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Clinical Index of Stable Febrile Neutropenia

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41. Lymphoma

to confirm the diagnosis, provided other morphophenotypic findings are consistent with the diagnosis. Poor prognostic features must be mentioned in the report, including blastoid and pleomorphic morphologic variants. The proliferation index as measured by Ki67 or Mib-1 (used to calculate MIPI score) is to be reported. In cases where it is difficult to differentiate MCL from CLL, flow cytometry for CD200 and IHC for SOX11 may be performed 13 . CLINICAL PRACTICE GUIDELINE LYHE-002 Version 11 I. Diagnosis (...) Lymphoma CLINICAL PRACTICE GUIDELINE LYHE-002 Version 11 LYMPHOMA Effective Date: July 2018 The recommendations contained in this guideline are a consensus of the Alberta Provincial Hematology Tumour Team synthesis of currently accepted approaches to management, derived from a review of relevant scientific literature. Clinicians applying these guidelines should, in consultation with the patient, use independent medical judgment in the context of individual clinical circumstances to direct care

2016 CPG Infobase

42. Treatment Options for Relapsed or Refractory Multiple Myeloma

Treatment Options for Relapsed or Refractory Multiple Myeloma ©Institute for Clinical and Economic Review, 2016 Treatment Options for Relapsed or Refractory Multiple Myeloma: Effectiveness, Value, and Value-Based Price Benchmarks Final Evidence Report and Meeting Summary June 9, 2016 Institute for Clinical and Economic Review ©Institute for Clinical and Economic Review, 2016 Page ii Final 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

2017 California Technology Assessment Forum

43. Imaging Program Guidelines: Pediatric Imaging

(over age 2) ? When at least one of the following is present: ? Focal neurologic findings at the time of the seizure ? Persistent neurologic deficit in the postictal period ? Idiopathic epilepsy with atypical clinical course ? Partial seizures ? Seizures increasing in frequency and severity despite optimal medical management ? Electroencephalogram (EEG) findings inconsistent with idiopathic epilepsy Complex febrile seizure (age 6 months – 5 years) ? When either of the following is present: ? More (...) Imaging Program Guidelines: Pediatric Imaging Clinical Appropriateness Guidelines: Advanced Imaging Imaging Program Guidelines: Pediatric Imaging Effective Date: November 20, 2017 Proprietary Guideline Last Revised Last Reviewed Administrative 07-26-2016 07-26-2016 Head and Neck 11-01-2016 11-01-2016 Chest 08-27-2015 07-26-2016 Abdomen and Pelvis 11-01-2016 11-01-2016 Spine 08-27-2015 07-26-2016 Extremity 08-27-2015 07-26-2016 Copyright © 2017. AIM Specialty Health. All Rights Reserved 8600 W

2017 AIM Specialty Health

44. Prevention, Diagnosis & Management of infective endocarditis

: • These conditions merit a high index of suspicion of IE (refer Sections 7.3 & 7.4). • In these patients, once a diagnosis of IE has been established or if there is strong clinical suspicion of IE, the patient should be sent to a specialist centre (refer Section 4.1.4). • The epidemiology of paediatric IE has evolved to reflect those with the advancement of interventions for CHD. It now broadly reflects the following groups: > Patients with prolonged use of central venous catheters in: » Corrected CHD during (...) Prevention, Diagnosis & Management of infective endocarditis CLINICAL PRACTICE GUIDELINES FOR THE PREVENTION, DIAGNOSIS & MANAGEMENT OF INFECTIVE ENDOCARDITISPUBLISHED BY: Clinical Practice Guidelines (CPG) Secretariat c/o Health Technology Assessment (HTA) Unit Medical Development Division Ministry of Health Malaysia 4 th floor, Block E1, Parcel E 62590 Putrajaya COPYRIGHT The owners of this publication are the National Heart Association of Malaysia (NHAM) and the Academy of Medicine Malaysia

2017 Ministry of Health, Malaysia

45. 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

46. 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

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2016 Infectious Diseases Society of America

47. 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

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2016 Infectious Diseases Society of America

48. 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

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2016 American Society of Clinical Oncology Guidelines

49. 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

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

reduction 32%). The median OS was significantly longer for patients who received DCF compared 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 gastric cancer is the subject of debate.[ ] The results of a study that randomly assigned 245 patients with metastatic gastric cancer to receive CF, FAMTX, or ELF demonstrated no significant difference in response rate, progression-free survival, or OS between the arms.[ ] Grades 3 and 4 neutropenia occurred in 35% to 43% of patients on all arms, but severe nausea and vomiting was more common

2018 PDQ - NCI's Comprehensive Cancer Database

51. 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 (...) is rarely 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

2018 PDQ - NCI's Comprehensive Cancer Database

52. 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

53. 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

54. 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

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

, pharmaceutical and biological aspects 26 2.2. Non-clinical aspects 26 2.2.1. Introduction 26 2.2.2. Pharmacology 27 2.2.3. Pharmacokinetics 32 2.2.4. Toxicology 34 2.2.5. Ecotoxicity/environmental risk assessment 36 2.2.6. Discussion on non-clinical aspects 36 2.2.7. Conclusion on the non-clinical aspects 37 2.3. Clinical aspects 37 2.3.1. Introduction 37 2.3.2. Pharmacokinetics 38 2.3.3. Pharmacodynamics 43 2.3.4. Immunogenicity 44 2.3.5. Discussion on clinical pharmacology 44 2.3.6. Conclusions on clinical (...) pharmacology 45 2.4. Clinical efficacy 46 2.4.1. Dose response study(ies) 46 2.4.2. Main study(ies) 46 2.4.3. Discussion on clinical efficacy 62 2.4.4. Conclusions on the clinical efficacy 64 2.5. Clinical safety 65 Immunological events 78 2.5.1. Discussion on clinical safety 80 2.5.2. Conclusions on the clinical safety 82 2.6. Risk Management Plan 82 2.7. Pharmacovigilance 86 2.8. Product information 86 2.8.1. User consultation 86 2.8.2. Additional monitoring 86 Assessment report EMA/798844/2017 Page 2/91

2018 European Medicines Agency - EPARs

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

. Problem statement 8 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active Substance 9 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 17 2.2.6. Recommendation(s) for future quality development 17 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 20 2.3.4. Toxicology 22 2.3.5. Ecotoxicity/environmental risk (...) assessment 29 2.3.6. Discussion on non-clinical aspects 31 2.3.7. Conclusion on the non-clinical aspects 33 2.4. Clinical aspects 34 2.4.1. Introduction 34 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 52 2.4.4. Discussion on clinical pharmacology 57 2.4.5. Conclusions on clinical pharmacology 63 2.5. Clinical efficacy 64 2.5.1. Dose response studies 64 2.5.2. Main study 66 2.5.3. Discussion on clinical efficacy 95 2.5.4. Conclusions on the clinical efficacy 97 2.6. Clinical safety 97 2.6.1

2018 European Medicines Agency - EPARs

57. 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

58. 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

59. Niraparib (Zejula) - Fallopian Tube Neoplasms, Ovarian Neoplasms, Peritoneal Neoplasms

Administration FE food effect FIGO Fédération Internationale de Gynécologie et d’Obstétrique FOSI Functional Assessment of Cancer Therapy – Ovarian Symptom Index FT-IR Fourier Transform Infrared Spectroscopy gBRCAmut germline BRCA mutation GC Gas Chromatography GCP goof clinical practise HDPE High Density Polyethylene hERG human Ether-a-go-go-related gene HMHDPE High Molecular Weight High Density Polyethylene HPLC High performance liquid chromatography HR hazard ratio HRD homologous recombination deficient (...) Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Assessment report EMA/648982/2017 Page 2/122 Table of contents 1. Background information on the procedure 7 1.1. Submission of the dossier 7 1.2. Steps taken for the assessment of the product 8 2. Scientific discussion 9 2.1. Problem statement 9 2.1.1. Disease or condition 9 2.1.2. Epidemiology 9 2.1.3. Biologic features 9 2.1.4. Clinical presentation, diagnosis and stage/prognosis 9

2017 European Medicines Agency - EPARs

60. 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

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