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Table 3 Summary of treatment-emergent AEs

From: A randomised, double-blind, placebo-controlled phase 1 study of the safety, tolerability and pharmacodynamics of volixibat in overweight and obese but otherwise healthy adults: implications for treatment of non-alcoholic steatohepatitis

AEs, no. of events, n (%) Placebo
(n = 21)
Volixibat
5 mg b.i.d.
(n = 9)
10 mg q.d.
(n = 9)
20 mg
q.d.
(n = 9)
2–5–10–20 mg q.d.
(n = 9)
30 mg q.d.
(n = 9)
40 mg q.d.
(n = 9)
80–40–20 mg q.d.
(n = 9)
Total
(n = 63)
Any AE 36, 14 (66.7) 44, 9 (100) 35, 9 (100) 46, 9 (100) 30, 9 (100) 21, 9 (100) 33, 9 (100) 22, 9 (100) 231, 63 (100)
AEs related to study drug 34, 12 (57.1) 39, 9 (100) 32, 9 (100) 45, 9 (100) 30, 9 (100) 18, 9 (100) 33, 9 (100) 22, 9 (100) 219, 63 (100)
AEs occurring in > 1 participant overall
Gastrointestinal disorders
 Diarrhoeaa 27, 11 (52.4) 33, 9 (100) 27, 9 (100) 32, 9 (100) 26, 9 (100) 16, 9 (100) 26, 9 (100) 22, 9 (100) 182, 63 (100)
 Anorectal discomfort 0 1, 1 (11.1) 0 0 0 2, 2 (22.2) 1, 1 (11.1) 0 4, 4 (6.3)
 Nausea 0 1, 1 (11.1) 1, 1 (11.1) 2, 1 (11.1) 1, 1 (11.1) 0 0 0 5, 4 (6.3)
 Abdominal pain 1, 1 (4.8) 0 1, 1 (11.1) 2, 2 (22.2) 0 0 0 0 3, 3 (4.8)
 Abdominal pain, upper 0 0 0 3, 3 (33.3) 0 0 0 0 3, 3 (4.8)
 Gastrointestinal sounds, abnormal 0 0 1,
1 (11.1)
0 1,
1 (11.1)
0 1,
1 (11.1)
0 3,
3 (4.8)
 Vomiting 0 1,
1 (11.1)
0 2,
1 (11.1)
1,
1 (11.1)
0 0 0 4,
3 (4.8)
 Defaecation urgency 0 0 0 2, 2 (22.2) 0 0 0 0 2, 2 (3.2)
Nervous system disorders
 Headache 2, 2 (9.5) 1, 1 (11.1) 0 1, 1 (11.1) 1, 1 (11.1) 0 3, 2 (22.2) 0 6, 5 (7.9)
General disorders and administrative site conditions
 Application site irritation 1, 1 (4.8) 0 1, 1 (11.1) 1, 1 (11.1) 0 0 0 0 2, 2 (3.2)
 Pyrexia 0 2, 2 (22.2) 0 0 0 0 0 0 2, 2 (3.2)
  1. Values are the number of events, followed by the number and percentage of participants experiencing the event [m, n (%)]. Data are from the safety analysis set
  2. aIncludes events described as ‘loose stools’ or ‘diarrhoea’
  3. AE, adverse event; b.i.d., twice daily; q.d., once daily