Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2004-002407-32 | EudraCT Number |
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
Cushing's disease is a rare serious condition that is caused by an adrenocorticotropic hormone (ACTH) secreting pituitary adenoma. This study assessed the long-term safety and efficacy of pasireotide in participants with Cushing's disease.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | Experimental | Participants received pasireotide 600 micrograms (μg) twice daily (BID) subcutaneously (SC) to achieve or maintain urinary free cortisol (UFC) normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pasireotide | Drug | Pasireotide 600 μg or 900 μg was administered as an SC injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits | A participant was considered a responder if the mean UFC from the two 24-hour urine samples collected at Month 6 was within normal limits. The normal range for UFC is 55 to 276 nmol/day. | Month 6 |
| Change From Baseline in Mean Urinary Free Cortisol (UFC) | 24-hour urine samples were collected to obtain mean UFC measurements. A negative mean change from baseline indicates improvement. | Core Baseline, Days 14/15 (Core study), Months 6, 12, 24 and 102 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had At Least One Adverse Event (AE) | An AE was any undesirable sign, symptom or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. AEs were assessed according to incident dose group: Pasireotide 1200 μg sc total daily dose (TDD), Pasireotide 1800 μg SC TDD and Pasireotide SC Any Dose. The incident dose for an AE was the last total daily dose administered on or prior to the AE onset date. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion / exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticlas | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23943009 | Result | Boscaro M, Bertherat J, Findling J, Fleseriu M, Atkinson AB, Petersenn S, Schopohl J, Snyder P, Hughes G, Trovato A, Hu K, Maldonado M, Biller BM. Extended treatment of Cushing's disease with pasireotide: results from a 2-year, Phase II study. Pituitary. 2014 Aug;17(4):320-6. doi: 10.1007/s11102-013-0503-3. |
Not provided
Not provided
The study included participants with Cushing's disease who received 15 days of pasireotide treatment in the Core Study CSOM230B2208 (NCT00088608). This study was an extension study of the Core Study.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | Participants received pasireotide 600 micrograms (μg) twice daily (BID) subcutaneously (SC) to achieve or maintain urinary free cortisol (UFC) normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Intent-to-treat (ITT) population included all participants who completed 15 days of treatment in Core study and experienced significant clinical benefit from treatment and received at least 1 dose in the Extension Period.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pasireotide 600 μg BID SC or Ramp up Dose 900 μg BID SC | Participants received pasireotide 600 μg BID SC to achieve or maintain UFC normalization. If UFC levels were increased at any time, participants received 900 μg BID SC, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Responders With Mean Urinary Free Cortisol (UFC) Within Normal Limits | A participant was considered a responder if the mean UFC from the two 24-hour urine samples collected at Month 6 was within normal limits. The normal range for UFC is 55 to 276 nmol/day. | Primary Efficacy Population included participants from ITT whose mean UFC at core-baseline, based on at least 2 UFC samples, was >1.0x upper limit of normal (ULN) or for whom the one and only UFC sample available at baseline was >2.0xULN. | Posted | Number | 95% Confidence Interval | percentage of responders | Month 6 |
|
Up to approximately 106 months
Safety Population included participants from ITT Population. ITT Population included participants who completed 15 days of treatment in the Core study, experienced significant clinical benefit without any unacceptable AEs, and received at least 1 dose in the extension period.
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 | Pasireotide 600 μg BID SC | Participants received pasireotide 600 μg BID SC, to achieve or maintain UFC normalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
Not provided
| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C517782 | pasireotide |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to approximately 106 months |
| Change From Baseline in Serum Cortisol Levels | Blood samples were withdrawn to obtain the serum cortisol levels. A negative change from baseline indicates improvement. | Core Baseline, Day 15 (Core study), Months 6, 12, 24, and Month 105 (end of the study) |
| Plasma Trough Concentrations (Ctrough) of Pasireotide in UFC Responders | Participants with Cushing's disease were considered responders if mean UFC levels from the 24-hour urine collections at Day 15 (Core study) and at extension Month 6, were within normal limits. Ctrough levels of pasireotide were measured at Day 15 of Core study and Month 6. | Day 15 (Core study) and Month 6 |
| Change From Baseline in Plasma Adrenocorticotropic Hormone (ACTH) Levels | Blood samples were withdrawn to obtain the ACTH levels. A negative change from baseline indicates improvement. | Core Baseline, Day 15 (Core study), Months 6, 12, 24 and Month 105 (end of the study) |
| Change From Baseline in Gene-expression and Protein in Blood and Urine for Biomarker Development | Baseline to end of the study |
| Portland |
| Oregon |
| 97239 |
| United States |
| University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | 19104-6149 | United States |
| Novartis Investigative Site | Paris | 75006 | France |
| Novartis Investigative Site | Essen | 45122 | Germany |
| Novartis Investigative Site | München | 80336 | Germany |
| Novartis Investigative Site | Ancona | AN | 60126 | Italy |
| Novartis Investigative Site | Belfast | BT12 6BA | United Kingdom |
| Participants Withdrew Consent |
|
| New Cancer Therapy |
|
| Reason not Specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Change From Baseline in Mean Urinary Free Cortisol (UFC) | 24-hour urine samples were collected to obtain mean UFC measurements. A negative mean change from baseline indicates improvement. | Primary Efficacy Population included participants from ITT whose mean UFC at core-baseline, based on at least 2 UFC samples, was >1.0x ULN or for whom the one and only UFC sample available at baseline was >2.0xULN. Number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Mean | Standard Deviation | nanomoles per 24 hours (nmol/24h) | Core Baseline, Days 14/15 (Core study), Months 6, 12, 24 and 102 |
|
|
|
| Secondary | Number of Participants Who Had At Least One Adverse Event (AE) | An AE was any undesirable sign, symptom or medical condition occurring after starting study drug even if the event is not considered to be related to study drug. AEs were assessed according to incident dose group: Pasireotide 1200 μg sc total daily dose (TDD), Pasireotide 1800 μg SC TDD and Pasireotide SC Any Dose. The incident dose for an AE was the last total daily dose administered on or prior to the AE onset date. | Safety Population included participants from ITT Population. ITT Population included participants who completed 15 days of treatment in the Core study, experienced significant clinical benefit without any unacceptable AEs, and received at least 1 dose in the extension period. | Posted | Count of Participants | Participants | Up to approximately 106 months |
|
|
|
| Secondary | Change From Baseline in Serum Cortisol Levels | Blood samples were withdrawn to obtain the serum cortisol levels. A negative change from baseline indicates improvement. | Primary Efficacy Population included participants from ITT whose mean UFC at core-baseline, based on at least 2 UFC samples, was >1.0x ULN or for whom the one and only UFC sample available at baseline was >2.0xULN. Number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Mean | Standard Deviation | nanomoles per liters (nmol/L) | Core Baseline, Day 15 (Core study), Months 6, 12, 24, and Month 105 (end of the study) |
|
|
|
| Secondary | Plasma Trough Concentrations (Ctrough) of Pasireotide in UFC Responders | Participants with Cushing's disease were considered responders if mean UFC levels from the 24-hour urine collections at Day 15 (Core study) and at extension Month 6, were within normal limits. Ctrough levels of pasireotide were measured at Day 15 of Core study and Month 6. | Pharmacokinetic (PK) Population included participants from ITT who had at least one post dosing PK assessment up to the implementation of Amendment 2 when no further blood samples were collected for PK assessment (24 May 2007). | Posted | Mean | Standard Deviation | nanograms per milliliter (ng/mL) | Day 15 (Core study) and Month 6 |
|
|
|
| Secondary | Change From Baseline in Plasma Adrenocorticotropic Hormone (ACTH) Levels | Blood samples were withdrawn to obtain the ACTH levels. A negative change from baseline indicates improvement. | Primary Efficacy Population included participants from ITT whose mean UFC at core-baseline, based on at least 2 UFC samples, was >1.0x ULN or for whom the one and only UFC sample available at baseline was >2.0xULN. Number analyzed is the number of participants with data available for analysis at the given time point. | Posted | Mean | Standard Deviation | picomoles per litre (pmol/L) | Core Baseline, Day 15 (Core study), Months 6, 12, 24 and Month 105 (end of the study) |
|
|
|
| Secondary | Change From Baseline in Gene-expression and Protein in Blood and Urine for Biomarker Development | We have exhausted all efforts to locate this data and it has since been destroyed, therefore no data is available to report for this outcome measure. | Posted | Baseline to end of the study |
|
|
| 0 |
| 19 |
| 2 |
| 19 |
| 19 |
| 19 |
| EG001 | Pasireotide 900 μg BID SC | Participants received 900 μg BID SC if UFC levels were increased at any time, until no safety or tolerability concerns were observed as per investigators assessment. If the participant was unable to tolerate the 900 μg BID, dosing of 600 μg three times a day was given. | 0 | 8 | 2 | 8 | 8 | 8 |
| Skin injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Amenorrhoea | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Injection site oedema | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (16.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood cortisol increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood creatine increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood sodium increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Bone marrow oedema | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Bunion | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Cyst | General disorders | MedDRA (16.0) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Homocystinaemia | Congenital, familial and genetic disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypogonadism | Endocrine disorders | MedDRA (16.0) | Systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Infrequent bowel movements | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA (16.0) | Systematic Assessment |
|
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Polydipsia | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Retinopathy hypertensive | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA (16.0) | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
|
| Tinea versicolour | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Ulcerative keratitis | Eye disorders | MedDRA (16.0) | Systematic Assessment |
|
| Umbilical hernia | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA (16.0) | Systematic Assessment |
|
| Vulvovaginitis | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (16.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
|
| Change from Core Baseline to Month 6 |
|
|
| Change from Core Baseline to Month 12 |
|
|
| Change from Core Baseline to Month 24 |
|
|
| Change from Core Baseline to Month 102 |
|
|
|
| Change from Core Baseline to Month 6 |
|
|
| Change from Core Baseline to Month 12 |
|
|
| Change from Core Baseline to Month 24 |
|
|
| Change from Core Baseline to Month 105 |
|
|
|
| Change from Core Baseline to Month 6 |
|
|
| Change from Core Baseline to Month 12 |
|
|
| Change from Core Baseline to Month 24 |
|
|
| Change from Core Baseline to Month 105 |
|
|