1     General Considerations

This section describes the implementation of the analysis dataset for QRS instruments as based on the Basic Data Structure (BDS) described in the Analysis Data Model Implementation Guide (ADaMIG). The ADaMIG can be found on the CDISC website at https://www.cdisc.org/standards/foundational/adam. The BDS was chosen as the model for analysis datasets of QRS instruments because it supports a wide variety of analyses, including summaries of total score by timepoint as well as change from baseline by timepoint. This data structure allows the ADaM variables PARAM and PARAMCD to come directly from Study Data Tabulation Model (SDTM) variables RS.RSTEST and RS.RSTESTCD, respectively, for individually captured questions items, thus ensuring traceability between SDTM and ADaM data. If other analyses are required that are not supported by the BDS, then consideration would be needed as to the appropriate structure. Analysis requirements always drive the design of the analysis datasets.

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These specific analysis implementation details for the APACHE II are meant to be used in conjunction with ADaMIG. All completed questionnaires, ratings, and scales documentation can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

1.1   Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the ADaMIG and is covered under Appendix C of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix C of the ADaMIG for a complete version of this material.

CDISC does not endorse any QRS instrument and does not specify how to conduct clinical assessments, protocols, or analyses. CDISC disclaims any liability for your use of this material.

1.2   Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the APACHE II in the CDISC library of QRS data standards supplements. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use the version attached to the QRS supplement to the SDTMIG, and the QRS supplement to the ADaMIG is based on the same version.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent versions of the SDTM and ADaM controlled terminologies should be accessed through the CDISC website (https://www.cdisc.org/standards/terminology).

1.3   Known Issues

The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity of disease measurement and mortality estimation tool for adult patients subjects applied within 24 hours of admission to an intensive care unit (ICU). The instrument's intended use is for newly admitted subjects to the ICU. The instrument consists of individual items that are summed up to create a total score. This instrument is generally collected once at Screening/Baseline and used as a predictor of mortality rather than an outcome measure. The total score is normally collected as part of the instrument with no instructions provided for handling missing data. In the majority of cases, where APACHE II is only assessed once and the collected total score used as a baseline covariate, the SDTM RS domain may be sufficient to support the analysis requirements. If this is the case, as a variable in ADSL copied directly from a result/value in SDTM may be sufficient to support analysis needs.

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The According to the instrument creator, Dr. William Knaus, the APACHE II total score is designed as a mortality prediction tool. It is not intended to influence the medical management or care of subjects during their ICU stay or to be calculated sequentially to show improvement or effect of interventions. A number of physiology measurements are used to calculate the APACHE II total scoreor effect of interventions. The worst values recorded during the initial 24 hours in the ICU is used. Alternatively, are recommended to be used in calculation of the total score but the measurements initially recorded during the subject’s admission can be used for practical reasons. The  

Although the APACHE II total score is the most widely used ICU mortality prediction score. It differs from the original APACHE score in some ways; the number of physiology measurements is decreased and the weight of some of the physiology measurements is adjusted. APACHE III and APACHE IV scores were also developed but are not commonly used because their statistical method is under copyright control. , it has a number of limitations and shortcomings. The total score is not intended to be applied to specific populations such as liver failure or HIV patients subjects and is not accurate when dealing with patients subjects transferred from another unit or another hospital. This is known as lead time bias and is addressed in APACHE III. hospital.

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showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ADQRS-326

The APACHE II total score must be recalibrated before it can be used in a population other than the general ICU population. ICU

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 ICU prediction scores in general need to be periodically recalibrated to reflect changes and improvements in practice and patient subject demographics. Be sure to discuss the use of this instrument with the appropriate regulatory authorities.

2     Rules and References

The primary source used in the development of this supplement is Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system . Critical Care Medicine 1985; 13(10):818–29. [1].

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showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ADQRS-328

All links are valid and referenced information is current as of the date of this ADaMIG QRS supplement. This supplement does not make recommendations for the handling of missing data or adoption of imputation methods.

3     Scoring Software

There is no known publicly available scoring software as of the date of this ADaMIG QRS supplement.

4     Introduction to the Instrument   

The APACHE II is a severity-of-disease classification system that uses a point score based on the initial values of 12 routine physiologic measurements, age, and previous health status. Scores range from 0 to 71 and higher scores correspond to more severe disease and a higher risk of death. The composite score is based on findings represented in other SDTM domains such as Laboratory Test Results (LB) and Vital Signs (VS).

5     Key Data Checks

The computed total score consists of integer values ranging from 0 to 71. The classification system consists of 11 physiology measures based on a numeric rating scale ( 0 -4) to 4,

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showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ADQRS-329

where 0 reflects values within the normal range and an increase in the numeric rating scale represents an increase in the abnormality of the physiology measure in either the high or low direction. The final physiology measure, For Serum Creatinine, the measure is assessed on the same scale but double points are assigned for subjects with acute renal failure. The measure evaluating extent of impaired consciousness is calculated as 15 minus the Glasgow Coma Score Scale (GCS) Score, is reversed; so that lower scores indicate mild or no head injury impairment and higher scores represent more severe impairment (possible head and/or central nervous system injury) and range from ( 0 -to 12). Chronological age is divided into disjoint categories and age groups which are assigned values of ( 0, 2, 3, 5, or 6

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showSummary false server Issue Tracker (JIRA)

. For patients with

serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ADQRS-330

.

For subjects with a history of severe organ system insufficiency or who are immunocompromised, a numeric rating of 2 or 5 is assigned for chronic health points, where 2 is assigned “for elective postoperative subjects” and 5 is assigned “for nonoperative or emergency postoperative subjects”. For subjects who do not have a history of severe organ system insufficiency or who are not immunocompromised, a numeric rating of 2 or 5 is assigned for chronic health points, where 2 is assigned “for elective postoperative patients” and 5 is assigned “for nonoperative or emergency postoperative patients”, a NOT DONE record may be retained from the source RS domain with the conditional branching flag (RSCBRFL="Y") populated. Additionally, a sponsor may choose to set AVAL=0 for subjects who do not meet the criteria for assigning chronic health points. This decision must be clearly documented, as the analysis value of 0 is logically derived or implied.

6     Example

6.1   Background

Analyses based on ADaM datasets may vary depending on the sponsor, therapeutic area, and the needs of regulatory authorities in their decision-making processes. This fictional example is provided for illustrative purposes only. The ADaM dataset describing the analysis results from an instrument is based on the protocol and statistical analysis plan (SAP) for the individual study.

The example dataset described here is intended to support a variety of analyses, ranging from simple univariate summary statistics on the actual total scores to other types of by-visit and repeated-measure analyses. For that reason, standard ADaM BDS variables such as AVAL (analysis value) have been included in the example. In addition, although not illustrated in the example, the APACHE II total score can be divided into categories (e.g., <17, >=17) reflecting disease severity or risk of death, and the frequency of subjects reporting in each category may be generated or used for analysis.

In the example presented here, it is assumed that the final APACHE II analysis dataset (ADAPCH) contains all of the original records, plus a record for the computed total acute physiology score and a record for the computed total APACHE II for each patient subject and assessment timepoint. The date of the assessment—and time of the assessment, if collected—should also be included in the dataset. For traceability, raw item-level responses from the SDTM RS.RSORRES variable, stored separately from the analysis variable AVAL, are included. Derivation type (DTYPE) should be used to clearly indicate records where missing values have been imputed using sponsor-defined imputation methods. If useful for analysis, a summary analysis dataset which includes only the computed total score records may also be created.

6.2   Example Analysis Dataset, Variable and Value-level Metadata

The ADAPCH Dataset Metadata table shows an example of how the APACHE II may be implemented in ADaM. The dataset metadata is a recommendation for the dataset name, label, structure, and keys. These can be modified for sponsor-specific standards and analyses. 

Definexmltable
Level Dataset Purpose Analysis Name ADAPCH
Dataset Label Structure Keys Class ADAPCH APACHE II Analysis Dataset 1 record per subject per analysis visit per parameter. USUBJID, AVISITN, ADT, PARAMN BASIC DATA STRUCTURE

The ADAPCH Variable Metadata table contains an example of analysis variable metadata for a subset of possible variables available for the APACHE II. Example value-level metadata are found in the Parameter Value Level List - ADAPCH [AVAL] metadata table. The ADAPCH Variable Metadata table does not include all of the possible variables that may be present in the Subject-Level Analysis Dataset (ADSL) and copied to the BDS structure analysis dataset, with the exception of the required STUDYID and USUBJID. For a complete list of available ADSL variables, consult the ADaMIG. Some ADSL variables (e.g., REGION1) were included in this example for stratification, and are not required. Additional covariates or other variables may be added as needed for analysis. Common BDS variables such as BASE and CHG have been omitted from the example as the majority analyses of APACHE II do not use these variables. There is no specific ordering of variables recommended in this supplement. The SDTM variables were placed next to the corresponding derived ADaM variables for illustration purposes only. 

Definexmltable
Multiple true Extra User Notes Dataset ADAPCH Level Variable Purpose Analysis
Variable Name Variable Label Type Controlled Terms Source Derivation User Notes STUDYID Study Identifier Char RS.STUDYID USUBJID Unique Subject Identifier Char RS.USUBJID SITEID Site Identifier  Char  ADSL.SITEID  RSSEQ Sequence Number Num RS.RSSEQ RSSEQ is included to provide traceability back to SDTM. ASEQ Analysis Sequence Number Num After sorting by key variables, renumber all the records from 1 to n within a subject. Provides a sequence number to derived rows which are not present in RSSEQ. ITTFL Intent-to-Treat Population Flag Char “Y”, “N” ADSL.ITTFL Conditional; must include at least 1 population flag. TRTP Planned Treatment Char "DRUG A + SOC", "SOC" Derivation should be defined by sponsor according to analysis needs.    Conditional; should include at least 1 treatment variable (e.g., TRTP, TRTA, TRTSEQP, TRT01P). PARAM Parameter Char   See Parameter Value Level List - ADAPCH table. PARAMCD Parameter Code  Char See Parameter Value Level List - ADAPCH table. PARAMN Parameter Number Num Number of the item in the order it appears on the form; assign a higher value to the derived total score record. PARCAT1 Parameter Category 1 Char "APACHE II" Set to RS.RSCAT for records that come directly from SDTM and "APACHE II" for any derived records such as total scores. VISIT Visit Name Char RS.VISIT RS.VISIT included for traceability. VISITNUM Visit Number Num RS.VISITNUM RS.VISITNUM included for traceability. AVISIT Analysis Visit Char AVISIT represents the analysis visit for the record. Refer to the SAP for additional details. AVISITN Analysis Visit (N) Num A numeric representation of AVISIT.  RSDTC Date/Time of Finding Char RS.RSDTC RS.RSDTC included for traceability. ADT Analysis Date Num Date portion of RS.RSDTC converted to numeric and displayed in a format such as DATE9. For derived total score records where PARAMCD in ("APCH1TPS" "APCH1TS"), this information will be copied from the individual records that comprise that instrument. ADY Analysis Relative Day Num ADT-ADSL.TRTSDT+1 if ADT≥TRTSDT; else, ADT-ADSL.TRTSDT if ADT<TRTSDT. This derivation is for example only. RSORRES Finding in Original Units Char RS.RSORRES RSORRESU Original Units Char RS.RSORRESU RSCBRFL Conditionally Branched Item Flag Char "Y" SUPPRS.RSCBRFL Represents that this item was '"NOT DONE' " due to conditional branching. AVAL is not populated on this record for this item due to conditional branching. AVAL Analysis Value Num See Parameter Value Level List - ADAPCH table. DTYPE Derivation Type Char "WOC" ABLFL Baseline Record Flag Char “Y” Set ABLFL="Y" on the record defined as the baseline value. This flag will only be populated on the derived acute physiology and APACHE II total score records (PARAMCD in ("APCH1TPS" "APCH1TS")) in this example. COUNTRY Country Char ADSL.COUNTRY Permissible if needed for analysis. Generally represented using ISO 3166-1 Alpha-3. Note that regulatory agency specific requirements (e.g., US FDA) may require other terminologies; in such cases, follow regulatory requirements.     REGION1 Geographic Region 1 Char ADSL.REGION1 Permissible if needed for analysis. REGION1N Geographic Region 1 (N) Num ADSL.REGION1N Permissible if needed for analysis.

...

Definexmltable
Extra User Notes Dataset ADAPCH Level Value Purpose Analysis Name AVAL
Variable Where Type Controlled Terms Source Derivation User Notes AVAL PARAMCD NOT IN NOTIN ("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 questions items are missing. Note that one out of the following two items: RSTESTCD=among item pairs RSTESTCD in ("APCH105A" or , "APCH105B" must be answered or RSTESTCD=) as well as RSTESTCD in ("APCH106A" or , "APCH106B" but ) only one item is expected to be answered and not both, respectively. The expectation is that issues with that issues pertaining to conditional branching (e.g., both items answered) are queried and fixed in SDTM RS. If this is not possible, the statistician will provide guidance and documentation of how to conduct the analysis given the circumstance (e.g. worst score). AVAL PARAMCD EQ "APCH1TS" (APCH1-Total APACHE II Score - Analysis) Num The sum of RS.RSSTRESN for RS.RSTESTCD in ("APCH101"-"APCH112") and "APCH114", "APCH115" if no questions items are missing. Note that one out of the following two items: RSTESTCD=among item pairs RSTESTCD in ("APCH105A" or , "APCH105B" must be answered or RSTESTCD=) as well as RSTESTCD in ("APCH106A" or , "APCH106B" but ) only one item is expected to be answered and not both, respectively. If a subject dies on or before Day 15, they are assigned the highest observed APACHE II score of any of the subjects at any time during the trial for their Total APACHE II Score at Day 15 (Day of Discharge). The assignment of the highest observed APACHE II score is for illustration purposes only and not meant as a recommendation. PARAMCD PARAMCD NOT IN NOTIN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) Char APCH1TC See CDISC Controlled Terminology for Clinical Classification Test Codes. RS.RSTESTCD for responses to individual questions items copied from SDTM. PARAMCD PARAMCD IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) Char APCH1PC See CDISC Controlled Terminology for Parameter Codes. PARAM PARAMCD NOT IN NOTIN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) Char APCH1TN See CDISC Controlled Terminology for Clinical Classification Test Names. RS.RSTEST for responses to individual questions items copied from SDTM. PARAM PARAMCD IN ("APCH1TPS" (APCH1-A: Total Acute Physiology Score - Analysis), "APCH1TS" (APCH1-Total APACHE II Score - Analysis)) Char APCH1PN See CDISC Controlled Terminology for Parameter Names.

6.3   Example Analysis Dataset 

The APACHE II Analysis Dataset tables below show the terminology and variables for implementing the example analysis dataset for this instrument in the BDS. This specific example is taken from a Phase II, randomized, controlled, open label multi-center study to assess the efficacy and safety of Drug A for the treatment of SARS-CoV-2 infected patients subjects with COVID-19 pneumonia and impaired respiratory function. The primary outcome measure is APACHE II Severity of Disease Score on Day 15 or on the Day of Discharge (Whichever whichever is Earlierearlier). This measure compares "Drug A + Standard of Care SOC" with "SOC" (SOC ) versus the = Standard of Care (SOC). 

In this example, the APACHE II score was measured within 24 hours of ICU admission, on or before Day 1 (prior to implementation of treatment), Day 7, and Day 15 or on the day of discharge (whichever was earlier). In the example, as per the SAP, participants subjects who died on Day 15 or earlier were assigned the highest observed APACHE II score of any of the participants subjects at any time during the trial (worst case imputation for deaths). This imputation method is for example purposes only and not meant to be a recommendation nor considered a common practice. Missing data values of for the parameters required for the derivation of the APACHE II score were replaced by the last available assessment. Item level imputation, in this example, is handled by the investigators and/or clinicians at the site and is considered source data, already captured in SDTM. The  --LNKID variable can be used to determine the source or input record used to assess that particular physiological item on APACHE II at that time point. SOC included a variety of supportive therapies that ranged from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral treatment, convalescent plasma, corticosteroids, antibiotics or other agents.

In the example, the SAP specifies that planned collected visits, including baseline measurements, are to be used in analyses and displays of results. In fact, no Unscheduled Visits 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 at that visit for the scoring of APACHE II. The records for 2 subjects are shown in the example datasets. The data for 3 visits is shown for the first subject, with no missing data. The data for 1 visit is shown for the second subject, who died before the Day 15 (Day of Discharge) Visit so the APACHE II total score is imputed to the worst case value of any subjects across any timepoints at that visit. Note that the worst case value is not shown in the sample data.

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The APACHE II Complete Analysis Dataset table shows all of the individual question item 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.

Dataset wrap
Name adapch
Dataset2 RSTEST Row STUDYID USUBJID SITEID RSSEQ ASEQ ITTFL TRTP PARAM PARAMCD PARAMN PARCAT1 VISIT VISITNUM AVISIT AVISITN RSDTC ADT ADY RSORRES RSORRESU RSCBRFL AVAL DTYPE ABLFL COUNTRY REGION1 REGION1N RSTESTCD RSCAT RSSTAT RSDY 1 STUDYX X-100-P0001 100 1 1 Y DRUG A + SOC APCH1-Temperature - Rectal APCH101 1 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 38.5-38.9 C 1 USA North America 1 APCH101 APCH1-Temperature - Rectal APACHE II -5 2 STUDYX X-100-P0001 100 2 2 Y DRUG A + SOC APCH1-Mean Arterial Pressure APCH102 2 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 110-129 mmHg 2 USA North America 1APCH102 APCH1-Mean Arterial Pressure APACHE II -5 3 STUDYX X-100-P0001 100 3 3 Y DRUG A + SOC APCH1-Heart Rate APCH103 3 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 70-109 beats/min 0 USA North America 1 APCH103 APCH1-Heart Rate APACHE II -5 4 STUDYX X-100-P0001 100 4 4 Y DRUG A + SOC APCH1-Respiratory Rate APCH104 4 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 25-34 breaths/min 1 USA North America 1 APCH104 APCH1-Respiratory Rate APACHE II 1-5 5 STUDYX X-100-P0001 100 5 5 Y DRUG A + SOC APCH1-Oxygenation: A-aDO2 APCH105A 5 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 Y USA North America 1 APCH105A APCH1-Oxygenation: A-aDO2 APACHE II NOT DONE -5 6 STUDYX X-100-P0001 100 6 6 Y DRUG A + SOC APCH1-Oxygenation: PaO2 APCH105B 6 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 61-70 mmHg 1 USA North America 1 APCH105B APCH1-Oxygenation: PaO2 APACHE II -5 7 STUDYX X-100-P0001 100 7 7 Y DRUG A + SOC APCH1-Arterial pH APCH106A 7 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 7.15-7.24 3 USA North America 1APCH106A APCH1-Arterial pH APACHE II -5 8 STUDYX X-100-P0001 100 8 8 Y DRUG A + SOC APCH1-Serum HCO3 APCH106B 8 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 Y USA North America 1 APCH106B APCH1-Serum HCO3 APACHE II NOT DONE -5 9 STUDYX X-100-P0001 100 9 9 Y DRUG A + SOC APCH1-Serum Sodium APCH107 9 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 150-154 mmol/L 1 USA North America 1 APCH107 APCH1-Serum Sodium APACHE II -5 10 STUDYX X-100-P0001 100 10 10 Y DRUG A + SOC APCH1-Serum Potassium APCH108 10 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 3.5-5.4 mmol/L 0 USA North America 1 APCH108 APCH1-Serum Potassium APACHE II -5 11 STUDYX X-100-P0001 100 11 11 Y DRUG A + SOC APCH1-Serum Creatinine APCH109 11 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 <0.6 mg/dL 2 USA North America 1 APCH109 APCH1-Serum Creatinine APACHE II -5 12 STUDYX X-100-P0001 100 12 12 Y DRUG A + SOC APCH1-Hematocrit APCH110 12 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 20-29.9 % 2 USA North America 1 APCH110 APCH1-Hematocrit APACHE II -5 13 STUDYX X-100-P0001 100 13 13 Y DRUG A + SOC APCH1-White Blood Count APCH111 13 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 20-39.9 10^9/L 2 USA North America 1 APCH111 APCH1-White Blood Count APACHE II -5 14 STUDYX X-100-P0001 100 14 14 Y DRUG A + SOC APCH1-15 Minus Glasgow Coma Score APCH112 14 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 3 3 USA North America 1APCH112 APCH1-15 Minus Glasgow Coma Score APACHE II -5 15 STUDYX X-100-P0001 100 15 15 Y DRUG A + SOC APCH1-A: Total Acute Physiology Score APCH113 15 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 18 18 USA North America 1 APCH113 APCH1-A: Total Acute Physiology Score APACHE II -5 16 STUDYX X-100-P0001 100 16 Y DRUG A + SOC APCH1-A: Total Acute Physiology Score - Analysis APCH1TPS 16 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 18 Y USA North America 1 -5 17 STUDYX X-100-P0001 100 16 17 Y DRUG A + SOC APCH1-B: Age Points APCH114 17 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 45-54 YEARS 2 USA North America 1 APCH114 APCH1-B: Age Points APACHE II -5 18 STUDYX X-100-P0001 100 17 18 Y DRUG A + SOC APCH1-C: Chronic Health Points APCH115 18 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 for elective postoperative patients 2 USA North America 1 APCH115 APCH1-C: Chronic Health Points APACHE II America 1-5 19 STUDYX X-100-P0001 100 18 19 Y DRUG A + SOC APCH1-Total APACHE II Score APCH116 19 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 22 22 USA North America 1 APCH116 APCH1-Total APACHE II Score APACHE II -5 20 STUDYX X-100-P0001 100 20 Y DRUG A + SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II SCREENING 1 Baseline 0 20142020-06-2429 24JUN201429JUN2020 -51 22 Y USA North America 1 -5 21 STUDYX X-100-P0001 100 19 21 Y DRUG A + SOC APCH1-Temperature - Rectal APCH101 1 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 38.5-38.9 C 1 USA North America 1 APCH101 APCH1-Temperature - Rectal APACHE II 7 22 STUDYX X-100-P0001 100 20 22 Y DRUG A + SOC APCH1-Mean Arterial Pressure APCH102 2 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 70–109 mmHg 0 USA North America 1APCH102 APCH1-Mean Arterial Pressure APACHE II 7 23 STUDYX X-100-P0001 100 21 23 Y DRUG A + SOC APCH1-Heart Rate APCH103 3 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 70-109 beats/min 0 USA North America 1 APCH103 APCH1-Heart Rate APACHE II 7 24 STUDYX X-100-P0001 100 22 24 Y DRUG A + SOC APCH1-Respiratory Rate APCH104 4 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 25-34 breaths/min 1 USA North America 1 APCH104 APCH1-Respiratory Rate APACHE II America 17 25 STUDYX X-100-P0001 100 23 25 Y DRUG A + SOC APCH1-Oxygenation: A-aDO2 APCH105A 5 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 Y USA North America 1APCH105A APCH1-Oxygenation: A-aDO2 APACHE II NOT DONE 7 26 STUDYX X-100-P0001 100 24 26 Y DRUG A + SOC APCH1-Oxygenation: PaO2 APCH105B 6 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 61-70 mmHg 1 USA North America 1 APCH105B APCH1-Oxygenation: PaO2 APACHE II 7 27 STUDYX X-100-P0001 100 25 27 Y DRUG A + SOC APCH1-Arterial pH APCH106A 7 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 7.25-7.32 2 USA North America 1 APCH106A APCH1-Arterial pH APACHE II 7 28 STUDYX X-100-P0001 100 26 28 Y DRUG A + SOC APCH1-Serum HCO3 APCH106B 8 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 Y USA North America 1APCH106B APCH1-Serum HCO3 APACHE II NOT DONE 7 29 STUDYX X-100-P0001 100 27 29 Y DRUG A + SOC APCH1-Serum Sodium APCH107 9 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 150-154 mmol/L 1 USA North America 1 APCH107 APCH1-Serum Sodium APACHE II 7 30 STUDYX X-100-P0001 100 28 30 Y DRUG A + SOC APCH1-Serum Potassium APCH108 10 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 3.5-5.4 mmol/L 0 USA North America 1 APCH108 APCH1-Serum Potassium APACHE II USA North America 17 31 STUDYX X-100-P0001 100 29 31 Y DRUG A + SOC APCH1-Serum Creatinine APCH109 11 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 0.6-1.4 mg/dL 0 USA North America 1 APCH109 APCH1-Serum Creatinine APACHE II 7 32 STUDYX X-100-P0001 100 30 32 Y DRUG A + SOC APCH1-Hematocrit APCH110 12 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 20-29.9 % 2 USA North America 1 APCH110 APCH1-Hematocrit APACHE II 7 33 STUDYX X-100-P0001 100 31 33 Y DRUG A + SOC APCH1-White Blood Count APCH111 13 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 15-19.9 10^9/L 1 USA North America 1 APCH111 APCH1-White Blood Count APACHE II 7 34 STUDYX X-100-P0001 100 32 34 Y DRUG A + SOC APCH1-15 Minus Glasgow Coma Score APCH112 14 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 1 1 USA North America 1APCH112 APCH1-15 Minus Glasgow Coma Score APACHE II 7 35 STUDYX X-100-P0001 100 33 35 Y DRUG A + SOC APCH1-A: Total Acute Physiology Score APCH113 15 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 10 10 USA North America 1 APCH113 APCH1-A: Total Acute Physiology Score APACHE II 7 36 STUDYX X-100-P0001 100 36 Y DRUG A + SOC APCH1-A: Total Acute Physiology Score - Analysis APCH1TPS 16 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 10 USA North America 17 37 STUDYX X-100-P0001 100 34 37 Y DRUG A + SOC APCH1-B: Age Points APCH114 17 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 45-54 YEARS 2 USA North America 1 APCH114 APCH1-B: Age Points APACHE II 7 38 STUDYX X-100-P0001 100 35 38 Y DRUG A + SOC APCH1-C: Chronic Health Points APCH115 18 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 for elective postoperative patients 2 USA North America 1 APCH115 APCH1-C: Chronic Health Points APACHE II 7 39 STUDYX X-100-P0001 100 36 39 Y DRUG A + SOC APCH1-Total APACHE II Score APCH116 19 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 14 14 USA North America 1 APCH116 APCH1-Total APACHE II Score APACHE II 7 40 STUDYX X-100-P0001 100 40 Y DRUG A + SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II DAY 7 7 Day 7 7 20142020-07-05 05JUL201405JUL2020 7 14 USA North America 17 41 STUDYX X-100-P0001 100 37 41 Y DRUG A + SOC APCH1-Temperature - Rectal APCH101 1 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 36-38.4 C 0 USA North America 1APCH101 APCH1-Temperature - Rectal APACHE II 15 42 STUDYX X-100-P0001 100 38 42 Y DRUG A + SOC APCH1-Mean Arterial Pressure APCH102 2 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 70–109 mmHg 0 USA North America 1 APCH102 APCH1-Mean Arterial Pressure APACHE II 15 43 STUDYX X-100-P0001 100 39 43 Y DRUG A + SOC APCH1-Heart Rate APCH103 3 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 70-109 beats/min 0 USA North America 1 APCH103 APCH1-Heart Rate APACHE II 15 44 STUDYX X-100-P0001 100 40 44 Y DRUG A + SOC APCH1-Respiratory Rate APCH104 4 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 12–24 breaths/min 0 USA North America 1APCH104 APCH1-Respiratory Rate APACHE II 15 45 STUDYX X-100-P0001 100 41 45 Y DRUG A + SOC APCH1-Oxygenation: A-aDO2 APCH105A 5 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 Y USA North America 1 APCH105A APCH1-Oxygenation: A-aDO2 APACHE II NOT DONE 15 46 STUDYX X-100-P0001 100 42 46 Y DRUG A + SOC APCH1-Oxygenation: PaO2 APCH105B 6 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 61-70 mmHg 1 USA North America 1APCH105B APCH1-Oxygenation: PaO2 APACHE II 15 47 STUDYX X-100-P0001 100 43 47 Y DRUG A + SOC APCH1-Arterial pH APCH106A 7 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 7.33-7.49 0 USA North America 1APCH106A APCH1-Arterial pH APACHE II 15 48 STUDYX X-100-P0001 100 44 48 Y DRUG A + SOC APCH1-Serum HCO3 APCH106B 8 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 Y USA North America 1APCH106B APCH1-Serum HCO3 APACHE II NOT DONE 15 49 STUDYX X-100-P0001 100 45 49 Y DRUG A + SOC APCH1-Serum Sodium APCH107 9 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 130-149 mmol/L 0 USA North America 1 APCH107 APCH1-Serum Sodium APACHE II America 115 50 STUDYX X-100-P0001 100 46 50 Y DRUG A + SOC APCH1-Serum Potassium APCH108 10 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 3.5-5.4 mmol/L 0 USA North America 1APCH108 APCH1-Serum Potassium APACHE II 15 51 STUDYX X-100-P0001 100 47 51 Y DRUG A + SOC APCH1-Serum Creatinine APCH109 11 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 0.6-1.4 mg/dL 0 USA North America 1 APCH109 APCH1-Serum Creatinine APACHE II 15 52 STUDYX X-100-P0001 100 48 52 Y DRUG A + SOC APCH1-Hematocrit APCH110 12 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 46-49.9 % 1 USA North America 1 APCH110 APCH1-Hematocrit APACHE II 15 53 STUDYX X-100-P0001 100 49 53 Y DRUG A + SOC APCH1-White Blood Count APCH111 13 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 3-14.9 10^9/L 0 USA North America 1 APCH111 APCH1-White Blood Count APACHE II 15 54 STUDYX X-100-P0001 100 50 54 Y DRUG A + SOC APCH1-15 Minus Glasgow Coma Score APCH112 14 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 0 0 USA North America 1 APCH112 APCH1-15 Minus Glasgow Coma Score APACHE II 15 55 STUDYX X-100-P0001 100 51 55 Y DRUG A + SOC APCH1-A: Total Acute Physiology Score APCH113 15 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 2 2 USA North America 1 APCH113 APCH1-A: Total Acute Physiology Score APACHE II USA North America 115 56 STUDYX X-100-P0001 100 56 Y DRUG A + SOC APCH1-A: Total Acute Physiology Score - Analysis APCH1TPS 16 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 2 USA North America 1 15 57 STUDYX X-100-P0001 100 52 57 Y DRUG A + SOC APCH1-B: Age Points APCH114 17 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 45-54 YEARS 2 USA North America 1 APCH114 APCH1-B: Age Points APACHE II 15 58 STUDYX X-100-P0001 100 53 58 Y DRUG A + SOC APCH1-C: Chronic Health Points APCH115 18 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 for elective postoperative patients 2 USA North America 1 APCH115 APCH1-C: Chronic Health Points APACHE II 15 59 STUDYX X-100-P0001 100 54 59 Y DRUG A + SOC APCH1-Total APACHE II Score APCH116 19 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 6 6 USA North America 1 APCH116 APCH1-Total APACHE II Score APACHE II 15 60 STUDYX X-100-P0001 100 60 Y DRUG A + SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 20142020-07-13 13JUL201413JUL2020 15 6 USA North America 1 15 61 STUDYX X-200-P0002 200 1 1 Y SOC APCH1-Temperature - Rectal APCH101 1 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 38.5-38.9 C 1 GBR Non-North America 0 APCH101 APCH1-Temperature - Rectal APACHE II -2 62 STUDYX X-200-P0002 200 2 2 Y SOC APCH1-Mean Arterial Pressure APCH102 2 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 110-129 mmHg 2 GBR Non-North America 0 APCH102 APCH1-Mean Arterial Pressure APACHE II -2 63 STUDYX X-200-P0002 200 3 3 Y SOC APCH1-Heart Rate APCH103 3 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 70-109 beats/min 0 GBR Non-North America 0 APCH103 APCH1-Heart Rate APACHE II -2 64 STUDYX X-200-P0002 200 4 4 Y SOC APCH1-Respiratory Rate APCH104 4 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 >=50 breaths/min 4 GBR Non-North America 0APCH104 APCH1-Respiratory Rate APACHE II -2 65 STUDYX X-200-P0002 200 5 5 Y SOC APCH1-Oxygenation: A-aDO2 APCH105A 5 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 Y GBR Non-North America 0 APCH105A APCH1-Oxygenation: A-aDO2 APACHE II NOT DONE -2 66 STUDYX X-200-P0002 200 6 6 Y SOC APCH1-Oxygenation: PaO2 APCH105B 6 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 61-70 mmHg 1 GBR Non-North America 0 APCH105B APCH1-Oxygenation: PaO2 APACHE II 1 GBR Non-North America 0-2 67 STUDYX X-200-P0002 200 7 7 Y SOC APCH1-Arterial pH APCH106A 7 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 <7.15 4 GBR Non-North America 0 APCH106A APCH1-Arterial pH APACHE II -2 68 STUDYX X-200-P0002 200 8 8 Y SOC APCH1-Serum HCO3 APCH106B 8 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 Y GBR Non-North America 0 APCH106B APCH1-Serum HCO3 APACHE II NOT DONE -2 69 STUDYX X-200-P0002 200 9 9 Y SOC APCH1-Serum Sodium APCH107 9 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 150-154 mmol/L 1 GBR Non-North America 0 APCH107 APCH1-Serum Sodium APACHE II -2 70 STUDYX X-200-P0002 200 10 10 Y SOC APCH1-Serum Potassium APCH108 10 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 3.5-5.4 mmol/L 0 GBR Non-North America 0 APCH108 APCH1-Serum Potassium APACHE II -2 71 STUDYX X-200-P0002 200 11 11 Y SOC APCH1-Serum Creatinine APCH109 11 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 <0.6 mg/dL 2 GBR Non-North America 0 APCH109 APCH1-Serum Creatinine APACHE II -2 72 STUDYX X-200-P0002 200 12 12 Y SOC APCH1-Hematocrit APCH110 12 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 20-29.9 % 2 GBR Non-North America 0 APCH110 APCH1-Hematocrit APACHE II -2 73 STUDYX X-200-P0002 200 13 13 Y SOC APCH1-White Blood Count APCH111 13 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 >=40 10^9/L 4 GBR Non-North America 0 APCH111 APCH1-White Blood Count APACHE II -2 74 STUDYX X-200-P0002 200 14 14 Y SOC APCH1-15 Minus Glasgow Coma Score APCH112 14 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 3 3 GBR Non-North America 0APCH112 APCH1-15 Minus Glasgow Coma Score APACHE II -2 75 STUDYX X-200-P0002 200 15 15 Y SOC APCH1-A: Total Acute Physiology Score APCH113 15 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 24 24 GBR Non-North America 0 APCH113 APCH1-A: Total Acute Physiology Score APACHE II -2 76 STUDYX X-200-P0002 200 16 Y SOC APCH1-A: Total Acute Physiology Score - Analysis APCH1TPS 16 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 24 Y GBR Non-North America 0-2 77 STUDYX X-200-P0002 200 16 17 Y SOC APCH1-B: Age Points APCH114 17 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 65-74 YEARS 5 GBR Non-North America 0 APCH114 APCH1-B: Age Points APACHE II -2 78 STUDYX X-200-P0002 200 17 18 Y SOC APCH1-C: Chronic Health Points APCH115 18 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 for elective postoperative patients 2 GBR Non-North America 0 APCH115 APCH1-C: Chronic Health Points APACHE II -2 79 STUDYX X-200-P0002 200 18 19 Y SOC APCH1-Total APACHE II Score APCH116 19 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 31 31 GBR Non-North America 0APCH116 APCH1-Total APACHE II Score APACHE II -2 80 STUDYX X-200-P0002 200 20 Y SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II SCREENING 1 Baseline 0 20142020-08-0304 03AUG201404AUG2020 -21 31 Y GBR Non-North America 0 -2 81 STUDYX X-200-P0002 200 21 Y SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II Day 15 (Day of Discharge) 15 09AUG201409AUG2020 5 38 WOC GBR Non-North America 0

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Due to the number of items on the 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.   RSSEQ was not included in this example because it would be null for all computed total score records. RSORRES is not shown because only derived total score records are displayed.

Dataset wrap
Name adapchs
Dataset2 Row STUDYID USUBJID SITEID ASEQ ITTFL TRTP PARAM PARAMCD PARAMN PARCAT1 VISIT VISITNUM AVISIT AVISITN ADT ADY AVAL DTYPE ABLFL COUNTRY REGION1 REGION1N 20 STUDYX X-100-P0001 100 20 Y DRUG A + SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II SCREENING 1 Baseline 0 24JUN201429JUN2020 -51 22 Y USA North America 1 40 STUDYX X-100-P0001 100 40 Y DRUG A + SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II DAY 7 7 Day 7 7 05JUL201405JUL2020 7 14 USA North America 1 60 STUDYX X-100-P0001 100 60 Y DRUG A + SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II DAY 15 15 Day 15 (Day of Discharge) 15 13JUL201413JUL2020 15 6 USA North America 1 80 STUDYX X-200-P0002 200 20 Y SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II SCREENING 1 Baseline 0 03AUG201404AUG2020 -21 31 Y GBR Non-North America 0 81 STUDYX X-200-P0002 200 21 Y SOC APCH1-Total APACHE II Score - Analysis APCH1TS 20 APACHE II Day 15 (Day of Discharge) 15 09AUG201409AUG2020 5 38 WOC GBR Non-North America 0

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