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All adverse reactions were graded as mild or moderate, and none led to discontinuation of study.
A total of 13 subjects (46.4 %) experienced adverse events that led to discontinuation of study drug.
Any subsequent increases in heart rate of > 30 bpm result in discontinuation of study drug for the duration of the study.
Safety data were registered for all patients, including all-cause mortality during the study episode until 30 days after catheter removal, and the discontinuation of study medication.
and in the 30 days following discontinuation of study therapy.
Premature discontinuation of study drug was imputed as a flare.
Both conditions were reversible with temporary discontinuation of study drugs.
No additional intervention was required beyond discontinuation of study drug.
Disease progression was the most common reason for discontinuation of study treatment (16 patients; 52%).
Symptoms resolved 7 to 9 days after discontinuation of study regimens.
Peripheral neuropathy was common and frequently resulted in the discontinuation of study medication.
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