Not provided
Not provided
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Study was terminated early for administrative reasons.
Not provided
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This 2 arm study will compare the efficacy and safety of CellCept plus corticosteroids, versus cyclophosphamide plus corticosteroids in the induction phase followed by azathioprine in the maintenance phase, in maintaining remission and renal function in patients with lupus nephritis. Patients will be randomized to receive CellCept 1g bid po plus corticosteroids for 24 weeks, followed by CellCept 0.75g bid po plus corticosteroids for the following 24 weeks, or cyclophosphamide 0.5-1.0g/m2 monthly plus corticosteroids for 24 weeks, followed by azathioprine 2mg/kg/day po plus corticosteroids for the following 24 weeks. Response rate will be assessed at the end of the induction phase, and at the end of study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate Mofetil | Experimental | Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID from Weeks 32 to 48. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48. |
|
| Cyclophosphamide/Azathioprine | Active Comparator | Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for subjects with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reaches 40 mg per day, followed by a reduction of 5 mg per day every 2 weeks until dose reaches 10 mg per day up to Week 48. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate Mofetil | Drug | 0.5 g PO BID from Day 0 to the end of Week 1, followed by 1.0 g PO BID from Weeks 2 through 24, and 0.75 g PO BID from Weeks 32 to 48 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event | CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | The median time, in months, to CR was defined as the time from randomization to CR event. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Percentage of Participants With Treatment Response Event by End of Treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | 100005 | China | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mycophenolate Mofetil | Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. |
| FG001 | Cyclophosphamide, Azathioprine | Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population: all participants who recieved at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mycophenolate Mofetil | Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Complete Response | The median time, in months, to CR was defined as the time from randomization to CR event. | Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
|
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
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 | Mycophenolate Mofetil | Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
The study was terminated early due to administrative reasons.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffman-LaRoche | 800-821-8590 | genentech@druginfo.com |
Not provided
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D000305 | Adrenal Cortex Hormones |
| D011239 | Prednisolone |
| D001379 | Azathioprine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Corticosteroids | Drug | 0.75 to 1.0 mg/kg/d PO (up to 60 kg/day) from Weeks 1 through 4; reduced by 10 mg/day every 2 weeks until dose reaches 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reaches 10 mg/day up to Week 48 |
|
|
| Azathioprine | Drug | 100 mg PO daily for participants with a body weight of 50 to 70 kg,150 mg PO daily for subjects with a body weight of more than 70 kg up to Week 48 |
|
| Cyclophosphamide | Drug | 0.75 g/m^2 IV every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2 to maintain a minimum WBC count of ≥ 2500 per mm^3 from Weeks 5 through 24 |
|
Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28. |
| Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR) | GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Percentage of Participants Terminating Treatment | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Time to Treatment Failure | Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
| Beijing |
| 100029 |
| China |
| Beijing | 100853 | China |
| Guangzhou | 510080 | China |
| Guangzhou | 510515 | China |
| Hangzhou | 310003 | China |
| Nanjing | 210008 | China |
| Shanghai | 200001 | China |
| Shanghai | 200003 | China |
| Shanghai | 200025 | China |
| Shenyang | 110001 | China |
| BG001 | Cyclophosphamide, Azathioprine | Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Cyclophosphamide, Azathioprine | Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. |
|
| Secondary | Percentage of Participants With Treatment Response Event by End of Treatment | Treatment response was defined by a reduction in the ratio of urine protein to creatinine to <3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28. | Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
|
|
| Secondary | Percentage of Participants With a Decrease of 25% or 50% in Glomerular Filtration Rate (GFR) | GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula. | Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
|
|
| Secondary | Percentage of Participants Terminating Treatment | Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
|
|
| Secondary | Time to Treatment Failure | Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of <0.5 g/24h or greater than (>) 1 g/24h or >0.5 g/24h or >2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test. | Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
|
|
| Primary | Complete Response (CR) by the End of Treatment - Percentage of Participants With an Event | CR was defined as a urinary protein value of less than (<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement. | Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed. | Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48 |
|
|
| 8 |
| 25 |
| 13 |
| 25 |
| EG001 | Cyclophosphamide, Azathioprine | Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48. | 5 | 27 | 18 | 27 |
| Pyrexia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Gastroenteritis | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Acute renal failure | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Herpes zoster | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hospitalization | Surgical and medical procedures | MedDRA 8.1 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Local swelling | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 8.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Weight increased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 8.1 | Non-systematic Assessment |
|
| Hyperuricemia | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Poor quality sleep | Nervous system disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Urinary tract infection | Renal and urinary disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Menstrual disorder | Reproductive system and breast disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Chest discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Sputum discoloured | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Sputum decreased | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Eyelid oedema | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Venous thrombosis limb | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 8.1 | Non-systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |