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Indomethacin administered in three doses of 25 mg per day was ineffective, as well as further dose increment that stopped at daily dose of 125 mg because of constant dull headache.
Three patients were discontinued by the sponsor: one (placebo) because of elevated blood glucose; one (18 mg) because of failure to meet entrance criteria (randomized in error); and one (18 mg) because of noncompliance.
One took a 100 mg dose to prevent infarction, whereas the other took 500 mg because of mild foot pain.
Only one patient in the NLTX group needed a single bolus dose of IV naloxone (0.4 mg) because of hypercapnia (pCO2 > 45).
Six patients had to reduce the dose of olanzapine to 2.5 mg because of grade 2 drowsiness, but no patients had to stop taking it.
In most cases, gastrointestinal adverse effects were only present for the first 2 3 days of treatment, except in two patients who only tolerated 0.9 mg because of vomiting and diarrhea at 1.2 mg.
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One patient (patient 9) in fact received 39 mg m−2 rather than 33 mg m−2 because of an error in calculation of body surface area and he had DLT.
In patients with castration-resistant prostate cancer, the dose of 10 mg m 2 had to be decreased to 8 mg m 2 because of severe gastrointestinal toxicity observed in four of the six initially enrolled patients.
The toxicity prompted a dose reduction of capecitabine to 825 mg m−2, because of four treatment-related deaths.
This dose was reduced to 15 20 mg m−2 because of severe acute toxicity in the first 10 patients.
We found no evidence that women have been under-represented in clinical trials of ibuprofen 400 mg because two thirds of all patients were women.
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CEO of Professional Science Editing for Scientists @ prosciediting.com