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Add baseline hepatic function class

Source: R/nif_class.R
add_bl_odwg.Rd

Based on the NCI ODWG criteria with TB the total (direct and indirect) serum bilirubin, and AST aspartate aminotransferase.

Usage

add_bl_odwg(
  obj,
  sdtm,
  observation_filter = "LBSPEC != 'URINE'",
  baseline_filter = "LBBLFL == 'Y'",
  summary_function = mean
)

Arguments

obj

A nif object.

sdtm

The corresponding sdtm object.

observation_filter

The filter term for the observation source data, as character.

baseline_filter

A filter term to identify the baseline condition, as character.

summary_function

The summary function to summarize multiple baseline values. Defaults to mean

Value

A nif object.

Details

  • normal: TB & AST ≤ upper limit of normal (ULN)

  • mild hepatic dysfunction: TB > ULN to 1.5 x ULN or AST > ULN

  • moderate hepatic dysfunction: TB >1.5–3 x ULN, any AST

  • severe hepatic dysfunction: TB >3 - 10 x ULN, any AST