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Table 2 Summary of treatment-emergent adverse events

From: Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial

Participants, n (%) Healthy volunteers Patients with T2DM
  Volixibat Placebo Volixibat
Placebo
(n = 12)
0.5 mg
(n = 10)
1 mg
(n = 9)
5 mg
(n = 9)
10 mg
(n = 9)
(n = 3) 10 mg
(n = 8)
Any adverse event 10 (83.3) 7 (70.0) 9 (100) 8 (88.9) 9 (100) 1 (33.3) 7 (87.5)
Treatment-related adverse events 6 (50.0) 7 (70.0) 8 (88.9) 8 (88.9) 9 (100) 1 (33.3) 6 (75.0)
Severe adverse events 0 0 0 0 0 0 0
Serious adverse events 0 0 0 0 1 (11.1)a 0 0
Deaths 0 0 0 0 0 0 0
Adverse events reported in >1 participant in any groupb
 Gastrointestinal disorders
  Diarrhoea 3 (25.0) 5 (50.0) 8 (88.9) 8 (88.9) 9 (100) 1 (33.3) 6 (75.0)
  Abdominal pain 3 (25.0) 3 (30.0) 5 (55.6) 6 (66.7) 7 (77.8) 1 (33.3) 3 (37.5)
  Gastrointestinal sounds abnormal 2 (16.7) 0 0 2 (22.2) 4 (44.4) 0 1 (12.5)
  Nausea 2 (16.7) 1 (10.0) 1 (11.1) 1 (11.1) 4 (44.4) 0 0
  Flatulence 0 1 (10.0) 2 (22.2) 0 4 (44.4) 1 (33.3) 0
  Abdominal distension 1 (8.3) 2 (20.0) 1 (11.1) 0 2 (22.2) 0 0
  Abdominal discomfort 1 (8.3) 1 (10.0) 2 (22.2) 0 0 0 0
  Dry mouth 0 0 0 0 0 0 2 (25.0)
 Nervous system disorders
  Headache 4 (33.3) 2 (20.0) 3 (33.3) 1 (11.1) 3 (33.3) 0 1 (12.5)
  Dizziness 1 (8.3) 0 0 0 2 (22.2) 0 1 (12.5)
 General disorders and administration site conditions
  Fatigue 1 (8.3) 0 2 (22.2) 1 (11.1) 0 0 0
  Influenza-like illness 0 0 0 2 (22.2) 0 0 0
 Infections and infestations
  Rhinitis 2 (16.7) 1 (10.0) 0 1 (11.1) 0 0 1 (12.5)
 Respiratory, thoracic and mediastinal disorders
  Oropharyngeal pain 3 (25.0) 0 1 (11.1) 0 0 0 0
 Musculoskeletal and connective tissue disorders
  Pain in extremity 0 0 2 (22.2) 0 0 0 0
  1. T2DM type 2 diabetes mellitus
  2. Data are from the safety analysis set
  3. aAblation of the retina with a bleed in the vitreous body of the right eye (moderate severity), which was not considered to be related to the study drug by the principal investigator. bReported by System Organ Class in descending order of frequency in the volixibat 10 mg group for healthy volunteers