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An estimated 128 patients from approximately 50 sites globally will be randomised (3:1) to selumetinib 75 mg twice daily or placebo in combination with dacarbazine 1000 mg/m on Day 1 of every 21-day cycle until objective disease progression, intolerable toxicity or occurrence of another discontinuation criterion.
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Reasons for switching to another OC or discontinuation will be requested if applicable.
No deaths were reported in three studies, 18 21 22 while another study reported discontinuation due to AEs and death combined.
A switch from one treatment modality to another or a discontinuation of treatment was considered as new treatment.
A medication gap could have resulted from any number of events, including switching to another antipsychotic or discontinuation of the antipsychotic drug.
Defining these events as occurring during drug treatment (usually for 12 weeks) or within 30 days of discontinuation, another meta-analysis showed that the risk was statistically insignificant.
At every ART visit, follow-up details with their dates are entered in the master card, and these include transfer to another ART clinic, treatment discontinuation and death.
Follow-up outcomes such as transfer to another ART clinic, treatment discontinuation and death are also entered in the master card.
In addition to tolerance and rebound insomnia, withdrawal following discontinuation is another major concern associated with hypnotic medications.
The dichotomy between ineffectiveness and toxicity as a physician-reported reason for drug discontinuation carries another problem: the issue of adjudication.
In another study of drug discontinuation, Wunderink et al randomised 128 patients who were in remission for six months (65 open withdrawal, 63 open continuation of drug).
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CEO of Professional Science Editing for Scientists @ prosciediting.com