Duchenne Muscular Dystrophy
Conditions
Keywords
Duchenne muscular dystrophy, myostatin, open-label
Brief summary
This study is an open-label extension to protocol B5161002 and will provide an assessment of the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects will be assigned to receive a monthly individualized maximum tolerated dose based on their tolerability profile/data from B5161002. This study will not contain a placebo comparator. Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test and pulmonary function tests) and pharmacokinetic testing.
Interventions
BIOLOGICALPF-06252616
Either 5mg/kg, 20mg/kg or 40mg/kg will be assigned to a subject based on their maximum tolerated dose from B5161002
Sponsors
Pfizer
Study design
Allocation
NA
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with Duchenne muscular dystrophy who enrolled and completed study B5161002. 2. Signed and dated informed consent document (ICD) indicating that the subject's parent or legal guardian/caregiver has been informed of all pertinent aspects of the study. 3. Subjects and their legal guardians/caregivers who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 4. Subject have; 1. Adequate hepatic function on screening laboratory assessments 2. GLDH less than 20 units/liter (2 x upper limit of normal \[ULN\]) 3. Iron content estimate on the liver MRI within the normal range.
Exclusion criteria
1. Unwilling or unable (eg, metal implants) to undergo examination with closed MRI. 2. All male subjects who are able to father children and are sexually active and at risk for impregnating a female partner, who are unwilling or unable to use a highly effective method of contraception. In addition, all sexually active male subjects who are unwilling or unable to prevent potential transfer of and exposure to drug through semen to their partners by using a condom consistently and correctly. . 3. Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are related to Pfizer employees directly involved in the conduct of the study. 4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation. 5. Participation in other studies involving investigational drug(s), with the exception of B5161002. 6. History of allergic or anaphylactic reaction to a therapeutic or diagnostic protein or additives of this investigational product.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Suicidal Ideation or Suicidal Behavior | 2 Years | The Columbia Suicide Severity Rating Scale (C-SSRS) was performed to identify the risk of suicide ideation or behavior. C-SSRS was conducted with the participant's caregiver/legal guardian on the participant's behalf throughout the study, rather than administering this evaluation directly with the study participants. If at any visit the participant endorsed a 4 or 5 on the C-SSRS ideation section or reported any suicidality behavior, then an evaluation of suicide risk (risk assessment) had to be completed and the participant must have been discontinued. The significant result of C-SSRS was determined by the investigator. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | 2 Years | Liver function evaluation included: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, total protein, albumin and glutamate dehydrogenase. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal; ULN=Upper Limit of Normal). |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | 2 Years | Renal function evaluation included: blood urea nitrogen (BUN), creatinine and uric acid. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal). |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | 2 Years | Electrolytes evaluation included: sodium, potassium, chloride, calcium, phosphate and bicarbonate. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal). |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | 2 Years | Hormone evaluations included free thyroxine (T4), thyroid stimulating hormone (TSH), lutenizing hormone (LH), follicle stimulating hormone (FSH), and androstenedione. Numbers of participants with abnormalities of LH, FSH and androstenedione were reported in different age groups. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal). |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | 2 Years | Clinical chemistry evaluation included glucose, creatine kinase (CK), troponin I, amylase, iron binding capacity, unsaturated iron binding capacity, transferrin saturation, iron and ferritin. Number of participants with iron abnormalities was reported in different age groups. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal). |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | 2 Years | Urinalysis Microscopy included: urine red blood cell (RBC), urine white blood cell (WBC), urine uric acid crystals, urine calcium oxalate crystals, urine amorphous crystals, urine bacteria, urine microscopic exam. Urinalysis Dipstick included: urine pH, urine glucose, urine ketones, urine protein, urine blood/hemoglobin, urine nitrite, urine leukocyte esterase. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood | 2 Years | Number of participants with blood detected in fecal samples is presented. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal). |
| Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Baseline, Weeks 13, 25, 37, 49, 61, 73 and 85. | Participants were asked to fast for at least 8 hours prior to collection of blood to evaluate serum iron, serum ferritin and % transferrin saturation. The unit of iron was mcg/dL; the unit of ferritin was ng/mL; the unit of %transferrin saturation was %. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations | 2 Years | Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A targeted nose and throat mucosal exam was performed to monitor for any signs of mucosal telangiectasias. The clinically significant physical examination results were determined by the investigator. |
| Summary of Pubertal Development by Tanner Stage | Screening, Baseline, Week 49. | Tanner staging was performed before the first dose of this study to monitor for signs of accelerated sexual development. The physical changes in pubertal development (pubic hair, penis and testes) were assessed using the system described by Marshall and Tanner. Stage 1 is preadolescent, Stages 2, 3, and 4 are initiation of puberty and Stage 5 is mature adult. Details about the system can be referred to Tanner JM. Growth at Adolescence. Blackwell Scientific Publications 1962; 2nd edition. Participant's Week 97 visit within study B5161002 (parent study) was collected as screening data. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Summary of Testicular Volume | Screening, Baseline, Week 49. | Testicular volume was used to monitor pubertal development. Participant's Week 97 visit within Study B5161002 (parent study) was collected as screening data in current study. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | 2 Years | The number of participants pre-dose supine blood pressure and pulse rate meeting categorical summarization criteria are recorded in this table. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg, the unit for pulse rate is: beats per minute \[BPM\]) |
| Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | 2 Years | The number of participants with data of pre-dose supine blood pressure meeting categorical summarization were recorded in this table. Overall Baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. (DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg). |
| Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | 2 Years | QTcF=QT/(60/Hour)\*\*(1/3). Means of replicates were used in the calculations. QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Baseline was defined as the average of the last triplicate pre-dose measurements prior to Day 1 in B5161004. |
| Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | 2 Years | QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Overall baseline was defined as the average of the last triplicate pre-dose measurements prior to the first day of dosing in study B5161002. |
| Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening and Week 49. | Liver Magnetic Resonance Imaging (MRIs) were sent to an independent central radiology imaging facility for calculation of the average R2\* value which was used to monitor for iron accumulation in the liver. Mean R2\* values had been used in the calculations. Normal: R2\* \<= 75 Hz at 1.5 T or \<=139 Hz at 3.0 T; Above Normal: R2\* \> 75 Hz and \<= 190 Hz at 1.5 T or R2\* \> 139 Hz and \<= 369 Hz at 3.0 T Mild overload: R2\* \> 190 Hz at 1.5 T or R2\* \> 369 Hz at 3.0 T Data from participant's Week 93 visit in Study B5161002 (parent study) were used for screening in the current study. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Baseline and Week 49. | The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Baseline, Weeks 49, 97, 146. | The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Baseline, Week 49. | The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Baseline, Weeks 49, 97, 146. | The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Bone Age to Chronological Age Ratio | Baseline and Week 49. | Bone age assessment was evaluated by the ratio of the bone age to the chronological age using the X rays of the hand and wrist. Ratio of bone age to chronological age was calculated by bone age/chronological age at scan date. Chronological age at scan date was calculated by (scan date - date of birth + 1)/365.25. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Screening (Week 97 visit within parent study B5161002) and Week 49 | Bone mineral density (BMD) was monitored by dual energy x-ray absorptiometry (DXA). DXA scans were obtained to evaluate bone mineral density of the spine and whole body without head. The height adjusted Z-score presented below is the number of standard deviations which compares the BMD of the participant to the average BMD matched for their age, sex and ethnicity. If the Z-score was -2 standard deviations or lower, the result was below the expected range for age. If the Z-score was above -2 standard deviations, the result was within the expected range for age. |
| Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | 2 Years | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. Treatment-related AEs were determined by the investigator. The number of participants with dose reduced or temporary discontinuation due to both all-causality and treatment-related AEs are presented below. |
| Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | 2 Years | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator. The number of participants with severe all-causality and treatment-related TEAEs are presented below. |
| Number of Participants Who Discontinued From the Study Due to TEAEs | 2 Years | An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. The number of participants who discontinued from the study due to both all-causality and treatment-related TEAEs are presented below. |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | 2 Years | Hematology evaluation included: hemoglobin, hematocrit, red blood cell (RBC) count, platelets, RBC morphology, white blood cell (WBC) count, absolute lymphocytes, absolute atypical lymphocytes, absolute total neutrophils, absolute total neutrophils count, absolute band cells, absolute basophils, absolute eosinophils and absolute monocytes. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal; LLN=Lower Limit of Normal). |
| Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | 2 Years | Coagulation evaluation included activated partial thromboplastin time (aPTT) and prothrombin time (PT). (ULN=Upper Limit of Normal). Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline on the 4SC - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | The 4SC quantified the time required for a participant to ascend 4 standard steps. The functional assessment of 4SC was conducted by a physiotherapist (or exercise physiologist). In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessments were completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Baseline, Weeks 13, 25, 49 and 73. | FVC was measured using the FVC maneuver by spirometry to evaluate respiratory muscle function. The best (largest) FVC measurement from a set of 3 was captured on the database. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the FVC - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | Forced vital capacity (FVC) was measured using the FVC maneuver by spirometry to evaluate respiratory muscle function. The best (largest) FVC measurement from a set of 3 was captured on the database. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Baseline, Weeks 13, 25, 49, 73. | The NSAA was a 17-item test that measured gross motor function. Each individual item was evaluated with either 0-unable to perform independently, 1-able to perform with assistance, 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the NSAA Score - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | The NSAA was a 17-item test that measured gross motor function. Each individual item was evaluated with either 0-unable to perform independently, 1-able to perform with assistance, 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Baseline, Weeks 13, 25, 49, 73. | Rise from supine was a timed functional test within NSAA. This test of time-to-stand from supine was analyzed separately for summary tabulation along with the total NSAA score. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | Rise from supine was a timed functional test within NSAA. This test of time-to-stand from supine was analyzed separately for summary tabulation along with the total NSAA score. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Baseline, Weeks 13, 25, 49, 73. | A time to event analysis was performed for loss of ambulation. Loss of ambulation was defined as the inability to walk unassisted and without braces for at least 10 m, as assessed and reported by the investigator at each study visit, and confirmed by the inability to walk/run 10 m (as 1 component of the NSAA) evaluated at the next visit at which timed function tests were performed. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | A time to event analysis was performed for loss of ambulation. Loss of ambulation was defined as the inability to walk unassisted and without braces for at least 10 m, as assessed and reported by the investigator at each study visit, and confirmed by the inability to walk/run 10 m (as 1 component of the NSAA) evaluated at the next visit at which timed function tests were performed. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Baseline, Weeks 13, 25, 49 and 73. | ROM of the ankle was evaluated by goniometry and any occurrences of ankle contractures were recorded. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of ankle ROM was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the Ankle ROM - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | ROM of the ankle was evaluated by goniometry and any occurrences of ankle contractures were recorded. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of ankle ROM was completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Baseline, Weeks 13, 25, 49 and 73. | The PUL scale was used to assess motor performance of the upper limb for individuals with DMD. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into 3 levels; shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 to 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores; shoulder maximum 16, middle level maximum score 34 and distal level maximum score 24. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of PUL was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the PUL Overall Score - Overall Baseline | Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | The PUL scale was used to assess motor performance of the upper limb for individuals with DMD. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into 3 levels; shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 to 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores; shoulder maximum 16, middle level maximum score 34 and distal level maximum score 24. This is the overall change from baseline which included the change since enrolling in parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002. |
| Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Baseline, Weeks 13, 25, 49 and 73. | The 6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of 6MWD was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the 6MWD - Overall Baseline | Baseline,Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | The 6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of 6MWD was completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was start of the study treatment in parent study B5161002. |
| Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | Baseline, Weeks 13, 25, 49 and 73. | The FEV1 was recorded as an absolute volume in litres and in terms of predicted values according to age, height, race and gender. The best single FEV1 measurement from a set of 3 was recorded in the database. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Baseline, Weeks 13, 25, 49 and 73. | PEFR was one of the Pulmonary Function Tests (PFTs). Three technically adequate peak expiratory flow rate (PEFR) maneuvers were performed and reported in Litres/Minute (L/min), and the highest single PEFR was reported in the database. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of PEFR was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Baseline, Weeks 13, 25, 49, 73. | Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, elbow extension, hip abduction and shoulder abduction. 95% Confidence Interval was not calculated when less than or equal to 3 participants' data were available. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
| Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Baseline,Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170. | Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, elbow extension, hip abduction and shoulder abduction. 95% Confidence Interval was not calculated when less than or equal to 3 participants' data were available. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was start of the study treatment in parent study B5161002. |
| Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Weeks 1, 25, 49 and 73 | — |
| Number of Participants With Anti-drug Antibodies (ADA) Development | Weeks 1, 25, 49, 73 and Early Termination | The criterion for positive result of ADA samples was ADA titer \>=1.88. The criterion for negative result of ADA samples was ADA titer \<1.88. |
| Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Baseline, Weeks 13, 25, 49, 73. | The 4SC quantified the time required for a participant to ascend 4 standard steps. The functional assessment of 4SC was conducted by a physiotherapist (or exercise physiologist). In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessments were completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004. |
Countries
Canada, Italy, Japan, United Kingdom, United States
Participant flow
Pre-assignment details
Study B5161004 was an open-label extension (OLE) to study B5161002. The parent study B5161002 was a Phase 2, randomized, 2-period, blinded, placebo controlled study to evaluate the safety, efficacy, PK and PD of domagrozumab administered to ambulatory boys diagnosed with DMD.
Participants by arm
| Arm | Count |
|---|---|
| Sequence 1 In study B5161002 (parent study) participants randomized to Sequence group 1 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by intravenous (IV) infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received domagrozumab every 4 weeks for a total of 48 weeks at 40 mg/kg, the maximum tolerated dose identified in Period 1. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study. | 19 |
| Sequence 2 In study B5161002 (parent study) participants randomized to Sequence group 2 received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg) in Period 1. At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. In Period 2, participants received placebo. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study. | 20 |
| Sequence 3 In study B5161002 (parent study) participants randomized to Sequence group 3 received placebo in Period 1 (48 weeks). In Period 2, participants received domagrozumab (PF-06252616) in a dose escalating fashion (5, 20 and 40 mg/kg). At each dose level, domagrozumab was administered over 2 hours by IV infusion every 4 weeks for a total of 16 weeks. There was no pause between Period 1 and Period 2 (48 weeks each). In study B5161004 (OLE) participants received domagrozumab 40 mg/kg (the maximum tolerated dose from B5161002) every 4 weeks until early termination of this study. The OLE study reports participants within the treatment assignment they received in the parent study. | 20 |
| Total | 59 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Other | 0 | 1 | 0 |
| Overall Study | Study terminated by sponsor | 18 | 18 | 19 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Sequence 1 | Sequence 2 | Sequence 3 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 20 Participants | 20 Participants | 59 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 9.1 years STANDARD_DEVIATION 1 | 10.2 years STANDARD_DEVIATION 0.9 | 10.4 years STANDARD_DEVIATION 1.1 | 9.9 years STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 18 Participants | 17 Participants | 18 Participants | 53 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 20 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 20 | 0 / 20 | 0 / 59 |
| other Total, other adverse events | 15 / 19 | 17 / 20 | 17 / 20 | 49 / 59 |
| serious Total, serious adverse events | 2 / 19 | 2 / 20 | 1 / 20 | 5 / 59 |
Outcome results
Primary
Bone Age to Chronological Age Ratio
Bone age assessment was evaluated by the ratio of the bone age to the chronological age using the X rays of the hand and wrist. Ratio of bone age to chronological age was calculated by bone age/chronological age at scan date. Chronological age at scan date was calculated by (scan date - date of birth + 1)/365.25. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline and Week 49.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Bone Age to Chronological Age Ratio | Baseline | 0.76 Ratio | Standard Deviation 0.213 |
| Sequence 1 | Bone Age to Chronological Age Ratio | Week 49 | 0.74 Ratio | Standard Deviation 0.197 |
| Sequence 2 | Bone Age to Chronological Age Ratio | Baseline | 0.74 Ratio | Standard Deviation 0.195 |
| Sequence 2 | Bone Age to Chronological Age Ratio | Week 49 | 0.65 Ratio | Standard Deviation 0.157 |
| Sequence 3 | Bone Age to Chronological Age Ratio | Week 49 | 0.70 Ratio | Standard Deviation 0.172 |
| Sequence 3 | Bone Age to Chronological Age Ratio | Baseline | 0.81 Ratio | Standard Deviation 0.177 |
| Total | Bone Age to Chronological Age Ratio | Week 49 | 0.70 Ratio | Standard Deviation 0.172 |
| Total | Bone Age to Chronological Age Ratio | Baseline | 0.77 Ratio | Standard Deviation 0.194 |
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline
The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline and Week 49.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Baseline - Observed Values | 56.000 Ratio of Ejected Blood | Standard Deviation 5.6569 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Week 49 - Change From Baseline | -3.000 Ratio of Ejected Blood | — |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Baseline - Observed Values | 60.750 Ratio of Ejected Blood | Standard Deviation 2.2174 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Week 49 - Change From Baseline | -1.500 Ratio of Ejected Blood | Standard Deviation 4.9497 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Baseline - Observed Values | 62.400 Ratio of Ejected Blood | Standard Deviation 5.6833 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Baseline - Observed Values | 60.636 Ratio of Ejected Blood | Standard Deviation 4.843 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - B5161004 Baseline | Week 49 - Change From Baseline | -2.000 Ratio of Ejected Blood | Standard Deviation 3.6056 |
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline
The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from cardiac MRIs. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 49, 97, 146.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 49 - Change From Baseline | -11.000 Ratio of Ejected Blood | Standard Deviation 2.8284 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 146 - Change From Baseline | -15.000 Ratio of Ejected Blood | — |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 97 - Change From Baseline | -10.000 Ratio of Ejected Blood | Standard Deviation 2.8284 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Baseline - Observed Values | 66.000 Ratio of Ejected Blood | Standard Deviation 8.4853 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Baseline - Observed Values | 61.250 Ratio of Ejected Blood | Standard Deviation 3.5 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 49 - Change From Baseline | -3.500 Ratio of Ejected Blood | Standard Deviation 1.9149 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 97 - Change From Baseline | -0.500 Ratio of Ejected Blood | Standard Deviation 2.8868 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Baseline - Observed Values | 61.333 Ratio of Ejected Blood | Standard Deviation 5.3541 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 146 - Change From Baseline | 3.500 Ratio of Ejected Blood | Standard Deviation 0.7071 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 97 - Change From Baseline | -0.800 Ratio of Ejected Blood | Standard Deviation 6.5727 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 49 - Change From Baseline | 0.000 Ratio of Ejected Blood | Standard Deviation 7.4498 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 146 - Change From Baseline | -2.667 Ratio of Ejected Blood | Standard Deviation 10.6927 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Baseline - Observed Values | 62.083 Ratio of Ejected Blood | Standard Deviation 5.125 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 49 - Change From Baseline | -3.273 Ratio of Ejected Blood | Standard Deviation 6.4357 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI - Overall Baseline | Week 97 - Change From Baseline | -2.364 Ratio of Ejected Blood | Standard Deviation 5.9038 |
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline
The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Week 49.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Baseline - Observed Values | 60.359 Ratio of Ejected Blood | Standard Deviation 3.7545 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Week 49 - Change From Baseline | -0.400 Ratio of Ejected Blood | Standard Deviation 5.0334 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Week 49 - Change From Baseline | -3.900 Ratio of Ejected Blood | Standard Deviation 8.9252 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Baseline - Observed Values | 62.461 Ratio of Ejected Blood | Standard Deviation 6.018 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Baseline - Observed Values | 62.543 Ratio of Ejected Blood | Standard Deviation 5.3731 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Week 49 - Change From Baseline | 2.200 Ratio of Ejected Blood | Standard Deviation 7.6056 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Baseline - Observed Values | 61.740 Ratio of Ejected Blood | Standard Deviation 5.117 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - B5161004 Baseline | Week 49 - Change From Baseline | -0.900 Ratio of Ejected Blood | Standard Deviation 7.458 |
Primary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline
The LVEF was the ratio of blood ejected during systole to blood in the ventricle at the end of diastole. LVEF was measured by cardiac magnetic resonance imaging (MRI) or echocardiography. The same method of cardiac imaging was used consistently for each participant. Cardiac MRIs were read by a central imaging vendor, while echocardiograms were read locally (at each site). The table presents the results from echocardiograms. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 49, 97, 146.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 146 - Change From Baseline | -1.240 Ratio of Ejected Blood | Standard Deviation 2.3416 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Baseline - Observed Values | 63.288 Ratio of Ejected Blood | Standard Deviation 4.3743 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 49 - Change From Baseline | -0.171 Ratio of Ejected Blood | Standard Deviation 5.7432 |
| Sequence 1 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 97 - Change From Baseline | -2.929 Ratio of Ejected Blood | Standard Deviation 5.406 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 97 - Change From Baseline | -1.810 Ratio of Ejected Blood | Standard Deviation 6.1321 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 49 - Change From Baseline | -1.040 Ratio of Ejected Blood | Standard Deviation 4.8861 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Baseline - Observed Values | 64.094 Ratio of Ejected Blood | Standard Deviation 4.3025 |
| Sequence 2 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 146 - Change From Baseline | -4.833 Ratio of Ejected Blood | Standard Deviation 4.2151 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 49 - Change From Baseline | -0.213 Ratio of Ejected Blood | Standard Deviation 6.1487 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 97 - Change From Baseline | -1.414 Ratio of Ejected Blood | Standard Deviation 6.4799 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Baseline - Observed Values | 64.073 Ratio of Ejected Blood | Standard Deviation 4.5848 |
| Sequence 3 | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 146 - Change From Baseline | -1.440 Ratio of Ejected Blood | Standard Deviation 11.6993 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Baseline - Observed Values | 63.802 Ratio of Ejected Blood | Standard Deviation 4.3395 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 146 - Change From Baseline | -2.650 Ratio of Ejected Blood | Standard Deviation 6.8514 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 97 - Change From Baseline | -2.097 Ratio of Ejected Blood | Standard Deviation 5.8924 |
| Total | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) by Echocardiogram - Overall Baseline | Week 49 - Change From Baseline | -0.462 Ratio of Ejected Blood | Standard Deviation 5.5142 |
Primary
Number of Participants Who Discontinued From the Study Due to TEAEs
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Treatment-related TEAEs were determined by the investigator. The number of participants who discontinued from the study due to both all-causality and treatment-related TEAEs are presented below.
Time frame: 2 Years
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to All-causality AEs | 0 Participants |
| Sequence 1 | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to Treatment-related AEs | 0 Participants |
| Sequence 2 | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to Treatment-related AEs | 0 Participants |
| Sequence 2 | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to All-causality AEs | 0 Participants |
| Sequence 3 | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to All-causality AEs | 1 Participants |
| Sequence 3 | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to Treatment-related AEs | 0 Participants |
| Total | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to All-causality AEs | 1 Participants |
| Total | Number of Participants Who Discontinued From the Study Due to TEAEs | Due to Treatment-related AEs | 0 Participants |
Primary
Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline
Participants were asked to fast for at least 8 hours prior to collection of blood to evaluate serum iron, serum ferritin and % transferrin saturation. The unit of iron was mcg/dL; the unit of ferritin was ng/mL; the unit of %transferrin saturation was %. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 37, 49, 61, 73 and 85.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: <120 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 120 - <144 | 3 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 144 - <200 | 3 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: <120 | 10 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 120 - <144 | 3 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 144 - <200 | 2 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: <120 | 8 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 120 - <144 | 3 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 144 - <200 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: <120 | 5 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 120 - <144 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 144 - <200 | 2 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: <120 | 6 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 120 - <144 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 144 - <200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: <120 | 13 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 120 - <144 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 144 - <200 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: <120 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 120 - <144 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 144 - <200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: <120 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 120 - <144 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 144 - <200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: >=200 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: <140 | 19 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: <140 | 14 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: <140 | 12 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: <140 | 7 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: <140 | 7 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: <140 | 2 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: <140 | 2 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: <140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: >=140 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation - Baseline: <45 | 15 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 45 - <50 | 3 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 50 - <69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: <45 | 12 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 45 - <50 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 50 - <69 | 2 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: <45 | 9 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 45 - <50 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 50 - <69 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: <45 | 4 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 45 - <50 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 50 - <69 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: <45 | 6 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 45 - <50 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 50 - <69 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: <45 | 1 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 45 - <50 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 50 - <69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: <45 | 2 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 45 - <50 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 50 - <69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: >=69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: <45 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 45 - <50 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 50 - <69 | 0 Participants |
| Sequence 1 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 45 - <50 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: <140 | 6 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 120 - <144 | 3 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 50 - <69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 50 - <69 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: <140 | 4 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: <45 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 45 - <50 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 50 - <69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: <120 | 6 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: <45 | 10 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: <140 | 2 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 50 - <69 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: <120 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 45 - <50 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 120 - <144 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: <140 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 144 - <200 | 2 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 45 - <50 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: <45 | 15 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 50 - <69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 120 - <144 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation - Baseline: <45 | 20 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: <45 | 4 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: <45 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 45 - <50 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 120 - <144 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 50 - <69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 144 - <200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 120 - <144 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 50 - <69 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: <120 | 10 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: <120 | 3 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: <140 | 20 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: <120 | 2 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 144 - <200 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: <45 | 2 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: <120 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 120 - <144 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 144 - <200 | 3 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: <140 | 17 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 45 - <50 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: <120 | 15 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 50 - <69 | 2 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: >=69 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 45 - <50 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: <140 | 12 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 120 - <144 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 45 - <50 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: >=200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 144 - <200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 144 - <200 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: <140 | 9 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 144 - <200 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 120 - <144 | 2 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: <45 | 6 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: >=140 | 0 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 144 - <200 | 1 Participants |
| Sequence 2 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: <120 | 18 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: <120 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 120 - <144 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 45 - <50 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 144 - <200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: <45 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: <120 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 120 - <144 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 50 - <69 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 144 - <200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: <120 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 120 - <144 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 144 - <200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: <140 | 20 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: <45 | 3 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: <140 | 16 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: <140 | 13 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 45 - <50 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: <140 | 12 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 45 - <50 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: <140 | 8 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 50 - <69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: <140 | 3 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: <140 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: <140 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: >=140 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation - Baseline: <45 | 18 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 45 - <50 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: <45 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 50 - <69 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: <45 | 13 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 45 - <50 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 45 - <50 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 50 - <69 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 50 - <69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: <45 | 9 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 45 - <50 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 50 - <69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 50 - <69 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: <120 | 10 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 120 - <144 | 6 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: <45 | 11 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 144 - <200 | 4 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: <120 | 9 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 120 - <144 | 7 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 45 - <50 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 144 - <200 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: <120 | 8 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 120 - <144 | 4 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 50 - <69 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 144 - <200 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: <120 | 10 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 120 - <144 | 2 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: >=69 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 144 - <200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: >=200 | 0 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: <120 | 6 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 120 - <144 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: <45 | 6 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 144 - <200 | 1 Participants |
| Sequence 3 | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 50 - <69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 120 - <144 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: <120 | 41 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 45 - <50 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 37: <140 | 28 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 120 - <144 | 6 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 120 - <144 | 11 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: <120 | 5 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 120 - <144 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: 144 - <200 | 7 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: <45 | 21 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 25: <140 | 37 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 120 - <144 | 3 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Baseline: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: <45 | 6 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: 144 - <200 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: <120 | 34 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 13: <140 | 47 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 120 - <144 | 10 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: <120 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Baseline: <140 | 59 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: 144 - <200 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 45 - <50 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 13: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: <120 | 26 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 144 - <200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: 120 - <144 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: 144 - <200 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 120 - <144 | 7 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 49: <120 | 15 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 45 - <50 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 85: <120 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: 50 - <69 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: <45 | 5 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation - Baseline: <45 | 53 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 45 - <50 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Baseline: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: 144 - <200 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: <45 | 40 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 85: <140 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 37: 50 - <69 | 3 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 45 - <50 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: <45 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 73: <140 | 6 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 61: 144 - <200 | 2 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: 50 - <69 | 5 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 45 - <50 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 85: 45 - <50 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron - Week 25: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 13: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: >=69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: >=200 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: <45 | 28 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 61: 50 - <69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 61: <140 | 9 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: <45 | 16 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 45 - <50 | 3 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 37: <120 | 21 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: >=140 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 49: 50 - <69 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: 50 - <69 | 4 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 73: 50 - <69 | 0 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Ferritin-Week 49: <140 | 21 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | Iron-Week 73: 144 - <200 | 1 Participants |
| Total | Number of Participants With Data of Serum Ferritin, Serum Iron and % Transferrin Saturation Meeting Categorical Summarization Criteria - B5161004 Baseline | %Transferrin Saturation Week 25: >=69 | 0 Participants |
Primary
Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs
An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. Treatment-related AEs were determined by the investigator. The number of participants with dose reduced or temporary discontinuation due to both all-causality and treatment-related AEs are presented below.
Time frame: 2 Years
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to All-causality AEs | 0 Participants |
| Sequence 1 | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to Treatment-related AEs | 0 Participants |
| Sequence 2 | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to Treatment-related AEs | 0 Participants |
| Sequence 2 | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to All-causality AEs | 0 Participants |
| Sequence 3 | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to All-causality AEs | 0 Participants |
| Sequence 3 | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to Treatment-related AEs | 0 Participants |
| Total | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to All-causality AEs | 0 Participants |
| Total | Number of Participants With Dose Reduced or Temporary Discontinuation Due to AEs | Due to Treatment-related AEs | 0 Participants |
Primary
Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria
Liver Magnetic Resonance Imaging (MRIs) were sent to an independent central radiology imaging facility for calculation of the average R2\* value which was used to monitor for iron accumulation in the liver. Mean R2\* values had been used in the calculations. Normal: R2\* \<= 75 Hz at 1.5 T or \<=139 Hz at 3.0 T; Above Normal: R2\* \> 75 Hz and \<= 190 Hz at 1.5 T or R2\* \> 139 Hz and \<= 369 Hz at 3.0 T Mild overload: R2\* \> 190 Hz at 1.5 T or R2\* \> 369 Hz at 3.0 T Data from participant's Week 93 visit in Study B5161002 (parent study) were used for screening in the current study.
Time frame: Screening and Week 49.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Above Normal | 0 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Mild Overload | 0 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Above Normal | 0 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Normal | 19 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Mild Overload | 0 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Mild Overload | 0 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Normal | 19 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Normal | 7 Participants |
| Sequence 1 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Above Normal | 0 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Normal | 6 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Normal | 20 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Mild Overload | 0 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Mild Overload | 0 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Mild Overload | 0 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Above Normal | 0 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Above Normal | 0 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Normal | 20 Participants |
| Sequence 2 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Above Normal | 0 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Above Normal | 0 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Normal | 20 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Above Normal | 0 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Mild Overload | 0 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Normal | 8 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Mild Overload | 0 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Normal | 20 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Above Normal | 0 Participants |
| Sequence 3 | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Mild Overload | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Normal | 59 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Normal | 21 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Mild Overload | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Mild Overload | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Total - Above Normal | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Above Normal | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Mild Overload | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Week 49 - Above Normal | 0 Participants |
| Total | Number of Participants With Iron Accumulation Data Meeting Categorical Summarization Criteria | Screening - Normal | 59 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry
Clinical chemistry evaluation included glucose, creatine kinase (CK), troponin I, amylase, iron binding capacity, unsaturated iron binding capacity, transferrin saturation, iron and ferritin. Number of participants with iron abnormalities was reported in different age groups. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin >140 ng/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose >1.5 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose <0.6 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y >120 | 12 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y >170 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y <50 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity <130 mcg/dL | 3 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation < 20% | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin <15 ng/mL | 4 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron Binding Capacity <37.6 mcg/dL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Amylase > 1.5 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation > 50% | 7 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity >375 mcg/dL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Troponin I >3.0 x ULN | 4 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | CK >2.0 x ULN | 19 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y <50 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y <50 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity >375 mcg/dL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation < 20% | 3 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation > 50% | 4 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity <130 mcg/dL | 4 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y >120 | 2 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y <50 | 3 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose <0.6 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose >1.5 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | CK >2.0 x ULN | 20 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Troponin I >3.0 x ULN | 4 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Amylase > 1.5 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron Binding Capacity <37.6 mcg/dL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y >170 | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin <15 ng/mL | 6 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin >140 ng/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y <50 | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose >1.5 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin >140 ng/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | CK >2.0 x ULN | 20 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation > 50% | 6 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin <15 ng/mL | 5 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Troponin I >3.0 x ULN | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Amylase > 1.5 x ULN | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation < 20% | 2 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity <130 mcg/dL | 3 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron Binding Capacity <37.6 mcg/dL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity >375 mcg/dL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y >120 | 2 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y >170 | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y <50 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose <0.6 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose <0.6 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y <50 | 3 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Glucose >1.5 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation > 50% | 17 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron Binding Capacity <37.6 mcg/dL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity >375 mcg/dL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | CK >2.0 x ULN | 59 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y <50 | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin >140 ng/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 1Y<=Age<11Y >120 | 16 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Troponin I >3.0 x ULN | 9 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Transferrin Saturation < 20% | 5 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Ferritin <15 ng/mL | 15 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Iron 11Y<=Age<18Y >170 | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Amylase > 1.5 x ULN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Clinical Chemistry | Unsaturated Iron Binding Capacity <130 mcg/dL | 10 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation
Coagulation evaluation included activated partial thromboplastin time (aPTT) and prothrombin time (PT). (ULN=Upper Limit of Normal). Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | aPTT >1.1 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | PT >1.1 x ULN | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | PT >1.1 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | aPTT >1.1 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | PT >1.1 x ULN | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | aPTT >1.1 x ULN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | aPTT >1.1 x ULN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Coagulation | PT >1.1 x ULN | 2 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes
Electrolytes evaluation included: sodium, potassium, chloride, calcium, phosphate and bicarbonate. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate >1.2 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) >1.1 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium >1.1 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium <0.95 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate <0.8 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium <0.9 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium >1.1 x ULN | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium >1.05 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) <0.9 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride <0.9 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride >1.1 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium <0.9 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium >1.05 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium <0.9 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium >1.1 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate <0.8 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate >1.2 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium >1.1 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium <0.95 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride >1.1 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride <0.9 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium <0.9 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) >1.1 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) <0.9 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium >1.1 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium <0.95 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium >1.05 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium <0.9 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium >1.1 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride <0.9 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride >1.1 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium <0.9 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate <0.8 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate >1.2 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) <0.9 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) >1.1 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride >1.1 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Chloride <0.9 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium <0.95 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate >1.2 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium >1.1 x ULN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Potassium <0.9 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) >1.1 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Bicarbonate (venous) <0.9 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium >1.1 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Calcium <0.9 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Sodium >1.05 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Electrolytes | Phosphate <0.8 x LLN | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood
Number of participants with blood detected in fecal samples is presented. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004 and who were evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Fecal Blood | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology
Hematology evaluation included: hemoglobin, hematocrit, red blood cell (RBC) count, platelets, RBC morphology, white blood cell (WBC) count, absolute lymphocytes, absolute atypical lymphocytes, absolute total neutrophils, absolute total neutrophils count, absolute band cells, absolute basophils, absolute eosinophils and absolute monocytes. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal; LLN=Lower Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute atypical lymphocytes >0 | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count >8.15 × 10^3/mcL | 6 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hematocrit <0.8 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute band cells >0.27 × 10^3/mcL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets >1.75 × ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute basophils >1.2 × ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute eosinophils >1.2 × ULN | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute monocytes >1.2 × ULN | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hemoglobin <0.8 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC Morphology >0 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count <0.6 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count >1.5 × ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC count <0.8 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute Lymphocytes <0.8 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute lymphocytes >1.2 × ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils <0.8 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets <0.5 × LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils >1.2 × ULN | 3 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count <1.35 × 10^3/mcL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets <0.5 × LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils <0.8 × LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC Morphology >0 | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count <0.6 × LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count >1.5 × ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count <1.35 × 10^3/mcL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils >1.2 × ULN | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute Lymphocytes <0.8 × LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC count <0.8 × LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count >8.15 × 10^3/mcL | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute lymphocytes >1.2 × ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute basophils >1.2 × ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets >1.75 × ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute eosinophils >1.2 × ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hemoglobin <0.8 × LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute monocytes >1.2 × ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hematocrit <0.8 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets <0.5 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count >8.15 × 10^3/mcL | 5 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils >1.2 × ULN | 2 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC Morphology >0 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hematocrit <0.8 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils <0.8 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute monocytes >1.2 × ULN | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count <0.6 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hemoglobin <0.8 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count <1.35 × 10^3/mcL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute lymphocytes >1.2 × ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count >1.5 × ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC count <0.8 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute eosinophils >1.2 × ULN | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute basophils >1.2 × ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute Lymphocytes <0.8 × LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets >1.75 × ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute monocytes >1.2 × ULN | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hemoglobin <0.8 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Hematocrit <0.8 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC count <0.8 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets <0.5 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Platelets >1.75 × ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | RBC Morphology >0 | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count <0.6 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | WBC count >1.5 × ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute Lymphocytes <0.8 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute lymphocytes >1.2 × ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute atypical lymphocytes >0 | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils <0.8 × LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophils >1.2 × ULN | 6 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count <1.35 × 10^3/mcL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute total neutrophil count >8.15 × 10^3/mcL | 12 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute band cells >0.27 × 10^3/mcL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute basophils >1.2 × ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hematology | Absolute eosinophils >1.2 × ULN | 2 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones
Hormone evaluations included free thyroxine (T4), thyroid stimulating hormone (TSH), lutenizing hormone (LH), follicle stimulating hormone (FSH), and androstenedione. Numbers of participants with abnormalities of LH, FSH and androstenedione were reported in different age groups. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal, ULN=Upper Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) <0.3mIU/mL | 2 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10-<12years) >41 ng/dL | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) >6.0mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) <0.3mIU/mL | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) >1.8mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10 - <12years) <7 ng/dL | 5 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) >4.0mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) <0.3 mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH <0.8 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) <11 ng/dL | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione(7 - <10 years) >31 ng/dL | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (7 - <10years) <3 ng/dL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH >1.2 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) <0.8 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13 years - <14 years) >10.80mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13years - <14 years) <0.70mIU/mL | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (7years - <9 years) <0.3mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) >10.50mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(7years - <9 years) >2.8mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) <0.50mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) <0.3mIU/mL | 8 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) >1.2 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) >8.90mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) <0.40mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) >2.8mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) >64 ng/dL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (9years - <11 years) >4.50mIU/mL | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH(7years - <9 years) >4.10mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH >1.2 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) <0.8 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) >1.2 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH <0.8 x LLN | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) <0.3mIU/mL | 5 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) >2.8mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) <0.3mIU/mL | 3 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) >1.8mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) <0.3 mIU/mL | 5 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) >4.0mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) <0.3mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) >6.0mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (9years - <11 years) >4.50mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) <0.40mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) >8.90mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) <0.50mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) >10.50mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13years - <14 years) <0.70mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13 years - <14 years) >10.80mIU/mL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (7 - <10years) <3 ng/dL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione(7 - <10 years) >31 ng/dL | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10 - <12years) <7 ng/dL | 3 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10-<12years) >41 ng/dL | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) <11 ng/dL | 4 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) >64 ng/dL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) <0.50mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) >2.8mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) <11 ng/dL | 6 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (7 - <10years) <3 ng/dL | 2 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) <0.3mIU/mL | 3 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH <0.8 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (9years - <11 years) >4.50mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione(7 - <10 years) >31 ng/dL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) >10.50mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) >8.90mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) <0.3 mIU/mL | 8 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) >1.2 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) >1.8mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) <0.40mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) >4.0mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13years - <14 years) <0.70mIU/mL | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10-<12years) >41 ng/dL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) <0.8 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) <0.3mIU/mL | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH >1.2 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) <0.3mIU/mL | 2 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10 - <12years) <7 ng/dL | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) >6.0mIU/mL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) >64 ng/dL | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13 years - <14 years) >10.80mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) <0.3mIU/mL | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(13years - <14 years) >6.0mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) >2.8mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (7 - <10years) <3 ng/dL | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10 - <12years) <7 ng/dL | 9 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (9years - <11 years) >4.50mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (9years - <11 years) <0.3mIU/mL | 16 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) <0.40mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) >64 ng/dL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (11years - <12 years) >8.90mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(7years - <9 years) >2.8mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) <0.50mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (7years - <9 years) <0.3mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (10-<12years) >41 ng/dL | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (12years - <13 years) >10.50mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH >1.2 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) <0.8 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13years - <14 years) <0.70mIU/mL | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH (13 years - <14 years) >10.80mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | TSH <0.8 x LLN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | FSH(7years - <9 years) >4.10mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione (12 - <14years) <11 ng/dL | 11 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) >1.8mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | Androstenedione(7 - <10 years) >31 ng/dL | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) <0.3 mIU/mL | 13 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | T4 (free) >1.2 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH(12years - <13 years) >4.0mIU/mL | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Hormones | LH (11years - <12 years) <0.3mIU/mL | 7 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function
Liver function evaluation included: total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase, total protein, albumin and glutamate dehydrogenase. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (LLN=Lower Limit of Normal; ULN=Upper Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Bilirubin >1.5 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | AST >3.0 x ULN | 16 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | ALT >3.0 x ULN | 19 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | GGT >3.0 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Alkaline Phosphatase >3.0 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein <0.8 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein >1.2 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin <0.8 x LLN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin >1.2 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Glutamate Dehydrogenase >1.0 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | ALT >3.0 x ULN | 18 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin >1.2 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | GGT >3.0 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Alkaline Phosphatase >3.0 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein <0.8 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein >1.2 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Glutamate Dehydrogenase >1.0 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin <0.8 x LLN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Bilirubin >1.5 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | AST >3.0 x ULN | 16 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin <0.8 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein >1.2 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Glutamate Dehydrogenase >1.0 x ULN | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Bilirubin >1.5 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | GGT >3.0 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein <0.8 x LLN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin >1.2 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | AST >3.0 x ULN | 15 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Alkaline Phosphatase >3.0 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | ALT >3.0 x ULN | 19 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Alkaline Phosphatase >3.0 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin <0.8 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein <0.8 x LLN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Glutamate Dehydrogenase >1.0 x ULN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Protein >1.2 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | AST >3.0 x ULN | 47 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | ALT >3.0 x ULN | 56 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | GGT >3.0 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Total Bilirubin >1.5 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Liver Function | Albumin >1.2 x ULN | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function
Renal function evaluation included: blood urea nitrogen (BUN), creatinine and uric acid. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (ULN=Upper Limit of Normal).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Blood Urea Nitrogen (BUN) >1.3 x ULN | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Uric Acid >1.2 x ULN | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Creatinine >1.3 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Blood Urea Nitrogen (BUN) >1.3 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Uric Acid >1.2 x ULN | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Creatinine >1.3 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Creatinine >1.3 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Blood Urea Nitrogen (BUN) >1.3 x ULN | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Uric Acid >1.2 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Blood Urea Nitrogen (BUN) >1.3 x ULN | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Uric Acid >1.2 x ULN | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Renal Function | Creatinine >1.3 x ULN | 0 Participants |
Primary
Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis
Urinalysis Microscopy included: urine red blood cell (RBC), urine white blood cell (WBC), urine uric acid crystals, urine calcium oxalate crystals, urine amorphous crystals, urine bacteria, urine microscopic exam. Urinalysis Dipstick included: urine pH, urine glucose, urine ketones, urine protein, urine blood/hemoglobin, urine nitrite, urine leukocyte esterase. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004.
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH >8 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Calcium Oxalate Crystals -Present | 4 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Amorphous Crystals -Present | 3 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine protein >=1 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine glucose >=1 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine WBC >=20 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine ketones >=1 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Microscopic Exam -Positive | 8 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Uric Acid Crystals -Present | 1 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine RBC >=20 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine Leukocyte Esterase >=1 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH <4.5 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine Bacteria >20 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine nitrite >=1 | 0 Participants |
| Sequence 1 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine blood/hemoglobin >=1 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine protein >=1 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Amorphous Crystals -Present | 3 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine Bacteria >20 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Microscopic Exam -Positive | 11 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH <4.5 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH >8 | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine glucose >=1 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine ketones >=1 | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine blood/hemoglobin >=1 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine nitrite >=1 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine Leukocyte Esterase >=1 | 1 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine RBC >=20 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine WBC >=20 | 0 Participants |
| Sequence 2 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Calcium Oxalate Crystals -Present | 7 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH >8 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine blood/hemoglobin >=1 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH <4.5 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine nitrite >=1 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Amorphous Crystals -Present | 2 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine Leukocyte Esterase >=1 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Microscopic Exam -Positive | 7 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine RBC >=20 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Calcium Oxalate Crystals -Present | 4 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine WBC >=20 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine glucose >=1 | 0 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine ketones >=1 | 1 Participants |
| Sequence 3 | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine protein >=1 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine Leukocyte Esterase >=1 | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine glucose >=1 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Calcium Oxalate Crystals -Present | 15 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine protein >=1 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH <4.5 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Amorphous Crystals -Present | 8 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine ketones >=1 | 2 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - urine blood/hemoglobin >=1 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine RBC >=20 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Uric Acid Crystals -Present | 1 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine Bacteria >20 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine nitrite >=1 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy-Urine Microscopic Exam -Positive | 26 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Microscopy - Urine WBC >=20 | 0 Participants |
| Total | Number of Participants With Laboratory Test Abnormalities (Without Regard to B5161004 Baseline Abnormality) - Urinalysis | Dipstick - Urine pH >8 | 1 Participants |
Primary
Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline
QTcF=QT/(60/Hour)\*\*(1/3). Means of replicates were used in the calculations. QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Baseline was defined as the average of the last triplicate pre-dose measurements prior to Day 1 in B5161004.
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004 and who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum(Max)QTcF Interval-ObservedValues<450msec | 18 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline30-<60msec | 2 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline<30msec | 16 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values450-<480msec | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline>= 60msec | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values480-<500msec | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values>=500msec | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline30-<60msec | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values>=500msec | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values480-<500msec | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline<30msec | 20 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline>= 60msec | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values450-<480msec | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum(Max)QTcF Interval-ObservedValues<450msec | 20 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values>=500msec | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum(Max)QTcF Interval-ObservedValues<450msec | 18 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values450-<480msec | 2 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values480-<500msec | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline<30msec | 18 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline30-<60msec | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline>= 60msec | 2 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values480-<500msec | 0 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline>= 60msec | 2 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline30-<60msec | 2 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values450-<480msec | 2 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum(Max)QTcF Interval-ObservedValues<450msec | 56 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval Increase From Baseline<30msec | 54 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Max QTcF Interval -Observed Values>=500msec | 0 Participants |
Primary
Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline
QT=time between the start of the Q wave and the end of the T wave in the heart's electrical cycle; QTcF=corrected QT (Fridericia correction). All scheduled ECGs were performed after the participant had rested quietly for at least 10 minutes in a supine position. Overall baseline was defined as the average of the last triplicate pre-dose measurements prior to the first day of dosing in study B5161002.
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline <30 | 11 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline >=60 | 1 Participants |
| Sequence 1 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Max-QTcF Interval IncreaseFromBaseline30-<60msec | 7 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline <30 | 15 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline >=60 | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Max-QTcF Interval IncreaseFromBaseline30-<60msec | 5 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Max-QTcF Interval IncreaseFromBaseline30-<60msec | 1 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline <30 | 17 Participants |
| Sequence 3 | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline >=60 | 2 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline <30 | 43 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum QTcF Interval Increase From Baseline >=60 | 3 Participants |
| Total | Number of Participants With Post-Baseline ECG Data Meeting Categorical Summarization Criteria - Overall Baseline | Max-QTcF Interval IncreaseFromBaseline30-<60msec | 13 Participants |
Primary
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline
The number of participants pre-dose supine blood pressure and pulse rate meeting categorical summarization criteria are recorded in this table. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. (DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg, the unit for pulse rate is: beats per minute \[BPM\])
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 3 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values>120BPM(<18years) | 2 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 1 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values < 90 (11-17 years) | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values<40BPM(<18 years) | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine DBP - Observed Values <50 (<18 years) | 1 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values <70+2×Age (2-10years) | 1 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine DBP - Observed Values <50 (<18 years) | 1 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 2 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 1 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values < 90 (11-17 years) | 1 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values <70+2×Age (2-10years) | 1 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values>120BPM(<18years) | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values<40BPM(<18 years) | 0 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 1 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine DBP - Observed Values <50 (<18 years) | 2 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values <70+2×Age (2-10years) | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values < 90 (11-17 years) | 1 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 3 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 5 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values<40BPM(<18 years) | 0 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values>120BPM(<18years) | 1 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 2 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 1 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 4 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values>120BPM(<18years) | 3 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine Pulse Rate-Observed Values<40BPM(<18 years) | 0 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values < 90 (11-17 years) | 2 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 9 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine DBP - Observed Values <50 (<18 years) | 4 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - B5161004 Baseline | Supine SBP - Observed Values <70+2×Age (2-10years) | 2 Participants |
Primary
Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline
The number of participants with data of pre-dose supine blood pressure meeting categorical summarization were recorded in this table. Overall Baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. (DBP=diastolic blood pressure, SBP=systolic blood pressure; The unit for blood pressure is: mmHg).
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 2 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 0 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 8 Participants |
| Sequence 1 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 4 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 3 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 8 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 4 Participants |
| Sequence 2 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 6 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 10 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 4 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 8 Participants |
| Sequence 3 | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 2 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine DBP >=20 | 16 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Decrease From Baseline in Supine SBP >=30 | 7 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine SBP >=30 | 10 Participants |
| Total | Number of Participants With Post-Baseline Vital Signs Data Meeting Categorical Summarization Criteria - Overall Baseline | Maximum Increase From Baseline in Supine DBP >=20 | 26 Participants |
Primary
Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs)
An AE was any untoward medical occurrence in a clinical investigation participant administered a product; the event did not need to have a causal relationship with the treatment or usage. TEAEs were AEs occurred following the start of treatment or AEs increasing in severity during treatment. Severe TEAEs were TEAEs that interfered significantly with participants' usual function. Treatment-related TEAEs were determined by the investigator. The number of participants with severe all-causality and treatment-related TEAEs are presented below.
Time frame: 2 Years
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | All-Causality TEAEs | 3 Participants |
| Sequence 1 | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | Treatment-Related TEAEs | 0 Participants |
| Sequence 2 | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | Treatment-Related TEAEs | 0 Participants |
| Sequence 2 | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | All-Causality TEAEs | 0 Participants |
| Sequence 3 | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | All-Causality TEAEs | 1 Participants |
| Sequence 3 | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | Treatment-Related TEAEs | 0 Participants |
| Total | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | All-Causality TEAEs | 4 Participants |
| Total | Number of Participants With Severe Treatment-Emergent Adverse Events (TEAEs) | Treatment-Related TEAEs | 0 Participants |
Primary
Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations
Physical examinations were conducted by a physician, trained physician's assistant, or nurse practitioner as acceptable according to local regulation. A targeted nose and throat mucosal exam was performed to monitor for any signs of mucosal telangiectasias. The clinically significant physical examination results were determined by the investigator.
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequence 1 | Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations | 0 Participants |
| Sequence 2 | Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations | 0 Participants |
| Sequence 3 | Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations | 0 Participants |
| Total | Number of Participants With Significant Results of Physical Examinations Including Nose and Throat Mucosal Examinations | 0 Participants |
Primary
Number of Participants With Suicidal Ideation or Suicidal Behavior
The Columbia Suicide Severity Rating Scale (C-SSRS) was performed to identify the risk of suicide ideation or behavior. C-SSRS was conducted with the participant's caregiver/legal guardian on the participant's behalf throughout the study, rather than administering this evaluation directly with the study participants. If at any visit the participant endorsed a 4 or 5 on the C-SSRS ideation section or reported any suicidality behavior, then an evaluation of suicide risk (risk assessment) had to be completed and the participant must have been discontinued. The significant result of C-SSRS was determined by the investigator.
Time frame: 2 Years
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Ideation | 0 Participants |
| Sequence 1 | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Behavior | 0 Participants |
| Sequence 2 | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Behavior | 0 Participants |
| Sequence 2 | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Ideation | 0 Participants |
| Sequence 3 | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Ideation | 0 Participants |
| Sequence 3 | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Behavior | 0 Participants |
| Total | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Ideation | 0 Participants |
| Total | Number of Participants With Suicidal Ideation or Suicidal Behavior | Suicidal Behavior | 0 Participants |
Primary
Summary of Pubertal Development by Tanner Stage
Tanner staging was performed before the first dose of this study to monitor for signs of accelerated sexual development. The physical changes in pubertal development (pubic hair, penis and testes) were assessed using the system described by Marshall and Tanner. Stage 1 is preadolescent, Stages 2, 3, and 4 are initiation of puberty and Stage 5 is mature adult. Details about the system can be referred to Tanner JM. Growth at Adolescence. Blackwell Scientific Publications 1962; 2nd edition. Participant's Week 97 visit within study B5161002 (parent study) was collected as screening data. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Screening, Baseline, Week 49.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Not Detected (ND) Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Screening | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Week 49 | 3 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, ND, Baseline | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Baseline | 12 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Baseline | 5 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Baseline | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, ND / NA, Baseline | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Baseline | 13 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2 Week 49 | 4 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Baseline | 5 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, ND/NA, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, ND, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Week 49 | 4 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Week 49 | 3 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Screening | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Baseline | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, ND, Screening | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Baseline | 13 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Baseline | 5 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Baseline | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Screening | 1 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Week 49 | 0 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Week 49 | 4 Participants |
| Sequence 1 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Week 49 | 3 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Week 49 | 2 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, ND, Screening | 1 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Baseline | 1 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Week 49 | 4 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Not Detected (ND) Screening | 1 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Baseline | 10 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, ND / NA, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, ND/NA, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Week 49 | 4 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Baseline | 9 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Baseline | 9 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Week 49 | 2 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, ND, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Baseline | 9 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Screening | 1 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Baseline | 11 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, ND, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Baseline | 10 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Week 49 | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Week 49 | 3 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Baseline | 1 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Screening | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2 Week 49 | 3 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Baseline | 0 Participants |
| Sequence 2 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Week 49 | 5 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, ND / NA, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Baseline | 11 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Baseline | 10 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Baseline | 9 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2 Week 49 | 3 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Baseline | 10 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, ND, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, ND, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Week 49 | 4 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Week 49 | 3 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Week 49 | 1 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Week 49 | 1 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, ND, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, ND/NA, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Week 49 | 1 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Not Detected (ND) Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Week 49 | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, ND, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Baseline | 12 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Screening | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Baseline | 8 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Baseline | 0 Participants |
| Sequence 3 | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Week 49 | 6 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Screening | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Baseline | 23 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, ND/NA, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Week 49 | 11 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2 Week 49 | 10 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, ND, Screening | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Screening | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, ND / NA, Baseline | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Baseline | 35 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, ND, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 1, Week 49 | 10 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 2, Week 49 | 10 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 3, Week 49 | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 4, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Penis, Stage 5, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, ND, Screening | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, ND, Baseline | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Baseline | 33 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Baseline | 24 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Baseline | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Baseline | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, ND, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 1, Week 49 | 9 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 2, Week 49 | 11 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 3, Week 49 | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 4, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Testes, Stage 5, Week 49 | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Not Detected (ND) Screening | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Screening | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 4, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 5, Screening | 0 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, ND, Baseline | 1 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 1, Baseline | 33 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 2, Baseline | 23 Participants |
| Total | Summary of Pubertal Development by Tanner Stage | Public Hair, Stage 3, Baseline | 2 Participants |
Primary
Summary of Testicular Volume
Testicular volume was used to monitor pubertal development. Participant's Week 97 visit within Study B5161002 (parent study) was collected as screening data in current study. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Screening, Baseline, Week 49.
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Summary of Testicular Volume | Left Testis Volume - Screening | 3.0 Milliliter | — |
| Sequence 1 | Summary of Testicular Volume | Left Testis Volume - Baseline | 2.7 Milliliter | Standard Deviation 1.07 |
| Sequence 1 | Summary of Testicular Volume | Left Testis Volume - Week 49 | 2.6 Milliliter | Standard Deviation 0.98 |
| Sequence 1 | Summary of Testicular Volume | Right Testis Volume - Screening | 3.0 Milliliter | — |
| Sequence 1 | Summary of Testicular Volume | Right Testis Volume - Baseline | 2.7 Milliliter | Standard Deviation 1.03 |
| Sequence 1 | Summary of Testicular Volume | Right Testis Volume - Week 49 | 2.6 Milliliter | Standard Deviation 0.98 |
| Sequence 2 | Summary of Testicular Volume | Left Testis Volume - Week 49 | 2.5 Milliliter | Standard Deviation 0.55 |
| Sequence 2 | Summary of Testicular Volume | Right Testis Volume - Week 49 | 2.5 Milliliter | Standard Deviation 0.55 |
| Sequence 2 | Summary of Testicular Volume | Left Testis Volume - Baseline | 2.8 Milliliter | Standard Deviation 1.06 |
| Sequence 2 | Summary of Testicular Volume | Right Testis Volume - Baseline | 2.8 Milliliter | Standard Deviation 0.97 |
| Sequence 3 | Summary of Testicular Volume | Left Testis Volume - Baseline | 2.7 Milliliter | Standard Deviation 1.63 |
| Sequence 3 | Summary of Testicular Volume | Right Testis Volume - Baseline | 2.6 Milliliter | Standard Deviation 1.64 |
| Sequence 3 | Summary of Testicular Volume | Left Testis Volume - Week 49 | 3.8 Milliliter | Standard Deviation 3.41 |
| Sequence 3 | Summary of Testicular Volume | Right Testis Volume - Week 49 | 3.6 Milliliter | Standard Deviation 3.46 |
| Total | Summary of Testicular Volume | Left Testis Volume - Baseline | 2.7 Milliliter | Standard Deviation 1.27 |
| Total | Summary of Testicular Volume | Left Testis Volume - Week 49 | 3.0 Milliliter | Standard Deviation 2.19 |
| Total | Summary of Testicular Volume | Right Testis Volume - Screening | 3.0 Milliliter | — |
| Total | Summary of Testicular Volume | Left Testis Volume - Screening | 3.0 Milliliter | — |
| Total | Summary of Testicular Volume | Right Testis Volume - Baseline | 2.7 Milliliter | Standard Deviation 1.23 |
| Total | Summary of Testicular Volume | Right Testis Volume - Week 49 | 3.0 Milliliter | Standard Deviation 2.2 |
Primary
Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time
Bone mineral density (BMD) was monitored by dual energy x-ray absorptiometry (DXA). DXA scans were obtained to evaluate bone mineral density of the spine and whole body without head. The height adjusted Z-score presented below is the number of standard deviations which compares the BMD of the participant to the average BMD matched for their age, sex and ethnicity. If the Z-score was -2 standard deviations or lower, the result was below the expected range for age. If the Z-score was above -2 standard deviations, the result was within the expected range for age.
Time frame: Screening (Week 97 visit within parent study B5161002) and Week 49
Population: Analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 -Screening | -0.687659 Standard Deviations | Standard Deviation 0.9152662 |
| Sequence 1 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 - Week 49 | -0.131374 Standard Deviations | Standard Deviation 0.9251749 |
| Sequence 1 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Screening | -1.936367 Standard Deviations | Standard Deviation 1.1544544 |
| Sequence 1 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Week 49 | -1.789347 Standard Deviations | Standard Deviation 1.173827 |
| Sequence 2 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 - Week 49 | -0.435384 Standard Deviations | Standard Deviation 0.5747293 |
| Sequence 2 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Screening | -1.956332 Standard Deviations | Standard Deviation 1.3561294 |
| Sequence 2 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Week 49 | -1.943538 Standard Deviations | Standard Deviation 1.6839551 |
| Sequence 2 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 -Screening | -0.587384 Standard Deviations | Standard Deviation 1.0241266 |
| Sequence 3 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Screening | -1.872619 Standard Deviations | Standard Deviation 1.4843432 |
| Sequence 3 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 - Week 49 | -0.152854 Standard Deviations | Standard Deviation 1.7877768 |
| Sequence 3 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Week 49 | -1.455670 Standard Deviations | Standard Deviation 1.5655008 |
| Sequence 3 | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 -Screening | -0.561789 Standard Deviations | Standard Deviation 1.0285799 |
| Total | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Week 49 | -1.732667 Standard Deviations | Standard Deviation 1.4033563 |
| Total | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 - Week 49 | -0.227106 Standard Deviations | Standard Deviation 1.1053887 |
| Total | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Anterior Posterior Spine Total L1 to L4 -Screening | -0.613225 Standard Deviations | Standard Deviation 0.9731687 |
| Total | Whole Body and Spine DXA: Bone Mineral Density Z-Score, Height Adjusted Over Time | Body Without Head - Screening | -1.921525 Standard Deviations | Standard Deviation 1.3187696 |
Secondary
Change From Baseline on the 4SC - Overall Baseline
The 4SC quantified the time required for a participant to ascend 4 standard steps. The functional assessment of 4SC was conducted by a physiotherapist (or exercise physiologist). In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessments were completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Baseline | 4.381 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 97 | 2.652 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 89 | 1.687 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 41 | 0.920 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 81 | 1.633 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 25 | 0.427 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 122 | 3.128 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 49 | 0.480 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 73 | 1.561 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 170 | 10.450 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 9 | -0.096 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 57 | 0.712 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 146 | 11.933 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 17 | 0.500 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 110 | 3.811 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 65 | 1.337 Seconds |
| Sequence 1 | Change From Baseline on the 4SC - Overall Baseline | Week 33 | 1.298 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 65 | 4.259 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 97 | 1.874 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 73 | 3.082 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 170 | 6.150 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 81 | 3.006 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 89 | 2.069 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 146 | 2.498 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 25 | 2.835 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 33 | 3.713 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 9 | 0.898 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 122 | 1.781 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 41 | 3.361 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Baseline | 5.664 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 49 | 2.391 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 110 | 2.748 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 57 | 3.827 Seconds |
| Sequence 2 | Change From Baseline on the 4SC - Overall Baseline | Week 17 | 2.270 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 81 | 2.262 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Baseline | 5.717 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 9 | 0.879 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 17 | 1.493 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 25 | 2.836 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 33 | 1.804 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 41 | 2.217 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 49 | 1.898 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 57 | 2.914 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 65 | 2.181 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 73 | 1.849 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 89 | 3.182 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 97 | 1.790 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 110 | 1.806 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 122 | 1.909 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 146 | 4.034 Seconds |
| Sequence 3 | Change From Baseline on the 4SC - Overall Baseline | Week 170 | 2.100 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 97 | 2.156 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 57 | 2.428 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 49 | 1.567 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 9 | 0.566 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 110 | 2.892 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 41 | 2.140 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 33 | 2.280 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Baseline | 5.268 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 122 | 2.318 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 25 | 2.018 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 17 | 1.390 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 81 | 2.270 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 170 | 7.060 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 89 | 2.255 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 73 | 2.157 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 65 | 2.601 Seconds |
| Total | Change From Baseline on the 4SC - Overall Baseline | Week 146 | 6.784 Seconds |
Secondary
Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline
The 4SC quantified the time required for a participant to ascend 4 standard steps. The functional assessment of 4SC was conducted by a physiotherapist (or exercise physiologist). In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessments were completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49, 73.
Population: This analysis population included all participants who had received at least 1 dose of study medication in current study B5161004.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 49 | 10.150 Seconds |
| Sequence 1 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 13 | 0.839 Seconds |
| Sequence 1 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 73 | 9.350 Seconds |
| Sequence 1 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 25 | 1.248 Seconds |
| Sequence 1 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Baseline | 7.268 Seconds |
| Sequence 2 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 25 | 0.319 Seconds |
| Sequence 2 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 49 | 0.998 Seconds |
| Sequence 2 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 73 | 3.100 Seconds |
| Sequence 2 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 13 | 0.821 Seconds |
| Sequence 2 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Baseline | 5.218 Seconds |
| Sequence 3 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 25 | 0.663 Seconds |
| Sequence 3 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Baseline | 5.373 Seconds |
| Sequence 3 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 13 | 0.400 Seconds |
| Sequence 3 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 49 | 2.400 Seconds |
| Sequence 3 | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 73 | 1.000 Seconds |
| Total | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 49 | 5.126 Seconds |
| Total | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 13 | 0.709 Seconds |
| Total | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Baseline | 6.050 Seconds |
| Total | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 25 | 0.765 Seconds |
| Total | Change From Baseline on the 4 Stair Climb (4SC) - B5161004 Baseline | Week 73 | 5.180 Seconds |
Secondary
Change From Baseline on the 6MWD - Overall Baseline
The 6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of 6MWD was completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was start of the study treatment in parent study B5161002.
Time frame: Baseline,Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 33 | -43.8 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 25 | -41.8 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Baseline | 409.1 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 9 | -11.6 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 41 | -54.2 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 89 | -96.7 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 57 | -72.2 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 81 | -78.9 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 49 | -59.8 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 146 | -224.0 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 97 | -80.7 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 73 | -77.2 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 17 | -36.8 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 170 | -184.0 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 110 | -115.5 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 65 | -74.5 Meters |
| Sequence 1 | Change From Baseline on the 6MWD - Overall Baseline | Week 122 | -142.5 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 122 | -69.8 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 110 | -87.9 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 25 | -8.2 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 146 | -53.2 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 170 | -90.5 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Baseline | 349.4 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 33 | -17.5 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 41 | -37.4 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 9 | -2.0 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 49 | -29.1 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 57 | -32.8 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 65 | -33.3 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 73 | -35.5 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 17 | -16.1 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 81 | -42.6 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 89 | -33.7 Meters |
| Sequence 2 | Change From Baseline on the 6MWD - Overall Baseline | Week 97 | -25.1 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 97 | -55.3 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 65 | -58.2 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 81 | -39.6 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 146 | -137.1 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 89 | -41.5 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 73 | -60.1 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Baseline | 363.7 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 25 | -29.6 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 110 | -126.1 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 17 | -15.6 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 49 | -37.3 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 9 | -9.3 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 41 | -34.9 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 122 | -155.0 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 57 | -52.6 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 33 | -34.9 Meters |
| Sequence 3 | Change From Baseline on the 6MWD - Overall Baseline | Week 170 | -206.5 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 170 | -160.3 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Baseline | 373.5 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 9 | -7.8 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 17 | -23.2 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 25 | -26.2 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 33 | -32.3 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 41 | -42.4 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 49 | -42.6 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 57 | -53.4 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 65 | -56.0 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 73 | -58.4 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 81 | -55.4 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 89 | -60.6 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 97 | -56.2 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 110 | -109.4 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 122 | -122.8 Meters |
| Total | Change From Baseline on the 6MWD - Overall Baseline | Week 146 | -138.1 Meters |
Secondary
Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline
ROM of the ankle was evaluated by goniometry and any occurrences of ankle contractures were recorded. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of ankle ROM was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49 and 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Baseline | 0.6 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 13 | -2.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 25 | -2.2 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 49 | -1.7 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 73 | -2.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Baseline | 0.0 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 13 | -0.8 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 25 | -1.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 49 | -4.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 73 | -1.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 25 | -1.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 49 | -3.3 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 49 | -6.2 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 73 | -3.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Baseline | -3.1 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 13 | 0.4 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 73 | 3.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 25 | -1.7 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Baseline | -0.4 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 13 | -1.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 25 | -2.1 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 13 | 0.8 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 73 | 5.5 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Baseline | -7.8 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 49 | -4.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Baseline | -10.3 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 49 | -3.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 13 | -0.9 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 73 | 0.5 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 25 | -2.4 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 73 | -1.7 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 25 | -1.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Baseline | -4.7 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 73 | 2.5 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 13 | 0.2 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 13 | -1.3 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 25 | -2.2 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Week 49 | -3.9 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Left Ankle - Baseline | -2.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle Range of Motion (ROM) - B5161004 Baseline | Right Ankle - Week 49 | -3.5 Degrees of Passive Flexion |
Secondary
Change From Baseline on the Ankle ROM - Overall Baseline
ROM of the ankle was evaluated by goniometry and any occurrences of ankle contractures were recorded. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of ankle ROM was completed at approximately the same time of day. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Baseline | 6.7 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 170 | -6.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 73 | -2.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 146 | -12.6 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 146 | -10.0 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 122 | -8.7 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 81 | -6.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 97 | -7.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 110 | -8.3 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 97 | -7.9 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 89 | -9.9 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 89 | -9.4 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 25 | -2.3 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 9 | -1.8 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 81 | -5.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 73 | -3.6 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 33 | -1.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Baseline | 7.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 65 | -4.7 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 57 | -2.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 41 | -2.4 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 170 | -7.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 49 | -3.8 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 41 | -2.7 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 49 | -3.2 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 122 | -7.6 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 33 | 0.4 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 25 | -1.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 57 | -3.5 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 110 | -7.4 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 17 | -2.2 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 9 | -1.9 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 65 | -4.1 Degrees of Passive Flexion |
| Sequence 1 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 17 | -2.5 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 33 | -2.4 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Baseline | 2.6 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 9 | -0.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 17 | -2.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 25 | -4.7 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 41 | -3.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 49 | -5.5 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 57 | -6.1 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 65 | -5.4 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 73 | -4.6 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 81 | -2.7 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 89 | -6.3 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 97 | -10.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 110 | -5.9 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 122 | -5.7 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 146 | -10.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 170 | -6.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Baseline | 1.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 9 | -0.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 17 | -1.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 25 | -4.5 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 33 | -1.6 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 41 | -3.1 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 49 | -4.5 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 57 | -5.3 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 65 | -5.4 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 73 | -3.0 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 81 | -1.4 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 89 | -6.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 97 | -10.6 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 110 | -5.9 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 122 | -6.8 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 146 | -9.2 Degrees of Passive Flexion |
| Sequence 2 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 170 | -3.5 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 49 | -2.3 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Baseline | 1.5 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 9 | -1.3 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 57 | -5.8 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Baseline | 1.6 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 17 | -2.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 110 | -10.4 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 25 | -3.1 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 65 | -5.2 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 33 | -3.4 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 9 | -0.2 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 41 | -2.7 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 41 | -2.1 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 49 | -2.5 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 122 | -12.7 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 57 | -7.9 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 33 | -1.9 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 65 | -6.6 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 73 | -8.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 25 | 0.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 170 | -12.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 81 | -10.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 146 | -12.1 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 89 | -8.4 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 89 | -10.4 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 97 | -9.3 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 81 | -8.7 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 110 | -9.9 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 17 | -1.0 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 122 | -11.5 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 73 | -6.6 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 146 | -10.9 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 97 | -11.8 Degrees of Passive Flexion |
| Sequence 3 | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 170 | -9.0 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 97 | -9.1 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 97 | -10.0 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 65 | -5.6 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Baseline | 3.0 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 57 | -5.1 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 9 | -0.9 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 25 | -2.4 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 9 | -1.3 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Baseline | 3.7 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 65 | -4.9 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 73 | -4.9 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 17 | -2.0 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 49 | -3.7 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 89 | -8.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 146 | -11.4 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 25 | -3.1 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 110 | -8.1 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 110 | -7.9 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 81 | -5.6 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 33 | -1.5 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 41 | -2.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 17 | -1.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 73 | -4.6 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 41 | -2.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 170 | -7.2 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 170 | -7.7 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 89 | -8.1 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 49 | -3.6 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 33 | -1.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 81 | -5.9 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 146 | -10.6 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 57 | -5.2 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Left Ankle - Week 122 | -8.8 Degrees of Passive Flexion |
| Total | Change From Baseline on the Ankle ROM - Overall Baseline | Right Ankle - Week 122 | -9.3 Degrees of Passive Flexion |
Secondary
Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline
The FEV1 was recorded as an absolute volume in litres and in terms of predicted values according to age, height, race and gender. The best single FEV1 measurement from a set of 3 was recorded in the database. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49 and 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 25 | 0.1473 Litres |
| Sequence 1 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 49 | 0.3057 Litres |
| Sequence 1 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Baseline | 1.3694 Litres |
| Sequence 1 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 13 | 0.1113 Litres |
| Sequence 1 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 73 | 0.7500 Litres |
| Sequence 2 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 25 | 0.1175 Litres |
| Sequence 2 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 49 | 0.2083 Litres |
| Sequence 2 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 13 | 0.1307 Litres |
| Sequence 2 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Baseline | 1.4235 Litres |
| Sequence 2 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 73 | 0.2550 Litres |
| Sequence 3 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 25 | 0.0923 Litres |
| Sequence 3 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Baseline | 1.5335 Litres |
| Sequence 3 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 13 | -0.0014 Litres |
| Sequence 3 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 49 | 0.1000 Litres |
| Sequence 3 | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 73 | 0.2800 Litres |
| Total | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 49 | 0.2100 Litres |
| Total | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 13 | 0.0827 Litres |
| Total | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Baseline | 1.4436 Litres |
| Total | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 25 | 0.1175 Litres |
| Total | Change From Baseline on the Forced Expiratory Volume in One Second (FEV1) - B5161004 Baseline | FEV1 - Week 73 | 0.4580 Litres |
Secondary
Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline
FVC was measured using the FVC maneuver by spirometry to evaluate respiratory muscle function. The best (largest) FVC measurement from a set of 3 was captured on the database. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49 and 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 49 | 0.2086 Litres |
| Sequence 1 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 13 | 0.0344 Litres |
| Sequence 1 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 73 | 0.2800 Litres |
| Sequence 1 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 25 | 0.0718 Litres |
| Sequence 1 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Baseline | 1.6550 Litres |
| Sequence 2 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 25 | 0.1467 Litres |
| Sequence 2 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 49 | 0.2633 Litres |
| Sequence 2 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 73 | 0.3750 Litres |
| Sequence 2 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 13 | 0.1106 Litres |
| Sequence 2 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Baseline | 1.7029 Litres |
| Sequence 3 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 25 | 0.1086 Litres |
| Sequence 3 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Baseline | 1.8678 Litres |
| Sequence 3 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 13 | 0.0380 Litres |
| Sequence 3 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 49 | 0.0671 Litres |
| Sequence 3 | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 73 | 0.1450 Litres |
| Total | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 49 | 0.1755 Litres |
| Total | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 13 | 0.0615 Litres |
| Total | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Baseline | 1.7461 Litres |
| Total | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 25 | 0.1100 Litres |
| Total | Change From Baseline on the Forced Vital Capacity (FVC) - B5161004 Baseline | Week 73 | 0.2667 Litres |
Secondary
Change From Baseline on the FVC - Overall Baseline
Forced vital capacity (FVC) was measured using the FVC maneuver by spirometry to evaluate respiratory muscle function. The best (largest) FVC measurement from a set of 3 was captured on the database. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Baseline | 1.3753 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 97 | 0.2932 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 89 | 0.2406 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 41 | 0.1484 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 81 | 0.2263 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 25 | 0.0679 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 122 | 0.2973 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 49 | 0.1328 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 73 | 0.1706 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 170 | 0.5500 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 9 | 0.1205 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 57 | 0.1063 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 146 | 0.4629 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 17 | 0.0837 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 110 | 0.2781 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 65 | 0.2005 Litres |
| Sequence 1 | Change From Baseline on the FVC - Overall Baseline | Week 33 | 0.1463 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 65 | 0.1830 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 97 | 0.1365 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 73 | 0.1925 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 170 | 0.2850 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 81 | 0.1353 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 89 | 0.1960 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 146 | 0.4167 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 25 | 0.1140 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 33 | 0.0740 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 9 | 0.1089 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 122 | 0.3708 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 41 | 0.1115 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Baseline | 1.5810 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 49 | 0.1350 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 110 | 0.2256 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 57 | 0.1735 Litres |
| Sequence 2 | Change From Baseline on the FVC - Overall Baseline | Week 17 | 0.0700 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 81 | 0.2045 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Baseline | 1.6265 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 9 | -0.0435 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 17 | 0.0585 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 25 | -0.0135 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 33 | 0.1100 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 41 | 0.1320 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 49 | 0.1565 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 57 | 0.1656 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 65 | 0.1726 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 73 | 0.1330 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 89 | 0.2145 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 97 | 0.2375 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 110 | 0.2407 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 122 | 0.3221 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 146 | 0.3114 Litres |
| Sequence 3 | Change From Baseline on the FVC - Overall Baseline | Week 170 | 0.4900 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 97 | 0.2212 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 57 | 0.1486 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 49 | 0.1417 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 9 | 0.0602 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 110 | 0.2483 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 41 | 0.1303 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 33 | 0.1095 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Baseline | 1.5302 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 122 | 0.3305 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 25 | 0.0559 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 17 | 0.0705 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 81 | 0.1890 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 170 | 0.4417 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 89 | 0.2158 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 73 | 0.1652 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 65 | 0.1853 Litres |
| Total | Change From Baseline on the FVC - Overall Baseline | Week 146 | 0.3960 Litres |
Secondary
Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline
Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, elbow extension, hip abduction and shoulder abduction. 95% Confidence Interval was not calculated when less than or equal to 3 participants' data were available. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49, 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Baseline | 4.39 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 73 | -0.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 49 | -1.13 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 13 | -0.21 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 49 | -0.81 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 25 | -0.08 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 73 | -1.25 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 49 | -0.44 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 13 | 0.06 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Baseline | 4.23 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Baseline | 4.13 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 25 | -0.29 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 73 | -1.25 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 49 | -0.49 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 13 | -0.48 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 73 | -1.15 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 25 | -0.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 73 | -0.30 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 13 | -0.14 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Baseline | 3.83 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Baseline | 3.31 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 25 | -0.05 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 73 | -0.45 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 49 | -0.74 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 13 | -0.23 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Baseline | 3.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 25 | -0.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 13 | -0.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 25 | -0.40 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 13 | -0.16 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Baseline | 4.33 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 73 | -0.60 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 49 | -0.59 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 25 | -0.44 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 49 | -0.34 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 25 | -0.60 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 73 | -0.70 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 49 | -0.49 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 13 | -0.34 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Baseline | 4.21 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Baseline | 4.14 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Baseline | 3.99 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 73 | -0.30 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 49 | -1.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 13 | -0.49 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 73 | -0.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 25 | -0.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 13 | -0.04 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 25 | -0.65 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 49 | -0.66 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 13 | -0.42 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Baseline | 3.24 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 13 | -0.55 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 25 | -0.38 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 49 | -0.47 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 73 | -0.95 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Baseline | 3.24 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 25 | -0.68 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 49 | -0.60 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 73 | -1.25 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Baseline | 3.74 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 13 | -0.22 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 25 | -0.58 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 49 | -0.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 73 | -1.55 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Baseline | 4.18 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 13 | -0.85 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 25 | -1.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 49 | -1.27 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 73 | -1.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Baseline | 5.29 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 13 | -0.46 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 25 | -0.75 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 49 | -0.94 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 73 | -2.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Baseline | 5.55 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 13 | -0.75 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 25 | -0.94 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 49 | -0.66 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 73 | -2.15 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Baseline | 4.54 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 13 | -0.44 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 25 | -0.73 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 49 | -0.07 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 73 | 0.00 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Baseline | 4.48 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 13 | -0.13 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 25 | -1.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 49 | -0.23 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 73 | -1.35 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Baseline | 3.95 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 13 | -0.31 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 25 | -0.53 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 49 | -0.45 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 73 | -1.30 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Baseline | 4.26 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 13 | -0.55 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 25 | -0.81 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 49 | -0.60 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 73 | -1.55 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 25 | -0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Baseline | 4.99 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 13 | -0.51 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 13 | -0.36 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 49 | -0.16 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 25 | -0.52 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 73 | 0.20 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 49 | 0.01 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Baseline | 3.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 73 | 0.30 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 25 | -0.09 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Baseline | 4.59 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 73 | 0.20 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 13 | -1.02 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Baseline | 3.91 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 25 | -0.92 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 49 | -0.07 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 49 | -0.54 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 73 | -0.25 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 25 | 0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Baseline | 2.83 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Baseline | 4.81 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 13 | -0.39 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 13 | -0.93 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 13 | -0.27 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 25 | -0.94 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 13 | -0.31 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 49 | -0.69 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Baseline | 2.94 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 73 | -0.45 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 25 | -0.59 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Baseline | 3.75 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 73 | -0.10 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 13 | -0.28 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 13 | -0.18 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 25 | 0.32 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 49 | -0.36 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Baseline | 3.07 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 73 | -0.70 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 25 | -0.44 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Baseline | 4.92 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 73 | -0.05 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 13 | -0.26 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 49 | -0.23 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 25 | -0.11 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 49 | -0.39 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 73 | -0.60 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 49 | 0.00 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 49 | -0.50 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 73 | 0.30 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 49 | -0.68 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 49 | -0.47 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 25 | -0.81 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Baseline | 4.99 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 13 | -0.35 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 25 | -0.29 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Baseline | 3.16 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 13 | -0.44 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 13 | -0.23 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Baseline | 3.13 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 49 | -0.57 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 25 | -0.54 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Baseline | 3.67 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 49 | -0.56 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 73 | -0.82 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 49 | -0.57 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 73 | -1.05 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 73 | -0.62 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 73 | -0.75 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Right - Week 73 | -0.92 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 73 | -0.58 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 73 | -0.73 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 73 | -0.95 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Baseline | 4.45 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion-Left - Week 25 | -0.45 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 49 | -0.41 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Baseline | 3.84 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 13 | -0.61 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 49 | -0.41 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 73 | -1.12 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 25 | -0.50 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 25 | -0.76 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Baseline | 4.82 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Baseline | 4.05 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 13 | -0.50 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 49 | -0.33 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 25 | -0.31 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 13 | -0.36 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 25 | -0.32 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Left - Week 73 | -0.28 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 13 | -0.24 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Left - Week 25 | -0.42 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Week 25 | -0.44 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Baseline | 4.55 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Right - Week 13 | -0.31 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Flexion - Right - Baseline | 3.77 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Elbow Extension-Left - Week 49 | -0.45 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Knee Extension - Right - Week 13 | -0.47 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Hip Abduction - Left - Week 49 | -0.55 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - B5161004 Baseline | Shoulder Abduction - Right - Week 13 | -0.37 Kilograms |
Secondary
Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline
Muscle strength was quantified by means of a handheld dynamometer. The following muscle groups were evaluated: knee extension, elbow flexion, elbow extension, hip abduction and shoulder abduction. 95% Confidence Interval was not calculated when less than or equal to 3 participants' data were available. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was start of the study treatment in parent study B5161002.
Time frame: Baseline,Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 9 | -0.47 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 57 | -0.18 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 17 | 0.09 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 170 | -4.55 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 17 | -0.70 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 17 | 0.56 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 25 | -0.31 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 9 | -0.24 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 33 | 0.42 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 41 | -0.18 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Baseline | 3.85 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Baseline | 6.12 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 49 | 0.92 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 57 | 0.13 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 170 | -7.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 65 | 0.19 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 49 | 0.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 73 | 0.12 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 9 | -0.43 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 9 | -0.54 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 81 | 0.03 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Baseline | 5.99 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 89 | 0.08 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 25 | -0.67 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 170 | -4.30 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 33 | -0.56 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 17 | 0.03 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 41 | -0.60 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 49 | -0.73 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 9 | -0.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 146 | -3.36 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 57 | -1.11 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 41 | -0.20 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 25 | -0.64 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 97 | 0.05 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 122 | -3.31 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 110 | 0.04 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 110 | -2.28 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 73 | -0.14 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 81 | -0.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 33 | -0.74 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 97 | -1.80 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 122 | -0.07 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 146 | -1.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 89 | -2.16 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 17 | -0.88 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 33 | -0.16 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 25 | -1.66 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 41 | -0.61 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 81 | -1.99 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 33 | -1.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 41 | -1.53 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 122 | -0.68 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 73 | -1.78 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 49 | -1.27 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 57 | -1.67 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 49 | -0.56 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 17 | 0.08 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 25 | -0.12 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 57 | -1.01 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 65 | -0.88 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 17 | 0.06 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 73 | -1.07 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 81 | -0.91 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 81 | -0.71 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 9 | -0.19 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 89 | -1.00 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 25 | -0.74 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 97 | -0.76 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Baseline | 3.80 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 110 | -1.12 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 49 | 0.36 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 122 | -1.77 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 110 | -0.25 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 170 | -3.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 146 | -1.70 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 33 | -0.65 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 170 | -4.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 146 | -0.89 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Baseline | 4.58 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 9 | -0.11 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 122 | -0.53 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left -Week 17 | -0.37 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 41 | -0.43 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 25 | -0.72 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 97 | 0.07 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 33 | -0.59 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 33 | 0.09 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 41 | -0.77 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 97 | -0.02 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 89 | -2.05 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 49 | -1.12 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 65 | -0.77 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 49 | -0.65 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 73 | -0.93 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 170 | -4.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 81 | -0.99 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 25 | -0.25 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 57 | -1.02 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 57 | -0.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 89 | -0.87 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 17 | 0.38 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 97 | -0.86 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 57 | -0.05 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 110 | -1.30 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 89 | 0.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 9 | -0.01 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 122 | -2.34 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 65 | -0.70 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Baseline | 3.55 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 65 | -1.01 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 170 | -7.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 146 | -2.00 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 170 | -5.35 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 146 | -3.21 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Baseline | 4.31 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 73 | -0.87 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 9 | 0.23 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 17 | 0.36 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 110 | -0.06 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 73 | -1.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 122 | -2.77 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 65 | -0.24 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 81 | 0.06 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 89 | 0.02 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 25 | -0.49 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 81 | -0.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 33 | 0.18 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 110 | -2.21 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 41 | -0.64 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 49 | 0.56 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 97 | -1.73 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 57 | -0.16 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 89 | -0.63 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 65 | -0.20 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 73 | 0.00 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 65 | -1.23 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 122 | -0.09 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 73 | -0.04 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 81 | -1.82 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 146 | -1.24 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 97 | -0.69 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 73 | -1.57 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 170 | -4.75 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Baseline | 4.14 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 110 | -0.99 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 81 | -0.43 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 65 | -1.28 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 89 | 0.37 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 41 | 0.14 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 57 | -1.44 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 97 | -0.11 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 9 | 0.56 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 65 | -0.10 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 110 | -0.18 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 89 | -0.84 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 122 | -1.81 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 49 | -1.23 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 97 | -0.71 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 110 | -1.28 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Baseline | 3.76 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 41 | -1.16 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 122 | -2.32 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 146 | -1.94 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 146 | -1.90 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 33 | -0.74 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 170 | -4.70 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Baseline | 4.66 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 146 | -1.50 Kilograms |
| Sequence 1 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 25 | -1.27 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 110 | -2.05 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 25 | 0.02 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 17 | -0.26 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 41 | -0.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 17 | -0.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 122 | -0.58 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 33 | 0.13 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 33 | -0.45 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 17 | -0.51 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 170 | -0.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 9 | 1.02 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 81 | -0.44 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 25 | -0.23 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Baseline | 3.51 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 89 | -1.80 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 41 | -1.07 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 33 | -0.80 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 49 | -0.43 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Baseline | 5.91 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 41 | -0.41 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 41 | -0.60 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 89 | 0.14 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 41 | -0.19 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 146 | -0.75 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 49 | -0.67 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Baseline | 3.49 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 170 | -0.45 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 81 | -1.97 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 57 | -0.63 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 41 | -0.22 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 97 | -1.79 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 65 | -0.33 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 65 | -0.17 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 25 | -0.71 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 9 | 1.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 110 | -0.86 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 73 | 0.04 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 49 | -0.47 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 73 | -0.31 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 49 | -0.46 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 81 | -0.62 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 9 | 0.77 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 25 | 0.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 49 | -0.66 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 89 | -0.44 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 122 | -0.66 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 170 | -1.75 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 73 | -0.23 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 25 | -0.14 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 41 | -0.47 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 57 | -1.16 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 81 | -0.30 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 33 | -0.36 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 110 | -1.01 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 146 | -0.83 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 57 | -0.06 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 41 | -0.29 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 17 | 0.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Baseline | 5.38 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 57 | -0.57 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 49 | -0.66 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 89 | -0.52 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 9 | 0.65 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 17 | -0.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 57 | -0.42 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 89 | -0.69 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 89 | -0.58 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 122 | -2.03 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 57 | -0.60 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 97 | -0.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 25 | 0.13 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 146 | -1.44 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 9 | 0.76 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Baseline | 4.24 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 65 | -0.46 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 110 | -1.06 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 110 | -1.79 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 97 | -0.35 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 97 | -0.07 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 73 | 0.13 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 33 | -0.54 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 97 | -1.24 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 9 | 0.58 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 170 | -1.25 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 110 | -1.22 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 73 | 0.31 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 122 | -0.77 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 33 | -0.39 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 89 | -1.45 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 49 | -1.04 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 33 | -0.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 122 | -0.13 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 81 | -0.62 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 17 | 0.17 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 122 | -0.95 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 81 | -1.52 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Baseline | 4.24 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 25 | -0.14 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 110 | -0.68 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 122 | -0.91 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 57 | -0.66 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 33 | -0.54 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 41 | -0.44 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 73 | -0.39 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 65 | -0.30 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 41 | -0.87 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 146 | -0.26 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 89 | -0.84 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 146 | -0.90 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 49 | -0.59 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 25 | 0.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 81 | -0.29 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 57 | -0.49 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 57 | -0.77 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 146 | -1.13 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 49 | -0.45 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 73 | -1.24 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 170 | -1.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 81 | -0.30 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 57 | -0.65 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 17 | -0.15 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 17 | -0.16 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 97 | -0.49 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 65 | -0.20 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 170 | -0.90 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 33 | -0.91 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Baseline | 5.10 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 73 | -0.26 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 65 | 0.03 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 9 | 0.22 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 170 | -2.00 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 81 | -0.67 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 110 | -0.86 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 146 | -0.72 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 9 | 1.19 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 89 | -0.58 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 73 | -0.19 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Baseline | 4.33 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 89 | -0.32 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 97 | -0.48 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 25 | -0.03 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 170 | -2.00 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 17 | -0.03 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 110 | -0.94 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 65 | -0.67 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 170 | -0.90 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 65 | -0.16 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 122 | -0.63 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 122 | -2.78 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 65 | -1.12 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 73 | -0.36 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 146 | -0.75 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 9 | 1.05 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 146 | -0.48 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Baseline | 5.39 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 170 | -1.45 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 33 | -0.37 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 146 | -0.42 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 97 | -0.68 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Baseline | 4.21 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 49 | -0.29 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 122 | -0.48 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 81 | 0.17 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 9 | 1.06 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 97 | -0.28 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 25 | 0.41 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 65 | -0.06 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left -Week 17 | -0.05 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 110 | -1.08 Kilograms |
| Sequence 2 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 97 | -0.32 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 17 | -0.16 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 33 | 0.12 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 41 | 0.07 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 49 | 0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 57 | 0.34 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 73 | -0.24 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Baseline | 2.90 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 9 | 0.20 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 17 | 0.17 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 25 | -0.02 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 33 | 0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 41 | -0.02 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 49 | 0.25 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 57 | -0.01 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 65 | 0.12 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 73 | 0.27 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 81 | 0.22 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 89 | 0.09 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 97 | -0.05 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 110 | -0.36 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 122 | 0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 146 | 0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 170 | -0.20 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Baseline | 2.96 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 9 | 0.26 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 17 | 0.30 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 25 | 0.27 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 33 | 0.20 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 41 | -0.12 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 49 | 0.04 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 57 | 0.09 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 65 | 0.28 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 73 | 0.17 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 81 | 0.59 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 89 | 0.17 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 97 | -0.04 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 110 | -0.38 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 122 | 0.14 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 146 | -0.03 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 170 | -0.15 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Baseline | 3.83 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 9 | 0.01 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left -Week 17 | -0.05 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 25 | -0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 33 | -0.04 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 41 | -0.34 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 65 | -0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 73 | -0.11 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 49 | -0.18 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 57 | -0.29 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 81 | 0.03 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 89 | -0.17 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 97 | -0.57 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 110 | -0.85 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 81 | -0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 122 | -0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 146 | -0.63 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 170 | -1.15 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Baseline | 4.35 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 9 | 0.38 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 65 | -0.20 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 17 | 0.74 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 25 | 0.52 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 33 | 0.26 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 41 | 0.59 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 49 | 0.55 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 57 | 0.62 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 110 | 0.22 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 65 | 0.86 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 122 | 0.58 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 146 | 0.84 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 73 | 1.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 65 | 0.63 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 170 | -0.50 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Baseline | 4.53 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 81 | 1.35 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 89 | 0.78 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 97 | 0.40 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 89 | -0.35 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 97 | -0.55 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 110 | -1.05 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 122 | -0.61 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 146 | -0.53 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 170 | -1.25 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Baseline | 3.73 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 9 | 0.49 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 9 | 0.03 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 17 | 0.46 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 25 | 0.47 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 33 | 0.12 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 41 | 0.22 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 49 | 0.33 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 57 | 0.08 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 65 | 0.75 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 73 | 0.73 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 81 | 0.69 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 17 | 0.11 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 25 | 0.00 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 33 | 0.06 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 41 | -0.26 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 49 | -0.01 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 57 | -0.23 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 89 | 0.68 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 97 | 0.18 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 146 | 1.13 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 73 | 0.55 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 110 | -0.23 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 122 | 0.52 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 9 | -0.16 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 17 | -0.12 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 25 | -0.38 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 33 | -0.55 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 41 | -0.67 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 49 | -0.85 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 81 | 0.58 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 73 | -0.02 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 81 | -0.23 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 89 | -0.27 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 97 | -0.82 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 110 | -1.89 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 122 | -1.04 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 146 | -0.57 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 170 | 1.60 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Baseline | 5.21 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 170 | -0.30 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Baseline | 5.08 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 9 | 0.08 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 25 | -0.21 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 33 | -0.39 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 41 | -0.28 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 49 | -0.34 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 57 | -0.69 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 65 | -0.26 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 73 | 0.15 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 57 | -0.73 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 65 | -0.42 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 89 | -0.21 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 97 | -0.44 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 110 | -1.42 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 122 | -0.44 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 146 | -0.56 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 170 | -0.75 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Baseline | 3.44 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 89 | 0.23 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 25 | 0.25 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 9 | 0.08 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 17 | 0.11 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 110 | -0.01 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 81 | 0.08 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 97 | 0.33 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 122 | 0.24 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 146 | -0.16 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 170 | 0.85 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Baseline | 3.46 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 9 | 0.12 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 17 | 0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 25 | 0.49 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 33 | 0.42 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 41 | 0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 49 | 0.66 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 57 | 0.33 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 65 | 0.25 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 73 | 0.58 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 81 | 0.86 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 89 | 0.55 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 97 | 0.46 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 110 | -0.08 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 122 | 0.14 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 146 | 0.19 Kilograms |
| Sequence 3 | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 170 | -0.20 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 17 | -0.37 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Baseline | 4.20 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 170 | -2.40 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 33 | 0.00 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 25 | -0.72 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 146 | -0.99 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 122 | -1.23 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 49 | 0.18 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 33 | -0.68 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 110 | -1.11 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 97 | -0.64 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 146 | -0.86 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 41 | -0.83 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 89 | -0.67 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 97 | 0.08 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 122 | -0.71 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 49 | -0.87 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 89 | 0.42 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Baseline | 4.69 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 122 | -0.36 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 57 | -1.11 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 81 | 0.38 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 170 | -2.80 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 57 | -0.19 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 65 | -0.89 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 73 | 0.47 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 146 | -0.22 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 110 | -0.81 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 73 | -0.87 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 122 | 0.15 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 97 | -0.40 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 57 | -1.06 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 110 | -0.22 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 65 | 0.18 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 73 | -0.55 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 65 | -0.69 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 65 | -0.01 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 89 | -1.35 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 49 | 0.20 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 41 | -0.06 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 89 | -0.40 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 97 | -1.31 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 33 | 0.19 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 25 | 0.15 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 81 | -0.31 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 17 | 0.36 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 110 | -1.89 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 57 | 0.12 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 65 | -0.63 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 57 | -0.08 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Week 9 | 0.60 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 122 | -1.89 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Left - Baseline | 4.59 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 170 | -2.57 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 146 | -1.19 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 73 | 0.11 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 146 | -1.66 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 73 | -0.24 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 122 | -0.98 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 170 | -3.37 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 57 | -0.63 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 81 | -0.56 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 65 | -0.29 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Baseline | 3.75 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 110 | -1.12 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 97 | -0.59 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 170 | -1.82 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 81 | 0.22 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 57 | -0.46 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 9 | 0.21 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 89 | -0.53 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 81 | -0.42 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 49 | -0.29 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 17 | 0.13 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 49 | -0.65 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 73 | -0.44 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 65 | -0.39 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 146 | -0.69 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 57 | -0.58 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 89 | 0.03 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 81 | -1.22 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 41 | -0.50 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 33 | -0.36 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 89 | -0.03 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 110 | -0.32 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 25 | -0.24 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left -Week 17 | -0.15 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Week 9 | 0.32 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Left - Baseline | 4.20 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 41 | -0.22 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 97 | 0.03 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 33 | -0.28 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 122 | -0.22 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 170 | -1.98 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 146 | -0.83 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 49 | 0.09 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 146 | -0.51 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 122 | -0.65 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 110 | -0.80 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 97 | 0.06 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 170 | -1.27 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 97 | -0.42 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 89 | -0.45 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 25 | -0.25 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Baseline | 3.86 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 81 | -0.25 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 73 | -0.37 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 17 | 0.04 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 9 | 0.05 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 65 | -0.26 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 57 | -0.53 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 41 | -0.01 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 17 | 0.03 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 49 | -0.32 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 49 | -0.90 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 41 | -0.39 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 41 | -1.00 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 33 | -0.81 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 110 | -0.40 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 73 | -0.69 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 25 | -0.72 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 17 | -0.27 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 25 | 0.16 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 81 | -1.23 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 9 | 0.16 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 122 | -0.09 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 33 | -0.30 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 89 | -1.28 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 110 | -0.43 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 73 | 0.19 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 25 | -0.07 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 97 | -1.28 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 65 | 0.15 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 146 | -0.37 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 9 | 0.29 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 110 | -1.98 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 97 | 0.01 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 89 | 0.10 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 33 | -0.09 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 122 | -2.04 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 49 | -0.47 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 41 | -0.38 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 33 | -0.28 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 17 | 0.14 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 146 | -1.63 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 25 | -0.26 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 17 | 0.04 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Week 9 | 0.20 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 170 | -2.10 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 81 | 0.04 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Baseline | 3.38 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Baseline | 5.52 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 73 | 0.29 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 65 | 0.25 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 57 | -0.15 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 81 | 0.07 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 49 | 0.18 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Right - Week 41 | -0.17 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Left - Week 170 | -2.62 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 41 | -0.19 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 33 | -0.10 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Right - Baseline | 3.42 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Baseline | 5.70 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 25 | -0.02 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 17 | 0.18 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Extension-Left - Week 170 | -1.65 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Knee Extension-Right - Week 9 | 0.28 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Hip Abduction-Right - Week 9 | 0.54 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Elbow Flexion-Right - Week 9 | 0.23 Kilograms |
| Total | Change From Baseline on the Myometry Based Muscle Strength - Overall Baseline | Shoulder Abduction-Left - Week 25 | 0.03 Kilograms |
Secondary
Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline
The NSAA was a 17-item test that measured gross motor function. Each individual item was evaluated with either 0-unable to perform independently, 1-able to perform with assistance, 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49, 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 49 | -3.6 Units on a Scale |
| Sequence 1 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 13 | -0.6 Units on a Scale |
| Sequence 1 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 73 | -5.5 Units on a Scale |
| Sequence 1 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 25 | -1.8 Units on a Scale |
| Sequence 1 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Baseline | 16.4 Units on a Scale |
| Sequence 2 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 25 | -0.7 Units on a Scale |
| Sequence 2 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 49 | -3.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 73 | -3.0 Units on a Scale |
| Sequence 2 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 13 | -1.7 Units on a Scale |
| Sequence 2 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Baseline | 17.1 Units on a Scale |
| Sequence 3 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 25 | -0.8 Units on a Scale |
| Sequence 3 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Baseline | 12.9 Units on a Scale |
| Sequence 3 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 13 | -0.4 Units on a Scale |
| Sequence 3 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 49 | -3.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 73 | -4.0 Units on a Scale |
| Total | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 49 | -3.3 Units on a Scale |
| Total | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 13 | -0.9 Units on a Scale |
| Total | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Baseline | 15.4 Units on a Scale |
| Total | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 25 | -1.0 Units on a Scale |
| Total | Change From Baseline on the Northstar Ambulatory Assessment (NSAA) Score - B5161004 Baseline | Week 73 | -4.2 Units on a Scale |
Secondary
Change From Baseline on the NSAA Score - Overall Baseline
The NSAA was a 17-item test that measured gross motor function. Each individual item was evaluated with either 0-unable to perform independently, 1-able to perform with assistance, 2-able to perform without assistance. A total score was achieved by summing all the individual items. The total score could range from 0 to 34 (fully-independent function). This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Baseline | 20.8 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 97 | -4.4 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 89 | -4.2 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 41 | -1.5 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 81 | -4.1 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 25 | 0.1 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 122 | -6.4 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 49 | -1.8 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 73 | -4.7 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 170 | -11.5 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 9 | -0.2 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 57 | -2.6 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 146 | -9.9 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 17 | 0.3 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 110 | -5.1 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 65 | -2.7 Units on a Scale |
| Sequence 1 | Change From Baseline on the NSAA Score - Overall Baseline | Week 33 | -0.4 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 65 | -3.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 97 | -6.7 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 73 | -5.1 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 170 | -12.0 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 81 | -4.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 89 | -6.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 146 | -8.3 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 25 | -1.4 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 33 | -1.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 9 | 0.4 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 122 | -7.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 41 | -2.7 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Baseline | 21.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 49 | -3.4 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 110 | -7.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 57 | -3.7 Units on a Scale |
| Sequence 2 | Change From Baseline on the NSAA Score - Overall Baseline | Week 17 | -2.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 81 | -6.0 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Baseline | 19.5 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 9 | -0.8 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 17 | -0.9 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 25 | -2.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 33 | -2.9 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 41 | -3.6 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 49 | -4.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 57 | -5.5 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 65 | -5.8 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 73 | -5.8 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 89 | -7.4 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 97 | -7.0 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 110 | -5.9 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 122 | -7.6 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 146 | -7.3 Units on a Scale |
| Sequence 3 | Change From Baseline on the NSAA Score - Overall Baseline | Week 170 | -7.0 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 97 | -6.1 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 57 | -3.9 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 49 | -3.1 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 9 | -0.2 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 110 | -6.1 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 41 | -2.6 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 33 | -1.6 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Baseline | 20.5 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 122 | -7.1 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 25 | -1.2 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 17 | -0.9 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 81 | -4.9 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 170 | -10.2 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 89 | -6.0 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 73 | -5.2 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 65 | -4.1 Units on a Scale |
| Total | Change From Baseline on the NSAA Score - Overall Baseline | Week 146 | -8.6 Units on a Scale |
Secondary
Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline
A time to event analysis was performed for loss of ambulation. Loss of ambulation was defined as the inability to walk unassisted and without braces for at least 10 m, as assessed and reported by the investigator at each study visit, and confirmed by the inability to walk/run 10 m (as 1 component of the NSAA) evaluated at the next visit at which timed function tests were performed. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49, 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 49 | 0.665 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 13 | -0.029 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 73 | 1.160 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 25 | 0.546 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Baseline | 6.245 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 25 | -0.172 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 49 | -0.735 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 73 | 0.480 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 13 | 0.383 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Baseline | 5.894 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 25 | 0.743 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Baseline | 5.800 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 13 | 0.089 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 49 | 0.488 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 73 | 0.600 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 49 | 0.139 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 13 | 0.158 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Baseline | 5.988 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 25 | 0.334 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - B5161004 Baseline | Week 73 | 0.680 Seconds |
Secondary
Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline
A time to event analysis was performed for loss of ambulation. Loss of ambulation was defined as the inability to walk unassisted and without braces for at least 10 m, as assessed and reported by the investigator at each study visit, and confirmed by the inability to walk/run 10 m (as 1 component of the NSAA) evaluated at the next visit at which timed function tests were performed. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Baseline | 5.780 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 97 | 0.928 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 89 | 1.287 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 41 | 0.445 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 81 | 1.243 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 25 | 0.468 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 122 | 1.195 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 49 | 0.360 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 73 | 1.156 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 170 | 3.300 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 9 | 0.159 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 57 | 1.018 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 146 | 2.138 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 17 | 0.173 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 110 | 1.085 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 65 | 1.482 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 33 | 0.348 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 65 | 0.988 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 97 | 0.883 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 73 | 1.128 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 170 | 2.090 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 81 | 0.625 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 89 | 0.837 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 146 | 1.588 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 25 | 0.719 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 33 | 0.417 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 9 | 0.008 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 122 | 1.416 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 41 | 0.471 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Baseline | 5.862 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 49 | 0.869 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 110 | 1.238 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 57 | 1.573 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 17 | 0.115 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 81 | 0.687 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Baseline | 6.609 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 9 | 0.114 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 17 | 0.083 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 25 | 0.110 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 33 | 0.264 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 41 | 0.845 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 49 | 0.145 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 57 | 0.539 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 65 | 0.745 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 73 | 0.324 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 89 | 0.460 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 97 | 0.670 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 110 | 0.300 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 122 | 0.914 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 146 | 1.662 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 170 | 1.800 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 97 | 0.837 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 57 | 1.102 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 49 | 0.482 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 9 | 0.096 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 110 | 0.936 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 41 | 0.567 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 33 | 0.348 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Baseline | 6.078 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 122 | 1.205 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 25 | 0.446 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 17 | 0.126 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 81 | 0.882 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 170 | 2.320 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 89 | 0.897 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 73 | 0.933 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 65 | 1.121 Seconds |
| Total | Change From Baseline on the NSAA - Time to Complete 10 m Run/Walk - Overall Baseline | Week 146 | 1.785 Seconds |
Secondary
Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline
Rise from supine was a timed functional test within NSAA. This test of time-to-stand from supine was analyzed separately for summary tabulation along with the total NSAA score. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49, 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 13 | 0.330 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 49 | 0.670 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 25 | -0.113 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Baseline | 4.517 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 25 | 1.463 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Baseline | 6.508 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 13 | 1.353 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 49 | 1.518 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 73 | 10.170 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 13 | -0.038 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 25 | -0.167 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Baseline | 6.250 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 73 | 2.300 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 49 | 2.978 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Baseline | 5.948 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 49 | 2.072 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 25 | 0.569 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 73 | 6.235 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - B5161004 Baseline | Week 13 | 0.662 Seconds |
Secondary
Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline
Rise from supine was a timed functional test within NSAA. This test of time-to-stand from supine was analyzed separately for summary tabulation along with the total NSAA score. This is the overall change from baseline which included the change since enrolling in the parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 33 | 1.382 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 146 | -0.400 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 65 | 1.590 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 57 | 1.577 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 41 | 1.184 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 110 | 0.792 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 49 | 1.642 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 97 | 1.009 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 17 | 10.251 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 122 | -0.133 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 89 | 2.538 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Baseline | 6.440 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 25 | 1.283 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 9 | -0.140 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 81 | 2.153 Seconds |
| Sequence 1 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 73 | 2.664 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 81 | 2.422 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Baseline | 7.059 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 9 | 0.486 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 17 | 1.123 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 25 | 0.514 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 33 | 0.392 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 41 | 0.526 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 49 | 0.730 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 57 | 1.376 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 65 | 1.570 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 73 | 1.765 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 89 | 3.249 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 97 | 2.418 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 110 | 3.753 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 122 | 4.543 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 146 | 5.295 Seconds |
| Sequence 2 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 170 | 13.780 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 33 | 1.143 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 65 | 1.907 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Baseline | 7.046 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 73 | 2.266 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 25 | 1.456 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 81 | 1.971 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 17 | 1.148 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 170 | 4.300 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 89 | 2.824 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 146 | 4.978 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 97 | 1.933 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 9 | 0.867 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 110 | 2.884 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 41 | 1.620 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 49 | 1.630 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 122 | 1.750 Seconds |
| Sequence 3 | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 57 | 1.316 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 122 | 2.573 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 97 | 1.860 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 65 | 1.672 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 25 | 1.086 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 49 | 1.350 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 146 | 4.521 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 73 | 2.244 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 33 | 1.000 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 17 | 4.693 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 110 | 2.769 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 81 | 2.190 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Baseline | 6.840 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 41 | 1.086 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 57 | 1.439 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 89 | 2.860 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 9 | 0.356 Seconds |
| Total | Change From Baseline on the NSAA - Time to Stand From Supine - Overall Baseline | Week 170 | 9.040 Seconds |
Secondary
Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline
PEFR was one of the Pulmonary Function Tests (PFTs). Three technically adequate peak expiratory flow rate (PEFR) maneuvers were performed and reported in Litres/Minute (L/min), and the highest single PEFR was reported in the database. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of PEFR was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49 and 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 49 | -31.171 L/min |
| Sequence 1 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 13 | -17.014 L/min |
| Sequence 1 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 73 | 6.800 L/min |
| Sequence 1 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 25 | -16.260 L/min |
| Sequence 1 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Baseline | 200.314 L/min |
| Sequence 2 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 25 | 0.767 L/min |
| Sequence 2 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 49 | 11.700 L/min |
| Sequence 2 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 73 | 5.600 L/min |
| Sequence 2 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 13 | 20.613 L/min |
| Sequence 2 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Baseline | 187.200 L/min |
| Sequence 3 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 25 | 39.250 L/min |
| Sequence 3 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Baseline | 185.882 L/min |
| Sequence 3 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 13 | 8.214 L/min |
| Sequence 3 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 49 | 50.967 L/min |
| Sequence 3 | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 73 | 36.000 L/min |
| Total | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 49 | 8.305 L/min |
| Total | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 13 | 4.326 L/min |
| Total | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Baseline | 190.558 L/min |
| Total | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 25 | 9.341 L/min |
| Total | Change From Baseline on the Peak Expiratory Flow Rate (PEFR)- B5161004 Baseline | Week 73 | 12.160 L/min |
Secondary
Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline
The PUL scale was used to assess motor performance of the upper limb for individuals with DMD. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into 3 levels; shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 to 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores; shoulder maximum 16, middle level maximum score 34 and distal level maximum score 24. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of PUL was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49 and 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 49 | -1.6 Units on a Scale |
| Sequence 1 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 13 | -1.2 Units on a Scale |
| Sequence 1 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 73 | -13.5 Units on a Scale |
| Sequence 1 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 25 | -1.2 Units on a Scale |
| Sequence 1 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Baseline | 65.6 Units on a Scale |
| Sequence 2 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 25 | -3.0 Units on a Scale |
| Sequence 2 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 49 | -7.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 73 | -7.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 13 | -1.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Baseline | 65.3 Units on a Scale |
| Sequence 3 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 25 | -0.3 Units on a Scale |
| Sequence 3 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Baseline | 63.8 Units on a Scale |
| Sequence 3 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 13 | -1.8 Units on a Scale |
| Sequence 3 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 49 | -2.6 Units on a Scale |
| Sequence 3 | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 73 | -6.0 Units on a Scale |
| Total | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 49 | -3.8 Units on a Scale |
| Total | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 13 | -1.5 Units on a Scale |
| Total | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Baseline | 64.9 Units on a Scale |
| Total | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 25 | -1.5 Units on a Scale |
| Total | Change From Baseline on the Performance of Upper Limb (PUL) Overall Score - B5161004 Baseline | Week 73 | -9.0 Units on a Scale |
Secondary
Change From Baseline on the PUL Overall Score - Overall Baseline
The PUL scale was used to assess motor performance of the upper limb for individuals with DMD. The PUL scale includes 22 items; an entry item defining the starting functional level, and 21 items subdivided into 3 levels; shoulder (4 items), middle (9 items) and distal (8 items). Scoring options per item may not be uniform and may vary from 0-1 to 0-6, according to the performance, with higher values corresponding to better performance. A total maximum score of 74 is achieved by adding the individual level scores; shoulder maximum 16, middle level maximum score 34 and distal level maximum score 24. This is the overall change from baseline which included the change since enrolling in parent study B5161002. Overall baseline was defined as the last pre-dose assessment prior to the first day of dosing in study B5161002. Week 1 was counted starting from the study treatment in study B5161002.
Time frame: Baseline, Weeks 9,17,25,33,41,49,57,65,73,81,89,97,110,122,146,170.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Baseline | 66.3 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 97 | -1.4 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 89 | -0.4 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 41 | -0.1 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 81 | -0.7 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 25 | 0.7 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 122 | -1.4 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 49 | 0.1 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 73 | -1.0 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 170 | -14.0 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 9 | -0.7 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 57 | -0.3 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 146 | -2.3 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 17 | -0.5 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 110 | -1.5 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 65 | 0.6 Units on a Scale |
| Sequence 1 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 33 | 0.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 65 | -0.9 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 97 | -2.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 73 | -1.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 170 | -4.0 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 81 | -1.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 89 | -2.9 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 146 | -6.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 25 | 0.3 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 33 | -0.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 9 | 0.5 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 122 | -2.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 41 | -0.4 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Baseline | 66.9 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 49 | -0.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 110 | -3.2 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 57 | -0.8 Units on a Scale |
| Sequence 2 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 17 | -0.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 81 | -1.5 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Baseline | 66.9 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 9 | -0.1 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 17 | -0.4 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 25 | 0.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 33 | -0.5 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 41 | -0.4 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 49 | -0.5 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 57 | -4.7 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 65 | -4.6 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 73 | -1.2 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 89 | -2.3 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 97 | -2.3 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 110 | -4.4 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 122 | -2.4 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 146 | -2.9 Units on a Scale |
| Sequence 3 | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 170 | -9.0 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 97 | -2.0 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 57 | -2.0 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 49 | -0.4 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 9 | -0.1 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 110 | -3.1 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 41 | -0.3 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 33 | -0.2 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Baseline | 66.7 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 122 | -2.2 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 25 | 0.4 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 17 | -0.4 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 81 | -1.1 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 170 | -9.0 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 89 | -1.9 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 73 | -1.3 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 65 | -1.7 Units on a Scale |
| Total | Change From Baseline on the PUL Overall Score - Overall Baseline | Week 146 | -3.8 Units on a Scale |
Secondary
Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline
The 6MWD evaluated ambulation ability by measuring the distance walked in 6 minutes. In order to provide optimal testing conditions and consistency in endpoint measurements, the functional assessment of 6MWD was completed at approximately the same time of day. Baseline was defined as the last assessment prior to dosing on Day 1 in B5161004. Week 1 was counted starting from the study treatment in study B5161004.
Time frame: Baseline, Weeks 13, 25, 49 and 73.
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure. Number analyzed refers to number of participants evaluable for specified rows of categories.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sequence 1 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 25 | -45.5 Meters |
| Sequence 1 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Baseline | 328.0 Meters |
| Sequence 1 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 49 | -98.0 Meters |
| Sequence 1 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 13 | -23.6 Meters |
| Sequence 1 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 73 | -110.0 Meters |
| Sequence 2 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 25 | -16.1 Meters |
| Sequence 2 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 13 | -26.1 Meters |
| Sequence 2 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 49 | -16.8 Meters |
| Sequence 2 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Baseline | 386.2 Meters |
| Sequence 2 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 73 | -41.5 Meters |
| Sequence 3 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 73 | -22.0 Meters |
| Sequence 3 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Baseline | 360.4 Meters |
| Sequence 3 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 13 | -8.4 Meters |
| Sequence 3 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 25 | -11.3 Meters |
| Sequence 3 | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 49 | -39.0 Meters |
| Total | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 73 | -65.0 Meters |
| Total | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 49 | -53.3 Meters |
| Total | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 13 | -20.1 Meters |
| Total | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Baseline | 356.5 Meters |
| Total | Change From Baseline on the Six Minute Walk Distance (6MWD) - B5161004 Baseline | Week 25 | -25.2 Meters |
Secondary
Number of Participants With Anti-drug Antibodies (ADA) Development
The criterion for positive result of ADA samples was ADA titer \>=1.88. The criterion for negative result of ADA samples was ADA titer \<1.88.
Time frame: Weeks 1, 25, 49, 73 and Early Termination
Population: The analysis population included all participants who had received at least 1 dose of study medication in current study B5161004. Number analyzed refers to the number of participants evaluable for specified rows of time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 -Negative <1.88 | 2 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1 - Negative <1.88 | 14 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 - Positive >= 1.88 | 0 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 -Negative <1.88 | 12 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 - Positive >=1.88 | 0 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1- Positive >=1.88 | 0 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Negative<1.88 | 16 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Positive>=1.88 | 0 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 -Negative <1.88 | 7 Participants |
| Sequence 1 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 - Positive >=1.88 | 0 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 -Negative <1.88 | 2 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1- Positive >=1.88 | 0 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Positive>=1.88 | 0 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Negative<1.88 | 14 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 - Positive >=1.88 | 0 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 -Negative <1.88 | 12 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 - Positive >= 1.88 | 0 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 -Negative <1.88 | 6 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1 - Negative <1.88 | 17 Participants |
| Sequence 2 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 - Positive >=1.88 | 0 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 - Positive >=1.88 | 0 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Negative<1.88 | 13 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 - Positive >=1.88 | 0 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 -Negative <1.88 | 8 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1 - Negative <1.88 | 14 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Positive>=1.88 | 0 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 -Negative <1.88 | 13 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1- Positive >=1.88 | 0 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 -Negative <1.88 | 2 Participants |
| Sequence 3 | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 - Positive >= 1.88 | 0 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Negative<1.88 | 43 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1- Positive >=1.88 | 0 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 1 - Negative <1.88 | 45 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 - Positive >=1.88 | 0 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 25 -Negative <1.88 | 37 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 - Positive >= 1.88 | 0 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 49 -Negative <1.88 | 21 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 - Positive >=1.88 | 0 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Week 73 -Negative <1.88 | 6 Participants |
| Total | Number of Participants With Anti-drug Antibodies (ADA) Development | Early Termination-Positive>=1.88 | 0 Participants |
Secondary
Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary
Time frame: Weeks 1, 25, 49 and 73
Population: The analysis population included all participants who had received at least 1 dose of study medication and had at least 1 PF-06252616 concentration measured in study B5161004. Participants without contributing to the summary statistics are excluded below. Number analyzed refers to number of participants evaluable for specified rows of time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sequence 1 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 1 | 145774.93 Nanogram Per Milliliter (ng/mL) | Standard Deviation 56594.3925 |
| Sequence 1 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 25 | 355111.67 Nanogram Per Milliliter (ng/mL) | Standard Deviation 90842.1052 |
| Sequence 1 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 49 | 405812.43 Nanogram Per Milliliter (ng/mL) | Standard Deviation 110320.246 |
| Sequence 1 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 73 | 401899.50 Nanogram Per Milliliter (ng/mL) | Standard Deviation 3068.1363 |
| Sequence 2 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 73 | 400176.00 Nanogram Per Milliliter (ng/mL) | Standard Deviation 84223.4887 |
| Sequence 2 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 1 | 33.3529 Nanogram Per Milliliter (ng/mL) | Standard Deviation 137.5176 |
| Sequence 2 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 49 | 379259.33 Nanogram Per Milliliter (ng/mL) | Standard Deviation 71128.3552 |
| Sequence 2 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 25 | 345943.67 Nanogram Per Milliliter (ng/mL) | Standard Deviation 73922.3955 |
| Sequence 3 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 73 | 401847.50 Nanogram Per Milliliter (ng/mL) | Standard Deviation 164854.168 |
| Sequence 3 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 25 | 488082.31 Nanogram Per Milliliter (ng/mL) | Standard Deviation 199634.909 |
| Sequence 3 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 49 | 459825.13 Nanogram Per Milliliter (ng/mL) | Standard Deviation 49395.4262 |
| Sequence 3 | Serum PF-06252616 (Domagrozumab) Concentration Versus Time Summary | Week 1 | 238433.36 Nanogram Per Milliliter (ng/mL) | Standard Deviation 119862.33 |