English to Russian Medical Medical: Pharmaceuticals

This measurement should be recorded even though the nodes are normal in order not to overstate progression should it be based on increase in size of the nodes.
As noted earlier, this means that patients with CR may not have a total sum of “zero” on the eCRF.
In trials where confirmation of response is required, repeated ‘not evaluable (NE)’ time point assessments may complicate best response determination.
The analysis plan for the trial must address how missing data/assessments will be addressed in determination of response and progression.
For example, in most trials it is reasonable to consider a patient with time point responses of PR-NE-PR as a confirmed response.
Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time should be reported as “symptomatic deterioration”.