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Toxicities were managed by treatment modification or interruption of olaparib until CTCAE grade ⩽1 or resolution.
No patient needed dose modification or interruption because of adverse events, and no patients withdrew from the study.
11 These LFT abnormalities occurred early in the course of treatment, during cycles 1 and 2, and were readily manageable with dose modification or interruption.
Overall, AEs were transient and manageable with sotatercept dose modification or interruption; only two patients discontinued treatment during the study due to AEs.
The proportion of patients in each group with a dose modification or interruption due to an AE was comparable (see supplementary table S1, available online only).
In 129 of 336 patients (38%) in vemurafenib group and in 44 of 282 patients (16%) in dacarbazine group the observed adverse effects forced the drug dose modification or interruption [ 19].
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While these practical measures may be used to manage grade 1 symptoms, effective management of grade 2 and grade 3 symptoms might require dose modifications or interruptions.
Dose modifications or interruptions are being allowed, based on specific criteria, for grade 2-3 hand-foot skin reaction (HFSR) and other AEs.
The incidence of dose modifications (reductions or interruptions) due to any AE was also generally similar between age groups.
26, 27, 33, 34 Although it is not known why these effects are observed, phosphorus and lipase levels should be monitored frequently during initial cycles of treatment and throughout the course of treatment, as some patients may require dose modifications or dose interruptions at some point during therapy.
Drug-related adverse events resulted in dose modification, dose interruption, or permanent discontinuation of study treatment in 31 (69%) patients overall (18 [72%] FOLFOX and 13 [65%] FOLFIRI).
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adjustment or interruption
modification or reconfiguration
modification or reinstatement
modification or fabrication
modification or improvement
modification or synthesis
modification or retrofitting
modification or packaging
modification or replacement
modification or interface
modification or conjugation
modification or coating
modification or implantation
modification or quality
modification or inactivation
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