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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-2039 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable 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 milligrams per deciliter [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 not sufficient) 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 in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate 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 management of hyperuricemia in patients with gout.
Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967).
All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Febuxostat | Drug | Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized. | Month 6 |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 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 or is Maintained at <6.0 mg/dL at Month 18 Visit. | Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized. | Month 18 |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 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 or is Maintained at <6.0 mg/dL at Month 36 Visit. | 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 or is Maintained at <6.0 mg/dL at Month 48 Visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized. | Baseline and Month 6 |
| Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Chair |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16911575 | Result | Colwell HH, Hunt BJ, Pasta DJ, Palo WA, Mathias SD, Joseph-Ridge N. Gout Assessment Questionnaire: Initial results of reliability, validity and responsiveness. Int J Clin Pract. 2006 Oct;60(10):1210-7. doi: 10.1111/j.1742-1241.2006.01104.x. Epub 2006 Aug 15. | |
| 19141576 | Result | Schumacher HR Jr, Becker MA, Lloyd E, MacDonald PA, Lademacher C. Febuxostat in the treatment of gout: 5-yr findings of the FOCUS efficacy and safety study. Rheumatology (Oxford). 2009 Feb;48(2):188-94. doi: 10.1093/rheumatology/ken457. |
| Label | URL |
|---|---|
| Uloric Package Insert | View source |
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Subjects were to have completed 4 weeks of double-blind dosing in Study TMX-00-004 (NCT00174967) before enrollment in once daily (QD) treatment groups. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.
Subjects were enrolled at 23 investigational sites in the United States from 21 March 2001 to 29 December 2006
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| ID | Title | Description |
|---|---|---|
| FG000 | Febuxostat 40 mg QD | Febuxostat 40 mg, orally, once daily, based on serum urate level. |
| FG001 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily, based on serum urate level. |
| FG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily, based on serum urate level. |
| FG003 | Total Febuxostat |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Febuxostat 40 mg QD | Febuxostat 40 mg orally, once daily, based on serum urate level. |
| BG001 | Febuxostat 80 mg QD | Febuxostat 80 mg, orally, once daily, based on serum urate level |
| 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 Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 6 Visit. | Serum urate values were obtained at the Month 6 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 6 visit was summarized. | Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 6 |
|
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 | Febuxostat 40 mg QD | Febuxostat 40 mg taken orally, once daily, based on serum urate level. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Conduction Disorders | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | 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
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| ID | Term |
|---|---|
| D000069465 | Febuxostat |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Febuxostat | Drug | Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level. |
|
|
| Febuxostat | Drug | Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level. |
|
|
Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized.
| Month 48 |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized. | Month 60 |
| Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <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. | Last Visit on treatment (up to 66 months). |
Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized. |
| Baseline and Month 12 |
| Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized. | Baseline and Month 18 |
| Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized. | Baseline and Month 24 |
| Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized. | Baseline and Month 36 |
| Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized. | Baseline and Month 48 |
| Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation. | Baseline and Month 60 |
| Percent Change in Serum Urate Levels From Baseline at Final Visit. | The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. | Baseline and Last Visit on treatment (up to 66 months). |
| 21169856 | Result | Whelton A, Macdonald PA, Zhao L, Hunt B, Gunawardhana L. Renal function in gout: long-term treatment effects of febuxostat. J Clin Rheumatol. 2011 Jan;17(1):7-13. doi: 10.1097/RHU.0b013e318204aab4. |
| Protocol Violation |
|
| Lost to Follow-up |
|
| Personal Reason(s) |
|
| Gout Flare |
|
| Reason Not Specified |
|
| BG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily, based on serum urate level |
| BG003 | Total | Total of all reporting groups |
| Subjects |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| History of Kidney Stone | Number | Subjects |
|
| Presence of Tophus | Number | Subjects |
|
| Race/Ethnicity | Number | Subjects |
|
| Renal Function | Impaired renal function was defined as serum creatinine >1.5 milligrams per deciliter (mg/dL) or a creatinine clearance of ≤80 milliliters per minute (mL/min) | Number | Subjects |
|
| Urine Uric Acid | Number | Subjects |
|
| Body Mass Index | Mean | Standard Deviation | kiligram per meter² (kg/m²) |
|
| Serum Urate | Mean | Standard Deviation | mg/dL |
|
Febuxostat 80 mg, orally, once daily, based on serum urate level. |
| OG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, orally, once daily, based on serum urate level. |
| OG003 | Total Febuxostat |
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 6 Visit. | Serum urate values were obtained at the Month 6 visit. The percent change in serum urate from baseline to the Month 6 visit was summarized. | Subjects with a serum urate value at the Month 6 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 6 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 6 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 12 Visit. | 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. | Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 12 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 18 Visit. | Serum urate values were obtained at the Month 18 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 18 visit was summarized. | Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 18 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 24 Visit. | 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. | Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 24 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 36 Visit. | 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. | Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 36 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 48 Visit. | Serum urate values were obtained at the Month 48 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 48 visit was summarized. | Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 48 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <6.0 mg/dL at Month 60 Visit. | Serum urate values were obtained at the Month 60 visit. The percentage of subjects whose serum urate was <6.0 mg/dL at the Month 60 visit was summarized. | Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Month 60 |
|
|
|
| Primary | Percentage of Subjects Whose Serum Urate Level Decreases to or is Maintained at <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. | Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Number | percentage of subjects | Last Visit on treatment (up to 66 months). |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 12 Visit. | Serum urate values were obtained at the Month 12 visit. The percent change in serum urate from baseline to the Month 12 visit was summarized. | Subjects with a serum urate value at the Month 12 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 12 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percentage of subjects | Baseline and Month 12 |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 18 Visit. | Serum urate values were obtained at the Month 18 visit. The percent change in serum urate from baseline to the Month 18 visit was summarized. | Subjects with a serum urate value at the Month 18 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 18 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 18 |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 24 Visit. | Serum urate values were obtained at the Month 24 visit. The percent change in serum urate from baseline to the Month 24 visit was summarized. | Subjects with a serum urate value at the Month 24 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 24 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 24 |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 36 Visit. | Serum urate values were obtained at the Month 36 visit. The percent change in serum urate from baseline to the Month 36 visit was summarized. | Subjects with a serum urate value at the Month 36 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 36 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 36 |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 48 Visit. | Serum urate values were obtained at the Month 48 visit. The percent change in serum urate from baseline to the Month 48 visit was summarized. | Subjects with a serum urate value at the Month 48 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 48 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 48 |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Month 60 Visit. | The secondary outcome was the mean percent change from baseline to Month 60 visit as assessed by serum urate levels collected at baseline and at the Month 60 visit by dose at observation. | Subjects with a serum urate value at the Month 60 visit were included in the analysis. Results were summarized by the dose the subject was receiving at the Month 60 visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Month 60 |
|
|
|
| Secondary | Percent Change in Serum Urate Levels From Baseline at Final Visit. | The percent change in serum urate from baseline to the final visit was summarized. The final visit was the last visit at which a serum urate value was collected. | Two subjects who did not have any post-baseline Serum Urate Level measurements were excluded from this analysis. Results were summarized by the dose the subject was receiving at the time of the final visit. Subjects must have been receiving that dose for at least 14 days prior to the visit. | Posted | Mean | Standard Deviation | percent change from baseline | Baseline and Last Visit on treatment (up to 66 months). |
|
|
|
| 3 |
| 12 |
| 5 |
| 12 |
| EG001 | Febuxostat 80 mg QD | Febuxostat 80 mg, taken orally, once daily, based on serum urate level | 14 | 116 | 44 | 116 |
| EG002 | Febuxostat 120 mg QD | Febuxostat 120 mg, taken orally, once daily, based on serum urate level | 4 | 37 | 9 | 37 |
| EG003 | Febuxostat Total | 21 | 116 | 53 | 116 |
| Supraventricular Arrhythmias | Cardiac disorders | MedDRA 9.1 | Systematic Assessment |
|
| Duodenal and Small Intestinal Stenosis and Obstruction | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Gastrointestinal Ulcers and Perforation, Site Unspecified | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Intestinal Ulcers & Perforation not elsewhere classified (NEC) | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pain and Discomfort NEC | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Cholecystitis and Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Abdominal and Gastrointestinal Infections | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Lower Respiratory Tract and Lung Infections | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Sepsis, Bacteraemia, Viraemia, and Infections | Infections and infestations | MedDRA 9.1 | Systematic Assessment |
|
| Cerebral Injuries NEC | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Fractures and Dislocations NEC | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Non-Site Specific Injuries NEC | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Radiation Injuries | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Intervertebral Disc Disorders | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Joint Related Disorders NEC | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Osteoarthropathies | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Pathological Fractures and Complications | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Spine and Neck Deformities | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Lip and Oral Cavity Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Prostatic Neoplasms Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Respiratory Tract and Pleural Neoplasms Benign NEC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Skin Neoplasms Malignant & Unspecified (Excluding Melanoma) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Systematic Assessment |
|
| Alzheimer's Disease (Including Subtypes) | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Central Nervous System Hemorrhages & Cerebrovascular Accidents | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Depressive Disorders | Psychiatric disorders | MedDRA 9.1 | Systematic Assessment |
|
| Bladder and Urethral Symptoms | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Liver Function Analyses | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Gastrointestinal Atonic and Hypomotility Disorders NEC | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Headaches NEC | Nervous system disorders | MedDRA 9.1 | Systematic Assessment |
|
| Hyperlipidaemias NEC | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
|
| White Blood Cell Analyses | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Muscle Related Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Renal Lithiasis | Renal and urinary disorders | MedDRA 9.1 | Systematic Assessment |
|
| Rashes, Eruptions and Exanthems | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Gastrointestinal Signs and Symptoms | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Nausea and Vomiting Symptoms | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
|
| Oedema NEC | General disorders | MedDRA 9.1 | Systematic Assessment |
|
| Triglyceride Analyses | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Arthropathies | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Joint Related Signs and Symptoms | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Muscle Pains | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Musculoskeletal and Connective Tissue Signs and Symptoms NEC | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Systematic Assessment |
|
| Blood Amylase Increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Skin Injuries NEC | Injury, poisoning and procedural complications | MedDRA 9.1 | Systematic Assessment |
|
| Weight Increased | Investigations | MedDRA 9.1 | Systematic Assessment |
|
| Blood Thyroid Stimulating Hormone Increased | Investigations | MedDRA 9.1 | 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 |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |