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The SAP specifies that planned collected visits, including baseline measurements, are to be used in analyses and displays of results, whereas unscheduled visits appear only in listings. In fact, no Unscheduled Visits exist in the source data. If the planned physiology assessment is not done or invalid, the investigator may choose to use a previous or repeat assessment of that parameter as the value to be used at that visit for the scoring of APACHE II. The total score records for 1 subject were collected at 3 visits, plus a derived last observed value (LOV) endpoint record for the APACHE II. Visit 1 is remapped to AVISIT = "BASELINE". There are 2 visits at AVISIT = "VISIT 2". However, because 1 visit was unscheduled, it is not used in the analysis and the ANL01FL value is null. Visits 5 and 6 are missing because the subject discontinued early due to an adverse event unrelated to treatment.  

Update the below dataset and title according to the current QRS Short_Name instrument.  

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The APACHE II Complete Analysis Dataset table shows all of the individual question responses for this example, as well as the computed total Acute Physiology score and the computed total APACHE II score. This example is considered to be the final analysis dataset for submission. Computed total scores can appear after the individual item responses, with appropriate labels for identification.

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Update the below dataset and title according to the current QRS Short_Name instrument.  

GDS SHORT FORM APACHE II Summary Analysis Dataset

Due to the number of items on the instrument and instrument and the fact that only the total APACHE II score records are required for analysis, the separate summary dataset shown in the following example, which contains only the total APACHE II score records, may also be created.  QSSEQ RSSEQ was not included in this example because it would be null for all computed total score records. QSORRES RSORRES is not shown because only derived total score records are displayed.

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