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Diarrhea Secondary to Medications

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41. Efficacy and safety of paclitaxel with or without targeted therapy as second-line therapy in advanced gastric cancer: A meta-analysis. Full Text available with Trip Pro

the databases of PubMed, Embase, Web of Science and the Cochrane Library published between January 2000 and August 2019. Only randomized controlled trials were eligible. Statistical analysis was performed by meta-analysis. The primary end points were progression-free survival and overall survival, objective response rate and adverse events were the secondary end points.A total of 4 randomized controlled trials with 1574 patients (PTX + targeted therapy, n = 786; PTX, n = 788) were included for the final (...) significant differences were observed in the incidences of grade 3 to 5 anemia, decreased appetite, nausea, diarrhea and abdominal pain between the two treatments (P >.05).Second-line PTX+targeted therapy is a more effective treatment option with tolerable safety profile for advanced gastric cancer as a result of improved survival, though with additional toxicity.

2020 Medicine

42. Comparison of oral rehydration therapies in acute diarrhoea: A network meta-analysis of randomized clinical trials

Comparison of oral rehydration therapies in acute diarrhoea: A network meta-analysis of randomized clinical trials Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. CRD bears no responsibility or liability for the content of this registration record, any associated files or external websites. Email salutation (e.g. "Dr Smith" or "Joanne") for correspondence (...) by full-text screening of the eligible articles for final inclusion. In each phase, 2 observers will independently assess each article. Discrepancies will be resolved through discussion, or by consulting a third investigator. ">Procedure for study selection Example : Title-abstract screening: 1. Not an original full research paper (e.g. review, editorial) 2. Not an in vivo animal study 3. No metastases/ only primary tumor 4. No control group 5. Combination therapy or contamination 6. Not about

2018 PROSPERO

43. CAR T-cell therapy: a summary of evidence

frameworks are in place, or under consideration, for the delivery of CAR T-cell therapy? Regulatory approvals At the time of writing, regulatory approvals of two CAR T-cell therapies have been granted by the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Health Canada (see Appendix 5). The US was the first to approve two CAR T-cell therapies for two indications: tisagenlecleucel (Kymriah, Novartis) received FDA approval in August 2017 for adults with relapsed or refractory (...) -cell therapy 30, 31, 34, 35, 42, 47, 52 • Large number of early stage, single-arm trials in small populations, and with short follow-up • Lack of familiarity with regulatory processes for those developing the treatments (more often universities or non-commercial bodies rather than pharmaceutical companies). 32 A report by CADTH looked at all medicines approved under a number of EMA, FDA and Health Canada special designations and indicated that CAR T-cell therapies have so far been eligible

2018 Sax Institute Evidence Check

44. Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease. Full Text available with Trip Pro

Oral 5-aminosalicylic acid for maintenance of medically-induced remission in Crohn's disease. The prevention of relapse is a major issue in the management of Crohn's disease. Corticosteroids, the mainstay of treatment of acute exacerbations, are not effective for maintenance of remission and its chronic use is limited by numerous adverse events. Randomised controlled trials assessing the efficacy of oral 5-aminosalicylic acid (5-ASA) agents for maintenance of medically-induced remission (...) in Crohn's disease have produced conflicting results.To conduct a systematic review to evaluate the efficacy and safety of oral 5-ASA agents for the maintenance of medically-induced remission in Crohn's disease.We searched MEDLINE, EMBASE, CENTRAL and the IBD Group Specialized Register from inception to 8 June 2016. We also searched reference lists and conference proceedings.We included randomised controlled trials that compared oral 5-ASA agents to either placebo or sulphasalazine in patients

2016 Cochrane

45. Drugs for multiple sclerosis - Drug Facts Box for Fingolimod

for? 1 To improve the symptoms of highly active relapsing remitting multiple sclerosis (as a disease-modifying therapy) Who is this drug for? 1 Adults with high disease activity despite treatment with a beta-interferon Adults with rapidly evolving severe relapsing remitting multiple sclerosis Who should not be taking this drug? 1 Patients under age 18 Patients with severe hepatic impairment Patients with high risk of infections or active infections, or malignancies 3 How is this drug administered? 1 (...) Orally as a capsule What dose of this drug is administered? 1 One 0.5 mg tablet How often is this drug administered? 1 Once daily What is the cost of this drug? One 28-tablet pack, sufficient for one patient for one month, costs £1,470 What are the adverse reactions associated with this drug? 1 Most commonly: influenza viral infections, headache, cough, diarrhoea, back pain, raised alanine transaminase Licensing timeline Launched in the UK in March 2011 Other information: Treatment with fingolimod

2013 West Midlands Clinical Support Unit

46. Liposomal formulation of daunorubicin & cytarabine (Vyxeos) - treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes

Liposomal formulation of daunorubicin & cytarabine (Vyxeos) - treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes Published 11 March 2019 1 SMC2130 liposomal formulation of daunorubicin/cytarabine 44mg/100mg powder for concentrate for solution for infusion (Vyxeos®) Jazz Pharmaceuticals UK Ltd 8 February 2019 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS (...) Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice is summarised as follows: ADVICE: following a full submission assessed under the end of life and ultra-orphan medicine process liposomal formulation of daunorubicin/cytarabine (Vyxeos ® ) is accepted for use within NHSScotland. Indication under review: The treatment of adults with newly diagnosed, therapy- related acute myeloid leukaemia (AML) or AML with myelodysplasia-related changes.In a randomised phase

2019 Scottish Medicines Consortium

47. Guidelines for the investigation of chronic diarrhoea in adults

to appraise the quality of evidence and grading of recommendations. These guidelines deal with clinical assessment in primary and secondary care of a patient with diar- rhoea, the exclusion of cancer or inflammation, and detecting common disorders such as bile acid diar- rhoea, microscopic colitis, lactose malabsorption or post radiation diarrhoea, together with rarer causes of malabsorption and surgical disorders as outlined in figure 1. Options for therapy are not dealt with as it is beyond the remit (...) of recommendation strong). group.bmj.com on April 16, 2018 - Published by http://gut.bmj.com/ Downloaded from 15 Arasaradnam RP , et al. Gut 2018;0:1–20. doi:10.1136/gutjnl-2017-315909 Guidelines after surgery but can also be seen after radiotherapy, in Crohn’s disease and secondary to some medications. 226 Small and large bowel resection clearly reduces absorptive capacity. At the extreme, this results in short bowel syndrome characterised clinically by chronic diarrhoea, dehydration, elec- trolyte

2018 British Society of Gastroenterology

48. Preventive effect of kampo medicine (hangeshashin-to, TJ-14) plus minocycline against afatinib-induced diarrhea and skin rash in patients with non-small cell lung cancer Full Text available with Trip Pro

TJ-14 (7.5 g/day) and minocycline (100 mg/day) were administered simultaneously from the start of afatinib administration. The primary end point was the incidence of ≥ grade 3 (G3) diarrhea (increase of ≥7 stools/day over baseline) during the first 4 weeks of treatment. The secondary end points were the incidence of ≥ G3 oral mucositis (severe pain interfering with oral intake) and $ G3 skin toxicity (severe or medically significant but not immediately life-threatening).A total of 29 patients (...) Preventive effect of kampo medicine (hangeshashin-to, TJ-14) plus minocycline against afatinib-induced diarrhea and skin rash in patients with non-small cell lung cancer Diarrhea and oral mucositis induced by afatinib can cause devastating quality of life issues for patients undergoing afatinib treatment. Several studies have shown that hangeshashin-to (TJ-14) might be useful for chemotherapy-induced diarrhea and oral mucositis. In this study, we investigated the prophylactic effects of TJ-14

2017 OncoTargets and therapy

49. The effectiveness of traditional Chinese medicine on intestinal flora in patients with diarrhea-predominant irritable bowel syndrome: a systematic review and meta-analysis of randomised controlled trials

The effectiveness of traditional Chinese medicine on intestinal flora in patients with diarrhea-predominant irritable bowel syndrome: a systematic review and meta-analysis of randomised controlled trials Print | PDF PROSPERO This information has been provided by the named contact for this review. CRD has accepted this information in good faith and registered the review in PROSPERO. The registrant confirms that the information supplied for this submission is accurate and complete. CRD bears (...) research paper (e.g. review, editorial) 2. Not an in vivo animal study 3. No metastases/ only primary tumor 4. No control group 5. Combination therapy or contamination 6. Not about analgesics used in the clinic Full text-screening: As above, with the addition of: 7. No relevant outcome measure reported ">Prioritise the exclusion criteria Example: Two reviewers will independently extract data from each article. We first try to extract numerical data from tables, text or figures

2019 PROSPERO

50. Neuropathic pain - drug treatment

, spinal cord injury, and multiple sclerosis. In many cases, it is not possible to completely cure the underlying disease or lesion or to reverse the neurological changes. Consequently, neuropathic pain is usually persistent in these cases. The general principles for prescribing drug treatment for neuropathic pain include considering: Contraindications and potential adverse effects, especially for people with comorbid conditions. Interactions with other medications. Comorbid conditions that may benefit (...) guideline referenced above. Previous changes Previous changes August 2012 — minor update. Minor typographical error corrected. May to September 2010 — topic updated. The evidence base has been reviewed in detail, and recommendations are more clearly justified and transparently linked to the supporting evidence. January 2009 — minor update. Drug safety advice from the MHRA (Medicines and Healthcare products Regulatory Agency) that all antiepileptic drug treatment (including carbamazepine and gabapentin

2019 NICE Clinical Knowledge Summaries

51. Zarxio (filgrastim-sndz) - medical review

Zarxio (filgrastim-sndz) - medical review CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 125553Orig1s000 MEDICAL REVIEW(S) Page 1 Secondary (Team Leader) Review Date February 3, 2015 From Albert Deisseroth, MD, PhD Subject Secondary Review BLA Number 125553 Applicant Sandoz Date of Submission May 8, 2014 PDUFA Goal Date March 8, 2015 Proprietary Name Zarxio Dosage Regimen 300 mcg/0.5 mL PFS, 480 mcg/0.8 mL PFS Approved Indications Patients with cancer receiving myelosuppressive (...) agent regimen was consistent with the proposed dose-schedule for chemotherapy-induced neutropenia. The majority of the subjects (89%) received all six planned cycles of therapy. The study population was monitored for deaths, serious adverse events, adverse events of interest, common adverse events, immunogenicity and common laboratory tests. Follow-up was through 4 weeks after the last dose of study drug. Analysis of the safety data for Study EP06-302 showed: • There were no related fatal TEAE

2015 FDA - Drug Approval Package

52. This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung a

This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung a This Study in Patients With Different Types of Cancer (Solid Tumours) Aims to Find a Safe Dose of Xentuzumab in Combination With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients (...) With Abemaciclib With or Without Hormonal Therapies. The Study Also Tests How Effective These Medicines Are in Patients With Lung and Breast Cancer. 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: NCT03099174 Recruitment Status

2017 Clinical Trials

53. Hydrocortisone (Alkindi) - replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to <18 years old)

Hydrocortisone (Alkindi) - replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to <18 years old) Published 08 October 2018 1 hydrocortisone 0.5mg, 1mg, 2mg and 5mg granules in capsules for opening (Alkindi ® ) SMC2088 Diurnal Limited 7 September 2018 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in NHSScotland. The advice (...) via the SMC Detailed Advice Document. Area Drug and Therapeutics Committees and NHS Boards are therefore asked to consider contract pricing when reviewing advice on medicines accepted by SMC. Patient access schemes: A patient access scheme is a scheme proposed by a pharmaceutical company in order to improve the cost-effectiveness of a medicine and enable patients to receive access to cost- 13 effective innovative medicines. A Patient Access Scheme Assessment Group (PASAG), established under

2018 Scottish Medicines Consortium

54. 2017 Focused update on Dual Antiplatelet Therapy (DAPT) Full Text available with Trip Pro

for the recommendations see . Table of Contents Abbreviations and acronyms 215 1. Preamble 216 2. Introduction 218 2.1 Short- and long-term outcomes after percutaneous coronary intervention 219 2.2 Risk of stent thrombosis in relation to stent type 219 2.3 Short- and long-term outcomes after coronary artery bypass surgery 219 2.4 Short- and long-term outcomes after medically managed acute coronary syndrome 219 3. Efficacy and safety of dual antiplatelet therapy and risk stratification tools 219 3.1 Dual antiplatelet (...) in patients treated with coronary artery bypass surgery for acute coronary syndrome 234 5.3 Dual antiplatelet therapy for prevention of graft occlusion 237 5.4 Gaps in the evidence 237 6. Dual antiplatelet therapy for patients with medically managed acute coronary syndrome 237 7. Dual antiplatelet therapy for patients with indication for oral anticoagulation 238 7.1 Risk stratification and strategies to improve outcome after percutaneous coronary intervention 238 7.2 Duration of triple therapy 239 7.3

2017 European Society of Cardiology

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

to thank Erin Lawler, Molly Morgan, and Aqsa Mugal for their contributions to this report.©Institute for Clinical and Economic Review, 2018 Page ii Evidence Report – CAR-T Therapies for B-Cell Cancers About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Through all its work (...) be assumed to support any part of this report, which is solely the work of the ICER team and its affiliated researchers. For a complete list of stakeholders from whom we requested input, please visit: https://icer-review.org/topic/car-t/. Expert Reviewers Charalambos (Babis) Andreadis, MD, MCSE Associate Professor of Clinical Medicine, Department of Medicine; Director, Clinical Research Support Office University of California, San Francisco (UCSF) Medical Center and UCSF Helen Diller Family Comprehensive

2018 California Technology Assessment Forum

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

and electrolyte balance, minimizing insensible water losses, and preventing infection. Given the immune mechanism of action of these medicines, use of immune suppression, such as with systemic corticosteroids, is warranted and should be offered, though the use of systemic corticosteroids has been more controversial for the treatment of SJS/TEN, in general. For DRESS/DIHS, high-dose and usually prolonged courses of systemic corticosteroids is first-line therapy following cessation of the offending drug (...) of Washington, and the Fred Hutchinson Cancer Research Center, Seattle, WA; and Tanyanika Phillips, CHRISTUS St Frances Cabrini Cancer Center, Alexandria, LA. Abstract Section: Purpose To increase awareness, outline strategies, and offer guidance on the recommended management of immune-related adverse events in patients treated with immune checkpoint inhibitor (ICPi) therapy. Methods A multidisciplinary, multi-organizational panel of experts in medical oncology, dermatology, gastroenterology, rheumatology

2018 American Society of Clinical Oncology Guidelines

57. Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer

in patients with early-stage, HER2-positive breast cancer. Neratinib causes substantial diarrhea, and diarrhea prophylaxis must be used. Additional information can be found at . INTRODUCTION Section: In 2016, ASCO published an adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for human epidermal growth factor receptor 2 (HER2)–positive breast cancers. ASCO updates its guidelines at intervals (...) breast cancer? Should neratinib be offered as extended adjuvant therapy for patients after combination chemotherapy and trastuzumab-based adjuvant therapy with early-stage, HER2-positive breast cancer? Target Population Patients who are being considered for, or who are receiving, systemic therapy following definitive surgery for early-stage invasive breast cancer, defined largely as invasive cancer anatomic stages I to IIIC Target Audience Medical oncologists, pathologists, surgeons, oncology nurses

2018 American Society of Clinical Oncology Guidelines

58. Comprehensive Systematic Review Summary: Disease-modifying Therapies for Adults with Multiple Sclerosis

Academy of Neurology AEs: adverse effects ALT: alanine aminotransferase ARRs: annualized relapse rates AST: aspartate aminotransferase CIS: clinically isolated syndrome CMSC: Consortium of Multiple Sclerosis Centers” COI: conflict of interest CV: curriculum vitae DMTs: disease-modifying therapies EDSS: Expanded Disability Status Scale FDA: US Food and Drug Administration GDDI: Guideline Development, Dissemination, and Implementation Subcommittee IOM: Institute of Medicine mIUs: milli-international (...) by the GDDI before and after the public comment period. Panel members developed the clinical questions and the data extraction template. The guideline panel defined DMTs as medications that aim to affect the clinical course of MS by decreasing relapses or slowing disease progression or both. The guideline panelists limited the search for relevant literature to medications that have been approved by the US Food and Drug Administration (FDA), Health Canada, or the European Medicines Agency

2018 American Academy of Neurology

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

to thank Erin Lawler, Molly Morgan, and Aqsa Mugal for their contributions to this report.©Institute for Clinical and Economic Review, 2018 Page ii Final Evidence Report – CAR-T Therapies for B-Cell Cancers About ICER The Institute for Clinical and Economic Review (ICER) is an independent non-profit research organization that evaluates medical evidence and convenes public deliberative bodies to help stakeholders interpret and apply evidence to improve patient outcomes and control costs. Through all its (...) or should be assumed to support any part of this report, which is solely the work of the ICER team and its affiliated researchers. For a complete list of stakeholders from whom we requested input, please visit: https://icer-review.org/topic/car-t/. Expert Reviewers Charalambos (Babis) Andreadis, MD, MCSE Associate Professor of Clinical Medicine, Department of Medicine; Director, Clinical Research Support Office University of California, San Francisco (UCSF) Medical Center and UCSF Helen Diller Family

2018 California Technology Assessment Forum

60. Neratinib for the treatment of patients with HER2-positive breast cancer after trastuzumab-based adjuvant therapy. DSD: Horizon Scanning in Oncology 66.

in the neratinib group compared to the placebo group (70 vs. 109 events). The two-year invasive DFS rate was 93.9% (95% CI 92.4–95.2) and 91.6% (95% CI 90.0–93.0) in the neratinib and placebo groups, respectively. At the time of primary analysis the secondary outcome, overall survival (OS), was immature, since the target number of OS events had not been reached. The most common treatment-emergent adverse event (AE) in the neratinib group was diarrhoea: Over 90% of the patients had diarrhoea of any grade (40 (...) Neratinib for the treatment of patients with HER2-positive breast cancer after trastuzumab-based adjuvant therapy. DSD: Horizon Scanning in Oncology 66. Neratinib for the treatment of patients with HER2-positive breast cancer after trastuzumab-based adjuvant therapy - Repository of AIHTA GmbH English | Browse - - - Neratinib for the treatment of patients with HER2-positive breast cancer after trastuzumab-based adjuvant therapy Grössmann, N. and Wolf, S. (2017): Neratinib for the treatment

2017 Austrian Institute of Health Technology Assessment

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