BICRBlinded Independent Central Review
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Opdivo and Yervoy demonstrated a disease control rate (DCR) of 54%, 43% and 49% per BICR using RECIST v1.1 across treatment arms A, B and C, respectively.
Moreover, entrectinib showed 83% (five out of six by BICR) confirmed intracranial ORR in patients with measurable brain metastases.
Combining all the recurrences discussed above for either a 1 x 1 step or a 2 x 2 step and taking the strategy of reducing the number of matrix-vector multiplications by introducing an auxiliary vector recurrence and changing variables adopted for the BiCOR method [7] as well as for the BiCR method [31], together lead to the CSBiCOR method.
The major efficacy outcome measures were ORR and DoR according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ, as assessed by BICR.
PFS as measured by Blinded Independent Central Review (BICR) evaluation, a pre-specified analysis supporting the primary endpoint, demonstrated a median PFS of 30.2 months vs 5.5 months for placebo.
Additionally, the primary endpoint of the OlympiAD trial was progression-free survival (PFS) as measured by a Blinded Independent Central Review (BICR), added the company.
The dual primary endpoints were OS and PFS, as assessed by blinded independent central review per RECIST (Response Evaluation Criteria in Solid Tumors) v1.1; key secondary endpoints included ORR, as assessed by BICR per RECIST 1.1, duration of response and safety.