TD Crossover


This example shows a crossover study, where subjects are given the period 1 treatment according to the first disease-assessment schedule until disease progression, then there is a rest period of 28 days prior to the start of period 2 treatment (i.e., re-baseline for period 2). The subjects are then given the period 2 treatment according to the second disease assessment schedule until disease progression.  This example also shows how two different reference/anchor dates can be used.

  • The Rest element is not represented as a row in the TD dataset, since no disease assessments occur during the Rest. Note that although the Rest epoch in this example is not important for TD, it is important that it is represented in other trial design datasets.

Row 1:Shows the disease assessment schedule for the first treatment period. The diagram above shows that this schedule repeats until disease progression. After the trial ended, the maximum number of repeats in this schedule was determined to be 6, so that is the value in TDNUMRPT for this schedule.
Row 2:Shows the disease assessment schedule for the second period. The pattern starts on the date identified in the ADSL variable ANCH2DT and repeats every 8 weeks with respective upper and lower limits of -1 week and + 1 week,. The maximum number of repeats that occurred on this schedule was 4.

td.xpt

td.xpt

RowSTUDYIDDOMAINTDORDERTDANCVARTDSTOFFTDTGTPAITDMINPAITDMAXPAITDNUMRPT
1ABC123TD1ANCH1DTP0DP8WP53DP9W6
2ABC123TD2ANCH2DTP0DP8WP53DP9W4
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

  • No labels