One patient in the olaparib 200-mg group
died as a result of a severe AE (cerebrovascular accident), which was
considered to be possibly related to olaparib treatment. However,
factors including deep vein thrombosis and concurrent anticoagulation
treatment may have contributed. One patient receiving olaparib
200 mg died as a result of an AE of myelodysplastic syndrome considered
by the investigator to be related to olaparib; however, this patient
had received extensive chemotherapy. Overall, the AEs reported in the
three treatment groups were compatible with previously reported
toxicity profiles.
There were no significant differences in improvement or worsening
rates between the olaparib treatment groups and thePLDgroup
for the FACT-O Symptom Index and Trial Outcome Index scores.
However, a higher improvement rate was noted for olaparib 400 mg
compared withPLDfor the totalFACT-Oscore (odds ratio, 7.23;95%
CI, 1.09 to 143.3; P.039).