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The response assessments should follow the RECIST criteria. For example, if a patient had a PR at one visit, the patient cannot have an SD at the next visit. If a patient had a PD at one visit, he or she cannot have a PR at the next visit.
The dates of assessment should be more realistic (we should have approximately, 3-week to 4-week cycles). Currently, there are patient whose first post-BL assessment occurs 1 to 2 years after randomization.
There should not be any response assessment at BL. Response assessment are done only post-BL.
The ADRS data should fit together with the ADTTE data. For example, the date of assessment of PD in the ADRS data set should match the date of PD in the ADTTE data set. Similarly, the date of death in ADTTE should be later than any assessment date in ADRS
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