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Clinical Index of Stable Febrile Neutropenia

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21. 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

2010 Infectious Diseases Society of America

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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)

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. 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

34. 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

35. 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

36. 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

37. Dinutuximab beta Apeiron - neuroblastoma

. Epidemiology 11 2.1.3. Biologic features 11 2.1.4. Clinical presentation, diagnosis and stage/prognosis 11 2.1.5. Management 12 2.2. Quality aspects 15 2.2.1. Introduction 15 2.2.2. Active Substance 16 2.2.3. Finished Medicinal Product 26 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 31 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 33 2.2.6. Recommendations for future quality development 34 2.3. Non-clinical aspects 34 2.3.1. Introduction 34 2.3.2 (...) . Pharmacology 34 2.3.3. Pharmacokinetics 37 2.3.4. Toxicology 39 2.3.5. Ecotoxicity/environmental risk assessment 41 2.3.6. Discussion on non-clinical aspects 41 2.3.7. Conclusion on the non-clinical aspects 43 2.4. Clinical aspects 43 2.4.1. Introduction 43 2.4.2. Pharmacokinetics 44 2.4.3. Pharmacodynamics 47 2.4.4. Discussion on clinical pharmacology 49 2.4.5. Conclusions on clinical pharmacology 52 2.5. Clinical efficacy 52 2.5.1. Dose response studies and main clinical studies 52 2.5.2. Discussion

2017 European Medicines Agency - EPARs

38. Ribociclib (Kisqali) - breast cancer

with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/506968/2017 Page 2/121 Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 7 2.1. Problem statement 7 2.1.1. Disease or condition 7 2.1.2. Epidemiology 8 2.1.3. Biologic features 8 2.1.4. Clinical presentation, diagnosis and stage/prognosis 8 2.1.5. Management 8 2.2. Quality aspects 10 (...) 2.2.1. Introduction 10 2.2.2. Active Substance 10 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations for future quality development 15 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 15 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 19 2.3.5. Ecotoxicity/environmental risk assessment 24 2.3.6. Discussion on non-clinical

2017 European Medicines Agency - EPARs

39. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

time ASO PCR allele specific oligonucleotide polymerase chain reaction AST aspartate aminotransferase Bcl B cell lymphoma BCRi B Cell receptor inhibitor BMI body mass index BR bendamustine rituximab CD cluster of differentiation CI confidence interval CLL chronic lymphocytic leukaemia CPP Critical process parameter CQA Critical Quality Attribute CR complete remission CRi complete remission with incomplete bone marrow recovery CSR clinical study report CT computed tomography CTLS clinical tumour (...) 2.2.3. Finished Medicinal Product 14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 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 18 2.3.1. Introduction 18 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical

2017 European Medicines Agency - EPARs

40. 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

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