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Clinical Index of Stable Febrile Neutropenia

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61. Rituximab (Blitzima) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma OR chronic lymphocytic leukaemia OR granulomatosis with polyangiitis (GPA or Wegener?s granulomatosis) and microscopic polyangiitis (MPA)

Circular dichroism Clinical disease activity index CDC Complement-dependent cytotoxicity CHO CHOP Chinese Hamster Ovary Cyclophosphamide, doxorubicin, vincristine, prednisolone CI Confidence interval CIPT CL Critical In-process Test Total body clearance CLL Chronic lymphocytic leukaemia CLT1 Cmax CELLTRION Plant I Maximum serum concentration after the second infusion CLT2 Cmax, 1 CELLTRION Plant II Maximum serum concentration after the first infusion Cmin Minimum serum concentration immediately before (...) Electrochemiluminescence Fc?RI ESR Fc gamma receptor R1 (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421793/2017 Page 5/161 Fc?RIIIa-V EULAR Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein

2017 European Medicines Agency - EPARs

62. Rituximab (Ritemvia) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma OR granulomatosis with polyangiitis (GPA or Wegener?s granulomatosis) and microscopic polyangiitis (MPA)

ESR Fc gamma receptor R1 (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421799/2017 Page 5/160 Fc?RIIIa-V EULAR Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein Higher (...) Substance 13 2.1.3. Finished Medicinal Product 16 2.1.4. Discussion on chemical, pharmaceutical and biological aspects 20 2.1.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.1.6. Recommendation(s) for future quality development 20 2.2. Non-clinical aspects 20 2.2.1. Introduction 20 2.2.2. Pharmacology 21 2.2.3. Pharmacokinetics 26 2.2.4. Toxicology 27 2.2.5. Ecotoxicity/environmental risk assessment 29 2.2.6. Discussion on non-clinical aspects 30 2.2.7. Conclusion on the non

2017 European Medicines Agency - EPARs

63. Rituximab (Rituzena (previously Tuxella)) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma OR chronic lymphocytic leukaemia OR granulomatosis with polyangiitis (GPA or Wegener?s granulomatosis) and microscopic polyangiitis (MPA)

under the serum concentration-time curve from the start of the first infusion to the last measurable concentration after the second infusion AUC0-t Area under the serum concentration-time curve from the start of first infusion to start of the second infusion AUCt-8 Area under the serum concentration-time curve from the start of second infusion to infinity BA Bioavailability BE Bioequivalence CCP Cyclic citrullinated protein CD CDAI Circular dichroism Clinical disease activity index CDC Complement (...) (CD64) Erythrocyte sedimentation rate Assessment report EMA/CHMP/421811/2017 Page 5/160 Fc?RIIIa-V EULAR Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein Higher Molecular Weight ICH Ig

2017 European Medicines Agency - EPARs

64. Ribociclib (Kisqali) - breast cancer

with all information of a commercially confidential nature deleted. Assessment report EMA/CHMP/506968/2017 Page 2/121 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 7 2.1. Problem statement 7 2.1.1. Disease or condition 7 2.1.2. Epidemiology 8 2.1.3. Biologic features 8 2.1.4. Clinical presentation, diagnosis and stage/prognosis 8 2.1.5. Management 8 2.2. Quality aspects 10 (...) 2.2.1. Introduction 10 2.2.2. Active Substance 10 2.2.3. Finished Medicinal Product 12 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 14 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 15 2.2.6. Recommendations for future quality development 15 2.3. Non-clinical aspects 15 2.3.1. Introduction 15 2.3.2. Pharmacology 15 2.3.3. Pharmacokinetics 17 2.3.4. Toxicology 19 2.3.5. Ecotoxicity/environmental risk assessment 24 2.3.6. Discussion on non-clinical

2017 European Medicines Agency - EPARs

65. Trumenba - meningococcal group b vaccine (recombinant, adsorbed)

. the classical complement cascade is initiated, ultimately resulting in the formation of a membrane attack complex late in the cascade by complement components C5-C9; and 4. insertion of the membrane attack complex into the meningococcal membrane resulting in bacterial cell lysis 2.1.3. Clinical presentation MnB disease has a sudden onset and fast progression, even in healthy individuals. Patients may initially present with a nonspecific febrile illness characterized by headache and fatigue but then progress (...) . Epidemiology and risk factors, screening tools/prevention 8 2.1.3. Clinical presentation 11 2.1.4. Management 11 2.1.5. About the product 12 2.2. Quality aspects 13 2.2.1. Introduction 13 2.2.2. Active Substance 13 2.2.3. Finished Medicinal Product 16 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 18 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 20 2.2.6. Recommendation(s) for future quality development 20 2.3. Non-clinical aspects 20 2.3.1. Introduction 20

2017 European Medicines Agency - EPARs

66. Dinutuximab beta Apeiron - neuroblastoma

. Epidemiology 11 2.1.3. Biologic features 11 2.1.4. Clinical presentation, diagnosis and stage/prognosis 11 2.1.5. Management 12 2.2. Quality aspects 15 2.2.1. Introduction 15 2.2.2. Active Substance 16 2.2.3. Finished Medicinal Product 26 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 31 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 33 2.2.6. Recommendations for future quality development 34 2.3. Non-clinical aspects 34 2.3.1. Introduction 34 2.3.2 (...) . Pharmacology 34 2.3.3. Pharmacokinetics 37 2.3.4. Toxicology 39 2.3.5. Ecotoxicity/environmental risk assessment 41 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 44 2.4.3. Pharmacodynamics 47 2.4.4. Discussion on clinical pharmacology 49 2.4.5. Conclusions on clinical pharmacology 52 2.5. Clinical efficacy 52 2.5.1. Dose response studies and main clinical studies 52 2.5.2. Discussion

2017 European Medicines Agency - EPARs

67. Rituximab (Truxima) - follicular lymphoma and diffuse large B cell non-Hodgkin?s lymphoma, chronic lymphocytic leukaemia, severe rheumatoid arthritis, granulomatosis with polyangiitis

measurable concentration after the second infusion AUC0-t Area under the serum concentration-time curve from the start of first infusion to start of the second infusion AUCt-8 Area under the serum concentration-time curve from the start of second infusion to infinity BA Bioavailability BE Bioequivalence CCP Cyclic citrullinated protein CD CDAI Circular dichroism Clinical disease activity index CDC Complement-dependent cytotoxicity CHO CHOP Chinese Hamster Ovary Cyclophosphamide, doxorubicin, vincristine (...) Fc gamma receptor 3a (CD16a) V type receptor European league against rheumatism FcRn GCP neonatal Fc receptor Good clinical practice GI Gastrointestinal GMP GPA Good Manufacturing Practice Granulomatosis with polyangiitis HACA Human anti-chimeric antibodies HAQ Health assessment questionnaire disability index HBV Hepatitis B virus HCP HMW Host Cell Protein Higher Molecular Weight ICH Ig International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals

2017 European Medicines Agency - EPARs

68. Venetoclax (Venclyxto) - Chronic, B-Cell Lymphocytic Leukemia

time ASO PCR allele specific oligonucleotide polymerase chain reaction AST aspartate aminotransferase Bcl B cell lymphoma BCRi B Cell receptor inhibitor BMI body mass index BR bendamustine rituximab CD cluster of differentiation CI confidence interval CLL chronic lymphocytic leukaemia CPP Critical process parameter CQA Critical Quality Attribute CR complete remission CRi complete remission with incomplete bone marrow recovery CSR clinical study report CT computed tomography CTLS clinical tumour (...) 2.2.3. Finished Medicinal Product 14 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 17 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 18 2.2.6. Recommendations for future quality development 18 2.3. Non-clinical aspects 18 2.3.1. Introduction 18 2.3.2. Pharmacology 19 2.3.3. Pharmacokinetics 23 2.3.4. Toxicology 25 2.3.5. Ecotoxicity/environmental risk assessment 31 2.3.6. Discussion on non-clinical aspects 33 2.3.7. Conclusion on the non-clinical

2017 European Medicines Agency - EPARs

69. Thiopurine S-methyltransferase testing for averting drug toxicity in patients receiving thiopurines: A systematic review and quality appraisal

Thiopurine S-methyltransferase testing for averting drug toxicity in patients receiving thiopurines: A systematic review and quality appraisal The Hospital for Sick Children Technology Assessment at SickKids (TASK) FULL REPORT THIOPURINE S-METHYLTRANSFERASE TESTING FOR AVERTING DRUG TOXICITY IN PATIENTS RECEIVING THIOPURINES: A SYSTEMATIC REVIEW AND QUALITY APPRAISAL Authors: Lilla M. Roy, RN, BScN, MSc Clinical Research Project Coordinator, Child Health Evaluative Services, The Hospital (...) . Ungar, MSc, PhD The Hospital for Sick Children Peter Gilgan Centre for Research and Learning 11th floor, 686 Bay Street Toronto, ON, Canada M5G 0A4 tel: (416) 813-7654, extension 303487, fax: (416) 813-5979, e-mail: wendy.ungar@sickkids.ca http://www.sickkids.ca/AboutSickKids/Directory/People/U/Wendy-Ungar.html Report No. 2015-02 Date: July 29, 2015 Available at: http://lab.research.sickkids.ca/task/reports-theses/ Co-investigators: Joseph Beyene, MSc, PhD Department of Clinical Epidemiology

2015 SickKids Reports

70. Muscle-invasive and Metastatic Bladder Cancer

into their clinical practice. Separate EAU guidelines documents are available addressing upper urinary tract tumours [1], non- muscle-invasive bladder cancer (Ta,T1 and carcinoma in situ) [2], and primary urethral carcinomas [3]. 1.2 Panel Composition The EAU Guidelines Panel consists of an international multidisciplinary group of experts from the fields of urology, pathology, radiology and oncology. All experts involved in the production of this document have submitted potential conflict of interest statements (...) . Recommendations have been rephrased and added to throughout the current document: 3.3.3 Recommendations for the assessment of tumour specimens Mandatory evaluations Depth of invasion (categories pT2 vs pT3a, pT3b or pT4); Margins with special attention paid to the radial margin, prostate, ureter, urethra and peritoneal fat and uterus and vaginal top. Histological subtype, if it has clinical implications; Extensive lymph node r epr esentation (mor e than nine); Optional evaluations Bladder wall blood vessel

2015 European Association of Urology

71. Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer

(in particular febrile neutropenia). Bevacizumab should be investigated further in the second-line setting. O'Shaughnessy et al, 2012 Systematic review Seven prospective studies including 1,813 patients and four retrospective studies including 1,087 patients First-line capecitabine monotherapy demonstrated superior median survival compared with CMF combination therapy; all other comparisons for efficacy were nonsignificant. Capecitabine monotherapy (1,000 mg/m 2 twice daily, for 14 d of a 21-d cycle) has (...) Chemo- and Targeted Therapy for Women with HER2 Negative (or unknown) Advanced Breast Cancer Chemotherapy and Targeted Therapy for Women With Human Epidermal Growth Factor Receptor 2–Negative (or unknown) Advanced Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline | Journal of Clinical Oncology Search in: Menu Article Tools ASCO SPECIAL ARTICLES Article Tools OPTIONS & TOOLS COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2014.56.7479

2014 American Society of Clinical Oncology Guidelines

72. HIV, viral hepatitis and STIs - a guide for primary care

, so that they are able to persist throughout the life of the host. During latency, the genome of the invading virus is maintained in stable form in the infected neural cell with no production of progeny virus for variable periods of time and no apparent cytotoxic effects. Periodically, reactivation of virus replication occurs with virus migrating back down axons to surface sites. The clinical severity of herpes simplex infections and the host’s capacity to control viral replication depends very (...) – A GUIDE FOR PRIMARY HEALTH CARE iii HIV , VIRAL HEPATITIS & STIs A GUIDE FOR PRIMARY CARE 2014 EDITION EXPERT REFERENCE GROUP (EDITORIAL OVERSIGHT) Dr Michael Burke Nepean Sexual Health & HIV Clinic Ms Tracey Cabrie Victorian Infectious Diseases Service, Melbourne Health Associate Professor Ben Cowie Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, University of Melbourne Professor Greg Dore The Kirby Institute, UNSW Australia Dr Seamus Duffy Tuggerah Medical Centre Dr

2014 Clinical Practice Guidelines Portal

73. Trifluridin/tipirACil in meTastatIc Colorectal Cancer

treatment to baseline CTCAE grades of the mentioned parameters will also be presented per visit using frequencies and percentages. Therapy management (use of relevant supportive medications) [ Time Frame: Baseline up to 3 years ] Number of patients receiving G-CSFs for prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia (Frequencies) Patient-reported outcomes (PROs) on quality of life (QoL) [ Time Frame: Baseline up to 3 years ] PRO-CTCAE: Questionnaire PRO-CTCAE is used to determine (...) Cancer (TACTIC) 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: NCT03665506 Recruitment Status : Recruiting First Posted : September 11, 2018 Last Update Posted : September 11, 2018 See Sponsor: Servier Collaborator: iOMEDICO

2018 Clinical Trials

74. Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

Frame: 12 months ] The duration of response (DoR) will be measured from the time of first documented response (CR or PR as per RECIST 1.1) until the first documented disease progression or death due to underlying cancer, or censored at the date of the last available tumor assessment. The clinical benefit rate (CBR) [ Time Frame: 8 weeks ] after 8 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable (...) population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1. The clinical benefit rate (CBR) [ Time Frame: 16 weeks ] after 16 weeks of treatment will be defined as the proportion of patients with CR or PR or Stable disease (SD). It will be described on the efficacy-evaluable population, together with its 95% CI. Tumor response will be evaluated according to RECIST 1.1. Progression-Free Survival (PFS) [ Time Frame: 12 months ] will be measured from C1D1 until the date

2018 Clinical Trials

75. 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

76. 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

77. 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

78. 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 (...) is rarely seen. Risk Factors Risk factors for adult HL include the following: Being in early adulthood (aged 20–39 years) (most often) or late adulthood (aged 65 years and older) (less often). Being male. Having a previous infection with the Epstein-Barr virus in the teenage years or early childhood. Having a first-degree relative with HL. Clinical Features These and other signs and symptoms may be caused by adult HL or by other conditions: Painless, swollen lymph nodes in the neck, axilla, or inguinal

2016 PDQ - NCI's Comprehensive Cancer Database

79. 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

80. Ixazomib (Ninlaro) - multiple myeloma

. Introduction 10 2.2.2. Active Substance 10 2.2.3. Finished Medicinal Product 13 2.2.4. Discussion on chemical, pharmaceutical and biological aspects 16 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects 17 2.2.6. Recommendation(s) for future quality development 17 2.3. Non-clinical aspects 17 2.3.1. Introduction 17 2.3.2. Pharmacology 17 2.3.3. Pharmacokinetics 26 2.3.4. Toxicology 33 2.3.5. Ecotoxicity/environmental risk assessment 48 2.3.6. Discussion on non-clinical aspects 48 (...) 2.3.7. Conclusion on the non-clinical aspects 50 2.4. Clinical aspects 50 2.4.1. Introduction 50 2.4.2. Pharmacokinetics 52 2.4.3. Pharmacodynamics 63 2.4.4. Discussion on clinical pharmacology 65 2.4.5. Conclusions on clinical pharmacology 67 2.5. Clinical efficacy 68 2.5.1. Dose response studies 68 2.5.2. Main study 71 2.5.3. Discussion on clinical efficacy 99 2.5.4. Conclusions on the clinical efficacy 102 2.6. Clinical safety 102 2.6.1. Discussion on clinical safety 115 2.6.2. Conclusions

2016 European Medicines Agency - EPARs

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