In this example, there is a rest period of 14 days prior to the start of the second disease-assessment schedule. This example also shows how 3 different reference/anchor dates can be used.
- The rest period is not represented as a row in the TD domain because no disease assessments occur during this period. Note that although the rest epoch in this example is not important for TD, it is important that this be represented in other trial design datasets.
- The second pattern of assessments starts on the date identified in the ADSL variable ANCH2DT and repeats every 12 weeks for a total of 4 repeats with respective upper and lower limits of -1 week and + 1 week.
- The third disease assessment schedule pattern follows on from the second pattern starting on the date identified in the ADSL variable ANCH3DT and repeats every 24 weeks with respective upper and lower limits of -1 week and + 1 week. The preceding schematic for the final disease-assessment pattern indicates that assessments will occur until disease progression, and this therefore leaves the pattern open-ended. However, when data are included in an analysis, the total number of repeats can be identified and the highest number of repeat assessments for any subject in that pattern must be recorded in the TDNUMRPT variable on the final pattern record. In this instance, the maximum number of observed assessments was 17.