Current Controlled Trials in Cardiovascular Medicine
Volume 6

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Methodological considerations in the design of trials for safety assessment of new drugs and chemical entities

Cornel Pater

Cornel Pater, Hannover, Germany

author email corresponding author email

Current Controlled Trials in Cardiovascular Medicine 2005, 6:1doi:10.1186/1468-6708-6-1


Published:	3 February 2005

Additional files

Additional File 1:

Frequency distribution of TU morphology changes across two groups.

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Additional File 2:

TU morphology changes in individual subjects.

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Additional File 3:

Frequency distribution of TU morphology changes across two groups.

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Additional File 4:

Frequency distribution of the PR/QRS/QTc(B/F/L) data matching PK sampling (for individuals and/or groups).

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Additional File 5:

Summary of PR/QRS/QTc(B/F/L) data (for individuals and/or groups).

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Additional File 6:

Normal ranges for the PR/QRS/QTc(B/F/L) data and for the QTc(B/F/L) relative changes to baseline.

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Additional File 7:

Frequency distribution of the baseline and on-treatment values pertaining the PR, QRS, QT, QTcB, QTcF and QTcL parameters as well as the D1 difference.

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Additional File 8:

Summary of outcome differences between the two groups regarding key ECG parameters.

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Additional File 9:

Alert criteria based on ECG findings (measurements) and rational for subject withdrawal from study.

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Additional File 10:

Characteristics of the cross-over and parallel study designs.

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Additional File 11:

Disease associated with prolonged QT/QTc interval.

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Additional File 12:

Abbreviations (Not mentioned in the text!)

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