Other Assessments. The assignment of subjects to subject samples, the disposition of subjects with respect to premature termination, reason for premature termination, drug exposure and treatment compliance will be summarized for the treatment group. Demographics and other baseline characteristics will be summarized for the treatment group. Medical history, including coding data will be summarized per primary SOC, per HLT by primary SOC and per PT by HLT and primary SOC. Major protocol deviations will be listed. Concomitant medication, including coding data will be summarized per assigned treatment period for incidence per subject, for primary therapeutic subgroup (the 3rd level ATC code) and for generic name by therapeutic subgroup.
Appears in 1 contract
Sources: Clinical Study Protocol
Other Assessments. The assignment of subjects to subject samples, the disposition of subjects with respect to premature termination, reason for premature termination, drug exposure and treatment compliance will be summarized for the per treatment group. Demographics and other baseline characteristics will be summarized for the per treatment group. Medical history, including coding data will be summarized per primary SOC, per HLT by primary SOC and per PT by HLT and primary SOC. Major protocol deviations will be listed. Concomitant medication, including coding data will be summarized per assigned treatment period for incidence per subject, for primary therapeutic subgroup (the 3rd level ATC code) and for generic name by therapeutic subgroup.
Appears in 1 contract
Sources: Clinical Study Protocol