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Clinical Index of Stable Febrile Neutropenia

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81. First- and Second-Generation Antipsychotics in Children and Young Adults: Systematic Review Update

of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. This report may be used and reprinted (...) without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders. AHRQ or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied. This report may

2017 Effective Health Care Program (AHRQ)

82. Guideline for the management of adults with Systemic Lupus Erythematosus Full Text available with Trip Pro

in the UK in 2012 [ ] and was most frequently observed in people of African-Caribbean and South Asian descent [ ]. The age-standardized incidence in the UK according to the Clinical Practice Research Datalink is 8.3/100 000/year for females and 1.4/100 000/year for males [ ], and the highest incidence rates are seen in those of African-Caribbean descent: 31.4/100 000/year, compared with 6.7/100 000/year for those of white European descent. The mean age at diagnosis is 48.9 years [ ], but it is lower (...) to the EULAR/ERA-EDTA recommendations for LN [ ] and provide their strengths of agreement (SOAs) with a summary of the most important items in those recommendations ( ). T able 1 Levels of evidence and grades of recommendation for diagnosis, assessment and monitoring of non-renal SLE Statement/item Number of studies Overall SIGN level of evidence Grade of recommendation Selected references covering items discussed in text Diagnosis from clinical and serological features Prognostic value of: Clinical

2017 British Society for Rheumatology

83. 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 (...) examination. • Laboratory investigations. • Microbiological investigations. • Histopathological examinations; HPE (when possible). • Imaging, namely echocardiography and radiological investigations. In difficult cases, consultation with other experts such as ID specialists, cardiac imaging specialists and microbiologists may be required.30 3.1 Clinical evaluation of suspected infective endocarditis The most common symptom at presentation (up to 87%) is fever associated with chills, poor appetite

2017 Ministry of Health, Malaysia

84. Imaging Program Guidelines: Pediatric Imaging

Pseudotumor cerebri Seizures and epilepsy Neonatal/Infantile seizure (age 2 years or younger) ? Initial evaluation of seizure not associated with fever ? Periodic follow-up at 6-month intervals up to 30 months, if initial imaging study is non-diagnostic Childhood/Adolescent seizure (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 (...) (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

2017 AIM Specialty Health

85. 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

86. Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Full Text available with Trip Pro

, such as acute generalized exanthematous pusulosis. Consider following patients closely using serial clinical photography. If mucous membrane involvement or blistering is observed on the skin, consider early admission to a burn center for further monitoring and management. Primer on monitoring for complicated cutaneous adverse drug reactions: ○ Review of systems: skin pain (“like a sunburn”), fevers, malaise, myalgias, arthralgias, abdominal pain, ocular discomfort or photophobia, sores or discomfort (...) 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

2018 American Society of Clinical Oncology Guidelines

87. Sofosbuvir for treating chronic hepatitis C

populations treated with sofosbuvir regimens. Adverse effects of treatment 3.23 The company presented data on adverse events for NEUTRINO, FISSION, FUSION, POSITRON and VALENCE. The most common adverse events among people receiving sofosbuvir and ribavirin therapy (with or without peginterferon alfa) were fatigue, headache, anaemia, nausea, insomnia, irritability, rash, pruritis, myalgia, decreased appetite, influenza-like illness, chills, pyrexia, and neutropenia. Of these events, fatigue and headache (...) ://www.nice.org.uk/terms-and- conditions#notice-of-rights). Page 21 of 103sensitivity analysis. Adverse event rates were obtained from the sofosbuvir clinical trials and published studies. The company incorporated the rates of grade 3 and 4 pruritus, diarrhoea and nausea, vomiting, rash, anaemia, thrombocytopenia, neutropenia, and depression from the trials into the model so that drug acquisition costs could be included for interventions associated with managing these adverse events. 3.32 The company used

2015 National Institute for Health and Clinical Excellence - Technology Appraisals

88. 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 (...) ) or with local extra-lymphatic extension (IIIE) Stage IV Diffuse involvement of one or more extralymphatic organs or sites ? A: No B symptoms ? B: at least one of the following: unexplained weight loss >10% baseline within 6 months of staging, unexplained fever >38 ° C, or drenching night sweats CLINICAL PRACTICE GUIDELINE LYHE-002 Version 11 II. Staging Page 2 of 3 For treatment planning, patients are divided into two groups by stage: 1. Limited Stage: Non-bulky stage IA(E) or IIA(E) ( 3 or non-adjacent

2016 CPG Infobase

89. Systemic juvenile idiopathic arthritis: canakinumab

was received from the manufacturer. In randomised controlled trials, canakinumab was effective in treating systemic juvenile idiopathic arthritis and allowed children and young people to taper their oral corticosteroid dose. However, risks of treatment include serious infections, neutropenia, leukopenia and thrombocytopenia. Macrophage activation syndrome has also been seen in clinical trials. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- conditions (...) of the second RCT (n=100), the relative risk reduction in time to flare of systemic juvenile idiopathic arthritis was 64% (hazard ratio 0.36; 95% confidence interval 0.17 to 0.75; p=0.003) with subcutaneous canakinumab 4 mg/kg every 4 weeks compared with placebo. Safety Safety Risks of canakinumab include serious infections, neutropenia, leukopenia, and thrombocytopenia. Macrophage activation syndrome has also been seen in clinical trials of canakinumab in children and young people with systemic juvenile

2014 National Institute for Health and Clinical Excellence - Advice

90. Systemic lupus erythematosus: oral mycophenolate

for up-to-date information. Summary Evidence from a Cochrane review of randomised controlled trials (RCTs) and quasi-RCTs suggests that mycophenolate mofetil is as effective as cyclophosphamide at inducing remission in lupus nephritis, but with a lower risk of ovarian failure. For maintenance therapy in lupus nephritis the Cochrane review found that mycophenolate mofetil was more effective than azathioprine for preventing relapse, with no increase in clinically important adverse events. Data in non (...) infections that can be fatal, sepsis and neutropenia. Mycophenolate has also been associated with pure red cell aplasia and serious gastrointestinal adverse events (Cellcept, Roche and Myfortic, Novartis summaries of product characteristics). P Patient factors atient factors For induction therapy in lupus nephritis, mycophenolate mofetil was found to be associated with a lower risk of toxic adverse events such as ovarian failure, alopecia and leucopenia, compared with cyclophosphamide. Reduced risk

2014 National Institute for Health and Clinical Excellence - Advice

91. Palbociclib (Ibrance) - locally advanced or metastatic breast cancer

Evaluation Criteria in Solid Tumors RH Relative Humidity RP2D recommended Phase 2 dose RP-HPLC Reversed-phase high performance liquid chromatography RR time from the peak of 1 QRS complex to the peak of the next as shown on the electrocardiogram SAE serious adverse event SAP Statistical Analysis Plan SCE Summary of Clinical Efficacy SCP Summary of Clinical Pharmacology Studies SCS Summary of Clinical Safety sCSR Supplemental Clinical Study Report SD stable disease sec second SOC system organ class Std (...) for toxicology and clinical studies through Phase 2. However, its physical properties were deemed unsuitable for commercial development. Therefore, the free base of palbociclib, which was found to have excellent physical and chemical stability, was selected for commercial use. Palbociclib exhibits polymorphism. The crystalline anhydrous Form A of palbociclib free base is the thermodynamically more stable form within the temperature ranges that are relevant to manufacturing and storage conditions

2016 European Medicines Agency - EPARs

92. Ixazomib (Ninlaro) - multiple myeloma

. Introduction 10 2.2.2. Active Substance 10 2.2.3. Finished Medicinal Product 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 16 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 17 2.3.1. Introduction 17 2.3.2. Pharmacology 17 2.3.3. Pharmacokinetics 26 2.3.4. Toxicology 33 2.3.5. Ecotoxicity/environmental risk assessment 48 2.3.6. Discussion on non-clinical aspects 48 (...) 2.3.7. Conclusion on the non-clinical aspects 50 2.4. Clinical aspects 50 2.4.1. Introduction 50 2.4.2. Pharmacokinetics 52 2.4.3. Pharmacodynamics 63 2.4.4. Discussion on clinical pharmacology 65 2.4.5. Conclusions on clinical pharmacology 67 2.5. Clinical efficacy 68 2.5.1. Dose response studies 68 2.5.2. Main study 71 2.5.3. Discussion on clinical efficacy 99 2.5.4. Conclusions on the clinical efficacy 102 2.6. Clinical safety 102 2.6.1. Discussion on clinical safety 115 2.6.2. Conclusions

2016 European Medicines Agency - EPARs

93. Onivyde - metastatic adenocarcinoma of the pancreas

under the plasma concentration time curve BMI Body Mass Index BSA Body Surface Area CA 19-9 Carbohydrate antigen 19-9 CBR Clinical Benefit Response CEP Certificate of Suitability of the EP CHMP Committee for Medicinal Products for Human use CI Confidence Interval CL Clearance Cmax Maximum plasma concentration Cmin Minimum plasma concentration CR Complete Response CSR Clinical Study Report CTCAE Common Terminology Criteria for Adverse Events CYP3A4 Cytochrome P450 3A4 dL Deciliter DMSO Dimethyl (...) four patients had DLTs (i.e, grade 4 leucopenia and neutropenia lasting for longer than 3 days; grade 3 febrile neutropenia and grade 3 diarrhoea). The dose was then reduced (120 mg/m 2 ), and 1 patient among a total of 6 treated at this dose level experienced a DLT (Grade 3 infection). Therefore, based on these results 120 mg/m 2 was determined as MTD for MM-398 single agent (see further details in Section 2.1.3). Overall, 2 patients with advanced pancreatic cancer patients, both treated at 180 mg

2016 European Medicines Agency - EPARs

94. Neofordex - dexamethasone. To treat adults with multiple myeloma

2.2.2. Finished medicinal product 11 2.2.3. Discussion on chemical, and pharmaceutical aspects 14 2.2.4. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.5. Recommendation 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 18 2.3.4. Toxicology 21 2.3.5. Ecotoxicity/environmental risk assessment 25 2.3.6. Discussion on non-clinical aspects 25 2.3.7. Conclusion on the non-clinical aspects 26 2.4 (...) . Clinical aspects 26 2.4.1. Introduction 26 2.4.2. Pharmacokinetics 27 2.4.3. Pharmacodynamics 32 2.4.4. Clinical efficacy 32 2.4.5. Clinical safety 45 2.4.6. Discussion on clinical aspects 46 2.4.7. Conclusions on clinical aspects 48 2.5. Pharmacovigilance 48 2.6. Product information 52 2.6.1. User consultation 52 3. Benefit-risk balance 52 4. Recommendation 53 Divergent Position 59 Assessment report EMA/CHMP/6613/2016 Page 3/61 List of abbreviations AE Adverse Event ASCT Autologous Stem Cell

2016 European Medicines Agency - EPARs

95. Portrazza - necitumumab

parameters, well justified and supported by appropriate data. The acceptance criteria proposed in the testing of the active substance and the finished product has been justified based on experience from clinical trials. In most cases the limits are not exactly covered by clinical experience but the small deviation is not considered to have a significant impact on safety and efficacy. The stability results indicate that the active substance and finished product are sufficiently stable and justify (...) 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. 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 28 2.3.4. Toxicology 30 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical aspects 34 2.4. Clinical aspects

2016 European Medicines Agency - EPARs

96. Oncaspar - pegaspargase

14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 16 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 16 2.2.6. Recommendations for future quality development 16 2.3. Non-clinical aspects 16 2.3.1. Introduction 16 2.3.2. Pharmacology 17 2.3.3. Pharmacokinetics 20 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 31 2.3.7. Conclusion on the non-clinical aspects 34 2.4. Clinical aspects (...) 34 2.4.1. Introduction 34 2.4.2. Pharmacokinetics 37 2.4.3. Pharmacodynamics 53 2.4.4. Discussion on clinical pharmacology 56 2.4.5. Conclusions on clinical pharmacology 59 2.5. Clinical efficacy 59 2.5.1. Dose response studies 59 2.5.2. Main studies 60 2.5.3. Discussion on clinical efficacy 93 2.5.4. Conclusions on the clinical efficacy 96 2.6. Clinical safety 96 2.6.1. Discussion on clinical safety 109 2.6.2. Conclusions on the clinical safety 115 2.7. Pharmacovigilance 115 2.8. Risk Management

2016 European Medicines Agency - EPARs

97. Crohn's disease: management

) should only be continued if there is clear evidence of ongoing active disease as determined by clinical symptoms, biological markers and investigation, including endoscopy if necessary. Specialists should discuss the risks and benefits of continued treatment with patients and consider a trial withdrawal from treatment for all patients who are in stable clinical remission. People who continue treatment with infliximab or adalimumab should have their disease reassessed at least every 12 months (...) frequent (3–4 or more) diarrhoeal stools daily. People with severe active Crohn's disease may or may not develop new fistulae or have extra-intestinal manifestations of the disease. This clinical definition normally, but not exclusively, corresponds to a Crohn's Disease Activity Index (CDAI) score of 300 or more, or a Harvey-Bradshaw score of 8 to 9 or above. [2012] [2012] 1.2.19 When using the CDAI and Harvey-Bradshaw Index, healthcare professionals should take into account any physical, sensory

2012 National Institute for Health and Clinical Excellence - Clinical Guidelines

98. Stroke and Transient Ischemic Attack ? Acute and Long-Term Management

without evidence of acute infarction. 1 Clinical symptoms typically last minutes to one hour (although they can last up to 24 hours). These symptoms can include motor, sensory, speech/language, vision or cerebellar disturbances. A TIA can be seen along the same pathophysiological process as a stroke. Even with the resolution of symptoms, an infarct may have occurred and should be treated as a continuum of the same disease process as a stroke. A stroke is defined as the sudden onset of focal (...) . See definition of emergent TIAs in Table 2. Investigation and treatment of strokes or TIAs should begin as soon as possible, preferably within 24 hours. Contact information for stroke/TIA assessment clinics throughout BC are listed in the Resources below. Investigations for urgent cases are recommended within 7 days, and within one month for semi-urgent cases. Table 2. TIA urgency classification TIA Urgency Classification Symptoms or Circumstances Emergent One or more of the following: • Symptoms

2015 Clinical Practice Guidelines and Protocols in British Columbia

99. 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

100. Cosentyx - secukinumab

CCV cardiovascular/cerebrovascular CHO Chinese hamster ovary Cmax maximum serum concentration after a single dose CMH Cochran-Mantel-Haenszel CRF case report/record form CSR clinical study report CTCAE Common Terminology Criteria for Adverse Events CYP cytochrome DDI drug-drug interaction DILI drug-induced liver injury DLQI Dermatology Life Quality Index dPGA dynamic Physician’s Global Assessment ECG electrocardiogram EQ-5D EuroQOL 5-Dimension Health Questionnaire © EMA European Medicines Agency (...) FAS Full Analysis Set FDA United States Food and Drug Administration FI fixed interval dosing GCP Good Clinical Practice GGT gamma-glutamyltransferase HA health authority HAQ-DI Health Assessment Questionnaire©-Disability Index HRQoL health-related quality of life hBD-2 human beta defensin-2 HLT high level term hsCRP high sensitivity C-reactive protein IBD inflammatory bowel disease IGA Investigator’s Global Assessment IGA mod 2007 IGA scale used in part of the phase II program, 6-point scale IGA

2015 European Medicines Agency - EPARs

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