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Clinical Index of Stable Febrile Neutropenia

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61. Addyi - Flibanserin

clinical practice are unknown. Estimates of the prevalence of HSDD in U.S. women vary widely, depending on the instruments used for assessment as well as menopausal status of the women studied. Two large survey studies have estimated the prevalence of HSDD in U.S. premenopausal women to be 7.7% to 14%, 2,3 potentially affecting 5.5 to 8.6 million U.S. women ages 20 to 49. However, methodological limitations inherent in these surveys, such as recall bias and low response rates (4.8% and 8.2 (...) %, respectively in West and Lieblum, et al.), makes it difficult to estimate the prevalence of HSDD in the U.S. There are no FDA approved pharmacotherapies to treat HSDD in either women or men. While psychological interventions – such as cognitive behavior therapy, sex therapy, or couples therapies – have been shown to decrease symptom severity in women with HSDD, 4 evidence from large, place-controlled clinical trials demonstrating effectiveness of psychological therapies is lacking. Testosterone has been

2015 FDA - Drug Approval Package

62. Kyprolis - carfilzomib

on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendation for future quality development 18 2.3. Non-clinical aspects 19 2.3.1. Introduction 19 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 24 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 32 2.3.7. Conclusion on the non-clinical aspects 35 2.4. Clinical aspects 35 2.4.1. Introduction 35 2.4.2. Pharmacokinetics 35 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical (...) pharmacology 44 2.4.5. Conclusions on clinical pharmacology 46 2.5. Clinical efficacy 46 2.5.1. Dose response studies 46 2.5.2. Main study 47 2.5.3. Discussion on clinical efficacy 86 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 88 2.6.1. Discussion on clinical safety 121 2.6.2. Conclusions on the clinical safety 127 2.7. Risk Management Plan 127 2.8. Pharmacovigilance 134 2.9. Product information 135 2.9.1. User consultation 135 2.9.2. Additional monitoring 135 Assessment report EMA

2015 European Medicines Agency - EPARs

63. Farydak - panobinostat

and biological aspects 17 2.2.6. Recommendations for future quality development 17 2.3. Non-clinical aspects 17 2.3.1. Introduction 17 2.3.2. Pharmacology 17 2.3.4. Toxicology 28 2.3.5. Ecotoxicity/environmental risk assessment 39 2.3.6. Discussion on non-clinical aspects 40 2.3.7. Conclusion on the non-clinical aspects 42 2.4. Clinical aspects 42 2.4.1. Introduction 42 2.4.2. Pharmacokinetics 43 2.4.3. Pharmacodynamics 49 2.4.4. Discussion on clinical pharmacology 50 2.4.5. Conclusions on clinical (...) pharmacology 53 2.5. Clinical efficacy 54 2.5.1. Dose response study 54 2.5.2. Main study 56 2.5.3. Discussion on clinical efficacy 84 2.5.4. Conclusions on the clinical efficacy 88 2.6. Clinical safety 89 2.6.1. Discussion on clinical safety 102 2.6.2. Conclusions on the clinical safety 107 2.7. Pharmacovigilance 107 2.8. Risk Management Plan 107 2.9. Product information 118 2.9.1. User consultation 118 Assessment report EMA/CHMP/496296/2015 Page 2/124 3. Benefit-Risk Balance 118 4. Recommendations 121

2015 European Medicines Agency - EPARs

64. Pruning Emtree: Does Focusing Embase Subject Headings Impact Search Strategy Precision and Sensitivity?

that there are thousands of reports of RCTs indexed in Embase that are not also indexed in MEDLINE. 2 Although Embase is a recommended key database it has several features that hinder efficient searching. One feature is the large number of Emtree index terms that are added to most Embase records: an average of 3 to 4 major terms and up to 50 minor terms. 3 MEDLINE records may contain an average of 10 to 20 (major or minor) index terms. 4 The volume of index terms can lead to poor precision in Embase searches (large (...) proportions of irrelevant records are retrieved) if the terms that are of only marginal relevance to a specific record are added by the indexers. When this occurs it can add to the record processing burden within the HTA process. This experience has led to informal pragmatic recommendations that search results can be reduced by carrying out searches of subject headings combined with subheadings (qualifiers) and/or searches with subject headings limited to those with a major focus (major headings). 4

2015 Canadian Agency for Drugs and Technologies in Health - Rapid Review

65. Neutropenic sepsis

) [ ], the international consensus report Surviving Sepsis Campaign (SSC): International Guidelines for Management of Sepsis and Septic Shock: 2016 [ ], the UK Sepsis Trust Sepsis Manual [ ] , and expert opinion in a review article on sepsis [ ], on neutropenic sepsis [ ; ], and on febrile neutropenia [ ; ]. Maintaining a high index of suspicion of neutropenic sepsis The information that neutropenic sepsis can be challenging to identify due to minimal or atypical symptoms and/or signs is based on the ESMO clinical (...) to the lack of epidemiology data [ ]. This approach is supported by the ESMO clinical guidelines, which highlight the importance of prompt recognition of possible infection and sepsis in people with febrile neutropenia and initial management within one hour of the recognition of suspected sepsis [ ]. Expert opinion in a review article notes that people with neutropenic sepsis who appear clinically stable can deteriorate rapidly and require urgent specialist assessment [ ], and this is supported by expert

2019 NICE Clinical Knowledge Summaries

66. Recommendations for the use of first-line chemotherapy for the treatment of women with epithelial ovarian cancer

Oncology. 2011; 120S98 69. Pavelka JC, Brown RS, Karlan BY, et al. Effect of obesity on survival in epithelial ovarian cancer. Cancer. 2006; 107(7):1520-4 70. Au-Yeung G, Webb PM, DeFazio A, et al. Impact of obesity on chemotherapy dosing for women with advanced stage serous ovarian cancer in the Australian Ovarian Cancer Study (AOCS). Gynecol Oncol. 2014; 133(1):16-22 71. Laskey RA, Poniewierski MS, Lopez MA, et al. Predictors of severe and febrile neutropenia during primary chemotherapy for ovarian (...) Recommendations for the use of first-line chemotherapy for the treatment of women with epithelial ovarian cancer First-line chemotherapy for the treatment of women with epithelial ovarian cancer Recommendations for the use of first-line chemotherapy for the treatment of women with epithelial ovarian cancer June 2014 | Incorporates published evidence to March 2014 A CLINICAL PRACTICE GUIDELINE DEVELOPED BY CANCER AUSTRALIA This document supplements information about use of chemotherapy for women

2015 Cancer Australia

67. Gastric Cancer Treatment (PDQ®): Health Professional Version

with patients who received CF (9.2 months; 95% CI, 8.4–10.6; vs. 8.6 months; 95% CI, 7.2–9.5; HR, 1.29; 95% CI, 1.0–1.6; log-rank P = .02; risk reduction = 23%).[ ][ ] There were high toxicity rates in both arms.[ ] Febrile neutropenia was more common in patients who received DCF (29% vs. 12%), and the death rate on the study was 10.4% for patients on the DCF arm and 9.4% for patients on the CF arm. Whether the CF regimen should be considered as an index regimen for the treatment of patients with metastatic (...) = .0162). Toxicity rates were similar between groups (26% required hospitalizations in the ECF/ECX group and 25% in the FLOT group). However, types of side effects differed, with increased nausea, thromboembolic events, and anemia in the ECF/ECX group versus higher rates of grade 3/4 infections, neutropenia, diarrhea, and neuropathy in the FLOT group. Treatment Options Under Clinical Evaluation for Stage I Gastric Cancer Treatment options under clinical evaluation for stage I gastric cancer include

2018 PDQ - NCI's Comprehensive Cancer Database

68. Breast Cancer Treatment (PDQ®): Health Professional Version

).[ ] Aromatase inhibitors or inactivators.[ , ] Risk-reducing mastectomy.[ ] Risk-reducing oophorectomy or ovarian ablation.[ - ] (Refer to the PDQ summary on for more information about factors that decrease the risk of breast cancer.) Screening Clinical trials have established that screening asymptomatic women using mammography, with or without clinical breast examination, decreases breast cancer mortality. (Refer to the PDQ summary on for more information.) Diagnosis Patient evaluation When breast cancer (...) is suspected, patient management generally includes the following: Confirmation of the diagnosis. Evaluation of the stage of disease. Selection of therapy. The following tests and procedures are used to diagnose breast cancer: Mammography. Ultrasound. Breast magnetic resonance imaging (MRI), if clinically indicated. Biopsy. Contralateral disease Pathologically, breast cancer can be a multicentric and bilateral disease. Bilateral disease is somewhat more common in patients with infiltrating lobular

2018 PDQ - NCI's Comprehensive Cancer Database

69. Adult Hodgkin Lymphoma Treatment (PDQ®): Health Professional Version

areas. Presence of . Early favorable group: Clinical stage I or II without any of the adverse prognostic factors listed above. Early unfavorable group: Clinical stage I or II with one or more of the adverse prognostic factors listed above. Advanced-stage adverse prognostic factors: For patients with advanced-stage HL, the International Prognostic Factors Project on Advanced Hodgkin's Disease developed the International Prognostic Index with a score that is based on the following seven adverse (...) seen. Risk Factors Risk factors for adult HL include the following: Being in early adulthood (aged 20–39 years) (most often) or late adulthood (aged 65 years and older) (less often). Being male. Having a previous infection with the Epstein-Barr virus in the teenage years or early childhood. Having a first-degree relative with HL. Clinical Features These and other signs and symptoms may be caused by adult HL or by other conditions: Painless, swollen lymph nodes in the neck, axilla, or inguinal area

2018 PDQ - NCI's Comprehensive Cancer Database

70. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications

in the management of this uncommon but potentially deadly infection. The clinical variability and complexity in infective endocarditis, however, dictate that these recommendations be used to support and not supplant decisions in individual patient management. Introduction Infective endocarditis (IE) is an uncommon infectious disease with an annual incidence ranging from 3 to 7 per 100 000 person-years in the most contemporary population surveys. Although relatively rare, IE continues to be characterized (...) . Although the overall IE incidence has remained stable, , , the incidence of IE caused by Staphylococcus aureus has increased, and S aureus is now the most common causative organism in most of the industrialized world. The emergence of S aureus IE is due in part to the increasing importance of healthcare contact as a leading risk associated with infection. Characteristics of IE patients have also shifted toward an increased mean patient age, a higher proportion of prosthetic valves and other cardiac

2016 Infectious Diseases Society of America

71. Practice Guidelines for the Diagnosis and Management of Aspergillosis

persistently febrile despite broad-spectrum antibiotic therapy. Antifungal options include a lipid formulation of AmB (strong recommendation; high-quality evidence) , an echinocandin (caspofungin or micafungin) (strong recommendation; high-quality evidence) , or voriconazole (strong recommendation; moderate-quality evidence) . 75. Empiric antifungal therapy is not recommended for patients who are anticipated to have short durations of neutropenia (duration of neutropenia <10 days), unless other findings (...) Practice Guidelines for the Diagnosis and Management of Aspergillosis We use cookies to enhance your experience on our website. By continuing to use our website, you are agreeing to our use of cookies. You can change your cookie settings at any time. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America | Clinical Infectious Diseases | Oxford Academic Search Account Menu Menu Navbar Search Filter Mobile Microsite Search

2016 Infectious Diseases Society of America

72. Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer

of the following comparisons: single-agent versus single-agent hormone therapies, single-agent versus combination endocrine therapies, endocrine therapy with or without HER2-targeted therapies, endocrine therapy with or without mTOR inhibitors, endocrine therapy with or without CDK 4/6 inhibitors, and endocrine therapy with or without novel agents. Articles were also required to report on primary outcomes of interest (including OS, PFS or TTP, or clinical benefit rate [CBR; stable disease plus response rate (...) Endocrine Therapy for Hormone Receptor-Positive Metastatic Breast Cancer Endocrine Therapy for Hormone Receptor–Positive Metastatic Breast Cancer: American Society of Clinical Oncology Guideline | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLE Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2016.67.1487 Journal of Clinical Oncology - published online before print May 23, 2016 PMID: Endocrine Therapy

2016 American Society of Clinical Oncology Guidelines

73. Multiple Myeloma: Evidence Report

Multiple Myeloma: Evidence Report ©Institute for Clinical and Economic Review, 2016 Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness, Value, and Value-Based Price Benchmarks Evidence Report May 5, 2016 Institute for Clinical and Economic Review ©Institute for Clinical and Economic Review, 2016 Page ii Evidence Report – Multiple Myeloma Return to Table of Contents AUTHORS ICER Staff University of Washington School of Pharmacy Modeling Group Daniel A. Ollendorf, PhD (...) Chief Scientific Officer, Institute for Clinical and Economic Review Rick Chapman, PhD, MS Director of Health Economics, Institute for Clinical and Economic Review Sonya Khan, MPH Program Director, Institute for Clinical and Economic Review Elizabeth T. Russo, MD Research Scientist, Institute for Clinical and Economic Review Patricia G. Synnott, MALD, MS Research Associate, Institute for Clinical and Economic Review Steven D. Pearson, MD, MSc President, Institute for Clinical and Economic Review

2016 California Technology Assessment Forum

74. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications

are intended to assist in the management of this uncommon but potentially deadly infection. The clinical variability and complexity in infective endocarditis, however, dictate that these recommendations be used to support and not supplant decisions in individual patient management. Introduction Infective endocarditis (IE) is an uncommon infectious disease with an annual incidence ranging from 3 to 7 per 100 000 person-years in the most contemporary population surveys. Although relatively rare, IE continues (...) substantially. Although the overall IE incidence has remained stable, , , the incidence of IE caused by Staphylococcus aureus has increased, and S aureus is now the most common causative organism in most of the industrialized world. The emergence of S aureus IE is due in part to the increasing importance of healthcare contact as a leading risk associated with infection. Characteristics of IE patients have also shifted toward an increased mean patient age, a higher proportion of prosthetic valves and other

2015 American Heart Association

75. Diagnosis and Management of Aplastic Anaemia

Protocols and guidelines for the management of febrile neutropenia, including the assessment and management of fungal infections, are well developed and clinicians should follow local hospital and National Institute for Health and Care Excellence guidance (Phillips et al , ). Empirical anti‐fungal therapy, as per local guidelines, should be initiated early for patients with clinically suspected IFIs, as these patients have persistent neutropenia. Granulocyte transfusions may be potentially life saving (...) be given as an in‐patient. ATG is a powerful immunosuppressive agent; it should only be used in centres that are familiar with using the drug and with its side effects. Prior to starting ATG: The patient should be clinically stable and ideally afebrile. Platelet count increment studies should be performed to exclude platelet refractoriness. Prophylactic antiviral, antibiotic and antifungal drugs should be administered according to local policy. For patients aged >60 years, careful assessment of co

2015 British Committee for Standards in Haematology

76. Muscle-invasive and Metastatic Bladder Cancer

into their clinical practice. Separate EAU guidelines documents are available addressing upper urinary tract tumours [1], non- muscle-invasive bladder cancer (Ta,T1 and carcinoma in situ) [2], and primary urethral carcinomas [3]. 1.2 Panel Composition The EAU Guidelines Panel consists of an international multidisciplinary group of experts from the fields of urology, pathology, radiology and oncology. All experts involved in the production of this document have submitted potential conflict of interest statements (...) . Recommendations have been rephrased and added to throughout the current document: 3.3.3 Recommendations for the assessment of tumour specimens Mandatory evaluations Depth of invasion (categories pT2 vs pT3a, pT3b or pT4); Margins with special attention paid to the radial margin, prostate, ureter, urethra and peritoneal fat and uterus and vaginal top. Histological subtype, if it has clinical implications; Extensive lymph node r epr esentation (mor e than nine); Optional evaluations Bladder wall blood vessel

2015 European Association of Urology

77. Acute Pain Management: Scientific Evidence

appropriate advice, before relying on the information in any important matter. Enquiries on the content of the material should be directed to the Therapeutic Goods Administration (www.tga.gov.au). Disclaimer This document aims to combine a review of the best available evidence for acute pain management with current clinical and expert practice, rather than to formulate specific clinical practice recommendations. It is designed to provide information based on the best evidence available at the time (...) of publication to assist in decision-making. The information provided is not intended to over-ride the clinical expertise of health care professionals and its use is subject to the clinician’s judgement and the patient’s preference in each individual case. There is no substitute for the skilled assessment of each individual patient’s health status, circumstances and perspectives, which health care practitioners will then use to select the treatments that are relevant and appropriate to that person

2015 Clinical Practice Guidelines Portal

78. Isavuconazonium sulfate (BAL8557) (Cresemba)

, but with an indolent, or slowly progressing infection. The partial and complete success rate of 36.4% (4/11 patients) in the refractory group provides support for efficacy, as this represents a salvage regimen. Additionally, 31.6% of primary therapy patients were assessed to be stable (no progression of infection), which is a clinically relevant favorable outcome in this typically immunosuppressed patient population. The study report did not discuss reductions in patient immunosuppression, as increasing host (...) Isavuconazonium sulfate (BAL8557) (Cresemba) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 207500Orig1s000 / 207501Orig1s000 MEDICAL REVIEW(S) Clinical Review Edward Weinstein, MD, PhD NDA 207500 and 207501, 505 (b)(1) Cresemba ® (Isavuconazonium Sulfate) 1 CLINICAL REVIEW Application Type NDA 505 (b)(1) Application Number(s) 207500 and 207501 Priority or Standard Priority Submit Date(s) July 8, 2014 Received Date(s) July 8, 2014 PDUFA Goal Date March 8, 2015 Division / Office

2014 FDA - Drug Approval Package

79. Dinutuximab (Unituxin)

reduction and in patients who experience loss of vision [see Dosage and Administration (2.3)]. 5.7 Bone Marrow Suppression In Study 1, severe (Grade 3 or 4) thrombocytopenia (39% vs. 25%), anemia (34% vs. 16%), neutropenia (34% vs. 13%), and febrile neutropenia (4% vs. 0 patients) occurred more commonly in patients in the Unituxin/RA group compared to patients treated with RA alone. Monitor peripheral blood counts closely during therapy with Unituxin. Reference ID: 3711777Addendum to Clinical Review (...) morphine sulfate (50 mcg/kg) intravenously immediately prior to initiation of Unituxin and then continue as a morphine sulfate drip at an infusion rate of 20 to 50 mcg/kg/hour during and for two hours following completion of Unituxin. ? Administer additional 25 mcg/kg to 50 mcg/kg intravenous doses of morphine sulfate as needed for pain up to once every 2 hours followed by an increase in the morphine sulfate infusion rate in clinically stable patients. ? Consider using fentanyl or hydromorphone

2014 FDA - Drug Approval Package

80. Sylvant - siltuximab

2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 11 2.2.3. Finished Medicinal Product 15 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendations for future quality development 18 2.3. Non-clinical aspects 19 2.3.1. Introduction 19 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 22 2.3.4. Toxicology 23 2.3.5. Ecotoxicity/environmental risk assessment 27 2.3.6 (...) . Discussion on non-clinical aspects 27 2.3.7. Conclusion on the non-clinical aspects 29 2.4. Clinical aspects 29 2.4.1. Introduction 29 2.4.2. Pharmacokinetics 30 2.4.3. Pharmacodynamics 33 2.4.4. Discussion on clinical pharmacology 35 2.4.5. Conclusions on clinical pharmacology 36 2.5. Clinical efficacy 36 2.5.1. Dose response study 37 2.5.2. Main study 39 2.5.3. Discussion on clinical efficacy 58 2.5.4. Conclusions on the clinical efficacy 61 2.6. Clinical safety 61 2.6.1. Conclusions on the clinical

2014 European Medicines Agency - EPARs

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