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| Name | Class |
|---|---|
| Kyowa Kirin Co., Ltd. | INDUSTRY |
Not provided
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The primary objectives of this study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KRN23 | Experimental | KRN23 subcutaneous (SC) injections every 4 weeks. Starting doses will be based on the subject's last dose in study KRN23-INT-001 (NCT02312687) or KRN23-INT-002 (NCT01571596). Doses may be titrated to achieve the target peak serum phosphorus range. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KRN23 | Biological | solution for SC injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related. | Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks). |
| Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Clinically significant changes from baseline reported as adverse events are presented. | Through Week 184 |
| Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category | Clinically significant changes from baseline reported as adverse events are presented. | Through Week 184 |
| Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category | Clinically significant changes from baseline reported as adverse events are presented. | Through Week 184 |
| Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Ultragenyx Pharmaceutical Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University California San Francisco Hospital | San Francisco | California | 94143 | United States | ||
| Yale University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36072994 | Derived | Weber TJ, Imel EA, Carpenter TO, Peacock M, Portale AA, Hetzer J, Merritt JL, Insogna K. Long-term Burosumab Administration Is Safe and Effective in Adults With X-linked Hypophosphatemia. J Clin Endocrinol Metab. 2022 Dec 17;108(1):155-165. doi: 10.1210/clinem/dgac518. |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | KRN23 | KRN23 subcutaneous (SC) injections every 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | KRN23 | KRN23 SC injections every 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs), Treatment Emergent AEs (TEAEs), Serious AEs (SAEs), and AEs Leading to Discontinuation or Death | An AE is defined as any untoward medical occurrence, whether or not considered drug related. An SAE or serious suspected adverse reaction is an AE or suspected adverse reaction that at any dose, in the view of either the investigator or sponsor, results in any of the following outcomes: death; a life-threatening AE; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; a congenital anomaly/birth defect; an important medical event. A TEAE is an AE that occurred on or after the first burosumab dose. AEs were graded as 1 (mild), 2 (moderate), 3 (severe), 4 (life-threatening), 5 (death). AEs were classified by the Investigator as possibly related, probably related, or definitely related. | Safety Analysis Set | Posted | Count of Participants | Participants | Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks). |
Screening through the end of study plus 4-8 weeks. The mean duration of burosumab exposure was 165.6 weeks (range: 68-184 weeks).
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KRN23 | KRN23 SC injections every 4 weeks | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hereditary Non-Polyposis Colorectal Cancer Syndrome | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information | Ultragenyx Pharmaceutical Inc | 1-888-756-8567 | medinfo@ultragenyx.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2017 | Nov 26, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 27, 2016 | Nov 26, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D053098 | Familial Hypophosphatemic Rickets |
| ID | Term |
|---|---|
| D063730 | Rickets, Hypophosphatemic |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000601956 | burosumab |
Not provided
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Clinically significant changes from baseline reported as adverse events are presented. |
| Through Week 184 |
| Number of Participants With Clinically Significant Changes From Baseline in ECGs | Clinically significant changes from baseline reported as adverse events are presented. | Through Week 184 |
| Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category | Clinically significant changes from baseline reported as adverse events are presented. | Through Week 184 |
| Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline | Through Week 184 |
| Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing | Through Week 184 |
| Change From Baseline Over Time in Serum Phosphorus | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in Serum iPTH | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in Serum Total FGF23 | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in Serum Free FGF23 | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in Serum 1,25(OH)2D | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Ovr Time in 2-hour Urine TmP/GFR | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in in 2-hour Urine TRP | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in FEP | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in 24-hour Urine Phosphorus | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in 24-Hour Urine Calcium | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in 24-Hour Urine Creatinine | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in Total ALP | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in BALP | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in CTx | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| Change From Baseline Over Time in P1NP | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
| New Haven |
| Connecticut |
| 06510 |
| United States |
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Houston Methodist Reasearch Institute | Houston | Texas | 77030 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Serum Phosphorus | Mean | Standard Deviation | mg/dL |
|
| Serum Intact Parathyroid Hormone (iPTH) | Mean | Standard Deviation | pg/mL |
|
| Serum Total Fibroblast Growth Factor 23 (FGF23) | Mean | Standard Deviation | pg/mL |
|
| Serum Free FGF23 | Mean | Standard Deviation | pg/mL |
|
| Serum 1,25-dihydroxy vitamin D [1,25(OH)2D] | Mean | Standard Deviation | pg/mL |
|
| 2-hour Urine TmP/GFR | TmP/GFR: ratio of renal tubular maximum phosphate reabsorption rate to glomerular filtration rate | Mean | Standard Deviation | mg/dL |
|
| 2-hour Urine Tubular Reabsorption of Phosphate (TRP) | Mean | Standard Deviation | fraction of phosphorus reabsorbed |
|
| Fractional Excretion of Phosphorus (FEP) | Mean | Standard Deviation | fraction of phosphorus excreted |
|
| 24-hour Urine Phosphorus | Mean | Standard Deviation | g/24hr |
|
| 24-Hour Urine Calcium | participants with an assessment | Mean | Standard Deviation | mg/24hr |
|
| 24-Hour Urine Creatinine | Mean | Standard Deviation | mg/24hr |
|
| 24-Hour Urine Calcium/Creatinine Ratio | participants with an assessment | Mean | Standard Deviation | mg/mg |
|
| Total Alkaline Phosphatase (ALP) | Mean | Standard Deviation | U/L |
|
| Bone-Specific Alkaline Phosphatase (BALP) | Mean | Standard Deviation | mcg/L |
|
| Carboxy Terminal Cross-Linked Telopeptide of Type I Collagen (CTx) | Mean | Standard Deviation | pg/mL |
|
| Procollagen Type N-Propeptide (P1NP) | Mean | Standard Deviation | ng/mL |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | KRN23 | KRN23 SC injections every 4 weeks |
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Vital Signs | Clinically significant changes from baseline reported as adverse events are presented. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Laboratory Values, by Category | Clinically significant changes from baseline reported as adverse events are presented. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Physical Exams, by Category | Clinically significant changes from baseline reported as adverse events are presented. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Echocardiogram (ECHO) Tests | Clinically significant changes from baseline reported as adverse events are presented. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in ECGs | Clinically significant changes from baseline reported as adverse events are presented. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Number of Participants With Clinically Significant Changes From Baseline in Renal Ultrasound, by Category | Clinically significant changes from baseline reported as adverse events are presented. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Number of Participants Positive for Anti-KRN23 Antibodies and Neutralizing Antibodies at Baseline and Anytime Post-Baseline | Participants tested for neutralizing antibodies (n=4) are those who were positive for anti-KRN23 antibodies at any time during the study. | Posted | Count of Participants | Participants | Through Week 184 |
|
|
|
| Primary | Percentage of Participants Reaching Serum Phosphorus Normal Range at Baseline and Any Time After Dosing | Pharmacodynamic (PD) Analysis Set: all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data. | Posted | Number | 95% Confidence Interval | percentage of participants | Through Week 184 |
|
|
|
| Primary | Change From Baseline Over Time in Serum Phosphorus | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in Serum iPTH | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in Serum Total FGF23 | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Mean | Standard Error | pg/mL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in Serum Free FGF23 | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in Serum 1,25(OH)2D | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Ovr Time in 2-hour Urine TmP/GFR | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | mg/dL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in in 2-hour Urine TRP | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | fraction of phosphorus reabsorbed | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in FEP | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | fraction of phosphorus excreted | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in 24-hour Urine Phosphorus | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | g/24hr | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in 24-Hour Urine Calcium | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | mg/24hr | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in 24-Hour Urine Creatinine | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | mg/24hr | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in 24-Hour Urine Calcium/Creatinine Ratio | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | mg/mg | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in Total ALP | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | U/L | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in BALP | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | mcg/L | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in CTx | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| Primary | Change From Baseline Over Time in P1NP | PD Analysis Set (all participants who received at least 1 dose of burosumab and had evaluable serum/urinary data) with an assessment at given time point. | Posted | Least Squares Mean | Standard Error | ng/mL | Baseline, Weeks 24, 48, 72, 96, 120, 144 |
|
|
|
|
| 20 |
| 9 |
| 20 |
| 20 |
| 20 |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Medical Device Site Joint Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Adenocarcinoma Of Colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Chordoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lung Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Hemianaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vertigo Positional | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Conjunctival Haemorrhage | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Visual Impairment | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vitreous Floaters | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal Distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal Pain Lower | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Faecal Incontinence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intestinal Dilatation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Irritable Bowel Syndrome | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Large Intestinal Stenosis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatic Calcification | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatic Duct Dilatation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cyst | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gravitational Oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection Site Erythema | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection Site Reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Medical Device Site Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tenderness | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ampulla Of Vater Stenosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Biliary Dilatation | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic Steatosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Seasonal Allergy | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthritis Infective | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Breast Abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Ear Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes Zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Infected Bite | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Localised Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Lyme Disease | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Otitis Externa | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngitis Streptococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sinusitis Bacterial | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Tooth Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Arthropod Bite | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Hand Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Procedural Hypertension | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Procedural Nausea | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Tooth Injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Amylase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Aspartate Aminotransferase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood Alkaline Phosphatase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood Cholesterol Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood Iron Decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood Pressure Decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Eosinophil Count Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Gamma-Glutamyltransferase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Haemoglobin Decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Oxygen Saturation Decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Smear Cervix Abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Urine Electrophoresis Abnormal | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bone Lesion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint Effusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint Range Of Motion Decreased | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain In Jaw | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Spinal Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemangioma Of Liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Aphasia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cervical Radiculopathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cubital Tunnel Syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Disturbance In Attention | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fine Motor Skill Dysfunction | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nerve Compression | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Neuropathy Peripheral | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Peroneal Nerve Palsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Restless Legs Syndrome | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinus Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Mental Status Changes | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bladder Prolapse | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypercalciuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nephrocalcinosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Renal Mass | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urethral Stenosis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urinary Hesitation | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urinary Retention | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Endometrial Hyperplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Menopausal Symptoms | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pelvic Pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Postmenopausal Haemorrhage | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Prostatitis | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Scrotal Oedema | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Testicular Swelling | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Uterine Cervical Squamous Metaplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vaginal Prolapse | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vulvovaginal Dryness | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vulvovaginal Pain | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Laryngospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sleep Apnoea Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Upper-Airway Cough Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dermal Cyst | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Leukoplakia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Papule | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ophthalmic Fluid Drainage | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D009140 |
| Musculoskeletal Diseases |
| D007015 | Hypophosphatemia, Familial |
| D015499 | Renal Tubular Transport, Inborn Errors |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008664 | Metal Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D017674 | Hypophosphatemia |
| D010760 | Phosphorus Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| Hyperglycemia |
|
| Elevated alanine aminotransferase |
|
| Elevated aspartate aminotransferase |
|
| Elevated gamma-glutamyl transferase |
|
| Proteinuria |
|
| Elevated amylase |
|
| Elevated alkaline phosphatase |
|
| Elevated lipase |
|
| Hypercalciuria |
|
| Worsening hypercholesterolemia |
|
| Decreased hemoglobin |
|
| Hypocalcemia (intermittent) |
|
| Hypovitaminosis D |
|
| Elevated cholesterol |
|
| Hyperparathyroidism |
|
| Urine electrophoresis abnormal |
|
| Dermal cyst |
|
| Osteoarthritis |
|
| Gravitational oedema |
|
| Hypoaesthesia |
|
| Neuropathy peripheral |
|
| Arthralgia |
|
| Peroneal nerve palsy |
|
| Spinal pain |
|
| Bone lesion |
|
| Femur fracture |
|
| Scrotal oedema |
|
| Synovial cyst |
|
| Testicular swelling |
|
| Thermal burn |
|
| Weight decreased |
|
| Nephrolithiasis |
|
| Title | Measurements |
|---|---|
|
| Baseline: Neutralizing Antibodies |
|
|
| Postbaseline: Neutralizing Antibodies |
|
|
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48 |
| GEE |
| < 0.0001 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| 0.68 |
| 2-Sided |
| 95 |
| 0.57 |
| 0.79 |
| Superiority |
| Change at Week 72 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 0.59 | 2-Sided | 95 | 0.44 | 0.75 | Superiority |
| Change at Week 96 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 0.47 | 2-Sided | 95 | 0.31 | 0.63 | Superiority |
| Change at Week 120 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 0.57 | 2-Sided | 95 | 0.41 | 0.73 | Superiority |
| Change at Week 144 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 0.59 | 2-Sided | 95 | 0.43 | 0.76 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE estimate |
| 0.1334 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| -11.17 |
| 2-Sided |
| 95 |
| -25.76 |
| 3.42 |
| Superiority |
| Change at Week 72 | GEE estimate | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -18.12 | 2-Sided | 95 | -27.07 | -9.17 | Superiority |
| Change at Week 96 | GEE estimate | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -25.28 | 2-Sided | 95 | -36.21 | -14.35 | Superiority |
| Change at Week 120 | GEE estimate | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -22.39 | 2-Sided | 95 | -31.51 | -13.26 | Superiority |
| Change at Week 144 | GEE estimate | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -28.33 | 2-Sided | 95 | -40.11 | -16.56 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| < 0.0001 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| 202525.38 |
| 2-Sided |
| 95 |
| 168364.92 |
| 236685.83 |
| Superiority |
| Change at Week 72 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 221481.03 | 2-Sided | 95 | 179628.07 | 263333.98 | Superiority |
| Change at Week 96 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 221674.07 | 2-Sided | 95 | 181313.34 | 262034.81 | Superiority |
| Change at Week 120 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 208270.02 | 2-Sided | 95 | 167217.98 | 249322.06 | Superiority |
| Change at Week 144 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 235953.55 | 2-Sided | 95 | 166110.59 | 305796.52 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| < 0.0001 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| 1244.99 |
| 2-Sided |
| 95 |
| 1166.10 |
| 1323.88 |
| Superiority |
| Change at Week 72 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 1298.49 | 2-Sided | 95 | 1233.56 | 1363.43 | Superiority |
| Change at Week 96 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 1311.05 | 2-Sided | 95 | 1238.30 | 1383.80 | Superiority |
| Change at Week 120 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 1368.68 | 2-Sided | 95 | 1327.40 | 1409.96 | Superiority |
| Change at Week 144 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 1298.41 | 2-Sided | 95 | 1208.31 | 1388.51 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| 0.3092 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| 2.70 |
| 2-Sided |
| 95 |
| -2.50 |
| 7.90 |
| Superiority |
| Change at Week 72 | GEE | 0.2958 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 2.62 | 2-Sided | 95 | -2.29 | 7.53 | Superiority |
| Change at Week 96 | GEE | 0.8796 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 0.31 | 2-Sided | 95 | -3.71 | 4.33 | Superiority |
| Change at Week 120 | GEE | 0.8396 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -0.48 | 2-Sided | 95 | -5.11 | 4.16 | Superiority |
| Change at Week 144 | GEE | 0.2284 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -3.43 | 2-Sided | 95 | -9.00 | 2.15 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| 0.47 |
| 2-Sided |
| 95 |
| 0.37 |
| 0.56 |
| Superiority |
| Change at Week 72 | LS Mean | 0.42 | 2-Sided | 95 | 0.28 | 0.56 | Superiority |
| Change at Week 96 | LS Mean | 0.44 | 2-Sided | 95 | 0.27 | 0.60 | Superiority |
| Change at Week 120 | LS Mean | 0.36 | 2-Sided | 95 | 0.23 | 0.48 | Superiority |
| Change at Week 144 | LS Mean | 0.47 | 2-Sided | 95 | 0.32 | 0.62 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| 0.01 |
| 2-Sided |
| 95 |
| -0.01 |
| 0.03 |
| Superiority |
| Change at Week 72 | LS Mean | 0.01 | 2-Sided | 95 | -0.01 | 0.04 | Superiority |
| Change at Week 96 | LS Mean | 0.05 | 2-Sided | 95 | 0.02 | 0.07 | Superiority |
| Change at Week 120 | LS Mean | 0.01 | 2-Sided | 95 | -0.02 | 0.03 | Superiority |
| Change at Week 144 | LS Mean | 0.02 | 2-Sided | 95 | -0.01 | 0.05 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| -0.01 |
| 2-Sided |
| 95 |
| -0.03 |
| 0.01 |
| Superiority |
| Change at Week 72 | LS Mean | -0.01 | 2-Sided | 95 | -0.04 | 0.01 | Superiority |
| Change at Week 96 | LS Mean | -0.05 | 2-Sided | 95 | -0.07 | -0.02 | Superiority |
| Change at Week 120 | LS Mean | -0.01 | 2-Sided | 95 | -0.03 | 0.02 | Superiority |
| Change at Week 144 | LS Mean | -0.02 | 2-Sided | 95 | -0.05 | 0.01 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| 0.02 |
| 2-Sided |
| 95 |
| -0.07 |
| 0.10 |
| Superiority |
| Change at Week 72 | LS Mean | 0.08 | 2-Sided | 95 | -0.01 | 0.16 | Superiority |
| Change at Week 96 | LS Mean | -0.01 | 2-Sided | 95 | -0.09 | 0.06 | Superiority |
| Change at Week 120 | LS Mean | -0.01 | 2-Sided | 95 | -0.12 | 0.10 | Superiority |
| Change at Week 144 | LS Mean | -0.05 | 2-Sided | 95 | -0.16 | 0.06 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| 15.15 |
| 2-Sided |
| 95 |
| -2.32 |
| 32.62 |
| Superiority |
| Change at Week 72 | LS Mean | 11.10 | 2-Sided | 95 | -14.33 | 36.53 | Superiority |
| Change at Week 96 | LS Mean | -16.65 | 2-Sided | 95 | -37.50 | 4.20 | Superiority |
| Change at Week 120 | LS Mean | 3.48 | 2-Sided | 95 | -32.53 | 39.49 | Superiority |
| Change at Week 144 | LS Mean | 28.55 | 2-Sided | 95 | -11.12 | 68.22 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| -70.79 |
| 2-Sided |
| 95 |
| -161.31 |
| 19.74 |
| Superiority |
| Change at Week 72 | LS Mean | -16.11 | 2-Sided | 95 | -110.96 | 78.73 | Superiority |
| Change at Week 96 | LS Mean | -41.74 | 2-Sided | 95 | -150.61 | 67.13 | Superiority |
| Change at Week 120 | LS Mean | -76.11 | 2-Sided | 95 | -237.29 | 85.08 | Superiority |
| Change at Week 144 | LS Mean | -96.06 | 2-Sided | 95 | -206.59 | 14.46 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
| LS Mean |
| 0.01 |
| 2-Sided |
| 95 |
| -0.01 |
| 0.04 |
| Superiority |
| Change at Week 72 | LS Mean | 0.00 | 2-Sided | 95 | -0.02 | 0.02 | Superiority |
| Change at Week 96 | LS Mean | -0.01 | 2-Sided | 95 | -0.04 | 0.02 | Superiority |
| Change at Week 120 | LS Mean | 0.00 | 2-Sided | 95 | -0.02 | 0.03 | Superiority |
| Change at Week 144 | LS Mean | 0.03 | 2-Sided | 95 | -0.01 | 0.08 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| 0.7640 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| -1.73 |
| 2-Sided |
| 95 |
| -13.00 |
| 9.55 |
| Superiority |
| Change at Week 72 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -22.28 | 2-Sided | 95 | -30.20 | -14.35 | Superiority |
| Change at Week 96 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -20.93 | 2-Sided | 95 | -27.92 | -13.94 | Superiority |
| Change at Week 120 | GEE | 0.0094 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -18.77 | 2-Sided | 95 | -32.93 | -4.60 | Superiority |
| Change at Week 144 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -25.72 | 2-Sided | 95 | -36.89 | -14.54 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| 0.2330 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| -2.68 |
| 2-Sided |
| 95 |
| -7.09 |
| 1.72 |
| Superiority |
| Change at Week 72 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -7.45 | 2-Sided | 95 | -9.54 | -5.36 | Superiority |
| Change at Week 96 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -8.08 | 2-Sided | 95 | -9.86 | -6.29 | Superiority |
| Change at Week 120 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -10.01 | 2-Sided | 95 | -13.07 | -6.95 | Superiority |
| Change at Week 144 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -10.89 | 2-Sided | 95 | -14.77 | -7.02 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| 0.4972 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| 41.45 |
| 2-Sided |
| 95 |
| -78.23 |
| 161.13 |
| Superiority |
| Change at Week 72 | GEE | 0.3288 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -61.96 | 2-Sided | 95 | -186.34 | 62.41 | Superiority |
| Change at Week 96 | GEE | 0.2772 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -68.62 | 2-Sided | 95 | -192.39 | 55.16 | Superiority |
| Change at Week 120 | GEE | 0.2907 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -53.41 | 2-Sided | 95 | -152.47 | 45.66 | Superiority |
| Change at Week 144 | GEE | 0.0800 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | -97.46 | 2-Sided | 95 | -206.57 | 11.65 | Superiority |
| Title | Measurements |
|---|---|
|
| Change at Week 72 |
|
|
| Change at Week 96 |
|
|
| Change at Week 120 |
|
|
| Change at Week 144 |
|
|
Change at Week 48
| GEE |
| < 0.0001 |
The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. |
| LS Mean |
| 44.40 |
| 2-Sided |
| 95 |
| 30.34 |
| 58.47 |
| Superiority |
| Change at Week 72 | GEE | 0.0002 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 28.30 | 2-Sided | 95 | 13.24 | 43.37 | Superiority |
| Change at Week 96 | GEE | < 0.0001 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 27.02 | 2-Sided | 95 | 13.81 | 40.22 | Superiority |
| Change at Week 120 | GEE | 0.1195 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 13.02 | 2-Sided | 95 | -3.37 | 29.40 | Superiority |
| Change at Week 144 | GEE | 0.2009 | The GEE model includes the change from baseline as the dependent variable, time as the categorical variable and adjusted for baseline measurement, with compound symmetry covariance structure. | LS Mean | 43.12 | 2-Sided | 95 | -22.96 | 109.20 | Superiority |