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Clinical Index of Stable Febrile Neutropenia

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161. Abilify Maintena (aripiprazole)

69 Abilify Maintena EMA/737723/2013 Page 2/70 List of abbreviations Acc Nucleus Accumbens ADP Action Potential Duration AE Adverse Event ALT Alanine transaminase/Alanine Aminotransferase ANCOVA Analysis of covariance AST Aspartate transaminase/Aspartate Aminotransferase AUC Area Under Curve BMI Body Mass Index CGI-I Clinical Global Impression - Improvement Scale CGI-SS Clinical Global Impression – Severity of Suicide CGI-S Clinical Global Impression – Severity Scale CHL Chinese Hamster Lung CHMP (...) and biological aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 14 2.2.6. Recommendation(s) for future quality development 14 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 18 2.3.5. Ecotoxicity/environmental risk assessment 25 2.3.6. Discussion on non-clinical aspects 26 2.3.7. Conclusion on the non-clinical aspects 27 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 27 2.4.3

2013 European Medicines Agency - EPARs

162. Teriflunomide

In general, these changes tend to occur early (within the first 6-12 weeks) and then remain stable. Reference ID: 3185084 19 Outliers The following chart displays the percent of patients who met criteria for potentially clinically important changes for the various laboratory analytes: Analyte Placebo Ter 7 Ter 14 Phosphorus >0.6 and 0.3 and 7 mmol/L 0.2% 1% 1% Creatinine >150 umol/L 0% 1% 1% > 2 X baseline 0% 1% 1% > 3 x Baseline 0% 1% 1% Uric acid 3 - 2.5 - 0.5 5% 10% 4.5% Lymphocytes 0.5 Giga/L 5% 7 (...) 6045) or glatiramer acetate (Study 6046) as additional support. The NDA has been reviewed by Drs. Prafull Shiromani and Sarah Miksinski, Office of New Drug Quality and Assessment (ONDQA, CMC); Dr. Tien-Mien Chen, ONDQA, Biopharmaceutics; Dr. Richard Houghtling, pharmacology/toxicology reviewer; Dr. Lois Freed, pharmacology supervisor; Dr. Matthew Jackson, statistician (carcinogenicity); Drs. Vaneeta Tandon, Joo-Yeon Lee, and Jeffrey Kraft, Office of Clinical Pharmacology; Dr. Katherine Bonson

2012 FDA - Drug Approval Package

163. Zinforo - ceftaroline fosamil

on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendation for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 21 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion on non-clinical aspects 26 2.3.6. Conclusion on the non-clinical aspects 27 2.4. Clinical aspects 27 2.4.1. Introduction 27 2.4.2. Pharmacokinetics 34 2.4.3. Pharmacodynamics 41 2.4.4. Discussion on clinical pharmacology 43 (...) 2.4.5. Conclusions on clinical pharmacology 44 2.5. Clinical efficacy 44 2.5.1. Dose response studies 44 2.5.2. Main studies 46 2.5.3. Discussion on clinical efficacy 92 2.5.4. Conclusions on the clinical efficacy 94 2.6. Clinical safety 95 2.6.1. Discussion on clinical safety 105 2.6.2. Conclusions on the clinical safety 105 2.7. Pharmacovigilance 105 2.8. User consultation 119 3. 119 Benefit-Risk Balance 4. 121 RecommendationsZinforo Assessment report Page 4/122 List of abbreviations %T>MIC

2012 European Medicines Agency - EPARs

164. Pixuvri - pixantrone dimaleate

and determined the dose limiting toxicity (DLT). There is a direct relationship between exposure and neutropenia. During the pivotal study after an initial decline from baseline to cycle 2, mean neutrophil nadirs remain stable through subsequent cycles. Data pooled from four single agent studies (AZA-I-01, 02, 03 and PIX 301) using different doses of pixantrone and in different cancer populations have shown a relationship between plasma exposure (AUC) and pharmacodynamic effect (PFS and neutropaenia (...) , pixantrone inhibited CYP1A2 at clinically relevant concentrations. The interaction has not been confirmed in vivo, however warnings in the SmPC for CYP1A2 substrates with narrow therapeutic index such as theophylline have been included (see SmPC section 4.5). The potential for pixantrone to reversibly inhibit CYP2B6 and CYP2C8 at clinically relevant concentration is low. Definite conclusions on the risk for inhibition of CYP2C8 activity cannot be drawn from the data submitted. Although the in vitro

2012 European Medicines Agency - EPARs

165. Inlyta - axitinib

EQ-VAS EuroQol EQ-5D visual analog scale FAS Full Analysis Set FCIR film-coated immediate release FIH First in human Inlyta CHMP assessment report Page 7/92 FGF Fibroblast growth factor FGFR Fibroblast growth factor receptor FKSI FACT-Advanced Kidney Cancer Symptom Index FKSI-DRS Functional Assessment of Cancer Therapy Kidney Symptom Index -Disease Related Symptoms FLVK FGF like VEGF kinase GI Gastrointestinal GCP Good Clinical Practice GLP Good Laboratoty Practice hERG Human Ether-à-go-go (...) substance to a more stable form, form XLI and changing the colour of the coating from white to red gave better protection against light. The purposeful degradation test demonstrated that the polymorphic form change and modification in coating system resulted in a chemically more stable formulation. The tablets used in early clinical trials were manufactured by a wet granulation process and were subsequently modified to dry granulation formulation to reduce processing time and material costs. A design

2012 European Medicines Agency - EPARs

166. Folotyn - pralatrexate

lymphoma DNA deoxyribonucleic acid dTMP deoxythymidine monophosphate EMA European Medicines Agency EU European Union FDA Food and Drug Administration FPGS folylpolyglutamyl synthetase G-CSF granulocyte colony stimulating factor GCP Good Clinical Practice GM-CSF granulocyte/macrophage colony stimulating factor HR hazard ratio HTLV human T-cell leukaemia virus ICH International Conference on Harmonisation IPI International Prognostic Index IWC International Workshop Criteria IV intravenous LFT liver (...) Prognostic Index, 5-year survival has been reported to be as low as 6%. Several clinical studies have reported a median survival of less than 2 years for patients with T-cell neoplasms and 5-year survival rates of less than 30%. Because of having an aggressive clinical course with poor outcomes, PTCL is typically treated with combination chemotherapy regimens like CHOP and its variants. The first-line response rates to CHOP chemotherapy have been reported to range between 50% and 70%. However, patients

2012 European Medicines Agency - EPARs

167. Perampanel (Fycompa)

-emergent SAEs coded to the following preferred terms: aplastic anemia, agranulocytosis, Stevens Johnson syndrome, toxic 2 In the Parkinson’s disease studies, for example, subjects could have clinically significant, but stable disease; in the epilepsy studies, subjects with clinically significant disease were excluded. Reference ID: 3197631Safety Team Leader Memo NDA 202834 7 epidermal necrolysis, acute renal failure, acute liver failure, rhabdomyolysis, angioedema, or anaphylaxis. There was one SAE (...) Perampanel (Fycompa) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 202834Orig1s000 MEDICAL REVIEW(S) Safety Team Leader Memo NDA 202834 1 Review and Evaluation of Clinical Data Safety Team Leader Memorandum ________________________________________________________________ NDA: 202834 Drug: Perampanel (FYCOMPA) Route: Oral Indication: Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization Sponsor: Eisai, Inc. Submission Date: 12/22/11

2012 FDA - Drug Approval Package

168. Adcetris (brentuximab vedotin)

, pharmaceutical and biological aspects 22 2.2.6. Recommendations for future quality development 22 2.3. Non-clinical aspects 23 2.3.1. Introduction 23 2.3.2. Pharmacology 23 2.3.3. Pharmacokinetics 25 2.3.4. Toxicology 28 2.3.5. Ecotoxicity/environmental risk assessment 33 2.3.6. Discussion on non-clinical aspects 34 2.3.7. Conclusion on the non-clinical aspects 40 2.4. Clinical aspects 40 2.4.1. Introduction 40 2.4.2. Pharmacokinetics 41 2.4.3. Pharmacodynamics 45 2.4.4. Discussion on clinical pharmacology (...) 45 2.4.5. Conclusions on clinical pharmacology 46 2.5. Clinical efficacy 46 2.5.1. Dose response studies 46 2.5.2. Main studies 47 Supportive studies 65 2.5.3. Discussion on clinical efficacy 68 2.5.4. Conclusions on the clinical efficacy 71 2.6. Clinical safety 72 2.6.1. Discussion on clinical safety 80 2.6.2. Conclusions on the clinical safety 84 2.7. Pharmacovigilance 84 2.8. User consultation 91 3. Benefit-Risk Balance 92 4. Recommendations 99 Adcetris CHMP assessment report Rev10.11 Page 3

2012 European Medicines Agency - EPARs

169. Alogliptin and alogliptin/pioglitazone

alone or in combination with metformin. Both the pioglitazone and metformin were stable for at least 8 weeks prior to Screening. Reference ID: 3247308 (b) (4)Clinical Review Valerie S.W. Pratt, M.D. NDAs 22-271 and 22-426 Nesina (alogliptin) and (alogliptin/pioglitazone FDC) 30 There was a 16 week treatment period and a follow-up visit 2 weeks after the end of treatment. The duration of the study for these subjects was approximately 24 weeks. Main Inclusion Criteria: • The subject has a historical (...) Alogliptin and alogliptin/pioglitazone CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022426Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Complete Response Application Number(s) 22-271 and 22-426 Priority or Standard Standard Submit Date(s) 7-26-12 Received Date(s) 7-26-12 PDUFA Goal Date 1-26-13 Division / Office DMEP/ODEII/OND Reviewer Name(s) Valerie S.W. Pratt, M.D. Review Completion Date 01-17-13 Established Name Alogliptin and alogliptin/pioglitazone FDC

2012 FDA - Drug Approval Package

170. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock Full Text available with Trip Pro

, American Thoracic Society, Asia Pacific Association of Critical Care Medicine, Associação de Medicina Intensiva Brasileira, Australian and New Zealand Intensive Care Society, Consorcio Centroamericano y del Caribe de Terapia Intensiva, European Respiratory Society, European Society of Clinical Microbiology and Infectious Diseases, German Sepsis Society, Indian Society of Critical Care Medicine, International Pan Arab Critical Care Medicine Society, Japanese Association for Acute Medicine, Japanese (...) therapy); he participates in the UK National Institute for Clinical and Healthcare Excellence Sepsis Guideline Development Group; he has served as an expert witness, disclosing that he is approached from time to time regarding expert witness testimony for ICU cases, which may involve patients who have sepsis and the testimony relates to generally accepted current standards of care, and formal guidance, as it currently pertains within the UK. Dr. Bellingan received funding from Faron (research

2016 European Respiratory Society

171. Trifluridin/tipirACil in meTastatIc Colorectal Cancer

treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages. Therapy management (use of relevant supportive medications) [ Time Frame: Baseline up to 3 years ] Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies) Patient-reported outcomes (PROs) on quality of life (QoL) [ Time Frame: Baseline up to 3 years ] PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine (...) Cancer (TACTIC) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03665506 Recruitment Status : Recruiting First Posted : September 11, 2018 Last Update Posted : September 11, 2018 See Sponsor: Servier Collaborator: iOMEDICO

2018 Clinical Trials

172. Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

Frame: 12 months ] The duration of response (DoR) will be measured from the time of first documented response (CR or PR as per RECIST 1.1) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment. The clinical benefit rate (CBR) [ Time Frame: 8 weeks ] after 8 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable (...) population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1. The clinical benefit rate (CBR) [ Time Frame: 16 weeks ] after 16 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1. Progression-Free Survival (PFS) [ Time Frame: 12 months ] will be measured from C1D1 until the date

2018 Clinical Trials

173. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack Full Text available with Trip Pro

is uncertain, but restarting antihypertensive therapy is reasonable after the first 24 hours for patients who have preexisting hypertension and who are neurologically stable. Limited data specifically assess the optimal BP target for secondary stroke prevention. Randomized clinical trial evidence among high-risk patients with DM indicates that there is no benefit in achieving an aggressive SBP of <120 versus <140 mm Hg. Observational studies among hypertensive patients with DM and coronary artery disease (...) , Council on Clinical Cardiology, and Council on Peripheral Vascular Disease Walter N. Kernan , Bruce Ovbiagele , Henry R. Black , Dawn M. Bravata , Marc I. Chimowitz , Michael D. Ezekowitz , Margaret C. Fang , Marc Fisher , Karen L. Furie , Donald V. Heck , S. Claiborne (Clay) Johnston , Scott E. Kasner , Steven J. Kittner , Pamela H. Mitchell , Michael W. Rich , DeJuran Richardson , Lee H. Schwamm , and John A. Wilson and on behalf of the American Heart Association Stroke Council, Council

2014 American Heart Association

174. HIV, viral hepatitis and STIs - a guide for primary care

, so that they are able to persist throughout the life of the host. During latency, the genome of the invading virus is maintained in stable form in the infected neural cell with no production of progeny virus for variable periods of time and no apparent cytotoxic effects. Periodically, reactivation of virus replication occurs with virus migrating back down axons to surface sites. The clinical severity of herpes simplex infections and the host’s capacity to control viral replication depends very (...) – A GUIDE FOR PRIMARY HEALTH CARE iii HIV , VIRAL HEPATITIS & STIs A GUIDE FOR PRIMARY CARE 2014 EDITION EXPERT REFERENCE GROUP (EDITORIAL OVERSIGHT) Dr Michael Burke Nepean Sexual Health & HIV Clinic Ms Tracey Cabrie Victorian Infectious Diseases Service, Melbourne Health Associate Professor Ben Cowie Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, University of Melbourne Professor Greg Dore The Kirby Institute, UNSW Australia Dr Seamus Duffy Tuggerah Medical Centre Dr

2014 Clinical Practice Guidelines Portal

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

Objectives 39 1.4 Target audience 39 1.5 Scope and components 40 1.5.1 Introductory chapters 40 1.5.2 Clinical guidance 40 1.5.3 Operational and service delivery guidance 40 1.5.4 Guidance for programme managers 41 1.5.5 Monitoring and evaluation 41 2. Guiding principles 43 2.1 Contribution to global health goals 44 2.2 Public health approach 44 2.3 Strengthening health systems through innovation and learning 44 2.4 Increasing the effectiveness and efficiency of programmes 45 2.5 Promoting human rights (...) of the guidelines 55 Continuum of care 56 4.1 Structure of presentation for new recommendations 58 4.2 Structure of presentation of selected recommendations from existing guidelines 58 4.3 How to use the guidelines for specific populations 59 4.3.1 Pregnant and breastfeeding women 59 4.3.2 Adolescents 61 4.3.3 Children 63 4.3.4 Key populations 64 5. Clinical guidelines across the continuum of care: HIV diagnosis and ARV drugs for HIV prevention 67 5.1 HIV testing and counselling 68 5.1.1 Introduction 68 5.1.2

2013 World Health Organisation HIV Guidelines

176. Central Venous Catheter Care for the Patient With Cancer Full Text available with Trip Pro

Update of the Clinical Practice Guideline for the use of Antimicrobial Agents in Neutropenic Patients with Cancer. Information on the management of febrile neutropenia in the outpatient setting can be found at . Specific therapy with standard antimicrobial agents should be initiated as soon as possible. Catheter-related BSIs are most commonly caused by coagulase-negative staphylococci, Staphylococcus aureus , and Candida species and less commonly with Bacillus species, Corynebacterium jeikeium (...) source of infection. Many approaches to quantify the number of organisms cultured from each site have been proposed. Although not specific to patients with cancer, there are recommendations for culturing and treatment in the IDSA 2009 Update of the Clinical Practice Guidelines for the Diagnosis and Management of Intravascular Catheter-Related Infection (pocket card can be found at ). The use of antimicrobial agents in patients with cancer and/or neutropenia are also clearly addressed in the IDSA 2010

2013 American Society of Clinical Oncology Guidelines

177. Cardiovascular Function and Treatment in ß-Thalassemia Major Full Text available with Trip Pro

in small studies, and its low sensitivity limits its use for diagnosis and as a prognostic tool. , Impaired diastolic function shown by CMR also had low sensitivity for identification of cardiac iron loading. 2.13 Vascular Effects of Iron Loading Patients with TM and normal cardiac iron levels documented by T2* and no clinical signs of cardiac dysfunction have increased aortic stiffness as assessed by pulse-wave velocity (carotid-femoral) and augmentation index compared with normal control subjects. 3 (...) , whereas in the case of agranulocytosis or neutropenia, the drug should be stopped immediately, and patients should contact their physician. Patients should also be advised to report immediately to their physician any symptoms indicative of infection, such as fever, sore throat, and flulike symptoms. 4.4 Deferasirox Deferasirox is an orally active tridentate chelator that binds iron in a 2:1 molar ratio. Single oral doses of deferasirox are absorbed rapidly, achieving peak plasma levels within 1 to 3

2013 American Heart Association

178. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer Full Text available with Trip Pro

(in particular febrile neutropenia). Bevacizumab should be investigated further in the second-line setting. O'Shaughnessy et al, 2012 Systematic review Seven prospective studies including 1,813 patients and four retrospective studies including 1,087 patients First-line capecitabine monotherapy demonstrated superior median survival compared with CMF combination therapy; all other comparisons for efficacy were nonsignificant. Capecitabine monotherapy (1,000 mg/m 2 twice daily, for 14 d of a 21-d cycle) has (...) . Serious adverse events, neutropenia, neutropenic fever, and peripheral neuropathy were significantly lower in weekly taxanes schedules. The incidence of nail changes and epiphora were significantly lower in the every 3 weeks docetaxel regimens. Li et al, 2010 Systematic review Two RCTs including 1,953 patients For patients with metastatic or locally advanced breast cancer who experienced disease progression while on or following an anthracycline with a taxane treatment, ixabepilone plus capecitabine

2014 American Society of Clinical Oncology Guidelines

179. Diagnosis and Management of Hepatitis C Infection in Infants, Children, and Adolescents

be spontaneous or treatment-induced. Spontaneous resolution of chronic HCV infection is when an individual who had CHC loses detectable serum HCV RNA without any treatment (2 negative HCV RNA tests at least 6 months apart) (11). Pathobiology of HCV HCV is an RNA virus within the Flaviviridae family, which includes yellow fever virus, West Nile virus, dengue virus, and others. It occupies its own genus (Hepacivirus) and there are 6 main types, clinically known as genotypes. The metabolic effects (...) (if cirrhosis is present) (2A; BII). Liver biopsy should be generally considered only if the result will influence medical decision making. Liver biopsy may be specifically useful to investigate unexplained clinical hepatic decompensation in a previously stable patient and in children who are being considered for antiviral treatment to assess severity of liver disease. It is reasonable to forego pretreatment liver biopsy in children with HCV genotypes 2 or 3 who have a high (>80%) probability of achieving

2012 North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition

180. Radioimmunotherapy for B-cell lymphoma with 90Y-radiolabelled itribumomab tiuxetan (Zevalin) ? SNMMI Endorsement**

(NHL). II. Background Information and Definitions A. Definitions 1. Radio-immunotherapy (RIT) for relapsed or refractory CD20-positive B-cell NHL means intravenous administration of 90 yttrium [ 90 Y]-labelled ibritumomab tiuxetan (Zevalin ® ). 2. 90 Y(III)chloride is produced through decay of the radioactive precursor nuclide 90 strontium [ 90 Sr]. The decay of 90 Y is accompanied by the release of beta radiation with a maximum energy of 2.281 MeV (99.98%) into stable 90 zirconium [ 90 Zr (...) . Usually it is advised that therapy should not be performed if these values are above 2.5 times the upper normal limit of the local laboratory. 8. Estimation of life expectancy (life expectancy > 3 months, Karnofsky index > 70%). A patient with a life expectancy of less than 3-4 weeks is unlikely to benefit from treatment. Similarly, patients showing rapidly progressing disease are not candidates for RIT because of delayed efficacy of the treatment. 9. Probably due to methodological problems

2012 Society of Nuclear Medicine and Molecular Imaging

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