The .study Argument

2022-11-04

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. - default: ACTARM.

demo_vars

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

demo_vars_lbls

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

evo_vars

Used in EGT01, LBT01 and VST01 which variables capture status and the evolution of the analysis. - default: 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: 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. - default: c("SMQ01", "SMQ02", "CQ01").

planarm

Used to specify the planned arm of the study. - default: ARM.

reason

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

safety_var

Used in AET01 the safety variables to be summarized. - default 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. - default: EOSSTT

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.)