharmacokinetic Profile in Terms of Trough Concentrations in Pediatric HoFH Taking a Daily Dose of Rosuvastatin 40mg | Day 376 | 7.14 ng/mL |