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.)