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'Intervention-related' AEs were defined as probably or most probably because of study treatment.
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A total of 10 patients discontinued study treatment because of AEs; eight of these patients discontinued during the first six cycles of study treatment.
The MTS patch was well tolerated, with 7.1 % of patients discontinuing study treatment because of AEs compared with 2.2%% in the OROS methylphenidate group and 1.2%% in the placebo group.
Overall, 18% of the patients discontinued study treatment because of AEs.
One patient in the FLOT was excluded from the analysis because of consent withdrawal before study treatment.
Of the remaining four patients who discontinued study treatment because of AEs, two discontinued, in part, because of febrile neutropenia and brain edema, which have not been reported in breast cancer trials of everolimus in the absence of a chemotherapy partner [ 32].
If more than half of the patients withdrew from the study treatment because of toxicities by the completion of the second cycle or if the IDMC decided that the study had to be discontinued, the trial would be terminated.
Notably, the most common AEs leading to discontinuation were lung-related AEs (six of ten patients who discontinued study treatment because of AEs).
A limitation of the present study was the open-label nature, which was necessary because of the different regimens of the study treatments; a double-dummy design would have enabled blinding but would have required a much larger number of injections for each patient.
One patient who entered into the study did not receive study treatment because of the presence of a major exclusion criterion (low creatinine clearance).
The event of visual disturbance was reported by the investigator as an SAE of level 2 severity and was judged to be possibly related to study treatment because of the temporal relationship, and study drug was permanently discontinued.
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