treatment-emergent adverse event

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treatment-emergent adverse event

An event that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state.
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The rate of permanent treatment discontinuation in the study due to a treatment emergent adverse event was higher in the Rebif arm (21.
In short-term (six-week) acute bipolar mania trials in combination with lithium or valproate, the most common treatment emergent adverse event associated with Zyprexa and lithium or valproate was dry mouth.
In short-term (three- and four-week) acute bipolar mania trials, the most common treatment emergent adverse event associated with olanzapine was drowsiness.
The overall incidence of Treatment Emergent Adverse Events was low, and there were no severe adverse events reported during the study for any subject.
The most common overall treatment emergent adverse events (AEs) (>25% patients) were neutropenia (53%), diarrhea and nausea (47%), upper respiratory tract infection (41%), pyrexia (37%) and fatigue, headache and cough (each 33%).
Safety data from the open-label UCERIS 9 mg clinical study indicated that overall frequencies of treatment emergent adverse events occurred to a similar extent regardless of which prior treatment group (UCERIS 9 mg, UCERIS 6 mg, Asacol 2400 mg, or placebo) the patient was in during the previous eight week pivotal Phase III clinical study.
The more common treatment emergent adverse events occurring in clinical trials of Anthim administered by IV infusion compared to placebo included headache, pruritus, cough, urticaria and rash.
Discontinuations due to treatment emergent adverse events were 4.
Most treatment emergent adverse events were mild to moderate (>96%), with no serious adverse events related to apremilast reported in this study.
In both treatment groups, the most common treatment emergent adverse events were nausea, vomiting, pyrexia (fever) and diarrhea.
In the 24-week extension period, the most commonly reported treatment emergent adverse events (greater than or equal to 5% of subjects) were upper respiratory tract infection (13%), vomiting (11%), abdominal pain (8%), diarrhea (6%), pyrexia (5%), nasopharyngitis (5%), pharyngitis streptococcal (5%), and sinusitis (5%).
The most common treatment emergent adverse events in the subgroup with dyslipidemia and the subgroup with hypertension were dry mouth, paraesthesia, constipation, upper respiratory tract infection, and nasopharyngitis.
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