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Clinical Index of Stable Febrile Neutropenia

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181. Investigation and management of Chronic Lymphocytic Leukaemia

finding on a routine full blood count. Clinical evaluation should elicit a family history of lymphoid malignancy, define the clinical stage (Table ) and determine whether B symptoms (fever, weight loss, night sweats), profound lethargy and cytopenias are CLL‐related, due to marrow infiltration, immune destruction or hypersplenism, or have an alternative cause. Table 2. Staging systems in CLL BINET Stage Features A <3 Lymphoid areas a The five lymphoid areas comprise: uni or bilateral cervical (...) the previous 6 months; Significant fatigue (i.e., Eastern Cooperative Oncology Group Performance Score 2 or worse; inability to work or perform usual activities); Fever higher than 38·0°C for two or more weeks without other evidence of infection; or Night sweats for more than 1 month without evidence of infection. Factors influencing the choice and duration of treatment The clinical heterogeneity of CLL and advanced age of many patients dictate that no single treatment approach is applicable to all

2012 British Committee for Standards in Haematology

182. FOLFIRINOX in Metastatic High Grade Gastroenteropancreatic Neuroendocrine Carcinomas

: Granulocyte colony-stimulating factor (G-CSF) The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment. Other Names: Filgrastim Cytokine Outcome Measures Go to Primary Outcome Measures : Objective Radiographic Response Rate (ORR) [ Time Frame: Up to 36 months ] The primary efficacy endpoint is objective response rate as determined (...) participants equally into two cohorts (first-line versus beyond first-line). Condition or disease Intervention/treatment Phase Gastro-enteropancreatic Neuroendocrine Tumor Pancreatic Cancer Neuroendocrine Carcinomas of Pancreas Islet Cell Carcinoma Drug: FOLFIRINOX Drug: Granulocyte colony-stimulating factor (G-CSF) Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 2 participants Intervention Model: Single Group Assignment Masking

2017 Clinical Trials

183. Breast Cancer Treatment (PDQ®): Health Professional Version

).[ ] Aromatase inhibitors or inactivators.[ , ] Risk-reducing mastectomy.[ ] Risk-reducing oophorectomy or ovarian ablation.[ - ] (Refer to the PDQ summary on for more information about factors that decrease the risk of breast cancer.) Screening Clinical trials have established that screening asymptomatic women using mammography, with or without clinical breast examination, decreases breast cancer mortality. (Refer to the PDQ summary on for more information.) Diagnosis Patient evaluation When breast cancer (...) is suspected, patient management generally includes the following: Confirmation of the diagnosis. Evaluation of the stage of disease. Selection of therapy. The following tests and procedures are used to diagnose breast cancer: Mammography. Ultrasound. Breast magnetic resonance imaging (MRI), if clinically indicated. Biopsy. Contralateral disease Pathologically, breast cancer can be a multicentric and bilateral disease. Bilateral disease is somewhat more common in patients with infiltrating lobular

2016 PDQ - NCI's Comprehensive Cancer Database

184. Melanoma Treatment (PDQ®): Health Professional Version

as the source cell for melanoma. The relatively avascular epidermis houses both basal cell keratinocytes and squamous epithelial keratinocytes, the source cells for basal cell carcinoma and squamous cell carcinoma, respectively. The separation between epidermis and dermis occurs at the basement membrane zone, located just inferior to the basal cell keratinocytes. Screening Refer to the PDQ summary on for more information. Clinical Features Melanoma occurs predominantly in adults, and more than 50 (...) of primary and metastatic tumors. The most important prognostic factors have been incorporated into the revised 2009 American Joint Committee on Cancer staging and include the following:[ , - ] Thickness and/or level of invasion of the melanoma. Mitotic index, defined as mitoses per millimeter. Ulceration or bleeding at the primary site. Number of regional lymph nodes involved, with distinction of macrometastasis and micrometastasis. Systemic metastasis. - Site—nonvisceral versus lung versus all other

2016 PDQ - NCI's Comprehensive Cancer Database

185. Gastric Cancer Treatment (PDQ®): Health Professional Version

reduction 32%). The median OS was significantly longer for patients who received DCF compared with patients who received CF (9.2 months; 95% CI, 8.4–10.6; vs. 8.6 months; 95% CI, 7.2–9.5; HR, 1.29; 95% CI, 1.0–1.6; log-rank P = .02; risk reduction = 23%).[ ][ ] There were high toxicity rates in both arms.[ ] Febrile neutropenia was more common in patients who received DCF (29% vs. 12%), and the death rate on the study was 10.4% for patients on the DCF arm and 9.4% for patients on the CF arm. Whether (...) the CF regimen should be considered as an index regimen for the treatment of patients with metastatic gastric cancer is the subject of debate.[ ] The results of a study that randomly assigned 245 patients with metastatic gastric cancer to receive CF, FAMTX, or ELF demonstrated no significant difference in response rate, progression-free survival, or OS between the arms.[ ] Grades 3 and 4 neutropenia occurred in 35% to 43% of patients on all arms, but severe nausea and vomiting was more common

2016 PDQ - NCI's Comprehensive Cancer Database

186. Ovarian Epithelial Cancer Treatment (PDQ®): Health Professional Version

, such as loss or inactivation of the tumor-suppressor p53 and BRCA1 or BRCA2 proteins.[ ] Therefore, high-grade serous adenocarcinomas arising from the fallopian tube and elsewhere in the peritoneal cavity, together with most ovarian epithelial cancers, represent extrauterine adenocarcinomas of Müllerian epithelial origin and are staged and treated similarly to ovarian cancer. Since 2000, FTC and PPC have usually been included in ovarian cancer clinical trials.[ ] Clear cell and endometrioid ovarian cancers (...) the following: Family history of ovarian cancer.[ - ] - A first-degree relative (e.g., mother, daughter, or sister) with the disease. Inherited risk.[ ] - BRCA1 or BRCA2 gene mutations.[ , ] Other hereditary conditions such as hereditary nonpolyposis colorectal cancer (HNPCC; also called Lynch syndrome).[ , ] Endometriosis.[ - ] Hormone therapy.[ , ] - Postmenopausal hormone replacement therapy. Obesity.[ - ] - High body mass index. Tall Height. [ - ] Family history and genetic alterations The most

2016 PDQ - NCI's Comprehensive Cancer Database

187. Adult Hodgkin Lymphoma Treatment (PDQ®): Health Professional Version

areas. Presence of . Early favorable group: Clinical stage I or II without any of the adverse prognostic factors listed above. Early unfavorable group: Clinical stage I or II with one or more of the adverse prognostic factors listed above. Advanced-stage adverse prognostic factors: For patients with advanced-stage HL, the International Prognostic Factors Project on Advanced Hodgkin's Disease developed the International Prognostic Index with a score that is based on the following seven adverse (...) with mediastinal lymphomas: the International Lymphoma Radiation Oncology Group guidelines. Blood 132 (16): 1635-1646, 2018. [ ] [ ] Early Favorable Classic HL Treatment Patients are designated as having early favorable classic Hodgkin lymphoma (HL) when they have clinical stage I or stage II disease and none of the following adverse prognostic factors: B symptoms (unexplained fever ≥38°C, soaking night sweats, unexplained weight loss ≥10% within 6 months). Extranodal disease. Bulky disease (≥10 cm or >33

2016 PDQ - NCI's Comprehensive Cancer Database

188. Langerhans Cell Histiocytosis Treatment (PDQ®): Health Professional Version

.[ ] Lack of childhood vaccinations.[ ] Efforts to define a viral cause have not been successful.[ , ] One study has shown that 1% of patients have a positive family history for LCH.[ ] Clinical Presentation LCH most commonly presents with a painful bone lesion, with skin being the second most commonly involved organ. Systemic symptoms of fever, weight loss, diarrhea, edema, dyspnea, polydipsia, and polyuria relate to specific organ involvement and or disease presentation, as noted below. Specific (...) remains about whether it is a malignant neoplasm with varying clinical behavior. The same BRAF V600E mutation has been found in other cancers, including malignant melanoma; however, V600E-mutated BRAF is also present in benign nevi, possibly indicating the need for additional mutations to render the cell malignant.[ ] Nevertheless, these findings have raised the possibility of targeted therapy with inhibitors already used in the treatment of melanoma. Several trials of BRAF inhibitors are open

2016 PDQ - NCI's Comprehensive Cancer Database

189. Chronic Lymphocytic Leukemia Treatment (PDQ®): Health Professional Version

patients. Large granular lymphocyte (LGL) leukemia is characterized by lymphocytosis with a natural killer cell immunophenotype (CD2, CD16, and CD56) or a T-cell immunophenotype (CD2, CD3, and CD8).[ - ] These patients often have neutropenia and a history of rheumatoid arthritis. The natural history is indolent, often marked by anemia and splenomegaly. This condition appears to fit into the clinical spectrum of Felty syndrome.[ ] A characteristic genetic finding in almost 50% of the patients with T (...) -cell LGL involves mutations in the STAT3 gene .[ ] Therapy includes low doses of oral cyclophosphamide or methotrexate, cyclosporine, and treatment of the bacterial infections acquired during severe neutropenia.[ , , , ] Prognostic Factors Prognostic markers help stratify patients in clinical trials, assess the need for therapy, and select the type of therapy.[ , , ] Prognostic factors that may help predict clinical outcome include cytogenetic subgroup, immunoglobulin mutational status, and CD38

2016 PDQ - NCI's Comprehensive Cancer Database

190. Langerhans Cell Histiocytosis Treatment (PDQ®): Health Professional Version

for LCH.[ ] Clinical Presentation LCH most commonly presents with a painful bone lesion, with skin being the second most commonly involved organ. Systemic symptoms of fever, weight loss, diarrhea, edema, dyspnea, polydipsia, and polyuria relate to specific organ involvement and or disease presentation, as noted below. Specific organs are considered high risk or low risk when involved with disease presentation. Risk refers to the risk of mortality in high-risk patients. Chronic recurrent involvement (...) remains about whether it is a malignant neoplasm with varying clinical behavior. The same BRAF V600E mutation has been found in other cancers, including malignant melanoma; however, V600E-mutated BRAF is also present in benign nevi, possibly indicating the need for additional mutations to render the cell malignant.[ ] Nevertheless, these findings have raised the possibility of targeted therapy with inhibitors already used in the treatment of melanoma. Several trials of BRAF inhibitors are open

2016 PDQ - NCI's Comprehensive Cancer Database

191. Pain (PDQ®): Health Professional Version

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): 944-7, 2013. [ ] Kim N, Matzon JL, Abboudi J, et al.: A Prospective Evaluation of Opioid Utilization After Upper-Extremity Surgical Procedures: Identifying Consumption Patterns and Determining Prescribing

2016 PDQ - NCI's Comprehensive Cancer Database

192. Oral Complications of Chemotherapy and Head/Neck Radiation (PDQ®): Health Professional Version

Therapies: Oral Care Study Group Systematic Reviews, MASCC/ISOO Complication Reference Citation Weighted Prevalence Bisphosphonate osteonecrosis [ ] 6.1% for all studies (mean) Studies with documented follow-up = 13.3% Studies with undocumented follow-up = 0.7% Epidemiological studies = 1.2% Dysgeusia [ ] CT only = 56.3% (mean) RT only = 66.5% (mean) Combined CT and RT = 76% (mean) Oral fungal infection [ ] Of clinical oral fungal infection (all oral candidiasis): Pretreatment = 7.5% During treatment (...) = 39.1% Posttreatment = 32.6% Of oral candidiasis clinical infection by cancer treatment: During HNC RT = 37.4% During CT = 38% Oral viral infection [ ] In patients treated with CT for hematologic malignancies: Patients with oral ulcerations/sampling oral ulcerations = 49.8% Patients sampling oral ulcerations = 33.8% Patients sampling independently of the presence of oral ulcerations = 0% In patients treated with RT: Patients with RT only/sampling oral ulcerations = 0% Patients with RT and adjunctive

2016 PDQ - NCI's Comprehensive Cancer Database

193. Votubia - everolimus

on the chemical, pharmaceutical and biological aspects 20 2.2.6. Recommendations for future quality development 20 2.3. Non-clinical aspects 20 2.3.1. Introduction 20 2.3.2. Pharmacology 21 2.3.3. Pharmacokinetics 25 2.3.4. Toxicology 29 2.3.5. Ecotoxicity/environmental risk assessment 40 2.3.6. Discussion on non-clinical aspects 41 2.3.7. Conclusion on the non-clinical aspects 43 2.4. Clinical aspects 43 2.4.1. Introduction 43 2.4.2. Pharmacokinetics 45 2.4.3. Pharmacodynamics 49 2.4.4. Discussion (...) on clinical pharmacology 51 2.4.5. Conclusions on clinical pharmacology 53 2.5. Clinical efficacy 53 2.5.1. Dose response study(ies) 53 2.5.2. Main study 53 2.5.3. Discussion on clinical efficacy 75 2.5.4. Conclusions on the clinical efficacy 76 2.6. Clinical safety 77 2.6.1. Discussion on clinical safety 84 2.6.2. Conclusions on clinical safety 89 2.7. Pharmacovigilance 89 2.8. User consultation 98 3. Benefit-Risk Balance 99 4. Recommendations 103 Votubia CHMP assessment report EMA/646111/2011 Rev10.10

2011 European Medicines Agency - EPARs

194. Victrelis - boceprevir

assessment report Rev10.10 Page 4/117 Medicinal product no longer authorised List of abbreviations AE adverse event ALT alanine transaminase ANC absolute neutrophil count aPTT Activated Partial Thromboplastin Time AUC area under the concentration-time curve BMI body mass index BND benzphetamine N-demethylase CHC chronic hepatitis C CHMP Committee for Medicinal Products for Human Use CI confidence interval CL/F apparent clearance C max maximum drug concentration CSR clinical study report CV coefficient (...) Substance 7 2.2.3. Finished Medicinal Product 9 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 11 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 11 2.3. Non-clinical aspects 11 2.3.1. Introduction 11 2.3.2. Pharmacology 11 2.3.3. Pharmacokinetics 15 2.3.4. Toxicology 17 2.3.5. Ecotoxicity/environmental risk assessment 19 2.3.6. Discussion on non-clinical aspects 20 2.3.7. Conclusion on the non-clinical aspects 23 2.4. Clinical aspects 24 2.4.1. 25 2.4.2

2011 European Medicines Agency - EPARs

195. Yervoy - ipilimumab

Table of contents 1. Background information on the procedure 6 1.1. Submission of the dossier 6 1.2. Steps taken for the assessment of the product 7 2. Scientific discussion 8 2.1. Introduction 8 2.2. Quality aspects 9 2.3. Non-clinical aspects 15 2.4. Clinical aspects 25 2.5. Clinical efficacy 31 2.6. Clinical safety 50 2.7. Pharmacovigilance 61 2.8. Benefit-Risk Balance 68 2.9. Recommendation 71 CHMP assessment report EMA/CHMP/557664/2011 Page 2/71 List of abbreviations ADCC antibody-dependent (...) concentration Cmin trough concentration Cminss trough concentration at steady state CNS central nervous system CPP critical process parameters CR complete response CSR clinical study report CTLA-4 cytotoxic T lymphocyte antigen 4 CV coefficient of variation DCR disease control rate DTIC dacarbazine ECOG Eastern Cooperative Oncology Group ELISA enzyme linked immunosorbent assay EU European Union GCP good clinical practice GFR glomerular filtration rate GI gastrointestinal GLP good laboratory practice HA

2011 European Medicines Agency - EPARs

196. Dificlir - fidaxomicin

, and pharmaceutical aspects 11 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 11 2.2.6. Recommendations for future quality development 12 2.3. Non-clinical aspects 12 2.3.1. Introduction 12 2.3.2. Pharmacology 12 2.3.3. Pharmacokinetics 14 2.3.4. Toxicology 15 2.3.5. Ecotoxicity/environmental risk assessment 23 2.3.6. Discussion on non-clinical aspects 23 2.3.7. Assessment of paediatric data on non-clinical aspects 24 2.3.8. Conclusion on the non-clinical aspects 24 2.4. Clinical (...) aspects 24 2.4.1. Introduction 24 2.4.2. Pharmacokinetics 25 2.4.3. Pharmacodynamics 32 2.4.4. Discussion on clinical pharmacology 36 2.4.5. Conclusions on clinical pharmacology 38 2.5. Clinical efficacy 38 2.5.1. Dose response study 38 2.5.2. Main studies 39 2.5.3. Discussion on clinical efficacy 62 2.5.4. Conclusions on the clinical efficacy 64 2.6. Clinical safety 64 2.6.1. Discussion on clinical safety 73 2.6.2. Conclusions on the clinical safety 75 2.7. Pharmacovigilance 75 2.8. User consultation

2011 European Medicines Agency - EPARs

197. Eurartesim - piperaquine tetraphosphate / dihydroartemisinin

on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 18 2.3.3. Pharmacokinetics 22 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 28 2.3.6. Discussion on non-clinical aspects 28 2.3.7. Conclusion on the non-clinical aspects 29 2.4. Clinical aspects 30 2.4.1. Introduction 30 2.4.2. Pharmacokinetics 30 2.4.3. Pharmacodynamics 47 2.4.4 (...) . Discussion on clinical pharmacology 56 2.4.5. Conclusions on clinical pharmacology 56 2.5. Clinical efficacy 57 2.5.1. Dose response studies 57 2.5.2. Main studies 57 2.5.3. Discussion on clinical efficacy 104 2.5.4. Conclusions on the clinical efficacy 104 2.6. Clinical safety 104 2.6.1. Discussion on clinical safety 118 2.6.2. Conclusions on clinical safety 119 2.7. Pharmacovigilance 120 2.8. User consultation 125 3. Benefit-Risk Balance 125 4. Recommendations 127 Assessment Report EMA/739355/2011 Page

2011 European Medicines Agency - EPARs

198. Benlysta (belimumab)

Systemic Lupus Erythematosus Disease Activity Index SLICC Systemic Lupus International Collaborating Clinics SMQ Standardised MedDRA Query SNF skilled nursing facility SOC system organ class SS Sjögren’s syndrome TNF tumor necrosis factor TQT thorough QT ULN upper limit of normal URTI upper respiratory tract infection US United States USAN United States Adopted Name UTI urinary tract infection TK Toxicokinetic V 2 volume of distribution for the peripheral compartment V ss volume of distribution (...) substance 9 2.2.3. Finished Medicinal Product 11 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 12 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 13 2.3. Non-clinical aspects 14 2.3.1. Introduction 14 2.3.2. Pharmacology 14 2.3.3. Pharmacokinetics 16 2.3.4. Toxicology 17 2.3.5. Ecotoxicity/environmental risk assessment 23 2.3.6. Discussion on non-clinical aspects 23 2.3.7. Conclusion on the non-clinical aspects 24 2.4. Clinical aspects 24 2.4.1

2011 European Medicines Agency - EPARs

199. Jevtana - cabazitaxel

of quantitation BM Bone metastasis BMI Body Mass Index BSA Body surface area CBZ Cabazitaxel CL Clearance CR / PR Complete response / partial response CT Computed tomography DoE Design of Experiment ECG Electrocardiography ECOG PS Eastern Cooperative Oncology Group performance status EU European Union GALT gut-associated lymphoid tissue GCP Good clinical practice GLP Good laboratory practice GMP Good manufacturing practices HCPC or mHRPC Hormone-resistant prostate cancer or metastatic hormonoe-resistant (...) ICH guidelines conditions is chemically stable for the proposed shelf life. At the time of the CHMP opinion, there were two quality issues that will be resolved as Follow-up Measures within an agreed timeframe. However, none of them is expected to have a negative impact on the Benefit Risk balance of the product. 2.3. Non-clinical aspects 2.3.1. Introduction Cabazitaxel (also known as XRP6258, RPR116258A) is a semi synthetic derivative from 10-deacetyl Baccatin III, which is extracted typically

2011 European Medicines Agency - EPARs

200. Teysuno - tegafur / gimeracil / oteracil

product quality characteristics, and these in turn lead to the conclusion that the product should have a satisfactory and uniform performance in the clinic. Stability tests indicate that the product under ICH guidelines conditions is chemically stable for the proposed shelf life. 3 6.32 of Vol. 4 Part I of the Rules Governing Medicinal Products in the European Union Teysuno CHMP ASSESSMENT REPORT EMA/CHMP/831565/2010 Page 14/67 2.3. Non-clinical aspects 2.3.1. Pharmacology Primary pharmacodynamic (...) Product 12 2.2.4. Discussion and conclusions on chemical, pharmaceutical and biological aspects 13 2.3. Non-clinical aspects 14 2.3.1. Pharmacology 14 2.3.2. Pharmacokinetics 16 2.3.3. Toxicology 18 2.3.4. Ecotoxicity/environmental risk assessment 25 2.3.5. Discussion and conclusions on non-clinical aspects 25 2.4. Clinical aspects 28 2.4.1. Introduction 28 2.4.2. Pharmacokinetics 31 2.4.3. Pharmacodynamics 34 2.4.4. Discussion and Conclusions on clinical pharmacology 35 2.5. Clinical efficacy 35

2011 European Medicines Agency - EPARs

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