PPT-Estimated costs of managing treatment-related adverse

eventsof nivolumab and docetaxel in the CheckMate 017 and CheckMate 057 phase III NSCLC trials Kartik Venkatachalam Intervista a Cesare Gridelli Background Nivo a PD1 antibody received FDA approval based on superior overall survival in metastatic squamous SQ and nonsquamous NSQ NSCLC patients who have progressed on or after platinumbased doublet chemotherapy The purpose of this study was to assess the frequency and associated costs of grade 24 AEs in the CheckMate 017 SQ and CheckMate 057 NSQ phase III pivotal trials of nivo vs doc in stage IIIBIV NSCLC Methods Patientlevel data from these two trials were utilized to estimate the frequency of TRAEs requiring management in the nivo and doc arms including serious and nonserious TRAEs Minimum followup for AE reporting at database lock was 12 months Grade 34 AE costs by event were identified from Healthcare Cost and Utilization Project HCUP data in 2010 which were adjusted to reflect 2012equivalent US costs Healthcare utilization associated with grade 2 AEs was based on clinical opinion and costs were based on HCUP or other sources as appropriate Results In both trials more TRAEs were observed with doc than with nivo Table and the cost of managing TRAEs was 158 and 107 times higher in the doc arm vs the nivo arm for the CheckMate 017 and CheckMate 057 trials respectively Patients in the doc arm incurred an additional 6585 and 5422 per patient in managing AEs compared with patients in the nivo arm in the above two trials respectively The total estimated costs of managing TRAEs during these trials are presented in the Table Conclusions Large estimated differences in costs were observed in managing TRAEs favoring nivo in the CheckMate 017 and CheckMate 057 pivotal trials The reduction in costs for managing AEs with the use of nivo should be considered when assessing the value of nivo in this patient population. FOR UPLANDS FARM. COLD SPRINGS NY. INTRODUCING . THE PLANTED BIOLOGICAL REACTOR (PBR). ®. . A . HYBRID MBBR & WETLAND . WASTEWATER TREATMENT . SYSTEM. What is a Planted Bed Bioreactor?. A versatile, natural, economical and ecological . Nonexpansion. States. Note: . Second-lowest-cost . silver plans for 2016; . 40-year-old . male nonsmoker; $13,000 annual income; “medium” user of health care; largest city in state. In some markets, the annual premium amount exceeded what a person at this income level could be required to pay by law. In these instances, the limit for the premium contribution as a share of income ($264) was used instead, with the reduced amount also reflected in the plan’s total expected cost. If the estimated out-of-pocket costs exceed a consumer’s out-of-pocket limit, then we report the out-of-pocket limit, rather than the out-of-pocket . Amanda Dean, MSN, ACNP-BC, RNFA. Director of Advanced Practice Providers. Banner MD Anderson. Objectives. Recognize and manage mechanism based adverse effects of current targeted agents including: GI distress, dermatologic toxicities, pneumonitis and  anti-angiogenesis  side effects. Reporting Requirements. Protocol References. Section. Title. 7.2. Safety-Related. Data Collection. 7.3. Expedited Adverse Event Reporting. Other References and Resources. 3. Manual for Expedited Reporting of Adverse Events to DAIDS (Version 2.0). Rachel Phillips & Victoria Cornelius. Review. “recommended improvements in the accuracy of harm data in RCT reports and a need to standardize practices for reporting.”. Review. “found that methods used to collect adverse event data, the frequency of collection, and the selection criteria used by authors for reporting adverse events vary substantially, and these events are often inadequately reported.”. Audra H. Nelson, M.S. 2009. Learning Objectives. By the end of this module, students will be able to:. Define adverse impact discrimination and perform the legally accepted calculation to discern if it exists in a given situation.. Holden Comprehensive Cancer Center. Protocol Development and Monitoring . Key definitions. Identifying, documenting and reporting Adverse Events. Investigator Responsibilities . How are research participants protected? . Objectives . Explain . Pharmacovigilance & various types of adverse drug reactions. . List . some common adverse effects & toxicities with examples. . Discuss . drug dependence & its public health importance. . MODULE 3 Adverse events following immunizationOverviewUnder recommended conditions all vaccines used in national immunization programmes are safe and e31ective if used correctly In practice however no For how long should costs be tracked?. In assessing how long costs should be tracked, the main objective should be to avoid misleading the decision-maker or user. For example, an early comparison of the costs of coronary artery bypass grafting (. Events. Robert Silbergleit, MD. Adverse Events – . key points. Do not report events EXISTING PRIOR to randomization . (unless there is a change in severity). Report the DIAGNOSIS, not the symptoms:. Investigator Kick-off Meeting. January 30-31, Clearwater, Florida. Jodie Riley, MISM and Robert Silbergleit. Adverse Events. Adverse Events (AEs) are “. . . any . untoward. medical occurrence in a subject that was not previously identified which does not necessarily have a causal relationship to the study drug…” . of . Life Among Patients Who Report Adverse Events . while on . Treatment . for . Drug-Resistant . TB in Johannesburg, South Africa.  . Denise Evans, . Tembeka Sineke. , Kate Schnippel, Helena . van . University of Massachusetts Software Engineering. Donna Ferullo,. Director of. Research Programs, ASA. April 1, 2010. A Survey Of…. Clinical Data Management. Global Project Management Lessons Learned.