Download tQT Dataset Description

tQT Dataset Description
Study Design: This was a 4 treatment 4 period crossover of two doses (low and high) of
a fictitious experimental drug, placebo, and active control (moxi).
Data collection: ECG interval data was collected at day 0 (baseline day) and at day 4
within each of the four periods. The collections were matched based on the time of day
in order that changes due to diurnal variation could be subtracted out. For this
experiment interval data was collected at hour 0, 0.5, 1, 2, 3, 4, 6, 9, and 12 for each of
day 0 and 4 for each period.
There are 24 subjects in the dataset. If there were no missing data there would have been
24 subjects x 9 timepoints per day x 2 days per period x 4 periods per subject = 1728
observations.
Dataset Details:
The SAS transport dataset was created in SAS version 8.2 on the Unix platform. All
variables have been labeled with decodes in the dataset.
Variable names were constructed whereby the first part of the variable name is the
interval, and a second part denotes the day (0 or 4) or change (c=day 4- day0; or cc=pbo
adjusted change from baseline or sometimes called delta-delta).
For example qt_0 is the QT interval from day 0; qt_c is the change from baseline (day 4 –
day 0 within the same period); and qt_cc is the placebo adjusted change from baseline