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Definexmltable
ExtraUser Notes
DatasetADAPCH
LevelValue
PurposeAnalysis
NameAVAL

Variable

Where

Type

Controlled Terms

Source

Derivation

User Notes

AVAL

PARAMCD NOT IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis))

Num



Set AVAL=RS.RSSTRESN.The analysis value is the result copied from SDTM.

AVAL

PARAMCD EQ "APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis)

Num



The sum of RS.RSSTRESN for RS.RSTESTCD in ("APCH101"-"APCH112") if no question are missing. Note that one out of the following two items: RSTESTCD="APCH105A" or "APCH105B" must be answered or RSTESTCD="APCH106A" or "APCH106B" but not both.

The expectation is that issues with conditional branching are fixed in SDTM RS.

AVAL

PARAMCD EQ "APCH1TS" (APCH1-Total APACHE II Score - Analysis)

Num



The sum of QSRS.QSSTRESN RSSTRESN for QSRS.QSTESTCD RSTESTCD in ("GDS0201APCH101"-"GDS0215APCH112") and "APCH114", "APCH115" if no question are missing.

  • If ≤5 responses are missing on an instrument, then AVAL is 15*(sum of non-missing QS.QSSTRESN for QS.QSTESTCD in ("GDS0201"-"GDS0215")/number of non-missing questions for QS.QSTESTCD in ("GDS0201"-"GDS0215"). If the result is a fraction, round up to the nearest integer.
  • If >5 responses are missing, do not calculate a total score, and do not create a total score record

    Note that one out of the following two items: RSTESTCD="APCH105A" or "APCH105B" must be answered or RSTESTCD="APCH106A" or "APCH106B" but not both.

    If a subject dies on or before Day 15, they are assigned the highest observed APACHE II score of any of the participants at any time during the trial for their Total APACHE II Score at Day 15 (Day of Discharge).


    6.3   Example Analysis Dataset 

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