Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-0184 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the safety and efficacy of febuxostat, once daily (QD), versus allopurinol in subjects with gout.
This was a randomized, controlled, double-blind study of 52 weeks duration. Subjects receiving prior urate-lowering therapy underwent a 2-week washout period prior to randomization. Subjects were then randomized to one of three treatment groups: febuxostat 80 milligram (mg), febuxostat 120 mg, or allopurinol 300 mg. Naproxen (250 mg twice daily) or colchicine (0.6 mg once daily) was provided for prophylaxis of acute gout flares during the washout period and the first 8 weeks of double-blind treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febuxostat 80 mg QD | Experimental |
| |
| Febuxostat 120 mg QD | Experimental |
| |
| Allopurinol 300 mg QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Febuxostat 80 mg, orally, once daily for up to 52 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject. | Last 3 Visits (up to 52 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized. | Week 28 |
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16339094 | Result | Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373. | |
| 18600509 | Result | Becker MA, MacDonald PA, Hunt BJ, Lademacher C, Joseph-Ridge N. Determinants of the clinical outcomes of gout during the first year of urate-lowering therapy. Nucleosides Nucleotides Nucleic Acids. 2008 Jun;27(6):585-91. doi: 10.1080/15257770802136032. |
| Label | URL |
|---|---|
| American College of Rheumatology | View source |
Not provided
Subjects currently receiving urate-lowering therapy discontinued those urate-lowering therapies and initiated prophylactic medications before enrollment in once daily (QD) treatment groups.
Subjects were enrolled at 112 investigative sites, 106 in the United States and 6 in Canada, from 11 July 2002 to 20 February 2004.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 52 weeks. |
| FG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 52 weeks. |
| FG002 | Allopurinol 300 mg QD | Allopurinol 300 mg, orally, once daily for up to 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 52 weeks. |
| BG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percentage of Subjects With the Last 3 Serum Urate Levels <6.0 Milligrams Per Deciliter (mg/dL) | Each subject's serum urate at the last 3 visits determined the subject's response for the primary efficacy variable. A subject who prematurely discontinued without least 3 postbaseline serum urate levels was considered a nonresponder; if at least 3 serum urate were obtained postbaseline, those 3 visits were used. The last 3 visits used may have differed for each subject. | Analysis was performed on the intent-to-treat (ITT) subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. | Posted | Number | Percentage of subjects | Last 3 Visits (up to 52 weeks) |
|
Not provided
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Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily for up to 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Disorders not elsewhere classified (NEC) | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea (Excl Infective) | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. VP, Clinical Science | Takeda Global Research & Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
Not provided
| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| D000493 | Allopurinol |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
Not provided
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| Febuxostat | Drug | Febuxostat 120 mg, orally, once daily for up to 52 weeks. |
|
|
| Allopurinol | Drug | Allopurinol 300 mg, capsules, orally, once daily for up to 52 weeks. |
|
Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized. |
| Week 52 |
| Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit | The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject. | Final Visit (up to 52 weeks) |
| Percent Change From Baseline in Serum Urate Levels at Week 28. | Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized. | Baseline and Week 28 |
| Percent Change From Baseline in Serum Urate Levels at Week 52. | Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized. | Baseline and Week 52 |
| Percent Change From Baseline in Serum Urate Levels at Final Visit | The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject. | Baseline and Final Visit (up to 52 weeks) |
| Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero. | Baseline and Week 28 |
| Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero. | Baseline and Week 52 |
| Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject. | Baseline and Final Visit (up to 52 weeks) |
| Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening. | The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero. | Baseline and Week 28 |
| Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening. | The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero. | Baseline and Week 52 |
| Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening. | Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject. | Baseline and Final Visit (up to 52 weeks) |
| Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52. | The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once. | Weeks 8 through 52 |
| 21353107 | Result | Wortmann RL, Macdonald PA, Hunt B, Jackson RL. Effect of prophylaxis on gout flares after the initiation of urate-lowering therapy: analysis of data from three phase III trials. Clin Ther. 2010 Dec;32(14):2386-97. doi: 10.1016/j.clinthera.2011.01.008. |
| 22052584 | Result | Chohan S, Becker MA, MacDonald PA, Chefo S, Jackson RL. Women with gout: efficacy and safety of urate-lowering with febuxostat and allopurinol. Arthritis Care Res (Hoboken). 2012 Feb;64(2):256-61. doi: 10.1002/acr.20680. |
| Uloric Package Insert | View source |
| Gout Flare |
|
| Personal Reason(s) |
|
| Other |
|
| Protocol Violation |
|
| BG002 | Allopurinol 300 mg QD | Allopurinol 300 mg, orally, once daily for up to 52 weeks. |
| BG003 | Total | Total of all reporting groups |
| subjects |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index | Number | subjects |
|
| Calculated Creatinine Clearance | Calculated creatinine clearance based on the Cockcroft-Gault equation using ideal body weight. | Number | subjects |
|
| Presence of Primary Palpable Tophus | Number | subjects |
|
| Race/Ethnicity | Number | subjects |
|
| OG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 52 weeks. |
| OG002 | Allopurinol 300 mg QD | Allopurinol 300 mg, orally, once daily for up to 52 weeks. |
|
|
|
| Secondary | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 28 Visit | Serum urate values were obtained at the Week 28 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 28 visit was summarized. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Number | Percentage of subjects | Week 28 |
|
|
|
|
| Secondary | Percentage of Subjects With Serum Urate <6.0 mg/dL at Week 52 Visit | Serum urate values were obtained at the Week 52 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Week 52 visit was summarized. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Number | Percentage of subjects | Week 52 |
|
|
|
|
| Secondary | Percentage of Subjects With Serum Urate <6.0 mg/dL at Final Visit | The percentage of subjects whose serum urate was <6.0 mg/dL at the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Number | Percentage of subjects | Final Visit (up to 52 weeks) |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Urate Levels at Week 28. | Serum urate values were obtained at the Week 28 visit. The percent change in serum urate was calculated as [(week 28 - baseline levels/baseline)]*100 and summarized. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Week 28 |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Urate Levels at Week 52. | Serum urate values were obtained at the Week 52 visit. The percent change in serum urate was calculated as [(week 52 - baseline levels/baseline)]*100 and summarized. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Week 52 |
|
|
|
|
| Secondary | Percent Change From Baseline in Serum Urate Levels at Final Visit | The percent change in serum urate from baseline to the Final visit was calculated as [(Final Visit - baseline levels/baseline)]*100 and summarized. The Final visit was the last visit with a serum urate value. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug and who had a baseline serum urate ≥8.0 mg/dL. Missing data were not imputed. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Final Visit (up to 52 weeks) |
|
|
|
|
| Secondary | Percent Change From Baseline in Tophus Size at Week 28, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 28 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 28 visit, the size was assumed to be zero. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | percent change from baseline | Baseline and Week 28 |
|
|
|
|
| Secondary | Percent Change From Baseline in Tophus Size at Week 52, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | The percent change from baseline in primary tophus size as determined by physical measurement was calculated as [(Week 52 - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at the Screening Visit. If the primary tophus was no longer palpable at the Week 52 visit, the size was assumed to be zero. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | percent change from baseline | Baseline and Week 52 |
|
|
|
|
| Secondary | Percent Change From Baseline in Tophus Size at Final Visit, as Determined by Physical Measurement, in Subjects With a Palpable Primary Tophus at Screening. | Percent change in primary tophus size was calculated as [(Final Visit - baseline sizes)/baseline]*100 for the subset of subjects with a primary palpable tophus at Screening. If tophus was not palpable at Final visit, the size was assumed to be 0. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had a palpable primary tophus measured at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | percent change from baseline | Baseline and Final Visit (up to 52 weeks) |
|
|
|
|
| Secondary | Change From Baseline in Total Number of Tophi at Week 28 in Subjects With Palpable Tophi at Screening. | The change from baseline at Week 28 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 28 visit, the total count was assumed to be zero. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | number of tophi | Baseline and Week 28 |
|
|
|
|
| Secondary | Change From Baseline in Total Number of Tophi at Week 52 in Subjects With Palpable Tophi at Screening. | The change from baseline at Week 52 in the total number of tophi per subject was calculated for the subset of subjects with palpable tophi at the Screening Visit. If the tophi were no longer palpable at the Week 52 visit, the total count was assumed to be zero. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | number of tophi | Baseline and Week 52 |
|
|
|
|
| Secondary | Change From Baseline in Total Number of Tophi at Final Visit in Subjects With Palpable Tophi at Screening. | Change in number of tophi/subject calculated for the subset of subjects with palpable tophi at Screening. If the tophi were not palpable at the Final Visit, total count was assumed to be 0. The timing of the final visit may have differed for each subject. | Analysis was performed on the ITT subjects, which were defined as all randomized subjects who took at least 1 dose of study drug, had a baseline serum urate ≥8.0 mg/dL, and had palpable tophi at baseline. Missing data were not imputed. | Posted | Median | Inter-Quartile Range | number of tophi | Baseline and Final Visit (up to 52 weeks) |
|
|
|
|
| Secondary | Percentage of Subjects Requiring Treatment for Gout Flares Between Weeks 8 and 52. | The percentage of subjects requiring treatment for a gout flare between Weeks 8 and 52 of the double-blind treatment period was summarized. A subject who reported more than 1 gout flare during this period was counted only once. | Analysis was performed on the ITT subjects who had at least one dose of study drug between Weeks 8 and 52. | Posted | Number | percentage of subjects | Weeks 8 through 52 |
|
|
|
|
| 10 |
| 256 |
| 164 |
| 256 |
| EG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily for up to 52 weeks. | 19 | 251 | 145 | 251 |
| EG002 | Allopurinol 300 mg QD | Allopurinol 300 mg, orally, once daily for up to 52 weeks. | 18 | 253 | 167 | 253 |
| Coronary Artery Disorders NEC | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Heart Failures NEC | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Ischaemic Coronary Artery Disorders NEC | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Rate and Rhythm Disorders NEC | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Ventricular Arrhythmias and Cardiac Arrest | Cardiac disorders | MedDRA 7.0 | Systematic Assessment |
|
| Acute and Chronic Pancreatitis | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Gastrointestinal Fistulae | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Gastrointestinal Ulcers and Perforation, Site Unspecified | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Intestinal Haemorrhages | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Intestinal Ulcers and Perforation NEC | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Peritoneal and Retroperitoneal Haemorrhages | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Umbilical Hernias | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Febrile Disorders | General disorders | MedDRA 7.0 | Systematic Assessment |
|
| Allergies to Food, Food Additives, Drugs and Other Chemicals | Immune system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Abdominal and Gastrointestinal Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Infections NEC | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Lower Respiratory Tract and Lung Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Skin Structures and Soft Tissue Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Staphylococcal Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Urinary Tract Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Viral Infections NEC | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Chest and Lung Injuries NEC | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Non-Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Coagulation and Bleeding Analyses | Investigations | MedDRA 7.0 | Systematic Assessment |
|
| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Osteoarthropathies | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Spine and Neck Deformities | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Colonic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Prostatic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Testicular Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 7.0 | Systematic Assessment |
|
| Central Nervous System Vascular Disorders NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Central nervous system Hemorrhages & Cerebrovascular Accidents | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Cervical Spinal Cord and Nerve Root Disorders | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Disturbances in Consciousness NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Encephalopathies NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Renal Failure and Impairment | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
|
| Renal Lithiasis | Renal and urinary disorders | MedDRA 7.0 | Systematic Assessment |
|
| Bronchospasm and Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Pneumothorax and Pleural Effusions NEC | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Pulmonary Thrombotic and Embolic Conditions | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Respiratory Failures (Excluding [Excl] Neonatal) | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Peripheral Embolism and Thrombosis | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
|
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Oedema NEC | General disorders | MedDRA 7.0 | Systematic Assessment |
|
| Influenza Viral Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Lower Respiratory Tract and Lung Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 7.0 | Systematic Assessment |
|
| Limb Injuries NEC (Including [Incl] Traumatic Amputation) | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Non-Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 7.0 | Systematic Assessment |
|
| Liver Function Analyses | Investigations | MedDRA 7.0 | Systematic Assessment |
|
| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 7.0 | Systematic Assessment |
|
| Headache NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Neurological Signs and Symptoms NEC | Nervous system disorders | MedDRA 7.0 | Systematic Assessment |
|
| Upper Respiratory Tract Signs and Symptoms | Respiratory, thoracic and mediastinal disorders | MedDRA 7.0 | Systematic Assessment |
|
| Vascular Hypertensive Disorders NEC | Vascular disorders | MedDRA 7.0 | Systematic Assessment |
|
No publication related to study results will be published prior to publication of a multi-center report submitted for publication within 18 months after conclusion or termination of a study. Results publications will be submitted to sponsor for review 60 days in advance of publication. Sponsor can require removal of confidential information unrelated to study results. Sponsor can embargo a proposed publication for another 60 days to preserve intellectual property.
| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| <0.001 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.031 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| <0.001 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.883 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| <0.001 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.164 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA |
| <0.001 |
P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA |
| <0.001 |
P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| ANOVA | 0.006 | P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| ANOVA |
| <0.001 |
P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| ANOVA | <0.001 | P-values for pairwise comparisons are from contrast within the framework of the one-way ANOVA model with treatment as a factor. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.011 |
P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.024 | P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.164 |
P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.619 | P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.372 |
P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.246 | P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.320 |
P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.411 | P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.188 |
P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.362 | P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.444 |
P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 0.719 | P-values for pairwise comparisons are from the Wilcoxon rank-sum test. Statistical significance was determined at the 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |
| 0.229 |
Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. |
| 95 |
| No |
| Superiority or Other |
| Fisher Exact | 0.266 | Statistical significance was determined at 0.05 level without adjustment for multiple comparisons. | 95 | No | Superiority or Other |