White Paper of Central Tendency

Contents

General Programming Notes:

White Paper of Central Tendency

Target 01

Target 02

Target 03

Target 04

Target 05

Target 06

Target 07

White Paper of Demographics

Target 08

White Paper of White Paper on Non-Compartmental PK

Target 09

Target 10

Target 11

Target 12

Target 13

Target 14

Target 15

White Paper on Outliers and Shifts

Target 16

Target 17

Target 18

Target 19

Target 20

Target 21

Target 22

White Paper of Hepatotoxicity

Target 23

White Paper of Adverse Events

White Paper of Hepatotoxicity Measures

Scriptathon2014 targets

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

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 continuous 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 summarizing baseline data must include a “total” column for studies with more than 1 arm.

White Paper of Central Tendency

Target 01

Box Plot - Observed Values of xxx Over Time

Annotations

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

Dataset: ADVS

Variables: TRTPN, PARAM, PARAMCD, AVAL, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

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

Target 02

Box Plot - Change in xxx Over Time

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: TRTPN, PARAM, PARAMCD, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

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

Target 03

Box Plot - Observed Values and Change in xxx Over Time

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: TRTPN, PARAM, PARAMCD, AVAL, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’Y’ and . < AVISITN < 99 and SAFFL=’Y’

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

Target 04

Box Plot - Mean of xxx Over Time

Annotations

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

Dataset: ADVS

Variables: TRTPN, PARAM, PARAMCD, AVAL, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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

Box Plot - Baseline-Related Measures

Annotations

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

Dataset: ADVS

Variables: STUDYID, TRTPN, PARAM, PARAMCD, AVAL, BASE, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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

Box Plot - Change from Baseline-Related Measures

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, TRTPN, PARAM, PARAMCD, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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, TRTPN, PARAM, PARAMCD, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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, TRTPN, PARAM, PARAMCD, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’Y’ and ADY > 1 and SAFFL=’Y’

See plot footnote for boxplot details.

Target 07

Box Plot - Change/Observed Baseline-Related Measures

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, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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, TRTPN, PARAM, PARAMCD, AVAL, CHG, ANLFL01, AVISIT, AVISITN

Record Selection: WHERE PARAMCD=’DIABP’ and ATPTN=815 and ANLFL01=’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

Demographics

Annotations

(Country is not available within sample datasets)

Dataset: ADSL

Variables: TRT01P, SEX, AGE, RACE, ETHNIC, WEIGHTBL

Record Selection: WHERE ITTFL=’Y’

White Paper of White Paper on Non-Compartmental PK

Target 09

List of PK parameters

Annotations

<None>

Target 10

List of PK concs

Annotations

<None>

Target 11

Plot PK concs, overlayed

Annotations

<None>

Target 12

Plot PK concs - subject by subject

Annotations

<None>

Target 13

Plot PK mean concs across subjects

Annotations

<None>

Target 14

Summary Table PK Parameters

Annotations

<None>

Target 15

Summary Table PK Concentrations

Annotations

<None>

White Paper on Outliers and Shifts

Target 16

Scatter Plot and Shift Summary for Quantitative Safety Measures – Individual Study

Annotations

<None>

Target 17

Treatment-Emergent Abnormal Summary for Qualitative Safety Measures – Individual Study

Annotations

<None>

Target 18

Scatter Plot and Shift Summary for Quantitative Safety Measures – Integrated Database

Annotations

<None>

Target 19

Treatment-Emergent Abnormal Summary for Qualitative Safety Measures – Integrated Database

Annotations

<None>

Target 20

Summary for Quantitative Safety Measures – Individual Study

Annotations

<None>

Target 21

Treatment-Emergent Abnormal, High or Low Values at Anytime

Annotations

<None>

Target 22

Shift Table Analyses

Annotations

<None>

White Paper of Hepatotoxicity

Target 23

Hy's Law Figure

Annotations

<None>

White Paper of Adverse Events

White Paper of Hepatotoxicity Measures