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204 results for

Clinical Index of Stable Febrile Neutropenia

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121. Granulocytopenia (Overview)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

122. Agranulocytosis (Overview)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

123. Lymphoma, Mantle Cell (Overview)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

124. Lymphoma, Mantle Cell (Treatment)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

125. Mesothelioma (Treatment)

was 50%. The most common nonhematologic toxicities included fatigue (20%), constipation (10%), vomiting (10%), and dehydration 10%. Hematologic toxicities included neutropenia (60%) and febrile neutropenia (10%). [ ] Single-agent pemetrexed Single-agent pemetrexed therapy showed a response rate of 10.5%, a median time to progressive disease of 6 months, and a median survival time of 14 months in chemo-naive patients. Of the pretreated patients, the response rate was 12.1% and median time (...) as possible is important to prevent postoperative complications. Pulmonary physiotherapy is very helpful because of the extensive lung resection in patients with malignant pleural mesothelioma. Follow-up Regular follow-up visits with an internist, pulmonary specialist, medical oncologist, and radiation oncologist are recommended. Next: Chemotherapy Currently, cisplatin as a single drug has been used as the standard drug for phase III clinical trials. None of the standard treatment options has improved

2014 eMedicine.com

126. Lymphoma, Mantle Cell (Follow-up)

ibrutinib 560 mg daily plus palbociclib 100 mg days 1-21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3-4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, respectively, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase II (...) be useful for determing clinically indolent MCL; may also help in diagnosis of CCND1-MCL Risk stratification The European Society for Medical Oncology (ESMO) recommends the 2008 MCL International Prognostic Index (MIPI) for risk stratification. [ ] The MIPI includes the following risk factors [ ] : Age: 50-59 (1 point); 60-69 (2 points); ≥70 (3 points) Eastern Cooperative Oncology Group (ECOG) performance status ≥2 (2 points) Lactate dehydrogenase level (ratio to upper limit of normal): 0.67-0.99 (1

2014 eMedicine.com

127. Mesothelioma (Follow-up)

was 50%. The most common nonhematologic toxicities included fatigue (20%), constipation (10%), vomiting (10%), and dehydration 10%. Hematologic toxicities included neutropenia (60%) and febrile neutropenia (10%). [ ] Single-agent pemetrexed Single-agent pemetrexed therapy showed a response rate of 10.5%, a median time to progressive disease of 6 months, and a median survival time of 14 months in chemo-naive patients. Of the pretreated patients, the response rate was 12.1% and median time (...) as possible is important to prevent postoperative complications. Pulmonary physiotherapy is very helpful because of the extensive lung resection in patients with malignant pleural mesothelioma. Follow-up Regular follow-up visits with an internist, pulmonary specialist, medical oncologist, and radiation oncologist are recommended. Next: Chemotherapy Currently, cisplatin as a single drug has been used as the standard drug for phase III clinical trials. None of the standard treatment options has improved

2014 eMedicine.com

128. Agranulocytosis (Diagnosis)

with solid tumors who have undergone mild- to moderate-intensity chemotherapy, who appear to be clinically stable, and who are in close proximity to an appropriate medical facility that can provide 24-hour access, the Clinical Index of Stable Febrile Neutropenia (CISNE) may be used as an additional tool to determine the risk of major complications. [ ] Splenectomy In individuals with neutropenia and Felty syndrome who have recurrent, life-threatening bacterial infections, splenectomy is the treatment (...) in neutropenic patients: effect of augmented gram-positive activity on infectious morbidity. National Cancer Institute of Canada Clinical Trials Group. Ann Intern Med . 1996 Aug 1. 125(3):183-90. . Freifeld A, Marchigiani D, Walsh T, Chanock S, Lewis L, Hiemenz J, et al. A double-blind comparison of empirical oral and intravenous antibiotic therapy for low-risk febrile patients with neutropenia during cancer chemotherapy. N Engl J Med . 1999 Jul 29. 341(5):305-11. . [Guideline] Taplitz RA, Kennedy EB, Bow EJ

2014 eMedicine.com

129. Transplants, Liver (Follow-up)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

130. Shock, Septic (Follow-up)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine Emergency Medicine

131. Transplants, Liver (Diagnosis)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

132. Transplants, Liver (Treatment)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

133. Shock, Septic (Treatment)

source of sepsis,” with daily reevaluation of the anti-infective therapy for potential de-escalation. [ , ] Generally, a 7- to 10-day treatment course is followed. Longer treatment regimens may be warranted in the presence of a slow clinical response, undrainable foci of infection, and immunologic deficiencies (eg, neutropenia). The use of procalcitonin or similar biomarkers may facilitate discontinuance of antibiotics in patients with clinical improvement and no further evidence of infection (...) host responses. Source control is an essential component of sepsis management. Venous access In all cases of septic shock, adequate venous access must be ensured for volume resuscitation. When sepsis is suspected, 2 large-bore (16-gauge) intravenous (IV) lines should be placed if possible to allow administration of aggressive fluid resuscitation and broad-spectrum antibiotics. Central venous access is useful when administering vasopressor agents and in establishing a stable venous infusion site

2014 eMedicine Emergency Medicine

134. Transplants, Liver (Overview)

months, risk of infection is similar to that of the general population. However, a high index of suspicion should always be maintained in transplant recipients. The most common causes of infection in the outpatient setting are the typical community-acquired pathogens, which are treated with the antimicrobials typically prescribed for nonimmunosuppressed patients (with caution regarding drug interactions). Incidence declines after 6-12 months if the recipient is on a stable immunosuppressant regimen (...) is suspected Cultures of blood, urine, pharynx, and/or sputum: Obtain if infection is suspected Imaging studies Chest radiography: Obtain in the presence of fever, cough, dyspnea, or abnormalities on chest examination Abdominal ultrasonography, computed tomography scan, or endoscopic retrograde cholangiopancreatography, as indicated Management of rejection or infection Every clinical complaint by the transplant patient should be taken seriously, and the transplant team should at least know of every

2014 eMedicine Emergency Medicine

135. 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

136. 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

137. 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

138. 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

139. Pixuvri - pixantrone dimaleate

, 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 (...) 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

2012 European Medicines Agency - EPARs

140. 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

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