Monday, August 25, 2008

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

10 comments:

Anonymous said...

the above links are not working can U please upload the material again Thank You.

Anonymous said...

Hi abovelinks are not working plz check it once

Anonymous said...

All above mentioned links are not working.Can you please upload it again.

shivabiotech.sas said...

TLF samples link is not working... somebody plz check

Anonymous said...

hi, couls u pls upload them again, links r not working plsss

raaja said...

LINKS ARE NOT WORKING CAN U PLEASE UPLOAD THE INFORMATION.
THANKS.

Manoj Pandey said...

kindly update this site with its links material

Srinadh Reddy said...

THIS IS VERY GOOD SITE FOR CLINICAL PROGRAMMERS,WHAT THEY GIVEN IN SITE EVERY THING IS VERY USEFUL INFORMATION.tHANQS A LOT FOR WHO DEVELOP D SITE

Yusra Fatima said...

Please update the links..they are not working

Post a Comment

ShareThis