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. Author manuscript; available in PMC: 2018 Feb 1.
Published in final edited form as: Clin Pharmacokinet. 2018 Feb;57(2):209–219. doi: 10.1007/s40262-017-0553-1

Table 1.

Number of subject-reported adverse events by dosing cohorts, grouped by category

Category Neurological Hearing Visual Gastrointestinal Chills

Dose (mg/kg) Headache Feeling abnormal Fatigue Dizziness Hypoacusis Tinnitus Blurred vision Nausea Vomiting Chills
15 0 0 0 0 0 0 0 0 0 0
30 0 0 0 0 0 0 0 0 0 0
60 1 0 0 0 1 2 0 1 1 0
90 2 1 1 0 3 0 1 1 0 2
120 3 1 2 2 3 4 2 2 1 2
130 3 2 4 1 4 4 1 3 1 6
140 5 0 2 3 6 4 2 2 1 7
150 2 0 0 2 2 1 0 1 1 1

Total 16 4 9 8 19 15 6 10 5 18

Data are presented as number of self-reported adverse events (AE) in each dose category. Many subjects reported more than one AE