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Clinical Index of Stable Febrile Neutropenia

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201. Ezogabine (Potiga)

presentation of Epilepsy related SAEs in the “All Phase II/III Group”, FSU Interval 54 Table 25 Epilepsy related adverse events, all phase II/III 55 Table 26 Neutropenia or Infection Related Adverse Events in More than 2 Patients (Safety Population: All Phase II/III Combined) 58 Table 27 Study RTG113215: Subjects with Hematologic Values of Potential Clinical Importance in Part B 60 Reference ID: 2957637Clinical Review Steven T. Dinsmore NDA 22345 Potiga / ezogabine 7 Table 28 Cardiac Rhythm/Conduction (...) Ezogabine (Potiga) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 022345Orig1s000 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 22-345 Priority or Standard Complete Response (Class 1) NDA resubmission Submit Date(s) April 15, 2011 Received Date(s) April 15, 2011 PDUFA Goal Date June 15, 2011 Division / Office DNP/OND1 Reviewer Name(s) Steven T. Dinsmore, D.O. Review Completion Date June 8, 2011 Established Name Ezogabine (Proposed) Trade Name POTIGA

2011 FDA - Drug Approval Package

202. A trial-based assessment of the cost-utility of bevacizumab and chemotherapy versus chemotherapy alone for advanced non-small cell lung cancer Full Text available with Trip Pro

was undertaken. The trial showed a median two-month survival benefit for bevacizumab. Monetary benefit and utility valuations: Utility estimates were taken from two published reports of utilities for the health states (stable disease on therapy; stable disease off therapy; fever and neutropenia; severe bleeding; and progressive disease) in the model (Doyle, et al. 2008, and Nafees, et al. 2008, see ‘Other Publications of Related Interest’ for bibliographic details). Measure of benefit: The measures (...) , Watkins J. Health state utilities for non-small cell lung cancer. Health and Quality of Life Outcomes 2008;6:84. Indexing Status Subject indexing assigned by NLM MeSH Angiogenesis Inhibitors /economics /therapeutic use; Antibodies, Monoclonal /economics /therapeutic use; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols /economics /therapeutic use; Bevacizumab; Carboplatin /administration & Carcinoma, Non-Small-Cell Lung /drug therapy; Clinical Trials as Topic; Cost

2011 NHS Economic Evaluation Database.

203. Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Treatment (PDQ®): Health Professional Version

transformation to AML. (Refer to the section of this summary for more information.) Juvenile myelomonocytic leukemia (JMML). JMML represents the most common myeloproliferative syndrome observed in young children. JMML occurs at a median age of 1.8 years. JMML characteristically presents with hepatosplenomegaly, lymphadenopathy, fever, and skin rash along with an elevated white blood cell (WBC) count and increased circulating monocytes.[ ] In addition, patients often have an elevated hemoglobin F (...) congenital neutropenia (Kostmann syndrome). - Shwachman-Diamond syndrome. - Diamond-Blackfan anemia. - Congenital amegakaryocytic thrombocytopenia. - CBL germline syndrome (particularly in JMML). - Li-Fraumeni syndrome ( TP53 mutations). Acquired syndromes Severe aplastic anemia. Paroxysmal nocturnal hemoglobinuria. Amegakaryocytic thrombocytopenia. Acquired monosomy 7. Familial MDS and AML syndromes Familial platelet disorder with a propensity to develop AML (associated with germline RUNX1 mutations

2015 PDQ - NCI's Comprehensive Cancer Database

204. Nutrition in Cancer Care (PDQ®): Health Professional Version

and metabolic) that precede substantial weight loss. Cachexia: the presence of significant weight loss or sarcopenia in the absence of simple starvation. - Weight loss >5% over the past 6 months; or - Body mass index <20 and degree of weight loss >2%; or - Sarcopenia and any degree of weight loss >2%. Refractory cachexia: cachexia that is clinically refractory, usually associated with advanced-stage cancer or rapid progression of disease that is unresponsive to treatment. Although anorexia may also (...) N, Bergerson S, et al., eds.: Oncology Nutrition for Clinical Practice. Chicago, Ill: Oncology Nutrition Dietetic Practice Group, 2013, pp 25-32. Wojtaszek CA, Kochis LM, Cunningham RS: Nutrition impact symptoms in the oncology patient. Oncology Issues 17 (2): 15-7, 2002. Martin L, Birdsell L, Macdonald N, et al.: Cancer cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol 31 (12): 1539-47, 2013. [ ] Huhmann MB

2015 PDQ - NCI's Comprehensive Cancer Database

205. Hepatitis C

or body piercings; needlestick injuries; vertical or sexual transmission; and travel to countries where hepatitis C is endemic. About 25–50% of people will spontaneously clear the virus without treatment, and about 50–80% will develop chronic hepatitis C infection. Complications of chronic hepatitis C infection include cirrhosis, HCC, decompensated end-stage liver disease, and death. Testing for hepatitis C should be considered in people with: Clinical features of possible hepatitis, including non (...) American and Hispanic people have lower sustained viral response rates with antiviral treatments than white and Asian people. Co-infection with HIV, hepatitis A, and/or hepatitis B. Body mass index greater than 25 kg/m 2 — associated with an increased risk of hepatic steatosis, which may lead to more severe fibrosis. Smoking — an independent risk factor for hepatitis and fibrosis. [ ; ; ; ; ; ] Causes Causes Hepatitis C virus is a blood-borne RNA virus of the family Flaviviridae and genus Hepacivirus

2016 NICE Clinical Knowledge Summaries

206. Orencia (abatacept (genetical recombination))

to ensure proper use of the product. 2. Conduct a large-scale post-marketing surveillance to thoroughly evaluate the safety of the product and to investigate the safety of long-term treatment with the product and the occurrences of infection, etc. 3. In order to confirm the efficacy (including the preventive effect on the progression of joint destruction) and safety of the product, conduct a double-blind comparative post-marketing clinical study using an appropriate control group. *Japanese Accepted (...) with rheumatoid arthritis has been demonstrated and its safety is acceptable in view of its observed benefits. Serious adverse drug reactions such as infection have been reported to be associated with the product. It is therefore necessary to carefully assess the risks and benefits upon thorough observation of the patient’s symptoms, etc., to fully inform the patient of the risks of the product, and to carefully monitor the clinical course of the patient after administration. After market launch

2010 Pharmaceuticals and Medical Devices Agency, Japan

207. Coronary Artery Bypass Graft Surgery: Guideline For

e133 2.1.6. Anastomotic Techniques e133 2.1.7. Intraoperative TEE: Recommendations e133 2.1.8. Preconditioning/Management of Myocardial Ischemia: Recommendations e135 2.2. Clinical Subsets e136 2.2.1. CABG in Patients With Acute MI: Recommendations e136 2.2.2. Life-Threatening Ventricular Arrhythmias: Recommendations e137 2.2.3. Emergency CABG After Failed PCI: Recommendations e138 2.2.4. CABG in Association With Other Cardiac Procedures: Recommendations e138 3. CAD Revascularization e139 3.1 (...) Comparing PCI Versus CABG for Left Main CAD e145 3.7.3. Revascularization Considerations for Left Main CAD e145 3.8. Proximal LAD Artery Disease e146 3.9. Clinical Factors That May In?uence the Choice of Revascularization e146 3.9.1. Diabetes Mellitus e146 3.9.2. Chronic Kidney Disease e146 3.9.3. Completeness of Revascularization e147 3.9.4. LV Systolic Dysfunction e147 3.9.5. Previous CABG e147 3.9.6. Unstable Angina/NonST-Elevation Myocardial Infarction e147 3.9.7. DAPT Compliance and Stent

2011 American College of Cardiology

208. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

.e661 2.1.6. Anastomotic Techniques .e662 2.1.7. Intraoperative TEE: Recommendations .e662 2.1.8. Preconditioning/Management of Myocardial Ischemia: Recommendations .e663 2.2. Clinical Subsets .e664 2.2.1. CABG in Patients With Acute MI: Recommendations .e664 2.2.2. Life-Threatening Ventricular Arrhythmias: Recommendations .e666 2.2.3. Emergency CABG After Failed PCI: Recommendations .e666 2.2.4. CABG in Association With Other Cardiac Procedures: Recommendations .e667 3. CAD Revascularization .e667 (...) 3.7.2. Studies Comparing PCI Versus CABG for Left Main CAD .e673 3.7.3. Revascularization Considerations for Left Main CAD .e674 3.8. Proximal LAD Artery Disease .e674 3.9. Clinical Factors That May Influence the Choice of Revascularization .e674 3.9.1. Diabetes Mellitus .e674 3.9.2. Chronic Kidney Disease .e675 3.9.3. Completeness of Revascularization .e675 3.9.4. LV Systolic Dysfunction .e675 3.9.5. Previous CABG .e675 3.9.6. Unstable Angina/Non–ST-Elevation Myocardial Infarction .e676 3.9.7. DAPT

2011 American Heart Association

209. Management of mature T-cell and and NK-cell neoplasms

clinical behaviour and poor prognosis. Excluding anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) and indolent MF, which have a good outcome (Gascoyne et al, 1999), 5 year survival for other nodal and extranodal T-cell lymphomas is about 30%. Most patients present with unfavourable international prognostic index (IPI) scores (>3) and poor performance status (PS). The similarity between progression free survival (PFS) and overall survival (OS) is an indication of the poor (...) , London 4 Kings College Hospital, London 5 Royal Free Hospital, London 6 St Johns Institute of Dermatology, London 7 Nottingham University Hospital NHS Trust, Nottingham BCSH Guidelines for the Management of Mature T-cell and NK-cell Neoplasms: Excluding cutaneous T-cell Lymphoma Updated August 2013 Page 2 of 99 Introduction The mature or peripheral T-cell neoplasms are a biologically and clinically heterogeneous group of rare disorders that result from clonal proliferation of mature post-thymic

2011 British Committee for Standards in Haematology

210. Buprenorphine Transdermal System (Butrans)

that the total daily doses did not exceed 2 grams for acetaminophen or 800 mg for ibuprofen. Medications such as aspirin and other non-steroidal anti-inflammatory drugs were to have been permitted only for conditions other than chronic pain (e.g., headache, fever, and cardiovascular Clinical Review by Robert Levin, M.D. NDA 21-306 BuTrans TM (Buprenorphine Transdermal System) 43 disease prophylaxis). If treatment with such drugs occurred the dose, frequency, and reason for ingestion was to have been recorded (...) Corticosteroids were to have been allowed if stable for at least 6 weeks prior to the screening visit. Glucosamine and/or chondroitin sulfate were to have been allowed if the dose was stable for at least 2 months prior to the study entry and is continued at the same dose for the duration of the study. Clinical Review by Robert Levin, M.D. NDA 21-306 BuTrans TM (Buprenorphine Transdermal System) 70 Ancillary Therapy: Ongoing transcutaneous electrical nerve stimulation (TENS), biofeedback, physical therapy

2010 FDA - Drug Approval Package

211. LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies

dose not to exceed 1200 mg/week. topotecan: orally, for first 5 days of each 21-day cycle. Maximum dose not to exceed 2.3 mg/m2 per day. Pegylated GCSF (PEG-GCSF) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting. Dose Expansion: 24 additional patients will be treated at the MTD in 2 (...) . pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting. Other Name: pegfilgrastim Outcome Measures Go to Primary Outcome Measures : The incidence of dose-limiting toxicities (DLTs) as a measure of safety and tolerability [ Time Frame: 21 days (one cycle) ] The maximum tolerated dose

2016 Clinical Trials

212. A Study Of The Safety And Effects Of One Or More Doses Of HSP-130 Injected Under The Skin In Women With Breast Cancer That Has Not Spread To Distant Sites In The Body.

the Effect Curve for Absolute Neutrophil Count From Time of Dose Administration to Time Infinity (AUEC_ANC Inf): Cycle 1 and Cycle 4 [ Time Frame: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose ] Absolute neutrophil count (ANC) is a measure of the number of neutrophil granulocytes (also known as polymorphonuclear cells, PMN's, polys, granulocytes, segmented neutrophils or segs) present in the blood. Incidence of Febrile Neutropenia: Cycle 1 and Cycle 4 [ Time Frame: Cycle (...) 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240 and 312 hours post-dose ] Febrile Neutropenia was defined as tympanic or axillary body temperature greater than (>) 38.5 °C for >1 hour and ANC less than (<) 1.0 *10^9/L. Incidence of Severe Neutropenia: Cycle 1 and Cycle 4 [ Time Frame: Cycle 1 and 4: Predose (0 hour), 48, 96, 144, 192, 240, and 312 hours post-dose ] Severe Neutropenia was defined as grade 4 neutropenia in which the ANC was < 0.5 x10^9/L. Time to ANC Recovery: Cycle 1 and Cycle 4

2016 Clinical Trials

213. Axitinib in R/M Salivary Gland Cancers of the Upper Aerodigestive Tract

or within 4 weeks of study entry. Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 2 weeks of start of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may not be substituted (...) with Inlyta®. These results prompted a phase II study to test the activity of axitinib in relapsed and/or metastatic and progressive ACC patients. Results were 9% of partial responses and 75% of stable disease as best overall response. Inlyta®, a potent VEGFR specific-inhibitor, has been approved by FDA as second line treatment for renal cancer. Based on preclinical and clinical data, we believe that targeting VEGFR might represent a rational basis to further test Inlyta® in patients with relapsed

2016 Clinical Trials

214. Lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinomas of the Salivary Glands: ACC-LEN14

entry. Previous therapy with lenvatinib (E7080) Radiotherapy during study or within 3 weeks of start of study drug. (Palliative radiotherapy will be allowed) Major surgery within 2 weeks of start of study Use of biologic response modifiers, such as G-CSF, within 3 week of study entry [G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator, however they may (...) in these parameters exists) Previous systemic therapy for metastatic disease is allowed for a maximum of 1 previous line of chemotherapy and/or 1 previous line of TKI Signed written informed consent Exclusion Criteria: Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study entry Subjects having > 1+ proteinuria on urine dipstick

2016 Clinical Trials

215. Irinotecan or oxaliplatin combined with 5-fluorouracil and leucovorin as first-line therapy for advanced colorectal cancer: a meta-analysis

and leucovorin versus oxaliplatin combined with fluorouracil and leucovorin as first-line treatment for advanced or metastatic colorectal cancer were eligible for inclusion. Trials not analysed on intervention-to-treat basis were excluded. Outcome measures were clinical efficacy (complete and partial response, stable and progressive disease, response rate, time to progression, duration of response, overall survival) and adverse effects (grade 3 or 4 toxicities according to the National Cancer Institute (...) ; seven RCTs); diarrhoea (RR 1.71, 95% CI 1.34 to 2.18; seven RCTs); and alopecia (RR 14.56, 95% CI 4.11 to 51.66; n=791 patients; two RCTs). No differences between groups were found in the incidence of mucositis and febrile neutropenia. However, the incidence of neurotoxicity (RR 0.06, 95% CI 0.03 to 0.14; n=2,095; seven RCTs), neutropenia (RR 0.70, 95% CI 0.55 to 0.91; seven RCTs) and thrombocytopenia (RR 0.18, 95% CI 0.05 to 0.61; n=1,151; four RCTs) were lower in the irinotecan group compared

2010 DARE.

216. Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours

with metastatic pancreatic adenocarcinoma compared to gemcitabine alone (median of 11.1 months versus 6.8 months, HR = 0.57 [0.45 - 0.73] p < 0.0001). The response rate and progression-free survival (PFS) have also been improved with these triple therapies; the response rates were 31.6% versus 9.4% p < 0.001 and the median PFS 6.4 months versus 3.3 months p < 0.001, respectively. The adverse events observed with the triple therapy occurred more frequently, for febrile neutropaenia (5.4%), with the need (...) . Safety and Efficacy of Modified Folfirinox Versus Gemcis in Bile Duct Tumours (AMEBICA) 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: NCT02591030 Recruitment Status : Recruiting First Posted : October 29, 2015 Last Update

2015 Clinical Trials

217. Safety, Tolerability and Pharmacokinetics of AZD1775 Plus MEDI4736 in Patients With Advanced Solid Tumours

Limiting Toxicities (DLTs) [ Time Frame: Up to 28 Days ] DLTs are defined as: Grade 4 haematologic toxicity for ≥7 days, including infection with febrile neutropenia, or Grade 4 thrombocytopenia. Grade 3 thrombocytopenia associated with Grade ≥2 bleeding. Non-haematologic toxicity ≥Grade 3. Grade 3 nausea, vomiting, or diarrhoea that does not respond within 48 hours. Grade 4 nausea, vomiting, and diarrhoea. ALT or AST ≥5 x but ≤8 x ULN that does not resolve to Grade 2 within 5 days. ALT or AST >8 x ULN (...) appropriate. The first day of Cycle 1 in Schedules B, C, and D will be preceded by a lead-in period of AZD1775 monotherapy to enable serial sampling for assessment of pharmacokinetic parameters. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 56 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I Study Assessing the Safety

2015 Clinical Trials

218. Pain

40 years. Ann Oncol 18 (9): 1437-49, 2007. Green CR, Hart-Johnson T: Cancer pain: an age-based analysis. Pain Med 11 (10): 1525-36, 2010. Gutgsell T, Walsh D, Zhukovsky DS, et al.: A prospective study of the pathophysiology and clinical characteristics of pain in a palliative medicine population. Am J Hosp Palliat Care 20 (2): 140-8, 2003 Mar-Apr. Caraceni A, Portenoy RK: An international survey of cancer pain characteristics and syndromes. IASP Task Force on Cancer Pain. International (...) Association for the Study of Pain. Pain 82 (3): 263-74, 1999. Barbera L, Molloy S, Earle CC: Frequency of non-cancer-related pain in patients with cancer. J Clin Oncol 31 (22): 2837, 2013. Childers JW, King LA, Arnold RM: Chronic Pain and Risk Factors for Opioid Misuse in a Palliative Care Clinic. Am J Hosp Palliat Care 32 (6): 654-9, 2015. Massaccesi M, Deodato F, Caravatta L, et al.: Incidence and management of noncancer pain in cancer patients referred to a radiotherapy center. Clin J Pain 29 (11): 944

2012 PDQ - NCI's Comprehensive Cancer Database

219. Nutrition in Cancer Care

support and leads to progressive functional impairment.”[ ] They classified three stages of cachexia and provided diagnostic criteria: Precachexia: early signs (clinical and metabolic) that precede substantial weight loss. Cachexia: the presence of significant weight loss or sarcopenia in the absence of simple starvation. Weight loss >5% over the past 6 months; or Body mass index <20 and degree of weight loss >2%; or Sarcopenia and any degree of weight loss >2%. Refractory cachexia: cachexia (...) cachexia in the age of obesity: skeletal muscle depletion is a powerful prognostic factor, independent of body mass index. J Clin Oncol 31 (12): 1539-47, 2013. Huhmann MB: Nutrition management of the surgical oncology patient. In: Leser M, Ledesma N, Bergerson S, et al., eds.: Oncology Nutrition for Clinical Practice. Chicago, Ill: Oncology Nutrition Dietetic Practice Group, 2013, pp 135-42. August DA, Huhmann M: Nutrition support of the cancer patient. In: Ross AC, Caballero B, Cousins RJ, et al., eds

2012 PDQ - NCI's Comprehensive Cancer Database

220. Myeloid Leukemia, Childhood Acute/Other Childhood Myeloid Malignancies

with hepatosplenomegaly, lymphadenopathy, fever, and skin rash along with an elevated white blood cell (WBC) count and increased circulating monocytes.[ ] In addition, patients often have an elevated hemoglobin F, hypersensitivity of the leukemic cells to granulocyte-macrophage colony-stimulating factor (GM-CSF), monosomy 7, and leukemia cell mutations in a gene involved in RAS pathway signaling (e.g., NF1 , KRAS/NRAS , PTPN11 , or CBL ).[ - ] (Refer to the section of this summary for more information.) Chronic (...) congenita. Bloom syndrome. Syndromes of growth and cell survival signaling pathway defects: Neurofibromatosis type 1 (particularly JMML development). Noonan syndrome (particularly JMML development). Severe congenital neutropenia (Kostmann syndrome). Shwachman-Diamond syndrome. Diamond-Blackfan anemia. Congenital amegakaryocytic thrombocytopenia. CBL germline syndrome (particularly in JMML). Li-Fraumeni syndrome ( TP53 mutations). Acquired syndromes Severe aplastic anemia. Paroxysmal nocturnal

2012 PDQ - NCI's Comprehensive Cancer Database

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