Which one safety term best describes the event

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Reference no: EM133370850

Question: Based on the event described below, which ONE safety term best describes the event? A patient with asthma is enrolled in a phase 3 clinical trial for an experimental asthma treatment that is administered by inhalation. The patient is 34 years old and is otherwise healthy. During the trial, the patient is dosed with the experimental treatment two times in the clinic, under supervision of a doctor. After the first two doses, the patient is allowed to take the experimental treatment home and can use it up to twice a day, as needed. After 5 days of using the treatment twice per day, on day 6 immediately after using the treatment, the patient experiences a bout of mild dizziness. The dizziness lasts for approximately 1 hour and then resolves without further treatment. The patient calls the study doctor to report the event, and the study doctor notes that dizziness is noted in the Investigator's Brochure (IB) as an expected AE due to the mechanism of action of the treatment.

Reference no: EM133370850

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