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. 2020 Feb 12;86(6):1113–1124. doi: 10.1111/bcp.14219

Table 2.

Treatment‐emergent adverse events occurring with P218 at doses of 10‐1000 mg or placebo in Part A and following 250 mg P218 in fed or fasted state in Part B

Adverse event, n subjects (%) Part A Part B (250 mg P218)
10 mg (n = 6) 30 mg (n = 6) 100 mg (n = 6) 250 mg (n = 6) 500 mg (n = 6) 750 mg (n = 6) 1000 mg (n = 6) Placebo (n = 14) Fasted (n = 8) Fed (n = 8)
Any adverse events 0 0 2 (33.3) 1 (16.7) 2 (33.3) 3 (50.0) 3 (50.0) 3 (21.4) 0 1 (12.5)
Presyncope 0 0 0 0 1 (16.7) 0 0 0 0 0
Dizziness 0 0 0 0 0 0 0 0 0 1 (12.5)
Abdominal pain 0 0 0 0 0 0 2 (33.3) 0 0 0
Constipation 0 0 1 (16.7) 1 (16.7) 0 0 0 0 0 0
Faeces soft 0 0 0 0 0 0 1 (16.7) 0 0 0
Nausea 0 0 0 0 0 0 0 0 0 1 (12.5)
Nasopharyngitis 0 0 0 0 0 2 (33.3) 0 1 (7.1) 0 0
Sinusitis 0 0 1 (16.7) 0 0 0 0 0 0 0
Back pain 0 0 0 0 0 2 (33.3) 0 0 0 0
Headache 0 0 0 0 1 (16.7) 0 1 (16.7) 1 (7.1) 0 1 (12.5)
Paraesthesia 0 0 0 0 0 0 0 0 0 1 (12.5)
Oropharyngeal pain 0 0 0 0 0 0 1 (16.7) 1 (7.1) 0 0

All events were mild, except one case of moderate back pain (Part A: 750 mg).