FDA 16-Jul-2012 17-Sep-2012 Confirmatory sample The SAPs for container Errors in treatment were low (20%). label analysis and the and consistent across sensitivity analyses are treatment arms, indicating a 3 major sets of analysis presented in Appendix 2. well-controlled process. Container labels. FDA provided sponsors Sensitivity analyses eCRF data entries with a sample of 236 sites demonstrate primary outcomes relative to IVRS selected from the 813 sites from ARISTOTLE maintained. assignments. with treated subjects that Please refer to summary were neither part of the Sensitivity analyses on response for CRL1 for detailed Convenience nor in the simulated medication response. First Random Sample. error frequencies for the ARISTOTLE conclusions.
FDA 16-Jul-2012 17-Sep-2012 Confirmatory sample (20%). 3 major sets of analysis Container labels. eCRF data entries relative to IVRS assignments. Sensitivity analyses on simulated medication error frequencies for the ARISTOTLE conclusions. The SAPs for container label analysis and the sensitivity analyses are presented in Appendix 2. FDA provided sponsors with a sample of 236 sites selected from the 813 sites with treated subjects that were neither part of the Convenience nor in the First Random Sample. Errors in treatment were low and consistent across treatment arms, indicating a well-controlled process. Sensitivity analyses demonstrate primary outcomes from ARISTOTLE maintained. Please refer to summary response for CRL1 for detailed response.