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Authorised
The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity
Osteoporosis and Reduced Bone mineral density (T scoresstress test) with reduced BMD (T scores< -1.0 on DEXA scan)
United Kingdom
2005-12-12

Authorised
A Study of the Effect of Tazemetostat (study drug) in Patients with Relapsed or Refractory Mesothelioma
Part 1 – Subjects with relapsed or refractory malignant mesothelioma regardless of BAP1 status Part 2 – Subjects with relapsed or refractory BAP1-deficient malignant mesothelioma MedDRA version: 19.1 Level: HLT Classification code 10027414 Term: Mesotheliomas malignant and unspecified System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10027407 Term: Mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10027406 Term: Mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10027408 Term: Mesothelioma malignant advanced System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: LLT Classification code 10062474 Term: Mesothelioma malignant localized System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: PT Classification code 10027411 Term: Mesothelioma malignant recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.1 Level: HLGT Classification code 10027412 Term: Mesotheliomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
France, United Kingdom, United States
2016-06-28

Authorised
The study being done to see if the Study Drug is safe, tolerable, and can help control seizure in children with epilepsy who are aged 4 to less than 12 years of age and who are already taking seizure medications. The study will also look at pharmacokinetics, which is used to find out the concentration of perampanel in your child’s blood over a period of time.
Epilepsy : 1) Partial-Onset Seizures (POS) 2) Primary Generalized Tonic-Clonic Seizures (PGTC) MedDRA version: 19.0 Level: HLT Classification code 10018101 Term: Generalised tonic-clonic seizures System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.0 Level: PT Classification code 10061334 Term: Partial seizures System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Australia, Austria, Belgium, Canada, France, Hungary, Italy, Japan, Korea, Republic of, Latvia, Poland, Spain, United States
2016-12-12

Authorised
An international study to evaluate the effectiveness of Talazoparib in men with a genomic defect and metastatic castration-resistant prostate cancer who received previous chemotherapy and progressed on hormonal treatment
Men With DNA Repair Defects and Metastatic Castration-Resistant Prostate Cancer Who Previously Received Taxane-Based Chemotherapy and Progressed on at Least 1 Novel Hormonal Agent (Enzalutamide and/or Abiraterone Acetate/Prednisone) MedDRA version: 20.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
Australia, Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Spain, United Kingdom, United States
2016-09-15

Authorised
Multiple escalating dose study of BAY 1093884 in adults with hemophilia A or B with or without inhibitors
Hemophilia A or B MedDRA version: 20.0 Level: LLT Classification code 10053751 Term: Hemophilia A with anti factor VIII System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053753 Term: Hemophilia A without inhibitors System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10053752 Term: Hemophilia B with anti factor IX System Organ Class: 100000004850 MedDRA version: 20.1 Level: LLT Classification code 10053754 Term: Hemophilia B without inhibitors System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Australia, Austria, Bulgaria, France, Hungary, Italy, Japan, Korea, Republic of, New Zealand, South Africa, Taiwan, United Kingdom
2018-04-12

Authorised
A study evaluating the diagnostic accuracy of [18F]-AV-1451 PET to detect and distinguish neurodegenerative disorders characterized by cerebral accumulation of the protein tau
Neurodegenerative disorders with Tau-pathology; including Alzheimer's disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and important differential diagnostic conditions. MedDRA version: 17.0 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10053643 Term: Neurodegenerative disorder System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: LLT Classification code 10009846 Term: Cognitive impairment System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: LLT Classification code 10012285 Term: Dementia due to Pick's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10012267 Term: Dementia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10067889 Term: Dementia with Lewy bodies System Organ Class: 10029205 - Nervous system disorders MedDRA version: 17.0 Level: PT Classification code 10036813 Term: Progressive supranuclear palsy System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Sweden
2014-08-05

Authorised
The BioFINDER 2 study - improved diagnostics and increased understanding of the underlying mechanisms of cognitive disorders
Neurodegenerative disorders with Tau-pathology; including, but not limited to, Alzheimers disease, progressive supranuclear palsy, frontotemporal dementia, corticobasal degeneration and mild cognitive impairment. MedDRA version: 19.1 Level: PT Classification code 10053643 Term: Neurodegenerative disorder System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: PT Classification code 10012267 Term: Dementia System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: PT Classification code 10067889 Term: Dementia with Lewy bodies System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: HLGT Classification code 10028037 Term: Movement disorders (incl parkinsonism) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: HLT Classification code 10001897 Term: Alzheimer's disease (incl subtypes) System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: LLT Classification code 10009846 Term: Cognitive impairment System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: LLT Classification code 10048598 Term: Cognitive disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: LLT Classification code 10001896 Term: Alzheimer's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: LLT Classification code 10012285 Term: Dementia due to Pick's disease System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: PT Classification code 10036813 Term: Progressive supranuclear palsy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 19.1 Level: PT Classification code 10074616 Term: Prodromal Alzheimer's;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Sweden
2017-01-30

Authorised
A Trial of Anti-PD-L1 Antibody (MPDL3280A) in Pediatric and Young Adult Patients with Previously Treated Solid Tumors
Pediatric solid tumors for which prior treatment has proven to be ineffective (i.e., relapsed or refractory) or intolerable MedDRA version: 18.0 Level: PT Classification code 10029547 Term: Non-Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10047987 Term: Wilms' tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10020328 Term: Hodgkin's lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10039022 Term: Rhabdomyosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10075333 Term: Soft tissue sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
Austria, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States
2015-05-05

Authorised
Investigation of the drug Lithium with Brain Imaging in people with Bipolar Disorder
Healthy volunteers Bipolar patients type 1 MedDRA version: 14.1 Level: LLT Classification code 10043890 Term: Tiredness System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: LLT Classification code 10028821 Term: Nausea with vomiting System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10013575 Term: Dizziness and giddiness System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10051385 Term: Drug-induced headache System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10021689 Term: Increased thirst System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: LLT Classification code 10036164 Term: Poor weight gain System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10044577 Term: Tremor of hands System Organ Class: 10029205 - Nervous system disorders MedDRA version: 14.1 Level: LLT Classification code 10027176 Term: Memory loss System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Germany
2012-07-18

Authorised
ovarian cancer treatment with intraabdominal chemotherapy (paclitaxel)
ovarian cancer (II,III,IV FIGO staging and tumoral recurrence) MedDRA version: 14.1 Level: LLT Classification code 10028584 Term: Myelosuppression System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1 Level: PT Classification code 10006093 Term: Bradycardia System Organ Class: 10007541 - Cardiac disorders MedDRA version: 14.1 Level: PT Classification code 10028813 Term: Nausea System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10012727 Term: Diarrhea System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: PT Classification code 10047700 Term: Vomiting System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1 Level: LLT Classification code 10028127 Term: Mucositis System Organ Class: 10018065 - General disorders and administration site conditions MedDRA version: 14.1 Level: PT Classification code 10003239 Term: Arthralgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: PT Classification code 10001760 Term: Alopecia System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10046544 Term: Urinary infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: PT Classification code 10021097 Term: Hypotension System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: PT Classification code 10028411 Term: Myalgia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1 Level: LLT Classification code 10038700 Term: Respiratory infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10034610 Term: Peripheral neuropathy NOS System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Cancer [C04]
Spain
2012-02-22

Authorised
Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de la RMN multimodale dans l'analyse des lésions de sclérose en plaques : étude longitudinale sur 3 ans d'une cohorte de 50 patients après un premier évènement ("CIS" patients) à haut risque de développer une sclérose en plaques. - USPIO-CIS
1. Multiple Sclerosis 2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive MedDRA version: 9.1 Level: LLT Classification code 10028246 Term: Multiple sclerosis aggravated MedDRA version: 9.1 Level: LLT Classification code 10028247 Term: Multiple sclerosis like syndrome MedDRA version: 9.1 Level: LLT Classification code 10028248 Term: Multiple sclerosis-like syndrome MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse MedDRA version: 9.1 Level: LLT Classification code 10053395 Term: Progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
France
2007-12-11

Authorised
A clinical study to evaluate the safety, tolerability, and efficacy of INCB001158 in combination with chemotherapy in subjects with advanced or metastatic solid tumors.
Phase 1: Advanced or metastatic solid tumors Phase 2: Advanced/metastatic microsatellite stable colorectal cancer (MSS-CRC), biliary tract cancer (BTC), gastroesophageal cancer (GC), and endometrial cancer (EC) and recurrent ovarian cancer (OC) MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10028982 Term: Neoplasm biliary tract System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10056267 Term: Gastroesophageal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: PT Classification code 10066697 Term: Ovarian cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
Belgium, United Kingdom, United States
2017-11-14

Authorised
Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL
Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously, -- AND who developed adverse events (AEs) corresponding to pre-specified newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome MedDRA version: 9.1 Level: LLT Classification code 10
Austria, France, Germany, Netherlands, Portugal
2008-02-29

Authorised
Etude comparative de l'imagerie cellulaire et inflammatoire (USPIO (SH U 555 C)) et de l'IRM multimodale 3 tesla dans l'analyse des lésions de la SEP et leur progression. Etude longitudinale sur 3 ans. - USPIO-Mitox
1. Multiple Sclerosis 2. Clinically isolated syndromes (at high risk to develop Multiple Sclerosis) MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: HLT Classification code 10052785 Term: Multiple sclerosis acute and progressive MedDRA version: 9.1 Level: LLT Classification code 10028246 Term: Multiple sclerosis aggravated MedDRA version: 9.1 Level: LLT Classification code 10028247 Term: Multiple sclerosis like syndrome MedDRA version: 9.1 Level: LLT Classification code 10028248 Term: Multiple sclerosis-like syndrome MedDRA version: 9.1 Level: LLT Classification code 10048393 Term: Multiple sclerosis relapse MedDRA version: 9.1 Level: LLT Classification code 10053395 Term: Progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063401 Term: Primary progressive multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10064137 Term: Progression of multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10028245 Term: Multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10048393 Term: Multiple sclerosis relapse MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10053395 Term: Progressive multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis MedDRA version: 9.1 Level: PT Classification code 10063400 Term: Secondary progressive multiple sclerosis
France
2008-02-07

Authorised
A Multi-Centre Prospective Controlled Trial Comparing Calcineurin Inhibitor Monotherapy With Sirolimus Monotherapy in Hepatitis C Infected Patients with Hepatic Fibrosis Following Liver Transplantation - Sirolimus and Hepatitis C following Liver Transplantation
Patients who have undergone liver transplantation and are infected with Hepatitis C virus. MedDRA version: 9.1 Level: HLT Classification code 10052779 Term: Transplant rejections MedDRA version: 9.1 Level: HLGT Classification code 10024970 Term: Respiratory tract infections MedDRA version: 9.1 Level: HLT Classification code 10046577 Term: Urinary tract infections MedDRA version: 9.1 Level: LLT Classification code 10001032 Term: Acute pyelonephritis MedDRA version: 9.1 Level: LLT Classification code 10040072 Term: Septicaemia MedDRA version: 9.1 Level: HLT Classification code 10019972 Term: Herpes viral infections MedDRA version: 9.1 Level: HLGT Classification code 10028440 Term: Mycobacterial infectious disorders MedDRA version: 9.1 Level: HLT Classification code 10015107 Term: Epstein-Barr viral infections MedDRA version: 9.1 Level: LLT Classification code 10011831 Term: Cytomegalovirus infection MedDRA version: 9.1 Level: LLT Classification code 10019974 Term: Herpes zoster MedDRA version: 9.1 Level: LLT Classification code 10058872 Term: Fungal sepsis MedDRA version: 9.1 Level: PT Classification code 10040808 Term: Skin cancer MedDRA version: 9.1 Level: LLT Classification code 10051358 Term: Post transplant lymphoproliferative disorder MedDRA version: 9.1 Level: HLT Classification code 10043555 Term: Thrombocytopenias MedDRA version: 9.1 Level: LLT Classification code 10037561 Term: Purpura thrombocytopenic MedDRA version: 9.1 Level: PT Classification code 10002034 Term: Anaemia MedDRA version: 9.1 Level: PT Classification code 10018932 Term: Haemolytic uraemic syndrome MedDRA version: 9.1 Level: PT Classification code 10024384 Term: Leukopenia MedDRA version: 9.1 Level: HLT Classification code 10029355 Term: Neutropenias MedDRA version: 9.1 Level: PT Classification code 10033661 Term: Pancytopenia MedDRA version: 9.1 Level: LLT Classification code 10013505 Ter
United Kingdom
2009-04-14

Authorised
RELY-ABLE long term multi-center extension of dabigatran treatment in patients with atrial fibrillation who completed the RE-LY trial and a cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes - RELY-ABLE
This is a study of the long term safety of dabigatran (intended indication: stroke prevention in patients with atrial fibrillation).Eligible patients received dabigatran during the RE-LY trial 1160.26.At the time of entry into RE-LY, patients had at least one risk factor for stroke (1) congestive heart failure, 2) left ventricular dysfunction, 3) age >75, 4) age >65 years with hypertension, diabetes or coronary artery disease or 5) previous stroke, systemic embolism or transient ischemic attack) MedDRA version: 9.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Sweden, United Kingdom
2008-09-25

Authorised
ENGOT-EN1/FANDANGO: A randomized double-blind phase II trial of combination chemotherapy with nintedanib or placebo for patients with endometrial cancer.
Histological confirmed endometrial cancer. (FIGO 2009) stage 3C2 or stage 4 or relapsed after adjuvant therapy for stage 1-3 disease. MedDRA version: 19.0 Level: PT Classification code 10014741 Term: Endometrial cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10014733 Term: Endometrial cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10014734 Term: Endometrial cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: LLT Classification code 10014735 Term: Endometrial cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10014736 Term: Endometrial cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: PT Classification code 10014740 Term: Endometrial cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) ;Therapeutic area: Diseases [C] - Cancer [C04]
Belgium, Denmark, Finland, France, Germany, Norway, Sweden
2016-04-29

Authorised
A Study of the Effect of Tazemetostat (study drug) in Patients with INI1-Negative Tumors or Relapsed/Refractory Synovial Sarcoma
Cohort 1: Rhabdoid tumors (malignant rhabdoid tumors, rhabdoid tumors of the kidney, atypical teratoid rhabdoid tumors, and selected tumors Cohort 2: Relapsed/refractory synovial sarcoma with SS18-SSX rearrangement Cohort 3: Other INI1-negative tumors or any solid tumor with EZH2 GOF (gain of function) mutation Cohort 4: Renal medullary carcinoma Cohort 5: Epithelioid sarcoma Cohort 6: Epithelioid sarcoma undergoing mandatory tumour biopsy Cohort 7: Poorly differentiated chordoma MedDRA version: 20.0 Level: LLT Classification code 10007284 Term: Carcinoma System Organ Class: 100000020935 MedDRA version: 20.0 Level: LLT Classification code 10064886 Term: Renal medullary carcinoma System Organ Class: 100000017669 MedDRA version: 20.0 Level: PT Classification code 10073134 Term: Extraskeletal myxoid chondrosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10026667 Term: Malignant peripheral nerve sheath tumor System Organ Class: 100000056040 MedDRA version: 20.0 Level: LLT Classification code 10073335 Term: Rhabdoid tumor System Organ Class: 100000143847 MedDRA version: 20.0 Level: PT Classification code 10042863 Term: Synovial sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLT Classification code 10015100 Term: Epithelioid sarcomas System Organ Class: 100000143528 ;Therapeutic area: Diseases [C] - Cancer [C04]
Australia, Belgium, Canada, France, Germany, Italy, Taiwan, United Kingdom, United States
2015-10-28

Authorised
Phase IV, open, low-level intervention, clinical trial to compare the immunogenicity in immunosuppressed patients of an adjuvanted anti-hepatitis B vaccine with an anti-hepatitis B vaccine with increased antigenic load
1. Autoinmune rheumatic diseases undertreated by rituximab or infliximab. 2. breast and lung cancer undertreated by chemotherapy 3. HIV 4. Haematopoietic progenitor cell transplantation (TCPH). MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870 MedDRA version: 20.0 Level: PT Classification code 10058467 Term: Lung neoplasm malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10020161 Term: HIV infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10063581 Term: Stem cell transplant System Organ Class: 10042613 - Surgical and medical procedures ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Spain
2018-07-25

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