Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1113-9814 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.
Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 mg/dL), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often insufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or partially of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate levels into a subsaturating range (usually <6.0 mg/dL) in which crystal formation and deposition are prevented or reversed.
Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for the management of hyperuricemia in patients with gout.
This study was originally designed and initiated having all subjects initially assigned to 80 mg febuxostat provided as an 80 mg tablet, to be administered orally. Subjects could be titrated to 120 mg, provided as one 40 and 80 mg tablet, between Months 2 and 6, if their serum uric acid rose > 6.0 mg/dL; the dose could be down-titrated to 80 mg if the serum uric acid decreased to < 3.0 mg/dL.
The protocol was amended to add a comparator arm, and to have subjects randomized to 80 or 120 mg febuxostat or allopurinol (100 or 300 mg, dependent on renal function). The information below reflects the treatments following the implementation of the revised protocol.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Febuxostat 80 mg QD | Experimental |
| |
| Febuxostat 120 mg QD | Experimental |
| |
| Allopurinol QD | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Febuxostat 80 mg, tablets, orally, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 1 visit was summarized. | Month 1 |
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. | Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized. | Month 12 |
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. | Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized. | Month 24 |
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. | Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized. | Month 36 |
| Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. | The percentage of subjects whose serum urate was <6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment. | Last Visit on treatment (up to 40 months). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment. | Last Visit on treatment (up to 40 months). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19286847 | Result | Becker MA, Schumacher HR, MacDonald PA, Lloyd E, Lademacher C. Clinical efficacy and safety of successful longterm urate lowering with febuxostat or allopurinol in subjects with gout. J Rheumatol. 2009 Jun;36(6):1273-82. doi: 10.3899/jrheum.080814. Epub 2009 Mar 13. |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
Not provided
Subjects were to have completed either 28 weeks or 52 weeks of double-blind dosing in Study C02-009 (NCT00174915) or C02-010 (NCT00102440), respectively before enrollment.
Subjects were enrolled at 174 investigative sites, including 168 in the United States and 6 in Canada, from 28 July 2003 to 26 February 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, taken orally, once daily. |
| FG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, taken orally, once daily |
| FG002 | Allopurinol QD | Allopurinol 100 mg or 300 mg, tablets, orally, once daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Febuxostat 80 mg QD | Febuxostat 80 mg, taken orally, once daily. |
| BG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, taken orally, once daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Based on Final Stable Treatment in study C02-021 |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Percent Change in Serum Urate Levels From Baseline to the Last Visit on Treatment. | The percent change in serum urate from baseline to the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment. | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis. | Posted | Mean | Standard Deviation | percent change from baseline | Last Visit on treatment (up to 40 months). |
|
Not provided
Not provided
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, taken orally, once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia Deficiencies | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea (Excl Infective) | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
Subjects may receive >1 treatment. Adverse events are summarized by treatment at time of observation and subjects who receive >1 treatment are summarized for each treatment they receive, so subjects at risk will not match number of participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Clinical Science | Takeda Global Research & Development Center, Inc. | 800-778-2860 | clinicaltrialregistry@tpna.com |
Not provided
| ID | Term |
|---|---|
| D006073 | Gout |
| D033461 | Hyperuricemia |
| 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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Febuxostat | Drug | Febuxostat 120 mg, tablets, orally, once daily. |
|
|
| Allopurinol | Drug | Allopurinol 100 mg or 300 mg, tablets, orally, once daily. |
|
|
| Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized. | Month 12 |
| Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized. | Month 24 |
| Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized. | Month 36 |
| Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized. | Final Visit (up to 40 months). |
| Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit. | The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized. | Final Visit (up to 40 months). |
| Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12. | The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized. | Month 12 |
| Percentage of Subjects Requiring Treatment for Gout Flare After Month 12. | The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized. | After Month 12 to Final Visit |
| Lost to Follow-up |
|
| Did not continue under Amendment 4 |
|
| Personal Reason(s) |
|
| Therapeutic Failure |
|
| Gout Flare |
|
| Reason Not Specified |
|
| BG002 | Allopurinol QD | Allopurinol 100 mg or 300 mg, tablets, orally, once daily. |
| BG003 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Based on Final Stable Treatment in study C02-021 | Count of Participants | Participants |
|
| Presence of Tophus | Based on Final Stable Treatment in study C02-021 | Number | participants |
|
| Race/Ethnicity | Based on Final Stable Treatment in study C02-021 | Number | participants |
|
| Renal Function | Based on Final Stable Treatment in study C02-021. Impaired defined as serum creatinine <1.5 mg/dL. | Number | participants |
|
| Body Mass Index (BMI) | Based on Final Stable Treatment in study C02-021 | Mean | Standard Deviation | kg/m² |
|
| Serum Urate | Based on Final Stable Treatment in study C02-021 | Mean | Standard Deviation | mg/dL |
|
| OG001 |
| Febuxostat 120 mg QD |
Febuxostat 120 mg, taken orally, once daily |
| OG002 | Allopurinol QD | Allopurinol 100 mg or 300 mg, tablets, orally, once daily. |
|
|
| Secondary | Percent Change From Baseline in Primary Tophus Size at Month 12 for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at the Month 12 visit. The percent change from baseline in primary tophus size to the Month 12 visit was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 12 visit were included in the analysis. | Posted | Median | Inter-Quartile Range | percent change from baseline | Month 12 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 1. | Serum urate values were obtained at the Month 1 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 1 visit was summarized. | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 1 visit and who had not changed from their initial treatment were included in the analysis. | Posted | Number | percentage of subjects | Month 1 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 12. | Serum urate values were obtained at the Month 12 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 12 visit was summarized. | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 12 visit and who had not changed from their initial treatment were included in the analysis. | Posted | Number | percentage of subjects | Month 12 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 24. | Serum urate values were obtained at the Month 24 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 24 visit was summarized. | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 24 visit and who had not changed from their initial treatment were included in the analysis. | Posted | Number | percentage of subjects | Month 24 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Month 36. | Serum urate values were obtained at the Month 36 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 36 visit was summarized. | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. Subjects with a serum urate value at the Month 36 visit and who had not changed from their initial treatment were included in the analysis. | Posted | Number | percentage of subjects | Month 36 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to < 6.0 mg/dL at Last Visit on Treatment. | The percentage of subjects whose serum urate was <6.0 mg/dL at the last visit on treatment was summarized. The last visit on treatment was the last visit at which a serum urate value was collected prior to any changes in drug and/or dose from the initial treatment assignment. | Results were summarized by the initial treatment the subject was assigned to before any changes in drug and/or dose. All subjects with a post-baseline serum urate level measurement while receiving their initial treatment were included in the analysis. | Posted | Number | percentage of subjects | Last Visit on treatment (up to 40 months). |
|
|
|
| Secondary | Percent Change From Baseline in Primary Tophus Size at Month 24 for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 24 visit. The percent change from baseline in primary tophus size to the Month 24 visit was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 24 visit were included in the analysis. | Posted | Median | Inter-Quartile Range | percent change from baseline | Month 24 |
|
|
|
| Secondary | Percent Change From Baseline in Primary Tophus Size at Month 36 for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and Month 36 visit. The percent change from baseline in primary tophus size to the Month 36 visit was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured at the Month 36 visit were included in the analysis. | Posted | Median | Inter-Quartile Range | percent change from baseline | Month 36 |
|
|
|
| Secondary | Percent Change From Baseline in Primary Tophus Size at Final Visit for Subjects With Palpable Tophi Measured at Baseline. | The area of the primary tophus was calculated based on the length and width of the tophus measured at baseline and final visit. The percent change from baseline in primary tophus size to the final visit was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline which was also measured while receiving their final stable treatment were included in the analysis. | Posted | Median | Inter-Quartile Range | percent change from baseline | Final Visit (up to 40 months). |
|
|
|
| Secondary | Percent Change From Baseline in the Total Number of Tophi for Subjects With Palpable Tophi at Final Visit. | The number of tophi were counted at baseline and final visits. The percent change from baseline in the number of tophi to the final visit was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. Subjects with a primary tophus at baseline who also had their tophi counted while receiving their final stable treatment were included in the analysis. | Posted | Mean | Standard Deviation | percent change from baseline | Final Visit (up to 40 months). |
|
|
|
| Secondary | Percentage of Subjects Requiring Treatment for Gout Flare up to Month 12. | The percentage of subjects requiring treatment for gout flare during the first twelve months of final stable treatment was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once. | Posted | Number | percentage of subjects | Month 12 |
|
|
|
| Secondary | Percentage of Subjects Requiring Treatment for Gout Flare After Month 12. | The percentage of subjects requiring treatment for gout flare after the first 12 months of final stable treatment was summarized. | Results were summarized by final stable treatment which was the treatment a subject was receiving after drug and/or dose changes were no longer allowed. A subject who reported more than one gout flare during the time interval was counted only once. | Posted | Number | percentage of subjects | After Month 12 to Final Visit |
|
|
|
| 98 |
| 801 |
| 444 |
| 801 |
| EG001 | Febuxostat 120 mg QD | Febuxostat 120 mg, taken orally, once daily | 50 | 487 | 257 | 487 |
| EG002 | Allopurinol QD | Allopurinol 100 mg or 300 mg, tablets, orally, once daily. | 16 | 178 | 66 | 178 |
| Thrombocytopenias | Blood and lymphatic system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Aortic Valvular Disorders | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac Conduction Disorders | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cardiomyopathies | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Coronary Artery Disorders not elsewhere classified (NEC) | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Heart Failures NEC | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ischaemic Coronary Artery Disorders | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Myocardial Disorders NEC | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Ventricular Arrhythmias and Cardiac Arrest | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
| Male Reproductive Tract Disorders Congenital | Congenital, familial and genetic disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hearing Losses | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
|
| Inner Ear Signs and Symptoms | Ear and labyrinth disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal Hernias, Site Unspecified | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Benign Neoplasms GastrointestinaI (Excluding Oral Cavity) | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Colitis (Excluding Infective) | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Diaphragmatic Hernias | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Duodenal and Small Intestinal Stenosis and Obstruction | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastrointestinal Atonic and Hypomotility Disorders NEC | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastrointestinal Disorders NEC | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Gastrointestinal Stenosis and Obstruction NEC | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Inguinal Hernias | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Intestinal Ulcers and Perforation NEC | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Umbilical Hernias | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hernias NEC | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pain and Discomfort NEC | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bile Duct Infections and Inflammations | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cholecystitis and Cholelithiasis | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Hepatocellular Damage and Hepatitis NEC | Hepatobiliary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Abdominal and Gastrointestinal Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bacterial Infections NEC | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bone and Joint Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Infections NEC | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Lower Respiratory Tract and Lung Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Sepsis, Bacteraemia, Viraemia, and Fungaemia NEC | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Staphylococcal Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Urinary Tract Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Cardiac and Vascular Procedural Complications | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Cerebral Injuries NEC | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Limb Injuries NEC (Including Traumatic Amputation) | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Lower limb Fractures and Dislocations | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Muscle, Tendon and Ligament Injuries | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Non-Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Non-Site Specific Procedural Complications | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Neurologic Diagnostic Procedures | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Diabetes Mellitus (Including Subtypes) | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| General Nutritional Disorders NEC | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Magnesium Metabolism Disorders | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Potassium Imbalance | Metabolism and nutrition disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bone Disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Intervertebral Disc Disorders | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Joint Related Disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Muscle Related Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Osteoarthropathies | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Spine and Neck Deformities | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| B-cell Lymphomas NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Bile Duct Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Breast and Nipple Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Colonic Neoplasms Malignant | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Endocrine Neoplasms Benign NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Neoplasms Benign Site Unspecified NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Non-Small Cell Malignant/Respiratory Tract Cell Type Specified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Oesophageal Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Ovarian Neoplasms Benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Pancreatic Neoplasms Malignant (Excl Islet Cell and Carcinoid) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Prostatic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Renal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
|
| Central Nervous System Haemorrhages and CVA | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Central Nervous System Vascular Disorders NEC | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Cervical Spinal Cord and Nerve Root Disorders | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Disturbances in Consciousness NEC | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neurologic Visual Problems NEC | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Neurological Signs and Symptoms NEC | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Paralysis and Paresis (Excl Cranial Nerve) | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Transient Cerebrovascular Events | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Renal Failure and Impairment | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Renal Lithiasis | Renal and urinary disorders | MedDRA 10.1 | Systematic Assessment |
|
| Renal Vascular and Ischaemic Conditions | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Breathing Abnormalities | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Bronchospasms and Obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Lower Respiratory Tract Inflam. and Immunologic Conditions | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Pulmonary Thrombotic and Embolic Conditions | Respiratory, thoracic and mediastinal disorders | MedDRA 10.1 | Systematic Assessment |
|
| Apocrine and Eccrine Gland Disorders | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Skin Neoplasms Benign | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Aortic Aneurysms and Dissections | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Non-Site Specific Necrosis and Vascular Insufficiency NEC | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Peripheral Aneurysms and Dissections | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Peripheral Embolism and Thrombosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Peripheral Vascular Disorders NEC | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Peripheral Vasoconstriction, Necrosis and Vascular Insuff. | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vascular Hypertensive Disorders NEC | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vascular Hypotensive Disorders NEC | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Oedema NEC | General disorders | MedDRA 10.1 | Systematic Assessment |
|
| Influenza Viral Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Lower Respiratory Tract and Lung Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Upper Respiratory Tract Infections | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Musculoskeletal and Connective Tissues Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Headache NEC | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
|
| Dermatitis and Eczema | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Vascular Hypertensive Disorders NEC | Vascular disorders | MedDRA 10.1 | 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 |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |