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As expected, discontinuations because of a gastrointestinal adverse event tended to be higher with traditional nonselective NSAIDs than with any other treatment.
43, 44, 46, 48 As may be expected, discontinuations due to treatment-emergent adverse events in the studies described here were reportedly more frequent with dapoxetine than with placebo, and more frequent with dapoxetine 60 mg than with 30 mg.
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The higher than expected discontinuation rates primarily due to gastrointestinal tolerability observed in the analyses of the 52-week data factored into the decision to terminate the clinical study.
The power and sample size were revised from the initial protocol (originally 400 patients per group) based on 1) a reassessment of the literature, resulting in a lower standard deviation for CIMT progression (originally 0.050), and 2) a lower than expected discontinuation rate, resulting in a larger evaluable sample than originally projected.
The gastrointestinal side effects associated with bromocriptine-QR are dose related and the "forced" titration scheme (rechallenge with study drug after an AE at a given dose and attempt to continue to uptitrate to achieve a maximum tolerated dose of 4.8 mg) likely contributed to a higher than expected discontinuation rate.
(In September 2010, Roche decided to stop dosing patients in the taspoglutide phase 3 trials because higher than expected discontinuation rates of taspoglutide-treated patients were observed, mainly due to gastrointestinal tolerability and the implementation of the risk-mitigation plan to address serious hypersensitivity reactions.
As expected, early discontinuation of dapsone was associated with a better prognosis.
As expected, after the discontinuation of treatment there was a significant increase in cellular and soluble activation markers in all participants.
Trials lasting six weeks would be expected to have few discontinuations.
Because the half-life of agomelatine is 2 hours and the drug has no active metabolites, any discontinuation symptoms would be expected during the first week after discontinuation of the active drug.
Both increased utilization and increased wastage (regardless of the reasons for discontinuation) are expected in mail order pharmacy.
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