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While double-blind is a frequently used term in trials discount 10mg prednisone visa, its meaning can vary to include blinding of patients prednisone 5 mg overnight delivery, caregivers purchase prednisone 20mg with mastercard, investigators, or other study staff. Double-dummy: The use of two placebos in a trial that match the active interventions when they vary in appearance or method of administrations (for example, when an oral agent is compared with an injectable agent). Effectiveness: The extent to which a specific intervention used under ordinary circumstances does what it is intended to do. Effectiveness outcomes: Outcomes that are generally important to patients and caregivers, such as quality of life, responder rates, number and length of hospitalizations, and ability to work. Data on effectiveness outcomes usually comes from longer-term studies of a “real-world” population. Effect size/estimate of effect: The amount of change in a condition or symptom because of a treatment (compared to not receiving the treatment). It is commonly expressed as a risk ratio (relative risk), odds ratio, or difference in risk. Efficacy: The extent to which an intervention produces a beneficial result under ideal conditions in a selected and controlled population. DRIs, AIIRAs, and ACE-Is Page 119 of 144 Final Report Drug Effectiveness Review Project Equivalence level: The amount which an outcome from two treatments can differ but still be considered equivalent, as in an equivalence trial, or the amount which an outcome from treatment A can be worse than that of treatment B but still be considered noninferior, as in a noninferiority trial. Equivalence trial: A trial designed to determine whether the response to two or more treatments differs by an amount that is clinically unimportant. This lack of clinical importance is usually demonstrated by showing that the true treatment difference is likely to lie between a lower and an upper equivalence level of clinically acceptable differences. Exclusion criteria: The criteria, or standards, set out before a study or review. Exclusion criteria are used to determine whether a person should participate in a research study or whether an individual study should be excluded in a systematic review. Exclusion criteria may include age, previous treatments, and other medical conditions. External validity: The extent to which results provide a correct basis for generalizations to other circumstances. For instance, a meta-analysis of trials of elderly patients may not be generalizable to children. Fixed-effect model: A model that calculates a pooled estimate using the assumption that all observed variation between studies is due to by chance. Studies are assumed to be measuring the same overall effect. Fixed-dose combination product: A formulation of two or more active ingredients combined in a single dosage form available in certain fixed doses. Forest plot: A graphical representation of the individual results of each study included in a meta- analysis and the combined result of the meta-analysis. The plot allows viewers to see the heterogeneity among the results of the studies. The results of individual studies are shown as squares centered on each study’s point estimate. A horizontal line runs through each square to show each study’s confidence interval—usually, but not always, a 95% confidence interval. The overall estimate from the meta-analysis and its confidence interval are represented as a diamond. The center of the diamond is at the pooled point estimate, and its horizontal tips show the confidence interval. Funnel plot: A graphical display of some measure of study precision plotted against effect size that can be used to investigate whether there is a link between study size and treatment effect. Half- life: The time it takes for the plasma concentration or the amount of drug in the body to be reduced by 50%. Harms: See Adverse Event DRIs, AIIRAs, and ACE-Is Page 120 of 144 Final Report Drug Effectiveness Review Project Hazard ratio: The increased risk with which one group is likely to experience an outcome of interest. For example, if the hazard ratio for death for a treatment is 0. Head-to-head trial: A trial that directly compares one drug in a particular class or group with another in the same class or group. Health outcome: The result of a particular health care practice or intervention, including the ability to function and feelings of well-being. For individuals with chronic conditions – where cure is not always possible – results include health-related quality of life as well as mortality.

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Efficacy of azacitidine of the Severe Aplastic Anemia and Pediatric Diseases Working Parties compared with that of conventional care regimens in the treatment of of the European Group for Blood and Marrow Transplantation cheap prednisone 40 mg amex. Haema- higher-risk myelodysplastic syndromes: a randomised buy 10mg prednisone with mastercard, open-label cheap 5 mg prednisone amex, tologica. Allogeneic hematopoietic cell activating an unrelated donor search for severe acquired aplastic transplantation in patients aged 60-70 years with de novo high-risk anemia. Allogeneic hematopoietic stem cell comparison with patients lacking donors who received azacytidine. Biol transplant for adults over 40 years old with acquired aplastic anemia. Outcome of allogeneic hematopoi- intermediate (int) or high risk myelodysplastic syndrome (MDS) etic cell transplantation from HLA-identical siblings for severe aplastic according to donor availability: a multicenter prospective non interven- anemia in patients over 40 years of age. A decision analysis of allogeneic application of unrelated allo-SCT for severe aplastic anemia. Bone bone marrow transplantation for the myelodysplastic syndromes: de- Marrow Transplant. Comparison between matched related improved outcome. Effect of age on outcome planted into adult patients with acquired aplastic anemia: multivariate of reduced-intensity hematopoietic cell transplantation for older patients and propensity score-matched analysis. Role of reduced-intensity condition- cyclophosphamide vs reduced dose cyclophosphamide plus fludarabine ing allogeneic hematopoietic stem-cell transplantation in older patients for allogeneic hematopoietic cell transplantation in patients with 80 American Society of Hematology aplastic anemia and hypoplastic myelodysplastic syndrome. Alemtuzumab with fludarabine and early results of a cyclophosphamide dose deescalation study show cyclophosphamide reduces chronic graft-versus-host disease after allo- life-threatening adverse events at predefined cyclophosphamide dose geneic stem cell transplantation for acquired aplastic anemia. Mullighan1 1Department of Pathology and Hematological Malignancies Program, St Jude Children’s Research Hospital, Memphis, TN Our understanding of the genetic basis of childhood acute lymphoblastic leukemia (ALL) has been greatly advanced by genomic profiling and sequencing studies. These efforts have characterized the genetic basis of recently described and poorly understood subtypes of ALL, including early T-cell precursor ALL, Philadelphia chromosome–like (Ph-like) ALL, and ALL with intrachromosomal amplification of chromosome 21, and have identified several rational therapeutic targets in high-risk ALL, notably ABL1-class and JAK-STAT inhibitors in Ph–like ALL. Deep sequencing studies are also refining our understanding of the genetic basis of clonal heterogeneity and relapse. These studies have elucidated the nature of clonal evolution during disease progression and identified genetic changes that confer resistance to specific therapeutic agents, including CREBBP and NT5C2. Genomic profiling has also identified common and rare inherited genetic variants that influence the risk of developing leukemia. These efforts are now being extended to ALL in adolescents and adults with the goal of fully defining the genetic landscape of ALL to further improve treatment outcomes in high-risk populations. These studies initially used sequencing, have refined the classification of ALL microarray profiling of structural genetic changes (using single ● To appreciate variation in prevalence of ALL subtypes with nucleotide polymorphism arrays or array-based comparative genomic age hybridization) and gene expression and Sanger sequencing of ● To understand that specific genetic alterations are associated limited numbers of genes. Current studies are using next-generation with treatment failure and are potential targets for therapy sequencing, including exome sequencing, transcriptome sequenc- ● To appreciate the relationship between clonal diversity and ing, and whole genome sequencing, to define the landscape of relapse genetic alterations in ALL comprehensively. Childhood acute lymphoblastic leukemia Acute lymphoblastic leukemia (ALL) is the most common pediatric Genetic subtypes of ALL tumor and, despite event-free survival rates now exceeding 85%, Recurring gross chromosomal changes are a hallmark of ALL, with remains the leading cause of cancer-related death in children and variation in frequency according to age. In childhood B-progenitor young adults due to the often intractable nature of ALL relapse. Ph-like rising incidence of adverse genetic alterations such as BCR-ABL1. ALL is a recently described subtype characterized by a gene Furthermore, there are remarkably few therapies targeted to specific expression profile similar to BCR-ABL1 [Philadelphia chromosome genes or pathways and these are urgently needed in view of the (Ph)–positive] ALL and a diverse range of kinase-activating rear- dose-limiting toxicities of existing combination chemotherapy. T-lineage ALL is characterized by activating mutations of NOTCH1 and rearrange- Over the last decade, there have been extensive efforts to use ments of transcription factors TLX1 (HOX11), TLX3 (HOX11L2), genome-wide profiling of genomic alterations in ALL to: (1) LYL1, TAL1, and MLL. High hyperdiploidy and ETV6-RUNX1 ALL are far less define each ALL subtype; (3) identify the nature of clonal heteroge- common in adults than in children and the prevalence of BCR- neity and how it influences treatment resistance and relapse; (4) ABL1 and Ph-like ALL rise with high-risk features and increasing 174 American Society of Hematology Table 1. Frequency of ALL subtypes according to age Childhood SR Childhood HR Adolescent Young adult N % N % N % N % BCR-ABL1 4 1. It is important to note that much remains to be learned family, IKZF1 (IKAROS), is required for lymphoid development. Even in childhood ALL, Mutation of IKZF1 is observed in 15% of B-ALL cases and is a which has been the most extensively sequenced, at least 11% of hallmark of BCR-ABL1 ALL and Ph-like ALL.

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Risk factors for intracerebral antagonists in the treatment of acute symptomatic venous thromboembo- hemorrhage in the general population: a systematic review order 5mg prednisone overnight delivery. Sidonio order 40 mg prednisone with mastercard, Jr2 1Departments of Medicine and Pathology order 10 mg prednisone visa, Microbiology & Immunology and 2Department of Pediatrics, Hemostasis & Thrombosis Clinic, Vanderbilt University, Nashville, TN VWD is the most common inherited bleeding disorder known. It is caused by a deficiency or dysfunction of the VWF molecule. Bleeding risk varies between modest increases in bleeding seen only with procedures to major risk of spontaneous hemorrhage depending upon the type of VWD. The treatment approach to VWD has changed little in the past 2 decades, but there are numerous subtleties in optimal management. Management includes the prevention or treatment of bleeding by raising endogenous VWF levels with medications such as desmopressin or providing exogenous VWF concentrates. Fibrinolytic inhibitors and topical hemostatic agents are also effective adjunctive measures. Bleeding specific to women presents a special challenge because of heavy menstrual bleeding and pregnancy. Successful management of pregnancy in patients with VWD involves coordination with obstetrics, anesthesia, and the coagulation laboratory monitoring VWF:RCo and FVIII:C levels. Prophylactic treatment with VWF concentrates is emerging as an effective preventive therapy in patients with severe disease. Antibodies to VWF present a special challenge in the management of rare patients with type 3 disease. New therapies on the horizon include recombinant VWF, anti-VWF aptamers, and medications such as IL-11 to raise VWF levels. The key to effective treatment of VWD is an accurate diagnosis of the specific type and selection of hemostatic products appropriate for the clinical situation. These definitions can be arbitrary and responses may not be adequate for all clinical situations. It is important to perform a Introduction trial with a standard DDAVP dose administered intravenously, VWD is an inherited autosomal disorder of deficient (type 1 or 3) or subcutaneously, or intranasally after baseline levels of VWF:Ag, dysfunctional (type 2 variants) VWF. It is characterized primarily VWF:RCo, and FVIII:C are drawn to document the patient’s by mucocutaneous bleeding, excessive hemorrhage after invasive adequate responsiveness before using the drug in a specific bleeding procedures, and, less commonly, by soft tissue hematomas and joint 1 situation. It is important to use the appropriate intranasal preparation bleeding in the more severe types. There are excellent clinical specifically for bleeding disorders with doses of 150 g/spray and guidelines published to facilitate the diagnosis and management of 2 not formulations for enuresis or diabetes insipidus, which are much the various types of VWD. The general approach to management lower and ineffective at releasing adequate VWF. Subsequent of VWD depends upon increasing the circulating concentration of measurements at multiple time points will give the best information functional VWF and/ or using adjunctive therapies to preserve or about immediate response and VWF half-life to screen for variants enhance clot formation. Desmopressin acetate (DDAVP) or estro- 5 that are rapidly metabolized, such as type 1C. Table 1 outlines gens can increase endogenous levels. Patients with type 1C may have an from plasma or synthesized by recombinant technology will raise excellent response shortly after DDAVP administration, but the functional VWF levels. Other therapies that can inhibit fibrinolysis multimers are cleared very rapidly, thus limiting the effectiveness of or enhance local clot formation are also effective adjuncts. Immediate potential complications of DDAVP in- with VWD are more symptomatic than men due to heavy menstrual clude flushing, hypotension/hypertension, gastrointestinal upset, bleeding and childbirth issues. Repeated dosing of this antidiuretic-hormone- benefit from prophylactic treatment with VWF but 5%–15% are mimicking drug can lead to hyponatremia and seizures; therefore, also at risk for inhibitor formation when exposed to VWF most clinical centers limit doses to no more than 2 or 3 consecutive concentrates. Restriction of free water will help prevent symptomatic low sodium levels. At our center, we provide a chart to assist patients Raising VWF levels: increasing endogenous and parents in determining fluid intake amounts (Table 2). Doses are production typically 24 hours apart because more frequent administration can DDAVP lead to tachyphylaxis and hyponatremia. DDAVP is the treatment of Desmopressin (1-desamino-8-D-arginine vasopressin) is a synthetic choice for 70%–80% of patients with VWD, including most type 1 derivative of the human antidiuretic hormone vasopressin. First patients and some patients with type 2A and 2M. When adequate described as a treatment for VWD in 1977,3 DDAVP raises VWF VWF response is proven with a DDAVP trial, it can be used for levels through its action on vasopressin V2 receptors, which prevention and treatment of most bleeding episodes.

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C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating R esults O ndansetronvs O ndansetron O D T vsO T Proportionwith noem esis:55% vs65% (p= 0 generic 20 mg prednisone amex. C h em oth erapy:H ead-to-h ead trials A uth or Y ear Setting H esketh rating A dverse events C om m ents O ndansetronvs O ndansetron Pectasides O D T vsO T 2007 AE sattributedtodrug:9% vs10% (p>0 generic prednisone 40mg without prescription. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o C h ildren F orni ch ildren N R /N R N R /N R /90 N R /0/90 N R N R Inadequate data Y es 2000 N otspecified 5 Jaing ch ildren trusted 40mg prednisone,females 4 wk run-inwith 35/33/33 0/0/33 N R N R N R Y es 2004 antiemetics acc. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination C h ildren F orni Y es,but Y es,but N R U nable to determine Y es N o F air 2000 not not N o N otspecified described described N o 5 N o Jaing N o N o Y es U nable to determine N o Y es Poor 2004 N o M ulticenter N o 3 N o O rch ard Y es,but Y es,but Y es U nable to determine N o Y es F air 1999 not not N o Single C enter described described N o 5 N o C orapcioglu Y es Y es Y es N o U nclear N o Poor 2005 N o 5 N o N o Sepulveda-Vildosola Y es Y es N o N o N R N o F air 2008 N o Single C enter N o 2-5 N o W h ite Y es Y es Y es U nable to determine Y es N o F air 2000 N o M ulticenter N o 4,5 N o Antiemetics Page 140 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o C h ildren F orni Y es N R 2000 N otspecified 5 Jaing Y es Supported inpartby a 2004 grantfrom th e M ulticenter C h ildh ood C ancer 3 F oundationofTaiwan. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o A dults A prepitantvs ondansetron Sch m oll N one N R /N o 5-H T3 R A s 516/N R /489 29/3/484 Y es U nclear Y es Y es 2006 with in48 h ours of N R day 1 >3 G ranisetronvs O ndansetron A bali none N R /N R N R /N R 158 N R /N R /158 N o N o Y es N o 2007 4,5 Barrajon women,alcoh olics, N R /N R N R /N R /136 16/0/120 Y es Y es Y es Y es 2000 priorch emo Single C enter 5 C h iou none N o/N R N R /N R /51 0/0/51 N R N R Y es Y es 2000 Single C enter 4,5 Antiemetics Page 142 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination A dults A prepitantvs ondansetron Sch m oll Y es Y es Y es Y es,2 inaprepitant Y es -modified ITT N o G ood 2006 N o group,1 incontrol = 5 patients N R Y es group excluded from >3 N o analysis. G ranisetronvs O ndansetron A bali N o N o N R N o N o N o Poor 2007 N R 4,5 N R N R Barrajon Y es Y es Y es N o N o Y es F air 2000 N o Single C enter N o 5 N o C h iou N o N o Y es N o Y es N o F air 2000 N o Single C enter N o 4,5 N o Antiemetics Page 143 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o A dults A prepitantvs ondansetron Sch m oll Y es M erck & C o,Inc 2006 N R >3 G ranisetronvs O ndansetron A bali N o N R 2007 4,5 Barrajon Y es N R 2000 Single C enter 5 C h iou Y es Smith K line Beech am 2000 Taiwansupplied Single C enter granisetronforth e 4,5 study. Antiemetics Page 144 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o C h ua none N R /N R 94/89/89 0/0/89 Y es N R N R Y es 2000 Single C enter 5 DelF avero kinetosis N R /N R N R /N R /973 6/1/966 Y es N R Y es Y es 1995 M ulticenter 5 deW it none N o/N R N R /45/40 0/0/40 N R N R Y es Y es 2001 N R 5 F ox-G eiman BM T;TBI N R /N R N R /N R /102 6/0/102 Y es Y es Y es Y es 2001 Single C enter 5 G ebbia none N R /N R N R /N R /182 16/0/166 N R N R Y es Y es 1994a Single C enter 5 Antiemetics Page 145 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination C h ua N o N o Y es U nable to determine N o Y es Poor 2000 N o Single C enter N o 5 N o DelF avero Y es Y es Y es N o N o Y es (7/973) F air 1995 N o M ulticenter N o 5 N o deW it Y es Y es Y es N o N o Y es F air 2001 N o N R N o 5 Y es F ox-G eiman Y es Y es Y es N o U nable to determine N o F air 2001 N o Single C enter N o 5 N o G ebbia N R N R Y es N o N o Y es F air 1994a N o Single C enter N o 5 N o Antiemetics Page 146 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o C h ua Y es N R 2000 Single C enter 5 DelF avero Y es Supported inpartby a 1995 grantfrom th e U mbrian M ulticenter C ancerA ssociation 5 (A. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o G ebbia none N R /N R N R /N R /164 8/0/158 N R N R Y es Y es 1994b Single C enter 3 G ralla corticosteroids N R /N R N R /N R /1054 13/0/1054 N R N R Y es Y es 1998 M ulticenter 5 Antiemetics Page 148 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination G ebbia N R N R Y es N o N o Y es F air 1994b N o Single C enter N o 3 N o G ralla Y es,but Y es,but Y es N o Y es N o F air 1998 not not N o M ulticenter described described N o 5 N o Antiemetics Page 149 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o G ebbia N o U niversity ofPalermo; 1994b Palermo,Italy Single C enter 3 G ralla Y es Smith K line Beech am 1998 Ph armaceuticals M ulticenter 5 Antiemetics Page 150 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o H errington women N o/N R 65/61/61 0/0/61 N R N R unable to Y es 2000 determine M ulticenter (reported for 4 evaluated pts) K alaycio A SC T,women N R /N R 48/48/48 3/45/45 N R N R Y es Y es 1998 N R 5 Jantunen none N o/N o N R /N R /166 34/2/130 Y es Y es N R Y es 1993 M ulticenter 3,4 L eonardi none N R /N R N R /N R /118 3/0/118 N R N R N R Y es 1996 M ulticenter 3,4,5 M antovani none N R /N R N R /N R /117 0/0/117 N R N R Y es Y es 1995 Single C enter 5 Antiemetics Page 151 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination H errington N o N o N o N o N o Y es Poor 2000 N o M ulticenter N o 4 N o K alaycio Y es Y es Y es U nable to determine N o Y es Poor 1998 N o N R N o 5 N o Jantunen N o N o Y es Y es N o Y es Poor 1993 N o 36/166 notevaluated M ulticenter N o 3,4 N o L eonardi N R N R Y es U nable to determine Y es N o Poor 1996 N o M ulticenter Y es 3,4,5 N o M antovani N R Y es,but N o N o Y es N o F air 1995 not Y es Single C enter described N o 5 N o Antiemetics Page 152 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o H errington Y es F unded inpartby 2000 Smith K line Beech am M ulticenter Ph armaceuticals 4 K alaycio Y es N R 1998 N R 5 Jantunen Y es N R 1993 M ulticenter 3,4 L eonardi Y es N R 1996 M ulticenter 3,4,5 M antovani Y es Th e auth ors state th at 1995 no supportforth is Single C enter study came directly 5 from a ph armaceutical company. Antiemetics Page 153 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o M artoni none N R /N R N R /N R /124 0/0/124 N R N R N R Y es 1995 Single C enter 5 M assidda women N R /N R N R /N R /60 N R /N R /60 N R N R Y es Y es 1996b N R 3 N avari women N R /N R N R /N R /994 7/0/987 N R N R Some differences Y es 1995 (N S) M ulticenter 5 N oble none N one/N R N R /N R /359 0/0/359 N R N R Y es Y es 1994 M ulticenter 3 O ge none N R /N R N R /N R /106 0/0/106 N R N R N R Y es 2000 N R 4,5 Park none N o/N R N R /N R /97 2/N R /95 N R N R Y es Y es 1997 Single C enter 5 Antiemetics Page 154 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o M artoni Y es N R 1995 Single C enter 5 M assidda Y es N otstated 1996b N R 3 N avari Y es Two auth ors are 1995 employees of M ulticenter Smith K line Beech am 5 Ph armaceuticals N oble Y es O ne auth oris an 1994 employee atSmith M ulticenter K line Beech am 3 Ph armaceuticals,U K O ge Y es N R 2000 N R 4,5 Park Y es N R 1997 Single C enter 5 Antiemetics Page 156 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o Perez women, Dexameth asone and N R /N R /1085 16/1/1085 N R N R Y es Y es 1998 corticosteroid use meth ylprednisolone M ulticenter was permitted/N R 4 Perez women,breast N o/N R N R /N R /623 //623 Y es N R Y es Y es 1998a cancer M ulticenter 3,4 Poon women,breast N R /N R N R /N R /20 0/0/20 N R N R Y es Y es 1997 cancer Single C enter 4 Antiemetics Page 157 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Perez Y es Y es Y es N o Y es N o F air 1998 N o M ulticenter N o 4 N o Perez Y es Y es Y es U nable to determine N o N o Poor 1998a N o M ulticenter N o 3,4 N o Poon Y es Y es N o N o Y es N o F air 1997 N o Single C enter N o 4 N o Antiemetics Page 158 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o Perez Y es Smith K line Beech am 1998 Ph armaceuticals M ulticenter 4 Perez Y es F unded by Smith K line 1998a Beech am M ulticenter Ph armaceuticals 3,4 Poon Y es N R 1997 Single C enter 4 Antiemetics Page 159 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o R aynov none N R /N R N R /N R /72 0/0/72 N R N R N R Y es 2000 Single C enter 5 R uff none N o/N R N R /N R /N R 1/N R /Various N R N R N R Y es 1994 M ulticenter 5 Slaby A SC T N R /N R N R /N R /45 0/0/45 N R N R Y es Y es 2000 Single C enter 5 Spector none N one/N one N R /N R /371 //371 N R N R Y es Y es 1998 M ulticenter 5 StewartL. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination R aynov N o N o N o U nable to determine U nable to determine U nable to determine Poor 2000 N o Single C enter N o 5 N o R uff Y es Y es N o N o N o U nable to determine Poor 1994 N o M ulticenter N o 5 N o Slaby N R N R N o N o Y es N o F air 2000 N o Single C enter N o 5 N o Spector Y es Y es N o N R Y es N o F air 1998 N o M ulticenter N o 5 N o StewartL. Y es Y es Y es N one N o N o Poor 2000 N o Single C enter N o 5 N o Antiemetics Page 161 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C ontrolled F unding Y ear groupstandard Setting ofcare Type ofC h em o R aynov Y es N R 2000 Single C enter 5 R uff Y es N R ,but4 auth ors are 1994 employed by G laxo. M ulticenter 5 Slaby Y es N R 2000 Single C enter 5 Spector Y es Supported by a grant 1998 from G laxo W ellcome M ulticenter Inc. Y es N R 2000 Single C enter 5 Antiemetics Page 162 of 492 Final Report Update 1 Drug Effectiveness Review Project Evidence Table 2. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or Subpopulation R un-in/W ash out Screened/ W ith drawn/ R andom iz ation A llocation G roups sim ilaratEligibility Y ear Eligible/ L ostto fu/ baseline criteria Setting Enrolled A nalyz ed specified Type ofC h em o Stewart,A. Q uality assessm ents ofch em oth erapy h ead-to-h ead trials A uth or C are Patients A ttrition L oss to follow up Intention-to-treat Postrandom iz ation Q uality rating Y ear provider m asked C rossover analysis exclusions Setting m asked A dh erence Type ofC h em o C ontam ination Stewart,A.

Prednisone
9 of 10 - Review by R. Reto
Votes: 259 votes
Total customer reviews: 259

 

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