Impact of the Adherence to Antiemetic Guidelines in Cancer Patients Undergoing Repeated Cycles of Either MEC or HEC Regimens in Eastern Europe (NERO - NAUSEA/EMESIS REGISTRY IN ONCOLOGY)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional observational study

Population studied

• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  1150

Study design details

• Main study objective:
  Guideline consistent and guideline inconsistent CINV prophylaxis measured by Complete Response (CR: no emesis and no use of rescue medication) during 120 h after chemotherapy
• Data analysis plan:
  Given the nature of the project descriptive statistics methods commonly used in epidemiological studies will be used. Part of the final report will be descriptive statistical evaluation of primary and secondary endpoints of the study, and all the monitored parameters in individual patients. Statistical analysis will respect the data types (continuous, ordinal and binary) and the distribution of values (normal and log-normal and other). Basic statistical parameters (mean, median, relative share) and reliability estimation indicators of the parameters in groups of patients (standard deviation (SD), confidence interval, and percentiles) will be calculated.