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Aspartate Aminotransferase

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242. Neratinib (Nerlynx) - Breast cancer, breast neoplasms

Akt protein kinase B ALT alanine aminotransferase AST aspartate aminotransferase AUC area under the curve BCS Biopharmaceutics Classification System CBR clinical benefit rate CHMP Committee for Medicinal Products for Human Use CI confidence interval CL/F oral clearance Cmax peak plasma concentration CMPH Committee for Medicinal Products for Human Use CNS central nervous system CRO contract research organization CV coefficient of variation CYP cytochrome DDFS distant disease-free survival DFS (...) in the rat. However this could be related to lower tolerable doses in the dog. Gastrointestinal toxicity has been observed with neratinib treatment and may be a result of an effect on epidermal cell growth. Liver and haematological changes Changes to clinical chemistry and haematological parameters were observed in both rats and dogs following both oral and intravenous neratinib. The main clinical chemistry changes were of increases in aspartate aminotransferase (AST) and alanine aminotransferase (ALT

2018 European Medicines Agency - EPARs

243. Caplacizumab (Cablivi) - thrombotic thrombocytopenic purpura (aTTP)

/490172/2018 Page 4/88 List of abbreviations Ab Antibody ADA anti-drug antibodies ADAMTS13 a disintegrin and metalloprotease with thrombospondin type 1 motif, member 13 AE adverse event ALT alanine aminotransferase aPTT activated partial thromboplastin time ATC Anatomical Therapeutic Chemical AST aspartate aminotransferase aTTP acquired thrombotic thrombocytopenic purpura AUC_D area under the curve dose corrected AUCSS area under the curve at steady state BED biologically effective dose CI confidence

2018 European Medicines Agency - EPARs

244. Ertugliflozin l-pyroglutamic acid / metformin hydrochloride (Segluromet) - Diabetes Mellitus, Type 2

. Additional considerations on the benefit-risk balance 157 3.8. Conclusions 157 4. Recommendations 157 Assessment report EMA/86928/2018 Page 4/159 List of abbreviations Abbreviation Definition %AR Applied radioactivity in percent A1C glycosylated haemoglobin A1c ADA American Diabetes Association AHA anti-hyperglycaemic agent AIBN 2,2'-Azobis(2-methylpropionitrile) ALT alanine aminotransferase Alu aluminium ANCOVA analysis of covariance ASaT All Subjects as Treated AST aspartate aminotransferase AUC area

2018 European Medicines Agency - EPARs

246. Ertugliflozin l-pyroglutamic acid (Steglatro) - Diabetes Mellitus, Type 2

Page 4/139 List of abbreviations Abbreviation Definition %AR applied radioactivity in percent A 1C glycosylated haemoglobin (haemoglobin A1c) ADA American Diabetes Association AHA anti-hyperglycaemic agent AIBN ALT (SGPT) 2,2'-Azobis(2-methylpropionitrile) alanine aminotransferase AST (SGOT) aspartate aminotransferase Alu aluminium AUC area under the concentration-time curve AUC inf area under the concentration-time curve from time zero to infinity AUC tau area under the concentration-time curve

2018 European Medicines Agency - EPARs

248. Ertugliflozin l-pyroglutamic acid / sitagliptin phosphate monohydrate (Steglujan) - Diabetes Mellitus, Type 2

AMP adenosine monophosphate AST (SGOT) aspartate aminotransferase AUC area under the concentration-time curve AUC inf area under the concentration-time curve from time zero to infinity BCS biopharmaceutical classification system BE bioequivalence BMI body mass index CHMP Committee for Medicinal Products for Human use CFU colony forming units CI confidence interval CKD chronic kidney disease cLDA constrained longitudinal data analysis C max maximum observed plasma concentration CPP critical process (...) considerations on the benefit-risk balance 137 3.8. Conclusions 137 4. Recommendations 137 Assessment report EMA/86941/2018 Page 4/139 List of abbreviations Abbreviation Definition %AR Applied radioactivity in percent A1C glycosylated hemoglobin (hemoglobin A1c) AACE American Association of Clinical Endocrinologists ABPM ambulatory blood pressure monitoring ADA American Diabetes Association AHA anti-hyperglycemic agent AIBN 2,2'-Azobis(2-methylpropionitrile) ALT (SGPT) alanine aminotransferase Alu aluminium

2018 European Medicines Agency - EPARs

249. Bevacizumab (Mvasi) - Cancer, colon, breast, lung, kidney, ovary, cervix

-risk balance 89 3.7. Conclusions 89 4. Recommendations 89 Assessment report EMA/798844/2017 Page 3/91 List of abbreviations ABP Amgen Biosimilar Protein ADA anti-drug antibody ADCC antibody dependent cell-mediated cytotoxicity ALK anaplastic lymphoma receptor tyrosine kinase ALT alanine aminotransferase ANC absolute neutrophil count AST aspartate aminotransferase ATO Amgen Thousand Oaks AUC area under the concentration-time curve AWA Amgen Washington BMI body mass index CCI container closure

2018 European Medicines Agency - EPARs

252. Masitinib mesylate (Alsitek) - Amyotrophic Lateral Sclerosis

sclerosis ALT Alanine Aminotransferase ANC Absolute Neutrophil Count AST Aspartate Aminotransferase Bid bis in diem/twice a day CAFS Combined Assessment of Function and Survival C-Findings Clinical Findings CRF Case Report Form CR Clinical Research CSF1R Colony-stimulating factor 1 receptor CYP Cytochrome P450 DLT Dose Limiting Toxicity ECOG Eastern Cooperative Oncology Group eCRF Electronic Case Report Form FVC Forced Vital Capacity ECG Electrocardiogram HDPE High Density Polyethylene HHD Handheld

2018 European Medicines Agency - EPARs

254. Plitidepsin (Aplidin) - Multiple Myeloma

. Recommendations following re-examination 149 Assessment report EMA/249101/2018 Page 5/156 List of abbreviations AE Adverse Event ALP Alkaline Phosphatase ALT Alanine Aminotransferase API Active pharmaceutical ingredient ASCT AST Autologous stem cell transplant Aspartate Aminotransferase ASMF Active substance master file AUC Area Under the Concentration Time Curve BM Bone Marrow BSA Body Surface Area BTZ Bortezomib t BuOH tert-butanol C Censored CFU Colony forming units CHMP Committee for Medicinal Products

2018 European Medicines Agency - EPARs

255. Inotersen sodium (Tegsedi) - Amyloidosis

EMA/411876/2018 Page 4/142 List of abbreviations A/C Urine albumin/creatinine ratio ADA Antidrug antibodies AE Adverse event AESI Adverse event of special interest ALT Alanine aminotransferase ANCOVA Analysis of covariance aPTT Activated partial thromboplastin time ASO Antisense oligonucleotide AST Aspartate aminotransferase ATTR Transthyretin amyloidosis AUC/ AUC 0-168h Area under the curve / Area under the curve baseline to 168 hours BMI Body mass index BCRP Human breast cancer resistance

2018 European Medicines Agency - EPARs

256. Ocrelizumab (Ocrevus) - multiple sclerosis

-life TK toxicokinetic Vss or or Vss/F volume of distribution at steady state; Vss is calculated with i.v. bolus input and Vss/F is calculated with extravascular input Clinical 9-HPT nine-hole peg test ALT alanine aminotransferase Assessment report EMA/790835/2017 Page 8/180 AST aspartate aminotransferase AUC area under the curve ADA anti-drug antibody ADCC antibody-dependent cellular cytotoxicity ADCP antibody-dependent cellular phagocytosis ANCOVA analysis of covariance ARR annualized relapse rate

2018 European Medicines Agency - EPARs

257. Letermovir (Prevymis) - to prevent illness caused by cytomegalovirus (CMV) in adults having an allogeneic haematopoietic stem cell transplant

transaminase AST Aspartate transaminase AUC Area under the concentration-time curve AUCtau Area under the concentration-time curve to the end of the dosing period AUCt,ss Area under the concentration-time curve steady state CMV Cytomegalovirus DAO Data-As-Observed DILI Drug-Induced Liver Injury ECI Event of clinical interest eGFR Estimated glomerular filtration rate FAS Full Analysis Set FSH Follicle-stimulating hormone GAP Genotypic Analysis Population GCCA Global Clinical Compliance Assurance GCV

2018 European Medicines Agency - EPARs

258. Proton beam therapy in adults

AMSTAR ANZCTR CADTH CENTRAL CIRT CNS CTCAE DARE EUnetHTA POP EMBASE GRADE Gy GyE HART HCC HR HTA ICER DEFINITION Three-dimensional conformal radiation therapy 95% confidence interval Alanine aminotransferase Aspartate aminotransferase Assessing the Methodological Quality of Systematic Reviews Australian New Zealand Clinical Trials Registry Canadian Agency for drugs and Technologies in Health Cochrane Controlled Register of Trials Carbon ion beam radiotherapy Central nervous system Common Terminology

2019 Belgian Health Care Knowledge Centre

259. Practice Advisory: Hepatitis B Prevention

liver disease include, but are not limited to, those with hepatitis C virus infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase or aspartate aminotransferase level greater than twice the upper limit of normal. This Practice Advisory was developed by the American College of Obstetricians and Gynecologists’ Immunization and Emerging Infections Expert Work Group in collaboration with Brenna L. Hughes, MD. References 1. Schillie S

2019 American College of Obstetricians and Gynecologists

260. Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

of statins. A genome-wide association study in participants from the SEARCH RCT evaluated 85 subjects who had developed definite myopathy (defined as muscle symptoms with CK >10 times the ULN) or “incipient myopathy” (defined as CK >3 times ULN and >5 times baseline levels, plus alanine aminotransferase [ALT] >1.7 times baseline levels without an elevated ALT alone at any other visit, with or without muscle symptoms) on simvastatin 80 mg and compared them with 90 participants who were also allocated

2019 American Gastroenterological Association Institute

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