Introduction

The .study argument in tlg-functions is used to pass values that are used in several tables.

The .study object

The following variables are best hard coded in the table-generating functions (with the possibility to the user to override some of these choices.):

actualarm

Used to specify the actual arm of the study. Typically ACTARM.

evo_vars

Used in LBT01 and EGT01, which variables capture status and the evolution of the analysis: generally c("AVAL", "CNG")

evo_vars_lbls

The label associated with the variables selected in evo_vars.

disc_reason_var

Used in DST01 to define reason for patient withdrawal. Default is DCSREAS

group_grades

Used in AET04 to put in correspondence severity levels and labels.

lbl_overall

used everywhere, the label associated with the overall column.

medconcept_var

Used in AET01 the medical concept variables to be summarized. Typically c("SMQ01", "SMQ02", "CQ01").

planarm

Used to specify the planned arm of the study. Typically ARM.

reason

used in DST01, the name of the column specifying study withdrawal): generally DCSREAS.

safety_var

Used in AET01 the safety variables to be summarized. Typically c("FATAL", "SER", "SERWD", "SERDSM", "RELSER", "WD", "DSM", "REL", "RELWD", "RELDSM", "SEV").

severity_grade

internal, used in AET03, capture the levels of severity of adverse events: generally corresponds to the levels of AESEVin adae.

status_var

Used in DST01 to define patient status.

summary_demo

Used in DMT01, the list of variables to be summarized.

summary_demo_lbl

Used in DMT01, the labels for the list of variables to be summarized.

visitvar

The variable used to define the visits. (Could this variable be different for each table, in which case it should be out of the .study object.)