List of the Variables in Each Dataset:
TLF samples
TABLES:
Screening Failures
Subject Disposition
Subject Disposition by Visit
Premature Discontinuation from Study Medication
Subject Disposition by Center
Protocol Deviations
Demographics and Baseline Characteristics
Medical and Surgical History
Gynecological History
Screening Pap Smear, Mammography, and Serum Pregnancy Test Results
Number (%) of Subjects Who Took Concomitant Medication
Duration of Treatment in Days and Study Drug Compliance
Number (%) of Subjects with Treatment-Emergent Adverse Events by Body System and Preferred Term
Number (%) of Subjects with Common (>=2%) Treatment-Emergent Adverse Events by Preferred Term, sorted by Descending Order of Incidence in the Trt-x
Number (%) of Subjects with Treatment-Emergent Adverse Events by Body System, Preferred Term, and Maximum Intensity
Number (%) of Subjects with Treatment-Emergent Thromboembolic Events
Number (%) of Subjects with Drug-Related Treatment-Emergent Adverse Events by Body System and Preferred Term
Number (%) of Subjects with Treatment-Emergent Adverse Events Causing Discontinuation
Physical Exam - Number (%) of Subjects with Transitions from Baseline to End of Treatment
Vital Signs Values and Change from Baseline by Visit and Treatment Group
Hematology Values and Change from Baseline to Final Visit - Descriptive Statistics by Visit and Treatment
Hematology Values and Change from Baseline by Visit and Treatment Group
Number (%) of Subjects with Transitions from Baseline to Postbaseline Visits by Treatment
Lead ECG: Number (%) of Subjects with Transitions from Screening - Overall Interpretation by Visit
Continuous Response - Descriptive Statistics by Visit and Treatment
Analysis of Continuous Response
Responder Analysis
Continuous Response - Descriptive Statistics by Pooled Center
LISTINGS:
Listing of Hematology Parameters with Low and High Flags
Listing of Blood Chemistry Parameters with Low and High Flags
Subject Listing for Adverse Events/ Serious Adverse Events
Subjects with Death Information
FIGURES/GRAPH"s
Bar Chart of Change in Diastolic & Systolic Blood Pressure at Final Visit
Bar Chart of Urine Drug Concentration Post-Dose Collections at 0 to 72 Hours in PK Studies (Standard Deviation plotted over Vertical Bars using annotation data sets in SAS)
Plot of Systolic Blood Pressure at 0 to 24 hours After Dosing of Study Drug
Plot of Plasma Drug Concentration at 0 to 72 Hours After Dosing in PK Studies (Mean and S.D. plotted at each point using annotation data sets in SAS)
Kaplan-Meire Survival Curve
Power Curve for Study Design Sample Size
source: www.njbiostatistics.com
Screening Failures
Subject Disposition
Subject Disposition by Visit
Premature Discontinuation from Study Medication
Subject Disposition by Center
Protocol Deviations
Demographics and Baseline Characteristics
Medical and Surgical History
Gynecological History
Screening Pap Smear, Mammography, and Serum Pregnancy Test Results
Number (%) of Subjects Who Took Concomitant Medication
Duration of Treatment in Days and Study Drug Compliance
Number (%) of Subjects with Treatment-Emergent Adverse Events by Body System and Preferred Term
Number (%) of Subjects with Common (>=2%) Treatment-Emergent Adverse Events by Preferred Term, sorted by Descending Order of Incidence in the Trt-x
Number (%) of Subjects with Treatment-Emergent Adverse Events by Body System, Preferred Term, and Maximum Intensity
Number (%) of Subjects with Treatment-Emergent Thromboembolic Events
Number (%) of Subjects with Drug-Related Treatment-Emergent Adverse Events by Body System and Preferred Term
Number (%) of Subjects with Treatment-Emergent Adverse Events Causing Discontinuation
Physical Exam - Number (%) of Subjects with Transitions from Baseline to End of Treatment
Vital Signs Values and Change from Baseline by Visit and Treatment Group
Hematology Values and Change from Baseline to Final Visit - Descriptive Statistics by Visit and Treatment
Hematology Values and Change from Baseline by Visit and Treatment Group
Number (%) of Subjects with Transitions from Baseline to Postbaseline Visits by Treatment
Lead ECG: Number (%) of Subjects with Transitions from Screening - Overall Interpretation by Visit
Continuous Response - Descriptive Statistics by Visit and Treatment
Analysis of Continuous Response
Responder Analysis
Continuous Response - Descriptive Statistics by Pooled Center
LISTINGS:
Listing of Hematology Parameters with Low and High Flags
Listing of Blood Chemistry Parameters with Low and High Flags
Subject Listing for Adverse Events/ Serious Adverse Events
Subjects with Death Information
FIGURES/GRAPH"s
Bar Chart of Change in Diastolic & Systolic Blood Pressure at Final Visit
Bar Chart of Urine Drug Concentration Post-Dose Collections at 0 to 72 Hours in PK Studies (Standard Deviation plotted over Vertical Bars using annotation data sets in SAS)
Plot of Systolic Blood Pressure at 0 to 24 hours After Dosing of Study Drug
Plot of Plasma Drug Concentration at 0 to 72 Hours After Dosing in PK Studies (Mean and S.D. plotted at each point using annotation data sets in SAS)
Kaplan-Meire Survival Curve
Power Curve for Study Design Sample Size
source: www.njbiostatistics.com
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