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Table 5 The frequency of side effects Side Effects Group 1 Group 2 Group 3 Group 4 Pain at injection area 1 1 1 1 Dizziness 1 0 1 1 Servical muscle spasm 1 0 0 1.
Table 6 Adverse events Adverse event during treatment Number of episodes Nasal Discomfort/Pain due to catheter 3 Nasal discomfort due to cooling 2 Hypertension 2 Mild epistaxis 1 Discomfort due to excess fluid dripping from nose 2 Adverse Event Following Treatment Transient recurrent sneezing 2 Runny nose 2 Strange taste 1 Strange smell 1 Dry eyes 1 Dizziness 1 Sinus pressure 1.
Grade 1 dizziness was reported in 8 patients.
The test was well tolerated (nausea = 1; dizziness = 1).
There were three patients with drug-related neurologic toxicity, primarily grade 1 dizziness.
In this study, only two of them complained of side effect (nausea 1, dizziness 1) who completed this trial.
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Of 611 patients treated, 40 (6.5 %) reported a total of 63 adverse reactions (ADRs), the most frequent being vomiting (21 patients; 3.4 %), nausea (14 patients; 2.3 %), dizziness (11 patients; 1.8 %) and somnolence (5 patients; 0.8 %) (Table 3).
The NNTps to prevent one event were 43 (24 to 253) for dizziness, 18 (11 to 41) for nausea, and 19 (13 to 38) for vomiting.
The adverse reactions were as follows: insomnia (15.2%), constipation (3.3%), blood prolactin elevation (0.9%), somnolence (1.9%), dizziness (0.9%), pruritus (0.9%), diarrhea (0.9%), malaise (0.9%), mood alteration (0.9%), eczema (0.5%), vomiting (0.5%), anemia (0.9%), and blood thyroid-stimulating hormone elevation (0.5%).
The clinical manifestation of ADRs included hypoglycemia (n=7), diarrhea (n=4), rash (n=4), abdominal distension (n=2), chills (n=1), vomiting (n=1), increased anal aerofluxus (n=1), itchiness (n=1), and dizziness (n=1).
The adverse events leading to discontinuation in >1.0% of enrolled patients at a duloxetine dose of 80 120 mg/d were somnolence (4.0%), dizziness (3.0%), diarrhea (2.0%), hypertension (2.0%), and vomiting (2.0%).
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com