Record the course assessment information when the course is completed, and the patient is evaluated or taken off treatment.
Description / Instructions
Enter the date the course started.
Start Date of Course^(d)^
Shows the Start Date of Course entered in the Course Initiation case report form.
Dose change from TAC entered on Course Initiation CRF^(m)^
Indicate if the patient's treatment was different from that specified by the Treatment Assignment Code (TAC) for this course as entered on the Course Initiation CRF. If the treatment was different, indicate whether this was planned or unplanned, and record the reason, e.g. dose reduction due to toxicity, on the Comments tab of this CRF.
1 - Yes, Planned - change in treatment had been decided before the start of the course, e.g., due to toxicity on a previous course.
Use pick list.
A "completed" course is one that has been conducted in accordance with the protocol with respect to length including the observation period (two day variance allowed). A course is regarded as "discontinued" if it was shorter than specified in the protocol. Select one of the following values:
Use pick list.
Select the patient's best disease state as assessed during the course. This determination must be adequately documented in the patient's medical record.
CR - Complete Response - There is a disappearance of all evidence of disease as assessed relative to the baseline at start of treatment, not to previous courses. They must be confirmed by repeat assessments to demonstrate a disappearance of all evidence of disease.
Evaluation of target lesions:
Use pick list.
Enter the reason why the Response Assessment is Not Evaluable (NE) or Not Assessed (NA). Some examples could include: protocol not followed, poor quality of scan, patient already treated.
Date of Response
Enter the date of the earliest evaluation which, upon confirmation, justifies an assessment of
Date of Progression
Enter the date of the evaluation used to determine the patient's disease status of progressive disease. Enter a date of progression if the disease progression occurred after an assessed better response (i.e. PR, CR, SD).
Any Adverse Events in this Course?(m)
Select "Yes" if any adverse event has occurred during this course. This includes adverse events with onset date belonging to a previous course that resolved during this course or that remain ongoing at the conclusion of this course.
Use pick list.
Legend: (d) derived field, (m) RDC mandatory, (c) for CTEP reporting only.
Date of Response or Onset Date of Progress must not be future dates.
Change the date to a value no later than the current date.
Response Notes entered and Response Assessment is different than "Not Evaluable" and "Not Assessed".
Remove the Response Notes if Response Assessment is different than "Not Evaluable" and "Not Assessed". Otherwise change the Response Assessment to "Not Evaluable" and "Not Assessed".
Response Assessment is "Not Evaluable" or "Not Assessed" and no Response Notes were entered.
Enter the Response Notes if Response Assessment is "Not Evaluable" or "Not Assessed". Otherwise change the Response Assessment to a selection other than "Not Evaluable" and "Not Assessed".
Date of Response is required when Response Assessment is CR, PR, MR, SD, or DU.
Enter the Date of Response or Review the Response Assessment.
Date of Progression is required when Response Assessment is PD.
Enter the Date of Progression or Review the Response Assessment.
Course Assessment marked as having adverse events, but there are no adverse events with an onset date that falls within this course start and end dates.
Change the field "Any Adverse Events in this Course?" to "NO" if no related adverse events exist. Otherwise enter the appropriate adverse events or adjust the appropriate adverse events dates.
Course Assessment marked as not having adverse events, but there is at least one adverse event with an onset date that falls within this course start and end dates.
Change the field "Any Adverse Events in this Course?" to "YES" if the related adverse events are appropriate. Otherwise remove the adverse events or correct the adverse events dates.
Start Date of Course
The Start Date of Course entered in the Course Initiation case report form.
End Date of Course
The day before the start date of the following course or the off treatment date.