LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS. The following abbreviations and specialist terms are used in this study protocol. 6MWD 6-minute walk distance 6MWT 6-minute walk test AE Adverse event ACA Anti-centromere ALP Alkaline phosphatase ALT Alanine aminotransferase XXX Anti-nuclear Anti-RNAP Anti-RNA polymerase enzyme Anti-U1RNP Anti-U1 nuclear ribosome Anti-U3RNP Anti-U3 nuclear ribosome Anti-Th/To Anti-ribonucleoprotein Anti-Ds-DNA Anti-double stranded DNA AST Aspartate aminotransferase ATP Adenosine triphosphate ATS American Thoracic Society AUC Area under the concentration-time curve BMI Body mass index BNP B-type natriuretic peptide BP Blood Pressure BUN Blood urea nitrogen CFR Code of Federal Regulations (US) CK Creatine kinase CKD Chronic kidney disease Cmax Maximum drug concentration in plasma CT Computed tomography CTD Connective tissue disease CTD-PAH Connective tissue disease-associated pulmonary arterial hypertension CTEPH Chronic thromboembolic pulmonary hypertension DSMB Data safety monitoring board EC Ethics Committee eCRF Electronic case report form ECG Electrocardiogram ECHO Echocardiogram EDC Electronic data capture eGFR Estimated glomerular filtration rate ERA Endothelin receptor antagonist FADH2 Xxxxxx adenine dinucleotide FDA Food and Drug Administration (US) FEV1 Forced expiratory volume FVC Forced vital capacity GCP Good Clinical Practice GGT Gamma-glutamyl transpeptidase HCV Hepatitis C virus HDPE High-density polyethylene Hgb Hemoglobin ICH International Conference on Harmonization IKKβ Inhibitor of nuclear factor kappa β kinase beta subunit INR International normalized ratio IRB Institutional Review Board IWRS Interactive Web Response System ITT Intent-to-treat Keap1 Xxxxx-like ECH associated protein-1 LDH Lactate dehydrogenase MAR Missing at random MCH Mean corpuscular hemoglobin MCHC Mean corpuscular hemoglobin concentration MCV Mean corpuscular volume MMRM Mixed model repeated measures MRI Magnetic resonance imaging NADH Nicotinamide adenine dinucleotide NF-κB Nuclear factor kappa-light-chain-enhancer of activated B-cells Nrf2 Nuclear factor (erythroid-derived 2)-related factor 2 NT-Pro BNP N-Terminal Pro-Brain Natriuretic Peptide NYHA FC New York Heart Association Functional Classification PAH Pulmonary arterial hypertension PCWP Pulmonary capillary wedge pressure PEF Peak expiratory flow PFT Pulmonary function test PH Pulmonary hypertension PK Pharmacokinetic RBC Red blood cell RHC Right heart catheterization ROS Reactive oxygen species SAE Serious adverse event ...
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS. The following abbreviations and specialist terms are used in this study protocol. A-101 40% A-101 Hydrogen Peroxide Topical Solution, 40% (w/w) AE Adverse event ANCOVA Analysis of Covariance ºC Degrees Centigrade CMH Xxxxxxx-Xxxxxx-Haenszel CRA Clinical Research Associate CRF Case Report Form CRO Contract Research Organization CS Clinically Significant
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS. The following abbreviations and specialist terms are used in this study protocol. ADP adenosine diphosphate AE adverse event AESI adverse event of special interest ASCO American Society of Clinical Oncology BIW twice weekly BRCA breast cancer susceptibility gene CBC complete blood count CI confidence interval CT computed tomography CTCAE Common Terminology Criteria for Adverse Events CYP cytochrome P450 DLT dose-limiting toxicity DNA deoxyribonucleic acid eCRF electronic case report form EOT End of Treatment EU European Union GCSF granulocyte colony-stimulating factor HR hazard ratio HRD homologous recombination deficiency HRR homologous recombination repair Ig immunoglobulin IL-2 interleukin-2 irAEI immune-related adverse event of interest IV intravenous mPD-1 mouse programmed death-1 MRI magnetic resonance imaging XXX objective response rate PARP poly(ADP-ribose) polymerase PD progressive disease PD-1 programmed death-1 PD-L1 programmed death-ligand 1 PD-L2 programmed death-ligand 2 PFS progression-free survival PK pharmacokinetic(s) PO orally PROC platinum-resistant ovarian cancer Q2W every 2 weeks Q3W every 3 weeks Q6W every 6 weeks QD once daily RECIST Response Evaluation Criteria in Solid Tumors SAE serious adverse event TEAE treatment-emergent adverse event TIL tumor-infiltrating lymphocyte TNBC triple-negative breast cancer US United States
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS. The following abbreviations and specialist terms are used in this study protocol. ABG arterial blood gas ACE angiotensin converting-enzyme AE adverse event ALP alkaline phosphatase ALT alanine transaminase AST aspartate transaminase AT1R angiotensin II type 1 receptor BP blood pressure BUN blood urea nitrogen CRA clinical research associate CRF case report form DSMB data safety monitoring board ECG electrocardiogram ECMO extracorporeal membrane oxygenation eCRF electronic case report form EOS end of study FiO2 fractional inspired oxygen GCP good clinical practice HR heart rate ICH International Conference on Harmonisation ICU intensive care unit IEC independent ethics committee INR international normalized ratio IRB institutional review board IV intravenous(ly) MAP mean arterial pressure mEq milliequivalent mmHg millimeter of mercury NE norepinephrine XXX norepinephrine-equivalent dose NIRS near-infrared spectroscopy PaCO2 carbon dioxide partial pressure PaO2 arterial oxygen partial pressure PE physical exam PELOD Pediatric Logistic Organ Dysfunction PIM2 Pediatric Index of Mortality 2 PRISM Pediatric Risk of Mortality PT prothrombin time PTT partial thromboplastin time RAAS renin angiotensin aldosterone system RR respiratory rate SAE serious adverse event SGOT serum glutamic-oxaloacetic transaminase SOC standard of care SOP standard operating procedures VA xxxx-arterial XX xxxx-venous WBC white blood cell
