...
The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity of disease measurement and mortality estimation tool for adult 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 to create a total score. This instrument is generally collected once at Screening/Baseline. 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, with a variable in variable in ADSL copied directly from a result/value in SDTM may be sufficient to support analysis needs.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-325 |
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...
Although the APACHE II total score is the most widely used ICU mortality prediction score, 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 subjects and is not accurate when dealing with subjects transferred from another unit or another hospital. This is known as lead time bias and is addressed in APACHE III.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-326 |
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The APACHE II total score must be recalibrated before it can be used in a population other than the general ICU population.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-327 |
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. ICU ICU prediction scores in general need to be periodically recalibrated to reflect changes and improvements in practice and subject demographics. Be sure to discuss the use of this instrument with the appropriate regulatory authorities.
...
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].| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-328 |
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.
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.
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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 to 4,| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-329 |
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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. 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 Scale (GCS) Score, so that lower scores indicate mild or no 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 age groups which are assigned values of 0, 2, 3, 5, or 6| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | ADQRS-330 |
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.
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 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.
...
| 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 items are missing. Note that among item pairs RSTESTCD in ("APCH105A", "APCH105B") as well as RSTESTCD in ("APCH106A", "APCH106B") only one item is expected to be answered and not both, respectively. | The expectation is 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 items are missing. Note that among item pairs RSTESTCD in ("APCH105A", "APCH105B") as well as RSTESTCD in ("APCH106A", "APCH106B") 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 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 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. |
|
|
...
| Dataset wrap |
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|
| Dataset2 |
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| 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 |
|---|
| 1 | STUDYX | X-100-P0001 | 100 | 1 | 1 | Y | DRUG A + SOC | APCH1-Temperature - Rectal | APCH101 | 1 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 38.5-38.9 | C |
| 1 |
|
| USA | North America | 1 | | 2 | STUDYX | X-100-P0001 | 100 | 2 | 2 | Y | DRUG A + SOC | APCH1-Mean Arterial Pressure | APCH102 | 2 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 110-129 | mmHg |
| 2 |
|
| USA | North America | 1 | | 3 | STUDYX | X-100-P0001 | 100 | 3 | 3 | Y | DRUG A + SOC | APCH1-Heart Rate | APCH103 | 3 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 70-109 | beats/min |
| 0 |
|
| USA | North America | 1 | | 4 | STUDYX | X-100-P0001 | 100 | 4 | 4 | Y | DRUG A + SOC | APCH1-Respiratory Rate | APCH104 | 4 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 25-34 | breaths/min |
| 1 |
|
| USA | North America | 1 | | 5 | STUDYX | X-100-P0001 | 100 | 5 | 5 | Y | DRUG A + SOC | APCH1-Oxygenation: A-aDO2 | APCH105A | 5 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 |
|
| Y |
|
|
| USA | North America | 1 | | 6 | STUDYX | X-100-P0001 | 100 | 6 | 6 | Y | DRUG A + SOC | APCH1-Oxygenation: PaO2 | APCH105B | 6 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 61-70 | mmHg |
| 1 |
|
| USA | North America | 1 | | 7 | STUDYX | X-100-P0001 | 100 | 7 | 7 | Y | DRUG A + SOC | APCH1-Arterial pH | APCH106A | 7 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 7.15-7.24 |
|
| 3 |
|
| USA | North America | 1 | | 8 | STUDYX | X-100-P0001 | 100 | 8 | 8 | Y | DRUG A + SOC | APCH1-Serum HCO3 | APCH106B | 8 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 |
|
| Y |
|
|
| USA | North America | 1 | | 9 | STUDYX | X-100-P0001 | 100 | 9 | 9 | Y | DRUG A + SOC | APCH1-Serum Sodium | APCH107 | 9 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 150-154 | mmol/L |
| 1 |
|
| USA | North America | 1 | | 10 | STUDYX | X-100-P0001 | 100 | 10 | 10 | Y | DRUG A + SOC | APCH1-Serum Potassium | APCH108 | 10 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 3.5-5.4 | mmol/L |
| 0 |
|
| USA | North America | 1 | | 11 | STUDYX | X-100-P0001 | 100 | 11 | 11 | Y | DRUG A + SOC | APCH1-Serum Creatinine | APCH109 | 11 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | <0.6 | mg/dL |
| 2 |
|
| USA | North America | 1 | | 12 | STUDYX | X-100-P0001 | 100 | 12 | 12 | Y | DRUG A + SOC | APCH1-Hematocrit | APCH110 | 12 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 20-29.9 | % |
| 2 |
|
| USA | North America | 1 | | 13 | STUDYX | X-100-P0001 | 100 | 13 | 13 | Y | DRUG A + SOC | APCH1-White Blood Count | APCH111 | 13 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 20-39.9 | 10^9/L |
| 2 |
|
| USA | North America | 1 | | 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 | 2020-06-29 | 29JUN2020 | 1 | 3 |
|
| 3 |
|
| USA | North America | 1 | | 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 | 2020-06-29 | 29JUN2020 | 1 | 18 |
|
| 18 |
|
| USA | North America | 1 | | 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 | 2020-06-29 | 29JUN2020 | 1 |
|
|
| 18 |
| Y | USA | North America | 1 | | 17 | STUDYX | X-100-P0001 | 100 | 16 | 17 | Y | DRUG A + SOC | APCH1-B: Age Points | APCH114 | 17 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-06-29 | 29JUN2020 | 1 | 45-54 | YEARS |
| 2 |
|
| USA | North America | 1 | | 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 | 2020-06-29 | 29JUN2020 | 1 | for elective postoperative patients |
|
| 2 |
|
| USA | North America | 1 | | 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 | 2020-06-29 | 29JUN2020 | 1 | 22 |
|
| 22 |
|
| USA | North America | 1 | | 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 | 2020-06-29 | 29JUN2020 | 1 |
|
|
| 22 |
| Y | USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 38.5-38.9 | C |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 70–109 | mmHg |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 70-109 | beats/min |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 25-34 | breaths/min |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 |
|
| Y |
|
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 61-70 | mmHg |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 7.25-7.32 |
|
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 |
|
| Y |
|
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 150-154 | mmol/L |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 3.5-5.4 | mmol/L |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 0.6-1.4 | mg/dL |
| 0 |
|
| USA | North America | 1 | | 32 | STUDYX | X-100-P0001 | 100 | 30 | 32 | Y | DRUG A + SOC | APCH1-Hematocrit | APCH110 | 12 | APACHE II | DAY 7 | 7 | Day 7 | 7 | 2020-07-05 | 05JUL2020 | 7 | 20-29.9 | % |
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 15-19.9 | 10^9/L |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 1 |
|
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 10 |
|
| 10 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 |
|
|
| 10 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 45-54 | YEARS |
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | for elective postoperative patients |
|
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-05 | 05JUL2020 | 7 | 14 |
|
| 14 |
|
| 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 | 2020-07-05 | 05JUL2020 | 7 |
|
|
| 14 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 36-38.4 | C |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 70–109 | mmHg |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 70-109 | beats/min |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 12–24 | breaths/min |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 |
|
| Y |
|
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 61-70 | mmHg |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 7.33-7.49 |
|
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 |
|
| Y |
|
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 130-149 | mmol/L |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 3.5-5.4 | mmol/L |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 0.6-1.4 | mg/dL |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 46-49.9 | % |
| 1 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 3-14.9 | 10^9/L |
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 0 |
|
| 0 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 2 |
|
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 |
|
|
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 45-54 | YEARS |
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | for elective postoperative patients |
|
| 2 |
|
| USA | North America | 1 | | 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 | 2020-07-13 | 13JUL2020 | 15 | 6 |
|
| 6 |
|
| 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 | 2020-07-13 | 13JUL2020 | 15 |
|
|
| 6 |
|
| USA | North America | 1 | | 61 | STUDYX | X-200-P0002 | 200 | 1 | 1 | Y | SOC | APCH1-Temperature - Rectal | APCH101 | 1 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 38.5-38.9 | C |
| 1 |
|
| GBR | Non-North America | 0 | | 62 | STUDYX | X-200-P0002 | 200 | 2 | 2 | Y | SOC | APCH1-Mean Arterial Pressure | APCH102 | 2 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 110-129 | mmHg |
| 2 |
|
| GBR | Non-North America | 0 | | 63 | STUDYX | X-200-P0002 | 200 | 3 | 3 | Y | SOC | APCH1-Heart Rate | APCH103 | 3 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 70-109 | beats/min |
| 0 |
|
| GBR | Non-North America | 0 | | 64 | STUDYX | X-200-P0002 | 200 | 4 | 4 | Y | SOC | APCH1-Respiratory Rate | APCH104 | 4 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | >=50 | breaths/min |
| 4 |
|
| GBR | Non-North America | 0 | | 65 | STUDYX | X-200-P0002 | 200 | 5 | 5 | Y | SOC | APCH1-Oxygenation: A-aDO2 | APCH105A | 5 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 |
|
| Y |
|
|
| GBR | Non-North America | 0 | | 66 | STUDYX | X-200-P0002 | 200 | 6 | 6 | Y | SOC | APCH1-Oxygenation: PaO2 | APCH105B | 6 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 61-70 | mmHg |
| 1 |
|
| GBR | Non-North America | 0 | | 67 | STUDYX | X-200-P0002 | 200 | 7 | 7 | Y | SOC | APCH1-Arterial pH | APCH106A | 7 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | <7.15 |
|
| 4 |
|
| GBR | Non-North America | 0 | | 68 | STUDYX | X-200-P0002 | 200 | 8 | 8 | Y | SOC | APCH1-Serum HCO3 | APCH106B | 8 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 |
|
| Y |
|
|
| GBR | Non-North America | 0 | | 69 | STUDYX | X-200-P0002 | 200 | 9 | 9 | Y | SOC | APCH1-Serum Sodium | APCH107 | 9 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 150-154 | mmol/L |
| 1 |
|
| GBR | Non-North America | 0 | | 70 | STUDYX | X-200-P0002 | 200 | 10 | 10 | Y | SOC | APCH1-Serum Potassium | APCH108 | 10 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 3.5-5.4 | mmol/L |
| 0 |
|
| GBR | Non-North America | 0 | | 71 | STUDYX | X-200-P0002 | 200 | 11 | 11 | Y | SOC | APCH1-Serum Creatinine | APCH109 | 11 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | <0.6 | mg/dL |
| 2 |
|
| GBR | Non-North America | 0 | | 72 | STUDYX | X-200-P0002 | 200 | 12 | 12 | Y | SOC | APCH1-Hematocrit | APCH110 | 12 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 20-29.9 | % |
| 2 |
|
| GBR | Non-North America | 0 | | 73 | STUDYX | X-200-P0002 | 200 | 13 | 13 | Y | SOC | APCH1-White Blood Count | APCH111 | 13 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | >=40 | 10^9/L |
| 4 |
|
| GBR | Non-North America | 0 | | 74 | STUDYX | X-200-P0002 | 200 | 14 | 14 | Y | SOC | APCH1-15 Minus Glasgow Coma Score | APCH112 | 14 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 3 |
|
| 3 |
|
| GBR | Non-North America | 0 | | 75 | STUDYX | X-200-P0002 | 200 | 15 | 15 | Y | SOC | APCH1-A: Total Acute Physiology Score | APCH113 | 15 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 24 |
|
| 24 |
|
| GBR | Non-North America | 0 | | 76 | STUDYX | X-200-P0002 | 200 |
| 16 | Y | SOC | APCH1-A: Total Acute Physiology Score - Analysis | APCH1TPS | 16 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 |
|
|
| 24 |
| Y | GBR | Non-North America | 0 | | 77 | STUDYX | X-200-P0002 | 200 | 16 | 17 | Y | SOC | APCH1-B: Age Points | APCH114 | 17 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 65-74 | YEARS |
| 5 |
|
| GBR | Non-North America | 0 | | 78 | STUDYX | X-200-P0002 | 200 | 17 | 18 | Y | SOC | APCH1-C: Chronic Health Points | APCH115 | 18 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | for elective postoperative patients |
|
| 2 |
|
| GBR | Non-North America | 0 | | 79 | STUDYX | X-200-P0002 | 200 | 18 | 19 | Y | SOC | APCH1-Total APACHE II Score | APCH116 | 19 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 | 31 |
|
| 31 |
|
| GBR | Non-North America | 0 | | 80 | STUDYX | X-200-P0002 | 200 |
| 20 | Y | SOC | APCH1-Total APACHE II Score - Analysis | APCH1TS | 20 | APACHE II | SCREENING | 1 | Baseline | 0 | 2020-08-04 | 04AUG2020 | -1 |
|
|
| 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 |
| 09AUG2020 | 5 |
|
|
| 38 | WOC |
| GBR | Non-North America | 0 |
|
|
...
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 |
|---|
|
| 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 | 29JUN2020 | 1 | 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 | 05JUL2020 | 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 | 13JUL2020 | 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 | 04AUG2020 | -1 | 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 | 09AUG2020 | 5 | 38 | WOC |
| GBR | Non-North America | |
|
|
...