Difference between revisions of "Scriptathon2014 targets"

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Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’
  
Line 88: Line 88:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’
  
Line 107: Line 107:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, AVAL, BASE, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, BASE, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’
  
Line 125: Line 125:
 
''Boxplot of change from last baseline to last post-baseline measure by STUDYID and TRTPN''<br />
 
''Boxplot of change from last baseline to last post-baseline measure by STUDYID and TRTPN''<br />
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’
  
 
''Boxplot of change from minimum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
''Boxplot of change from minimum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
Dataset:  ADVSMIN<br />
 
Dataset:  ADVSMIN<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
  
 
''Boxplot of change from maximum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
''Boxplot of change from maximum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
Dataset:  ADVSMAX<br />
 
Dataset:  ADVSMAX<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
  
Line 153: Line 153:
 
''Boxplot of change from last baseline to last post-baseline measure by STUDYID and TRTPN''<br />
 
''Boxplot of change from last baseline to last post-baseline measure by STUDYID and TRTPN''<br />
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’<br />
 
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.
 
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.
Line 159: Line 159:
 
''Boxplot of change from minimum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
''Boxplot of change from minimum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
Dataset:  ADVSMIN<br />
 
Dataset:  ADVSMIN<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’<br />
 
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.
 
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.
Line 165: Line 165:
 
''Boxplot of change from maximum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
''Boxplot of change from maximum baseline to minimum post-baseline records by STUDYID and TRTPN''<br />
 
Dataset:  ADVSMAX<br />
 
Dataset:  ADVSMAX<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’<br />
 
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.
 
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.
Line 285: Line 285:
  
 
Dataset:  ADVSMAX<br />
 
Dataset:  ADVSMAX<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CRIT1FL<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CRIT1FL<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
  
Line 314: Line 314:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, CRIT1FL, CRIT2FL<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, CRIT1FL, CRIT2FL<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))
  
Line 335: Line 335:
  
 
Dataset:  ADVSMAX<br />
 
Dataset:  ADVSMAX<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CRIT1FL<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CRIT1FL<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
  
Line 359: Line 359:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  STUDYID, USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, CRIT1FL, CRIT2FL<br />
+
Variables:  STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, CRIT1FL, CRIT2FL<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))
  
Line 381: Line 381:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, AVISIT, AVISITN, CRIT1FL<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, AVISIT, AVISITN, CRIT1FL<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’
  
Line 406: Line 406:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, CRIT1, CRIT1FL, , CRIT2, CRIT2FL<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CRIT1, CRIT1FL, , CRIT2, CRIT2FL<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))
  
Line 431: Line 431:
  
 
Dataset:  ADVS<br />
 
Dataset:  ADVS<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CHGCAT1<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CHGCAT1<br />
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’ and BNRIND ne 'Missing' and ANRIND ne 'Missing'
 
Record Selection:  WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’ and BNRIND ne 'Missing' and ANRIND ne 'Missing'
  
Line 459: Line 459:
  
 
Dataset:  ADLBHY<br />
 
Dataset:  ADLBHY<br />
Variables:  USUBJID, TRTPN, PARAM, PARAMCD, R2A1HI<br />
+
Variables:  USUBJID, TRTP, TRTPN, PARAM, PARAMCD, R2A1HI<br />
 
Record Selection:  WHERE PARAMCD in ('ALT', 'BILI') and ANL01FL=’Y’ and SAFFL=’Y’
 
Record Selection:  WHERE PARAMCD in ('ALT', 'BILI') and ANL01FL=’Y’ and SAFFL=’Y’
  

Revision as of 09:51, 31 January 2015

This Wiki page contains the scripting targets associated with the 2014 Script-athon.

File:Scriptathon2014 targets.docx

General Programming Notes:

  • The page margins used in this document mirror the margins required for US regulatory submissions. TFL fits within 9.25” x 6” common text area.
  • This document contains generic titles and footnotes to aid review.
  • Titles must be centered.
  • Footnotes must be left justified
  • Placeholders for the program, output, date generated, and source data footnotes do not need to be displayed for each shell but will be produced for each TFL consistent with the standard macro output.
  • P-values should follow the formats below (these guidelines align with medical journal requirements):
  • For p > 0.1, report the p-value to 2 decimal places
  • For 0.1 > p > 0.001, report the p-value to 3 decimal places
  • For p < 0.001, report p < 0.001.
  • Decimal places for continous data summaries should follow these guidelines:
  • The mean and estimates of precision (eg, variance, SD, SE, Confidence Intervals) should be displayed to 1 more decimal place than the collected data as should distributional parameters (eg, Q1, Q3) except the Minimum and Maximum which are to presented to the same decimal places as the collected data.
  • Percentages are to be displayed to at least one decimal place.
  • All tables summarising baseline data must include a “total” column for studies with more than 1 arm.

White Paper of Central Tendency

Target 01

Annotations
(assuming plot of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, SAFFL, CHG, ATPTN, AVAL, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

Boxplot of AVAL by AVISITN and TRTPN. Footnotes:

  • Box plot type=schematic, the box shows median, interquartile range (IQR, edge of the bar), min and max
  • within 1.5 IQR below 25% and above 75% (ends of the whisker). Values outside the 1.5 IQR below 25% and
  • above 75% are shown as outliers. Means plotted as different symbols by treatments


Target 02

Annotations
(assuming plot of change from baseline in diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

Boxplot of CHG by AVISITN and TRTPN. Footnotes:

  • Endpoint=last post-baseline measure; Box plot type=schematic; The box shows median, interquartile range (IQR, edge of the bar), min and max within 1.5 IQR below
  • 25% and above 75% (ends of the whisker). Values outside the 1.5 IQR below 25% and above 75% are shown as outliers. Means plotted as different symbols by treatments.
  • P value is for the treatment comparison from ANCOVA model Change=Baseline+Treatment


Target 03

Annotations
(assuming plot of observed values and change from baseline in diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

Boxplot of AVAL and CHG by AVISITN and TRTPN. See plot footnote for boxplot details.


Target 04

Annotations
(assuming plot of mean diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

Plot mean of AVAL by AVISITN and TRTPN. Offset points with TRTPN=81 by subtracting 0.05 from AVISITN. High-low values come from minimum and maximum AVAL at each AVISITN.

At risk subjects = subjects with a non-missing diastolic BP value at that visit.


Target 05

Annotations
(assuming plot of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, BASE, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’

Select the last post-baseline record (AVISITN=99), and plot AVAL and BASE from that record. See plot footnote for boxplot details.


Target 06

Annotations
(assuming plot of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Boxplot of change from last baseline to last post-baseline measure by STUDYID and TRTPN
Dataset: ADVS
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’

Boxplot of change from minimum baseline to minimum post-baseline records by STUDYID and TRTPN
Dataset: ADVSMIN
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’

Boxplot of change from maximum baseline to minimum post-baseline records by STUDYID and TRTPN
Dataset: ADVSMAX
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’

See plot footnote for boxplot details.


Target 07

Annotations
(assuming plot of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Boxplot of change from last baseline to last post-baseline measure by STUDYID and TRTPN
Dataset: ADVS
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.

Boxplot of change from minimum baseline to minimum post-baseline records by STUDYID and TRTPN
Dataset: ADVSMIN
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.

Boxplot of change from maximum baseline to minimum post-baseline records by STUDYID and TRTPN
Dataset: ADVSMAX
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANL01FL, AVISIT, AVISITN
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’
Plot BASE and AVAL in the observed value section, and CHG in the Changes from Baseline section.

See plot footnote for boxplot details.


White Paper of Demographics

Target 08

Annotations
(Country is not available within sample datasets)
Dataset: ADSL
Variables: USUBJID, TRT01P, SEX, AGE, RACE, ETHNIC, WEIGHTBL
Record Selection: WHERE ITTFL=’Y’


White Paper of White Paper on Non-Compartmental PK


Target 09

Annotations

<None>

Target 10

Annotations

<None>

Target 11

Annotations

<None>

Target 12

Annotations

<None>

Target 13

Annotations

<None>

Target 14

Annotations

<None>

Target 15

Annotations

<None>


White Paper on Outliers and Shifts

Target 16

Annotations
(assuming plot and table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVSMAX
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CRIT1FL
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’

Scatterplot:
Plot BASE vs AVAL for subjects with non-missing values for both variables. Use ANRLO and ANRHI for LLN and ULN reference lines.

Shift Table:
N = count of subjects in the dataset for the parameter and treatment group.
Max baseline result category: BNRIND. Max post-baseline result category: ANRIND.
n = count of subjects with each combination of BNRIND and ANRIND (SHIFT1 could also be used).
Percentage = 100 * n / N.

Treatment Emergent High Table:
Further subset to records where CRIT1FL is not missing.
Nx = count of subjects in the resulting dataset for the parameter and treatment group.
n = count of subjects with CRIT1FL='Y'.
Percentage = 100 * n / Nx.


Target 17

Annotations
(assuming table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, CRIT1FL, CRIT2FL
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))

Abnormal = CRIT1FL='Y' or CRIT2FL='Y'.
N = count of subjects in the resulting dataset for the parameter and treatment group.
n = count of subjects with CRIT1FL='Y' or CRIT2FL='Y'.
Percentage = 100 * n / N.
p-value from Fisher's exact test.


Target 18

Annotations
(assuming plot and table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVSMAX
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CRIT1FL
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’

Scatterplot:
Plot BASE vs AVAL by STUDYID for subjects with non-missing values for both variables. Use ANRLO and ANRHI for LLN and ULN reference lines.

Treatment Emergent High Table:
Further subset to records where CRIT1FL is not missing.
N = count of subjects in the resulting dataset for the parameter and treatment group.
n = count of subjects with CRIT1FL='Y'.
Percentage = 100 * n / N.


Target 19

Annotations
(assuming table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: STUDYID, USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, CRIT1FL, CRIT2FL
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))

Abnormal = CRIT1FL='Y' or CRIT2FL='Y'.
N = count of subjects in the resulting dataset for the parameter and treatment group.
n = count of subjects with CRIT1FL='Y' or CRIT2FL='Y'.
Percentage = 100 * n / N.
Odds ratio:
Heterogeneity p-value:
p-value:

Target 20

Annotations
(assuming plot and table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, AVISIT, AVISITN, CRIT1FL
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

Boxplot:
Plot AVAL by AVISITN and TRTPN. See plot footnote for boxplot details.

Treatment Emergent High Table:
Further subset to records where CRIT1FL is not missing.
N = count of subjects in the resulting dataset for the parameter and treatment group.
n = count of subjects with CRIT1FL='Y'.
Percentage = 100 * n / N. p-value from Fisher's exact test.


Target 21

Annotations
(assuming table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, CRIT1, CRIT1FL, , CRIT2, CRIT2FL
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ADY > 1 and SAFFL=’Y’ and (not missing(CRIT1FL) or not missing(CRIT2FL))

Abnormality Direction: Low
N = number of subjects with at least 1 record with non-missing CRIT2FL.
n = number of subjects with CRIT2FL='Y'.

Abnormality Direction: High
N = number of subjects with at least 1 record with non-missing CRIT1FL.
n = number of subjects with CRIT1FL='Y'.

Percentage = 100 * n / N.


Target 22

Annotations
(assuming table of diastolic blood pressure after lying down for 5 minutes over time for subjects in safety population)

Dataset: ADVS
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, AVAL, ANL01FL, BNRIND, ANRIND, SHIFT1, CHGCAT1
Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANL01FL=’Y’ and AVISITN=99 and SAFFL=’Y’ and BNRIND ne 'Missing' and ANRIND ne 'Missing'

Shift Table:
N = count of subjects in the dataset for the parameter and treatment group.
Baseline result category: BNRIND. Post-baseline result category: ANRIND.
n = count of subjects with each combination of BNRIND and ANRIND (SHIFT1 could also be used).
Percentage = 100 * n / N.

Change Summary:
N = count of subjects in the dataset for the parameter and treatment group.
n = count of subjects with specified CHGCAT1 value.
pvalue:


White Paper of Hepatotoxicity

Target 23

Annotations

Dataset: ADLBHY
Variables: USUBJID, TRTP, TRTPN, PARAM, PARAMCD, R2A1HI
Record Selection: WHERE PARAMCD in ('ALT', 'BILI') and ANL01FL=’Y’ and SAFFL=’Y’

Plot R2A1HI for ALT on the X-axis and R2A1HI for BILI on the Y-axis. Display axes using a logarithmic scale.


White Paper of Adverse Events

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White Paper of Hepatotoxicity Measures

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