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. 2021 Dec 18;88(5):2140–2155. doi: 10.1111/bcp.15137

TABLE 2.

Adverse events reported in part A and part C of the study (safety population a )

PART A b
Adverse event, n (%) c Placebo (N = 23) GSK3358699
1 mg (n = 5) 3 mg (n = 3) 10 mg (n = 6) 20 mg (n = 6) 25 mg (n = 12) 30 mg (n = 6) 40 mg (n = 6)
Any AE 4 (17) 2 (40) 3 (100) 2 (33) 3 (50) 8 (67) 4 (67) 3 (50)
Any nonserious treatment‐related AE 1 (4) 0 1 (33) 0 0 0 0 0
Diarrhoea 0 0 1 (33) 0 0 0 0 0
Nausea 0 0 1 (33) 0 0 0 0 0
Transaminase increased 1 (4) 0 0 0 0 0 0 0
AEs leading to withdrawal 0 1 (20) 0 1 (17) 0 0 0 0
Neutropenia 0 1 (20) 0 0 0 0 0 0
Ventricular tachycardia (nonsustained) 0 0 0 1 (17) 0 0 0 0
PART C d
Adverse event, n (%) c Placebo (N = 11) GSK3358699 10 mg QD (N = 14)
Any AE 7 (64) 7 (50)
Any nonserious treatment‐related AE 3 (27) 3 (21)
Tachycardia 1 (9) 1 (7)
Atrial fibrillation 1 (9) 0
Palpitations 1 (9) 0
Ventricular extrasystoles 0 1 (7)
Ventricular tachycardia (nonsustained) 0 1 (7)
Serious AE 0 1 (7)
Atrial fibrillation 0 1 (7)
AEs leading to withdrawal 1 (9) 3 (21)
Atrial fibrillation 0 1 (7)
Tachycardia 0 1 (7)
Ventricular tachycardia (nonsustained) 0 1 (7)
Keratitis 1 (9) 0

Abbreviation: AE, adverse event.

a

The safety population consisted of all randomized participants who received at least one dose of study treatment.

b

Part A was a single ascending‐dose crossover study in two interlocking cohorts. Each participant received a maximum of two single ascending oral doses of GSK3358699 (1, 3, 10, 20, 40 or 30 mg) and one dose of placebo.

c

The data presented represent the number of participants who experienced an adverse event.

d

In part C, participants received 10 mg of GSK3358699 or placebo daily for up to 14 days.