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Software Program

All Graphs

Title	Contributor/Email	Graph Type
Basic Survival Plot	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Survival Plot
Boxplot of Two Treatment Groups	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Boxplot
Change from Baseline by Baseline: Categorical QTc Analysis	Rich Anziano (richard.j.anziano@pfizer.com) Max Cherny (Max.2.Cherny@gsk.com)	Scatterplot
Cumulative Incidence for Alanine Aminotransferase (ALT): Elevations > 3 Times the Upper Limit of Normal	Robert Gordon (rgordon2@its.jnj.com)
Depicting Phase 2 Efficacy Results	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Diagnostic Plot of Linear Model	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Distribution of Alanine Aminotransferase (ALT) by Time and Treatment	Robert Gordon (rgordon2@its.jnj.com)	Boxplot
Dotplot of Primary SOC	Mat Soukup (email: Mat.Soukup@fda.hhs.gov) Sanjay Matange (email: Sanjay.Matange@sas.com)	Dotplot
EG QTc Longitudinal Trend	jianminlong@merck.com	Line Plot, Scatterplot, Other
Efficacy Across Sites	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Efficacy by Subgroup	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Efficacy of T4N5 The Lancet Data - Code Expands	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Forest Plot of Hazard Ratios by Patient Subgroups	Sanjay Matange (email: Sanjay.Matange@sas.com)	Forest Plot
Frequency Plot of the Change from Baseline in Alanine Aminotransferase by Visit	Robert Gordon (rgordon2@its.jnj.com)
HPA Axis Suppression	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Heat map	max.2.cherny@gsk.com Sanjay Matange (email: Sanjay.Matange@sas.com)
Individual QTc display	A. Paredes, Antonio.Paredes@fda.hhs.gov Max Cherny: Max2Cherny@gsk.com
Lab Parameter Shift Plots, Baseline vs. Study	Robert Gordon (rgordon2@its.jnj.com)	Scatterplot
Lab Shift Plots: Baseline versus Maximum	Susan Duke (susan.p.duke@gsk.com) Max Cherny (Max.2.Cherny@gsk.com)	Scatterplot
Liver Function Tests by Trial Day: At Risk Subjects	Robert Gordon (rgordon2@its.jnj.com)	Line Plot
Liver Test Safety Panel Over Time, Baseline vs. On-study	Robert Gordon (rgordon2@its.jnj.com)	Scatterplot
Local Reactions over Time	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Mean (and Mean Difference) of ALT (Alanine Aminotransferase) by Treatment : Profile Over Time	Robert Gordon (rgordon2@its.jnj.com)	Line Plot
Most Frequent On-Therapy AE Sorted by Risk Difference	FrankHarrell	Dotplot
P-risk (Risk Difference) Plot of Treatment Emergent Adverse Events at PT Level	Qi Jiang (email: Qjiang@amgen.com) SAS code contributed by Haijun Ma and Jun Wei	Volcano Plots
Profile Plot: Mean QTc by Time and Treatment	Rich Anziano (richard.j.anziano@pfizer.com) Max Cherny (Max.2.Cherny@gsk.com)	Line Plot
QT Correction Comparison	R.J. Anziano, Richard.J.Anziano@Pfizer.com	Scatterplot
Reports by SOC	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatter Plot of Maximum Transaminase versus Maximum Total Bilirubin	Robert Gordon (rgordon2@its.jnj.com)	Scatterplot
Scatterplot Conditioned on Race	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Scatterplot w/ Density and Smoothed Regression	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Scatterplot
Sensitivity Analysis of Missing Data	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Perspective Plot
Summary of All EG Parameters	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Systolic Blood Pressure (Main Profiles)	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	Line Plot
Time Course of Lab Test Values, Individual Subject	Robert Gordon (rgordon2@its.jnj.com)	Line Plot
Time to AE Occurrence	Mat Soukup (email: Mat.Soukup@fda.hhs.gov) Max Cherny (Max.2.Cherny@gsk.com)	Survival Plot

Number of topics: 36

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Graph Types

Graph Type	Title	Contributor/Email
	Reports by SOC	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
	Heat map	max.2.cherny@gsk.com Sanjay Matange (email: Sanjay.Matange@sas.com)
	Summary of All EG Parameters	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
	Individual QTc display	A. Paredes, Antonio.Paredes@fda.hhs.gov Max Cherny: Max2Cherny@gsk.com
	Frequency Plot of the Change from Baseline in Alanine Aminotransferase by Visit	Robert Gordon (rgordon2@its.jnj.com)
	Cumulative Incidence for Alanine Aminotransferase (ALT): Elevations > 3 Times the Upper Limit of Normal	Robert Gordon (rgordon2@its.jnj.com)
Boxplot	Boxplot of Two Treatment Groups	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Boxplot	Distribution of Alanine Aminotransferase (ALT) by Time and Treatment	Robert Gordon (rgordon2@its.jnj.com)
Line Plot, Scatterplot, Other	EG QTc Longitudinal Trend	jianminlong@merck.com
Perspective Plot	Sensitivity Analysis of Missing Data	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Survival Plot	Time to AE Occurrence	Mat Soukup (email: Mat.Soukup@fda.hhs.gov) Max Cherny (Max.2.Cherny@gsk.com)
Survival Plot	Basic Survival Plot	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Volcano Plots	P-risk (Risk Difference) Plot of Treatment Emergent Adverse Events at PT Level	Qi Jiang (email: Qjiang@amgen.com) SAS code contributed by Haijun Ma and Jun Wei
Dotplot	Most Frequent On-Therapy AE Sorted by Risk Difference	FrankHarrell
Dotplot	Dotplot of Primary SOC	Mat Soukup (email: Mat.Soukup@fda.hhs.gov) Sanjay Matange (email: Sanjay.Matange@sas.com)
Forest Plot	Forest Plot of Hazard Ratios by Patient Subgroups	Sanjay Matange (email: Sanjay.Matange@sas.com)
Line Plot	Liver Function Tests by Trial Day: At Risk Subjects	Robert Gordon (rgordon2@its.jnj.com)
Line Plot	Time Course of Lab Test Values, Individual Subject	Robert Gordon (rgordon2@its.jnj.com)
Line Plot	Systolic Blood Pressure (Main Profiles)	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Line Plot	Mean (and Mean Difference) of ALT (Alanine Aminotransferase) by Treatment : Profile Over Time	Robert Gordon (rgordon2@its.jnj.com)
Line Plot	Profile Plot: Mean QTc by Time and Treatment	Rich Anziano (richard.j.anziano@pfizer.com) Max Cherny (Max.2.Cherny@gsk.com)
Scatterplot	Scatterplot Conditioned on Race	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Liver Test Safety Panel Over Time, Baseline vs. On-study	Robert Gordon (rgordon2@its.jnj.com)
Scatterplot	Depicting Phase 2 Efficacy Results	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Lab Shift Plots: Baseline versus Maximum	Susan Duke (susan.p.duke@gsk.com) Max Cherny (Max.2.Cherny@gsk.com)
Scatterplot	Change from Baseline by Baseline: Categorical QTc Analysis	Rich Anziano (richard.j.anziano@pfizer.com) Max Cherny (Max.2.Cherny@gsk.com)
Scatterplot	Efficacy Across Sites	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Efficacy by Subgroup	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Lab Parameter Shift Plots, Baseline vs. Study	Robert Gordon (rgordon2@its.jnj.com)
Scatterplot	Local Reactions over Time	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Efficacy of T4N5 The Lancet Data - Code Expands	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Diagnostic Plot of Linear Model	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	Scatter Plot of Maximum Transaminase versus Maximum Total Bilirubin	Robert Gordon (rgordon2@its.jnj.com)
Scatterplot	Scatterplot w/ Density and Smoothed Regression	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)
Scatterplot	QT Correction Comparison	R.J. Anziano, Richard.J.Anziano@Pfizer.com
Scatterplot	HPA Axis Suppression	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)

Number of topics: 36

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Software Program

Title	Contributor/Email	Software Program
Basic Survival Plot	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Boxplot of Two Treatment Groups	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Change from Baseline by Baseline: Categorical QTc Analysis	Rich Anziano (richard.j.anziano@pfizer.com) Max Cherny (Max.2.Cherny@gsk.com)	R
Cumulative Incidence for Alanine Aminotransferase (ALT): Elevations > 3 Times the Upper Limit of Normal	Robert Gordon (rgordon2@its.jnj.com)	SAS
Depicting Phase 2 Efficacy Results	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Diagnostic Plot of Linear Model	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Distribution of Alanine Aminotransferase (ALT) by Time and Treatment	Robert Gordon (rgordon2@its.jnj.com)	SAS
Dotplot of Primary SOC	Mat Soukup (email: Mat.Soukup@fda.hhs.gov) Sanjay Matange (email: Sanjay.Matange@sas.com)	R, SAS
EG QTc Longitudinal Trend	jianminlong@merck.com	SAS
Efficacy Across Sites	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Efficacy by Subgroup	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Efficacy of T4N5 The Lancet Data - Code Expands	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Forest Plot of Hazard Ratios by Patient Subgroups	Sanjay Matange (email: Sanjay.Matange@sas.com)	SAS
Frequency Plot of the Change from Baseline in Alanine Aminotransferase by Visit	Robert Gordon (rgordon2@its.jnj.com)	SAS
HPA Axis Suppression	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Heat map	max.2.cherny@gsk.com Sanjay Matange (email: Sanjay.Matange@sas.com)	R, SAS
Individual QTc display	A. Paredes, Antonio.Paredes@fda.hhs.gov Max Cherny: Max2Cherny@gsk.com	R
Lab Parameter Shift Plots, Baseline vs. Study	Robert Gordon (rgordon2@its.jnj.com)	SAS
Lab Shift Plots: Baseline versus Maximum	Susan Duke (susan.p.duke@gsk.com) Max Cherny (Max.2.Cherny@gsk.com)	SAS, other
Liver Function Tests by Trial Day: At Risk Subjects	Robert Gordon (rgordon2@its.jnj.com)	SAS
Liver Test Safety Panel Over Time, Baseline vs. On-study	Robert Gordon (rgordon2@its.jnj.com)	SAS
Local Reactions over Time	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Mean (and Mean Difference) of ALT (Alanine Aminotransferase) by Treatment : Profile Over Time	Robert Gordon (rgordon2@its.jnj.com)	SAS
Most Frequent On-Therapy AE Sorted by Risk Difference	FrankHarrell	R, SAS
P-risk (Risk Difference) Plot of Treatment Emergent Adverse Events at PT Level	Qi Jiang (email: Qjiang@amgen.com) SAS code contributed by Haijun Ma and Jun Wei	SAS
Profile Plot: Mean QTc by Time and Treatment	Rich Anziano (richard.j.anziano@pfizer.com) Max Cherny (Max.2.Cherny@gsk.com)	R, SAS
QT Correction Comparison	R.J. Anziano, Richard.J.Anziano@Pfizer.com
Reports by SOC	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Scatter Plot of Maximum Transaminase versus Maximum Total Bilirubin	Robert Gordon (rgordon2@its.jnj.com)	SAS
Scatterplot Conditioned on Race	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Scatterplot w/ Density and Smoothed Regression	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Sensitivity Analysis of Missing Data	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Summary of All EG Parameters	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	SAS
Systolic Blood Pressure (Main Profiles)	Mat Soukup (email: Mat.Soukup@fda.hhs.gov)	R
Time Course of Lab Test Values, Individual Subject	Robert Gordon (rgordon2@its.jnj.com)	SAS
Time to AE Occurrence	Mat Soukup (email: Mat.Soukup@fda.hhs.gov) Max Cherny (Max.2.Cherny@gsk.com)	R, SAS

Number of topics: 36

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Topic revision: r25 - 24 Oct 2013 - 11:34:48 - MatSoukup

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