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Dose adjustment was made in the event of toxicity.
In the event of toxicity, dose modification and treatment delays were performed according to the protocol.
In the event of toxicity recurrence despite dose reduction, treatment was to be stopped.
Criteria for dose modification in the event of toxicity have been described previously (Reni et al, 2004b).
Following predetermined criteria, treatment could be temporarily interrupted and/or the dosage decreased by 1.5 mg/kg/day in the event of toxicity.
In the event of toxicity, a maximum of two-dose reductions were allowed provided the olaparib dose was ⩾50 mg bid.
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In patients receiving capecitabine, treatment was interrupted in the event of toxicities classified as grade 2 or higher.
A number of venom PLA2s have been shown to induce a variety of pharmacological effects although comprehensive studies of the actions of venom PLA2s in the various events of toxicity are scarce [ 6, 7].
Toxicities associated with olaparib monotherapy were managed by dose interruption; in the event of a toxicity recurring after dose interruption, or if olaparib dosing was interrupted owing to a grade ≥3 adverse event (AE), dose reduction to 200 mg bid (and then, if necessary, to 100 mg bid) was considered or required, respectively.
In the event of significant toxicity, dose reductions were implemented.
Delays and dose reductions were also instituted in the event of haematological toxicity as follows.
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