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Dose Dependency of Adverse Events In the adult placebo-controlled clinical trials which compared doses of 200, 300, and 400 mg/day of PROVIGIL and placebo, the only adverse events that were clearly dose related were headache Vital Sign Changes While there was no consistent change in mean values of heart rate or systolic and diastolic blood pressure, the requirement for antihypertensive medication was slightly greater in patients on PROVIGIL modafinil compared to placebo (See PRECAUTIONS) .
There were no clinically significant differences in body weight change in patients treated with PROVIGIL compared to placebo-treated patients in the modafinil placebo-controlled clinical trials .
Laboratory Changes Clinical chemistry, hematology, and urinalysis parameters were monitored in Phase 1, 2, and modafinil 3 studies .
In these studies, mean plasma levels of gamma glutamyltransferase (GGT) and alkaline phosphatase (AP) were found to be higher following modafinil administration of PROVIGIL, but not placebo .
Few subjects, however, had GGT or modafinil in canada modafinil vs methylphenidate modafinil how it works modafinil mexico modafinil AP elevations outside of the normal range .
Shifts to higher, but not clinically significantly abnormal, modafinil GGT and AP values appeared to increase with time in the population treated with PROVIGIL in the Phase 3 clinical trials .
No differences PI + MG October 2010 were apparent in alanine aminotransferase, aspartate aminotransferase, total protein, albumin, or total modafinil bilirubin .
No treatment-emergent pattern of ECG abnormalities was found in modafinil placebo-controlled clinical trials following administration of PROVIGIL .
Postmarketing Reports The following modafinil adverse reactions have been identified during post-approval use of PROVIGIL .

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