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Clinical Index of Stable Febrile Neutropenia

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101. Sivextro - tedizolid phosphate

to Hour 24.I BCRP breast cancer resistance protein BMI body mass index CA-MRSA community-acquired methicillin-resistant Staphylococcus aureus CDAD Clostridium difficile associated disease CE Clinically Evaluable CE-PTE Clinically Evaluable at PTE Cfr chloramphenicol-florfenicol resistance CFU/g CHMP log 10 Committee for Medicinal Products for Human Use CI confidence interval CL clearance CL/F apparent clearance CLSI Clinical and Laboratory Standards Institute cMITT Clinical modified ITT CQAs cSSTI (...) product is physically and chemically stable for up to 24 hours when reconstituted with WFI, and stored under the above-mentioned conditions. Compatibility of the drug product reconstituted with 0.9% aqueous NaCl solution in IV bags was studied in combination with different IV administration sets that represent those typically found in the clinical setting. Reconstituted solutions were evaluated for up to 24 hours under both room temperature and refrigerated conditions. All samples were tested

2015 European Medicines Agency - EPARs

102. Cariprazine HCl (Vraylar)

Cariprazine HCl (Vraylar) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 204370Orig1Orig2s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type CR response 2 nd cycle Application Number(s) 204370/067 Priority or Standard standard Submit Date(s) December17, 2014 Received Date(s) 12/17/2014 PDUFA Goal Date 6/17/2015 Division / Office DPP/ODE1 Reviewer Name(s) Lucas Kempf, MD Review Completion Date September 15, 2015 Established Name Cariprazine HCl (Proposed) Trade Name Vraylar (...) Therapeutic Class Antipsychotic Applicant Forest Laboratories, LLC. Formulation(s) capsules 1.5 mg, 3 mg, 4.5 mg, and 6 mg Dosing Regimen daily Indication(s) schizophrenia and acute Bipolar Manic episode Intended Population(s) Adult patients with schizophrenia and Bipolar Reference ID: 3820323 (b) (4)Template Version: March 6, 2009 Reference ID: 3820323NDA 204370 Clinical Review Lucas Kempf, MD Resubmission 2 nd cycle Vraylar, Cariprazine HCl 3 Table of Contents 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 7

2015 FDA - Drug Approval Package

103. 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

104. 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

105. Lynparza - olaparib

and biological aspects 20 2.2.1. Conclusions on the chemical, pharmaceutical and biological aspects 21 2.2.2. Recommendation(s) for future quality development 21 2.3. Non-clinical aspects 21 2.3.1. Introduction 21 2.3.2. Pharmacology 22 2.3.3. Pharmacokinetics 26 2.3.4. Toxicology 33 2.3.5. Ecotoxicity/environmental risk assessment 41 2.3.6. Discussion on non-clinical aspects 43 2.3.7. Conclusion on the non-clinical aspects 48 2.4. Clinical aspects 48 2.4.1. Introduction 48 2.4.2. Pharmacokinetics 52 2.4.3 (...) . Pharmacodynamics 64 2.4.4. Discussion on clinical pharmacology 68 2.4.5. Conclusions on clinical pharmacology 75 2.5. Clinical efficacy 76 2.5.1. Dose response studies 76 2.5.2. Main studies 78 2.5.3. Discussion on clinical efficacy 126 2.5.4. Conclusions on the clinical efficacy 131 2.6. Clinical safety 131 2.6.1. Discussion on clinical safety 163 2.6.2. Conclusions on the clinical safety 169 2.7. Pharmacovigilance 170 2.8. Risk Management Plan 170 2.9. Product information 183 2.9.1. User consultation 183

2015 European Medicines Agency - EPARs

106. Daclatasvir (DCV) (Daklinza)

Daclatasvir (DCV) (Daklinza) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 206843Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Resubmission Application Number(s) 206-843 Priority or Standard N/A Submit Date(s) February 13, 2015 Received Date(s) February 13, 2015 PDUFA Goal Date August 13, 2015 Division / Office DAVP/OAP Reviewer Name(s) Wendy Carter, D.O. Review Completion Date June 29, 2015 Established Name Daclatasvir (DCV) (Proposed) Trade Name Daklinza (...) 12 2.4 Important Safety Issues With Consideration to Related Drugs 12 2.5 Summary of Presubmission Regulatory Activity Related to Submission 12 2.6 Other Relevant Background Information 13 3 ETHICS AND GOOD CLINICAL PRACTICES 13 3.1 Submission Quality and Integrity 13 3.2 Compliance with Good Clinical Practices 13 3.3 Financial Disclosures 13 4 SIGNIFICANT EFFICACY/SAFETY ISSUES RELATED TO OTHER REVIEW DISCIPLINES 14 4.1 Chemistry Manufacturing and Controls 14 4.2 Clinical Microbiology 14 4.3

2015 FDA - Drug Approval Package

107. 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

108. Crizotinib (Xalkori) Resubmission for First Line Advanced NSCLC

Crizotinib (Xalkori) Resubmission for First Line Advanced NSCLC pan-Canadian Oncology Drug Review Initial Clinical Guidance Report Crizotinib (Xalkori) Resubmission for Advanced or Metastatic Non-Small Cell Lung Cancer July 3, 2015 DISCLAIMER Not a Substitute for Professional Advice This report is primarily intended to help Canadian health systems leaders and policymakers make well-informed decisions and thereby improve the quality of health care services. While patients and others may use (...) this report, they are made available for informational and educational purposes only. This report should not be used as a substitute for the application of clinical judgment in respect of the care of a particular patient or other professional judgment in any decision making process, or as a substitute for professional medical advice. Liability pCODR does not assume any legal liability or responsibility for the accuracy, completeness or usefulness of any information, drugs, therapies, treatments, products

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

109. 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

110. 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

111. Melanoma Treatment (PDQ®): Health Professional Version

as the source cell for melanoma. The relatively avascular epidermis houses both basal cell keratinocytes and squamous epithelial keratinocytes, the source cells for basal cell carcinoma and squamous cell carcinoma, respectively. The separation between epidermis and dermis occurs at the basement membrane zone, located just inferior to the basal cell keratinocytes. Screening Refer to the PDQ summary on for more information. Clinical Features Melanoma occurs predominantly in adults, and more than 50 (...) of primary and metastatic tumors. The most important prognostic factors have been incorporated into the revised 2009 American Joint Committee on Cancer staging and include the following:[ , - ] Thickness and/or level of invasion of the melanoma. Mitotic index, defined as mitoses per millimeter. Ulceration or bleeding at the primary site. Number of regional lymph nodes involved, with distinction of macrometastasis and micrometastasis. Systemic metastasis. - Site—nonvisceral versus lung versus all other

2018 PDQ - NCI's Comprehensive Cancer Database

112. 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

113. Childhood Non-Hodgkin Lymphoma Treatment (PDQ®): Health Professional Version

on the for specific information about the incidence, type, and monitoring of late effects in childhood and adolescent cancer survivors.) On the basis of immunophenotype, molecular biology, and clinical response to treatment, the vast majority of NHL cases occurring in childhood and adolescence fall into three categories: (Burkitt and Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma, and primary mediastinal B-cell lymphoma). . . Other rare types of pediatric NHL include the following (...) years, although outcome depends on a number of factors, including clinical stage and histology.[ ] Prognostic factors for childhood NHL include the following: . . . . . Response to therapy Response to therapy in pediatric lymphoma is one of the most important prognostic markers. Regardless of histology, pediatric NHL that is refractory to first-line therapy has a very poor prognosis.[ - ] Burkitt lymphoma/leukemia: One of the most important predictive factors is response to the initial prophase

2018 PDQ - NCI's Comprehensive Cancer Database

114. Ovarian Epithelial, Fallopian Tube, and Primary Peritoneal Cancer Treatment (PDQ®): Health Professional Version

carcinomas share molecular findings, such as loss or inactivation of the tumor-suppressor p53 and BRCA1 or BRCA2 proteins.[ ] Therefore, high-grade serous adenocarcinomas arising from the fallopian tube and elsewhere in the peritoneal cavity, together with most ovarian epithelial cancers, represent extrauterine adenocarcinomas of Müllerian epithelial origin and are staged and treated similarly to ovarian cancer. Since 2000, FTC and PPC have usually been included in ovarian cancer clinical trials (...) for ovarian (epithelial) cancer include the following: Family history of ovarian cancer.[ - ] - A first-degree relative (e.g., mother, daughter, or sister) with the disease. Inherited risk.[ ] - BRCA1 or BRCA2 gene mutations.[ , ] Other hereditary conditions such as hereditary nonpolyposis colorectal cancer (HNPCC; also called Lynch syndrome).[ , ] Endometriosis.[ - ] Hormone therapy.[ , ] - Postmenopausal hormone replacement therapy. Obesity.[ - ] - High body mass index. Tall Height. [ - ] Family history

2018 PDQ - NCI's Comprehensive Cancer Database

115. 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

116. Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection

eligibility for ART will mean that more people will start ART earlier. Importantly, in this guidance WHO emphasizes the need for differentiated approaches to care for people who are stable on ART, such as reducing the frequency of clinic visits and community ART distribution. Such efficiencies are essential if countries with a high burden of HIV infection are to manage their growing numbers of people receiving ART and reduce the burden on people receiving treatment and health facilities. The second (...) with tuberculosis, hepatitis, and other co-infections. The guidelines are ambitious in their expected impact, and yet simplified in their approach, and firmly rooted in evidence. They take advantage of recent findings from clinical trials confirming that the early use of ART keeps people living with HIV alive and healthier and reduces the risk of transmitting the virus to their sexual and drug-sharing partners. Earlier treatment has the further advantage of simplifying the operational demands on programmes

2016 World Health Organisation HIV Guidelines

117. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications Full Text available with Trip Pro

with today’s myriad healthcare-associated factors that predispose to infection. Moreover, changes in pathogen prevalence, in particular a more common staphylococcal origin, have affected outcomes, which have not improved despite medical and surgical advances. Methods and Results— This statement updates the 2005 iteration, both of which were developed by the American Heart Association under the auspices of the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular (...) 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

2016 Infectious Diseases Society of America

118. U.S. Cystic Fibrosis Foundation and European Cystic Fibrosis Society consensus recommendations for the management of nontuberculous mycobacteria in individuals with cystic fibrosis Full Text available with Trip Pro

that might contribute to NTM acquisition in individuals with CF include: low vitamin D, , the presence of gastro-oesophageal reflux disease, , low body mass index , or malnutrition. Screening How often should individuals with CF be screened for NTM? Recommendation 2 : The CF Foundation and the ECFS recommend that cultures for NTM be performed annually in spontaneously expectorating individuals with a stable clinical course. Recommendation 3 : The CF Foundation and the ECFS recommend that, in the absence (...) ’ (NTM-PD), , which is defined by the presence of specific microbiological, clinical and radiological features described in Diagnosis of NTM-PD in CF section. However, it has become clear that NTM can also transiently, intermittently or permanently reside within the lungs of individuals with CF without causing NTM-PD, thus representing asymptomatic infection and creating considerable difficulties in deciding how best to screen for and diagnose NTM. Further challenges exist in knowing how best

2016 Cystic Fibrosis Foundation

119. Practice Guidelines for the Diagnosis and Management of Aspergillosis Full Text available with Trip Pro

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

120. Current Diagnostic and Treatment Strategies for Specific Dilated Cardiomyopathies: A Scientific Statement From the American Heart Association Full Text available with Trip Pro

Current Diagnostic and Treatment Strategies for Specific Dilated Cardiomyopathies: A Scientific Statement From the American Heart Association Circulation. 2016;134:e579–e646. DOI: 10.1161/CIR.0000000000000455 December 6, 2016 e579 CLINICAL STATEMENTS AND GUIDELINES T he intent of this American Heart Association (AHA) scientific statement is to summarize our current understanding of dilated cardiomyopathies. There is special emphasis on recent developments in diagnostic approaches and therapies (...) for specific cardiomyopathies. Recommendations in this document are based on published studies, published practice guidelines from the American College of Cardiology (ACC)/AHA 1 and other organizations, 2,3 and the multidis- ciplinary expertise of the writing group. Existing evidence in epidemiology, clas- sification, diagnosis, and management of specific cardiomyopathies is usually derived from nonrandomized observational studies, registries, case reports, or expert opinion based on clinical experience

2016 American Heart Association

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