In a Danish multi-center study, quality control was performed on off-study data for high-risk @entity0 @entity1 included in protocols of adjuvant therapy. In the two protocols 4455 @entity1 were randomized and 2477 were registered off-study. Data from these @entity1 were validated by reviewing the @entity1 ' records. Incorrect data were observed in 16.2% of the cases who went off-study due to recurrence, other @entity5 or @entity204 . In 258 of 2133 @entity1 unidentical locations were demonstrated. Of these, 104 showed a time difference also. A major difference in site of recurrence was found in 107 @entity1 (5.0%), 43 of whom were upstaged from local to a distant recurrence and 64 were downstaged. A time difference of more than 30 days was found in 192 @entity1 (9.0%) and in 17 the difference exceeded 366 days. A time difference only was found in 88 @entity1 (4%). The major parameter in the statistical analysis of the two protocols, i.e. recurrence-free survival, was not significantly influenced by the validation.

Quality control of end results in a Danish adjuvant XXXX multi-center study.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity5 :: ('MESH:D009369', 'Disease') :: ['malignant disease'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer']
@entity0 :: (MESH:D001943,Disease) :: ['breast cancer']
