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Clinical Index of Stable Febrile Neutropenia

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21. KDIGO Clinical Practice Guideline for Acute Kidney Injury

KDIGO Clinical Practice Guideline for Acute Kidney Injury VOLUME 2 | ISSUE 1 | MARCH 2012 http://www.kidney-international.org OFFICIAL JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY KDIGO Clinical Practice Guideline for Acute Kidney Injury KI_SuppCover_2.1.indd 1 KI_SuppCover_2.1.indd 1 2/7/12 12:32 PM 2/7/12 12:32 PMKDIGO Clinical Practice Guideline for Acute Kidney Injury Tables and Figures iv Notice 1 Work Group Membership 2 KDIGO Board Members 3 Reference Keys 4 Abbreviations (...) and Acronyms 5 Abstract 6 Foreword 7 Summary of Recommendation Statements 8 Section 1: Introduction and Methodology 13 Chapter 1.1: Introduction 13 Chapter 1.2: Methodology 17 Section 2: AKI Definition 19 Chapter 2.1: Definition and classification of AKI 19 Chapter 2.2: Risk assessment 23 Chapter 2.3: Evaluation and general management of patients with and at risk for AKI 25 Chapter 2.4: Clinical applications 28 Chapter 2.5: Diagnostic approach to alterations in kidney function and structure 33 Section 3

2012 National Kidney Foundation

22. Clinical Practice Guideline for the Use of Antimicrobial Agents in Neutropenic Patients with Cancer

trials [ ]. Most clinicians (including Panel members) use and understand this clinically relevant categorization of “high-risk” in the context of fever and neutropenia. Low-risk patients are clinically defined by neutropenia anticipated to last ≤7 days, are clinically stable, and have no medical comorbid conditions. In addition to this clinical definition, the MASCC has developed a risk assessment scheme and a well-validated scoring method that can identify subgroups of febrile neutropenic patients (...) of the infection risks, diagnostic methods, and antimicrobial therapies required for management of febrile patients through the neutropenic period. Accordingly, algorithmic approaches to fever and neutropenia, infection prophylaxis, diagnosis, and treatment have been established during the past 40 years, guided and modified by clinical evidence and experience over time. The Infectious Diseases Society of America Fever and Neutropenia Guideline aims to provide a rational summation of these evolving algorithms

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2010 Infectious Diseases Society of America

23. To Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors

discontinuation or met one of the following criteria: - Common Terminology Criteria for Adverse Events (CTCAE) Grade (Gr) 3 or 4 nonhematologic toxicity (excluding transient transaminitis) - CTCAE Gr 3 or 4 nausea or vomiting that persisted > 5 days despite maximal anti-emetic treatment - CTCAE Gr 4 thrombocytopenia or anemia that persisted > 7 days or required transfusion > 7 days - CTCAE Gr 3 thrombocytopenia with bleeding - CTCAE Gr 4 uncomplicated neutropenia lasting > 7 days - Febrile neutropenia (...) To Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save

2013 Clinical Trials

24. Prostate cancer: diagnosis and management

to Notice of rights (https://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 22 of 51What are the risks associated with docetaxel treatment? A large UK randomised trial found that: 15 out of 100 people who took docetaxel developed febrile neutropenia (that is, they got a fever because the chemotherapy had reduced their white blood cells' ability to fight infection). 1 out of 100 people who took docetaxel died because of infections that, in the opinion of the investigators, they might (...) , consider a remote follow-up strategy for people with a stable PSA who have had no significant treatment complications, unless they are taking part in a clinical trial that needs formal clinic-based follow-up. [2019] [2019] 1.3.47 Follow up people with prostate cancer who have chosen a watchful waiting regimen with no curative intent in primary care only if protocols for this have been agreed between the local urological cancer MDT and the relevant primary care organisation(s). Measure their PSA

2019 National Institute for Health and Clinical Excellence - Clinical Guidelines

25. Treatment of Multiple Myeloma

Treatment of Multiple Myeloma Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice 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.18.02096 Journal of Clinical Oncology - published online before print April 1, 2019 PMID: Treatment of Multiple Myeloma: ASCO and CCO Joint Clinical Practice Guideline , MD 1 2 x Joseph Mikhael ; , MD 3 x (...) ; and , MD 21 x Tom Martin 1 City of Hope Cancer Center, Phoenix, AZ 2 International Myeloma Foundation, North Hollywood, CA 3 American Society of Clinical Oncology, Alexandria VA 4 Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada 5 UC San Diego Moores Cancer Center, La Jolla, CA 6 Emory University, Atlanta, GA 7 Mayo Clinic, Rochester MN 8 University of Rochester Medical Center, Rochester, NY 9 National Cancer Institute, Bethesda, MD 10 Juravinski Cancer Center, Hamilton, Ontario, Canada 11

2019 American Society of Clinical Oncology Guidelines

26. Prostate Cancer

characteristics of prostate cancer. Prostate, 2010. 70: 10. 144. Auprich, M., et al. Contemporary role of prostate cancer antigen 3 in the management of prostate cancer. Eur Urol, 2011. 60: 1045. 145. Nicholson, A., et al. The clinical effectiveness and cost-effectiveness of the PROGENSA(R) prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation. Health Technol Assess, 2015. 19: 1. 146. Wei, J.T., et al. Can urinary PCA3 (...) Broeck T., et al. A systematic review of oncological effectiveness and harms of primary local interventions for high-risk localized and locally advanced prostate cancer. PROSPERO International prospective register of systematic reviews, 2017. CRD42017078862 8. Willemse, P.M., et al. Systematic review of deferred treatment with curative intent for localised prostate cancer to explore heterogeneity of definitions, thresholds and criteria and clinical effectiveness. PROSPERO International prospective

2019 European Association of Urology

27. Muscle-invasive and Metastatic Bladder Cancer

., Sesterhenn I.A., editors. 2004, IARCC Press: Lyon. 58. Kapur, P., et al. Primary adenocarcinoma of the urinary bladder: value of cell cycle biomarkers. Am J Clin Pathol, 2011. 135: 822. 59. Ploeg, M., et al. Clinical epidemiology of nonurothelial bladder cancer: analysis of the Netherlands Cancer Registry. J Urol, 2010. 183: 915. 60. Beltran, A.L., et al. Clinicopathological characteristics and outcome of nested carcinoma of the urinary bladder. Virchows Arch, 2014. 465: 199. 61. Mukesh, M., et al. Small (...) , 2003. 169: 955. 66. Fossa, S.D., et al. Clinical significance of the “palpable mass” in patients with muscle-infiltrating bladder cancer undergoing cystectomy after pre-operative radiotherapy. Br J Urol, 1991. 67: 54. 67. Wijkstrom, H., et al. Evaluation of clinical staging before cystectomy in transitional cell bladder carcinoma: a long-term follow-up of 276 consecutive patients. Br J Urol, 1998. 81: 686. 68. Ploeg, M., et al. Discrepancy between clinical staging through bimanual palpation

2019 European Association of Urology

28. Prevention and Control of Methecillin-Resistant Staphylcoccus Aureus (MRSA)

hygiene is concentrated in activities known as the five moments for hand hygiene www.who.int/gpsc/tools/Five_moments/en/index. html (35). All senior medical, nursing, midwifery, allied health professional and administrative personnel, whose staff have clinical involvement, must ensure that staff understand the importance of hand hygiene, are familiar with, adhere to the national recommendations and participate in hand hygiene audit. Another study has highlighted the role of patients (...) Prevention and Control of Methecillin-Resistant Staphylcoccus Aureus (MRSA) Prevention and Control Methicillin-Resistant Staphylococcus aureus (MRSA) National Clinical Guideline No. 2 December 2013Guideline Development Group The Prevention and Control of Methicillin-resistant Staphylococcus aureus (MRSA) National Clinical Guideline was developed by the Royal College of Physicians Ireland (RCPI) Clinical Advisory Group on healthcare associated infections (HCAI) - Subgroup MRSA Guideline

2019 National Clinical Guidelines (Ireland)

29. Axicabtagene ciloleucel (Yescarta) - diffuse large B-cell lymphoma (DLBCL); primary mediastinal large B-cell lymphoma (PMBCL)

dysfunction (e.g. hepatic, renal, cardiac, and pulmonary). In addition worsening of underlying organ pathologies can occur in the setting of CRS. Patients with medically significant cardiac dysfunction should be managed by standards of critical care and measures such as echocardiography should be considered. Diagnosis of CRS requires excluding alternate causes of systemic inflammatory response, including infection. In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum (...) 1000 mg intravenously per day for 2 more days; if improves, then manage as above. Administer methylprednisolone 1000 mg intravenously per day for 3 days; if improves, then manage as above. Consider non-sedating, anti-seizure medicines (e.g., levetiracetam) for seizure prophylaxis. Infections and febrile neutropenia Serious infections have been very commonly observed with YESCARTA (see section 4.8). Patients should be monitored for signs and symptoms of infection before, during, and after YESCARTA

2018 European Medicines Agency - EPARs

30. Plitidepsin (Aplidin) - Multiple Myeloma

2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 24 2.2.6. Recommendations for future quality development 24 2.3. Non-clinical aspects 24 2.3.1. Introduction 24 2.3.2. Pharmacology 24 2.3.3. Pharmacokinetics 35 2.3.4. Toxicology 37 2.3.5. Ecotoxicity/environmental risk assessment 43 2.3.6. Discussion on non-clinical aspects 44 2.3.7. Conclusion on the non-clinical aspects 45 2.4. Clinical aspects 45 2.4.1. Introduction 45 2.4.2. Pharmacokinetics 47 2.4.3. Pharmacodynamics 56 (...) 2.4.4. Discussion on clinical pharmacology 59 2.4.5. Conclusions on clinical pharmacology 62 2.5. Clinical efficacy 62 2.5.1. Dose response study(ies) 62 2.5.2. Dose finding studies 62 2.5.3. Main study 63 2.5.4. Supportive studies 95 2.5.5. Discussion on clinical efficacy 98 2.5.6. Conclusions on the clinical efficacy 101 2.6. Clinical safety 101 2.6.1. Discussion on clinical safety 125 2.6.2. Conclusions on the clinical safety 128 2.7. Risk Management Plan 128 2.8. Pharmacovigilance 133 2.9. New

2018 European Medicines Agency - EPARs

31. Gemtuzumab ozogamicin (Mylotarg) - Leukemia, Myeloid, Acute

factors, screening tools/prevention 9 2.1.3. Biologic features 9 2.1.4. Clinical presentation, diagnosis and stage/prognosis 9 2.1.5. Management 9 2.2. Quality aspects 11 2.2.1. Introduction 11 2.2.2. Active Substance 12 2.2.3. Finished Medicinal Product 18 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 19 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.2.6. Recommendation(s) for future quality development 21 2.3. Non-clinical aspects 21 2.3.1 (...) . Introduction 21 2.3.2. Pharmacology 21 2.3.3. Pharmacokinetics 28 2.3.4. Toxicology 31 2.3.5. Ecotoxicity/environmental risk assessment 47 2.3.6. Discussion on non-clinical aspects 49 2.3.7. Conclusion on the non-clinical aspects 51 2.4. Clinical aspects 51 2.4.1. Introduction 51 2.4.2. Pharmacokinetics 55 2.4.3. Pharmacodynamics 60 2.4.4. Discussion on clinical pharmacology 63 2.4.5. Conclusions on clinical pharmacology 65 2.5. Clinical efficacy 65 2.5.1. Dose response studies 65 2.6. Main study

2018 European Medicines Agency - EPARs

32. MammaPrint test for personalised management of adjuvant chemotherapy decisions in early breast cancer

on the stage of the tumour at the time of diagnosis. Five-year breast cancer survival in Belgium is 100% for TNM Clinical Stage 0, 99.4% for stage I and falls to 28.0% for Stage IV. 4 More sophisticated tools to assess the likely prognosis of breast cancer, based on several classifications and patient characteristics have been developed in the recent years, some of them computerized, such as the Adjuvant!Online c , PREDICT d or the Nottingham Prognostic Index (NPI) e . Although different, most (...) considered. These included the Nottingham Prognosis Index (NPI) 18 or international clinical guidelines such as St Gallen 21, 27 and the US National Institutes of Health (NIH) guidelines 25 , or an approach where all patients received chemotherapy. 16 . The study by Ward et al. 18 referred to “clinical” practice as their main comparator, which combined the use of NPI, A!O and other prognostic information. The three studies comparing MammaPrint ® to other gene profiling tests, used in all cases Oncotype

2018 Belgian Health Care Knowledge Centre

33. Guidelines for the Management of Genital Herpes in New Zealand

Tests 9 Key Information to Discuss with a Patient Who Asks for a Blood Test 9 Table 1: Interpreting Blood Test Results 10 MANAGEMENT OF CLINICAL EPISODES OF GENITAL HERPES 10 Management of First Clinical Episode 12 Treatment algorithm – Management of First Episode of Genital Herpes 13 Treatment of First Episode Genital Herpes 14 Management of Recurrent Episodes of Genital Herpes 15 Treatment of Recurrent Genital Herpes 16 Genital Herpes in Immunocompromised Individuals 17 Treatment algorithm (...) – Management of Recurrent Episodes of Genital Herpes 18 GENITAL HERPES IN PREGNANCY 18 Maternal Fetal Transmission 19 Use of Antivirals in Pregnancy and Breastfeeding 19 Mode of Delivery 21 Special Situations in Pregnancy 21 Prevention of HSV in the Neonate 21 Summary of Clinical Management of First Episode Genital Herpes in Pregnancy 22 Treatment algorithm – Management of Women with Suspected Genital Herpes in Pregnancy 23 First Episode Genital Herpes: First and Second Trimester Acquisition 23 First

2017 New Zealand Sexual Health Society

34. Chimeric Antigen Receptor T-Cell Therapy for B-Cell Cancers: Effectiveness and Value

in asymptomatic patients who have completed initial treatment, unless high-level evidence suggests that such imaging will change the outcome. • Avoid the use of white cell stimulating factors for primary prevention of febrile neutropenia in patients whose risk for this complication is less than 20%. Comparative Clinical Effectiveness The comparative clinical effectiveness review of the CAR-T therapies with other salvage therapies for ALL or DLBCL was challenging because all of the clinical studies were small (...) % Febrile Neutropenia 13% 13% Tumor Lysis Syndrome 1% 1% There were no deaths or reported cases of cerebral edema. Finally, there are theoretical concerns about mutagenesis from the insertion of the transgene into the patient’s T-cells for both CAR-T therapies. The risk is likely to be quite low, but is an important long-term concern for further study. Controversies and Uncertainties First, as highlighted throughout the review, the studies of CAR-T therapies are all single-arm trials. Given

2018 California Technology Assessment Forum

35. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy

Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice 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.2017.77.6385 Journal of Clinical (...) Oncology - published online before print February 14, 2018 PMID: Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy: American Society of Clinical Oncology Clinical Practice Guideline x Julie R. Brahmer , x Christina Lacchetti , x Bryan J. Schneider , x Michael B. Atkins , x Kelly J. Brassil , x Jeffrey M. Caterino , x Ian Chau , x Marc S. Ernstoff , x Jennifer M. Gardner , x Pamela Ginex , x Sigrun Hallmeyer , x Jennifer Holter Chakrabarty , x

2018 American Society of Clinical Oncology Guidelines

36. Chimeric Antigen Receptor T-Cell Therapy for B-Cell Cancers: Effectiveness and Value

stimulating factors for primary prevention of febrile neutropenia in patients whose risk for this complication is less than 20%. Comparative Clinical Effectiveness The comparative clinical effectiveness review of the CAR-T therapies with other salvage therapies for ALL or DLBCL was challenged because all of the clinical studies were small, single-arm designs with limited follow-up and incomplete reporting. Since no trials had control groups, it was not possible to estimate the comparative benefits (...) of tisagenlecleucel in the JULIET trial are summarized in Table ES10 below. 29 Table ES10. Key Adverse Events in the JULIET Trial (n=99) Adverse Event All Grades Grade 3 or Higher Cytokine Release Syndrome 58% 23% Neurologic Toxicities 21% 12% Infections 34% 20% Cytopenias Not Resolved by Day 28 36% 27% Febrile Neutropenia 13% 13% Tumor Lysis Syndrome 1% 1% There were no deaths or reported cases of cerebral edema. Finally, there are theoretical concerns about mutagenesis from the insertion of the transgene

2018 California Technology Assessment Forum

37. Antimicrobial Prophylaxis Adult Patients With Cancer-Related Immunosuppression

physicians, nurses, and advanced practice providers who may treat patients with immunosuppression resulting from cancer treatment. Methods An Expert Panel convened to update clinical practice guideline recommendations on the basis of a systematic review of the medical literature. Key Recommendations A summary of antimicrobial prophylaxis recommendations can be found here and in . Antimicrobial prophylaxis: Recommendation 1.1: Risk of febrile neutropenia (FN) should be systematically assessed (...) of infection, although clinicians should also be mindful that severely or profoundly neutropenic patients may present with suspected infection in an afebrile state or even hypothermic. Prevention and appropriate management of febrile neutropenia (FN) is important because the rate of major complications (eg, hypotension, acute renal, respiratory, or heart failure) in the context of FN is approximately 25% to 30% and mortality up to 11%. , In the setting of severe sepsis or septic shock, the hospital

2018 Infectious Diseases Society of America

38. Antimicrobial Prophylaxis for Adult Patients with Cancer-Related Immunosuppression

physicians, nurses, and advanced practice providers who may treat patients with immunosuppression resulting from cancer treatment. Methods An Expert Panel convened to update clinical practice guideline recommendations on the basis of a systematic review of the medical literature. Key Recommendations A summary of antimicrobial prophylaxis recommendations can be found here and in . Antimicrobial prophylaxis: Recommendation 1.1: Risk of febrile neutropenia (FN) should be systematically assessed (...) of infection, although clinicians should also be mindful that severely or profoundly neutropenic patients may present with suspected infection in an afebrile state or even hypothermic. Prevention and appropriate management of febrile neutropenia (FN) is important because the rate of major complications (eg, hypotension, acute renal, respiratory, or heart failure) in the context of FN is approximately 25% to 30% and mortality up to 11%. , In the setting of severe sepsis or septic shock, the hospital

2018 American Society of Clinical Oncology Guidelines

39. Muscle-invasive and Metastatic Bladder Cancer

., Sesterhenn I.A., editors. 2004, IARCC Press: Lyon. 58. Kapur, P., et al. Primary adenocarcinoma of the urinary bladder: value of cell cycle biomarkers. Am J Clin Pathol, 2011. 135: 822. 59. Ploeg, M., et al. Clinical epidemiology of nonurothelial bladder cancer: analysis of the Netherlands Cancer Registry. J Urol, 2010. 183: 915. 60. Beltran, A.L., et al. Clinicopathological characteristics and outcome of nested carcinoma of the urinary bladder. Virchows Arch, 2014. 465: 199. 61. Mukesh, M., et al. Small (...) , 2003. 169: 955. 66. Fossa, S.D., et al. Clinical significance of the “palpable mass” in patients with muscle-infiltrating bladder cancer undergoing cystectomy after pre-operative radiotherapy. Br J Urol, 1991. 67: 54. 67. Wijkstrom, H., et al. Evaluation of clinical staging before cystectomy in transitional cell bladder carcinoma: a long-term follow-up of 276 consecutive patients. Br J Urol, 1998. 81: 686. 68. Ploeg, M., et al. Discrepancy between clinical staging through bimanual palpation

2018 European Association of Urology

40. Prostate Cancer

characteristics of prostate cancer. Prostate, 2010. 70: 10. 144. Auprich, M., et al. Contemporary role of prostate cancer antigen 3 in the management of prostate cancer. Eur Urol, 2011. 60: 1045. 145. Nicholson, A., et al. The clinical effectiveness and cost-effectiveness of the PROGENSA(R) prostate cancer antigen 3 assay and the Prostate Health Index in the diagnosis of prostate cancer: a systematic review and economic evaluation. Health Technol Assess, 2015. 19: 1. 146. Wei, J.T., et al. Can urinary PCA3 (...) Broeck T., et al. A systematic review of oncological effectiveness and harms of primary local interventions for high-risk localized and locally advanced prostate cancer. PROSPERO International prospective register of systematic reviews, 2017. CRD42017078862 8. Willemse, P.M., et al. Systematic review of deferred treatment with curative intent for localised prostate cancer to explore heterogeneity of definitions, thresholds and criteria and clinical effectiveness. PROSPERO International prospective

2018 European Association of Urology

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