LBT16 [Spec Added]

[barnett11]

Table Name

LBT16

Description

Laboratory Test Results -- NCI CTCAE v5 Grade by Visit and Baseline Status, when Post-BL Grade is Based on BL Value

Analysis dataset

ADLB

Analysis filtering

For Low Direction - WGRLOVFL = "Y" & PARCAT1="SI"
For High Direction - WGRHIVFL = "Y" & PARCAT1="SI"

Analysis population

SE

Column Variable

ACTARM

Analysis variables

PARAMCD
AVISIT
ATOXGR
BTOXGR
BNRIND

Analysis concept

Separate tables are generated for each direction (i.e. increase or decrease).
Applicable to lab tests, ALP, ALT, AST, BILI, GGT, using NCI CTCAE v5 in which the grading criteria are applicable to post-baseline values only.
It is optional to include patients with missing baseline values and display missing baseline data as ‘missing’ (see grey shaded lines in the mock-up shell).

Statistics

Table entries provide the number of patients at the specified visit with the grade indicated in the first column, among patients with non-missing value at that visit and a baseline status as indicated in the second column.

As an option, allow study teams to further split ‘Not ’ in Column 2 into ‘Normal’ and ‘<Below/Above> Normal’ if Baseline contains abnormal values in the opposite direction.

Default treatment of zero count rows

Remove zero count rows by default

Additional comments