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. 2019 Mar 7;30(4):641–652. doi: 10.1681/ASN.2018080832

Table 2.

Summary of AEs

AE category Tenapanor Placebo, n=82 Tenapanor
3 mg Twice Daily, n=74 10 mg Twice Daily, n=73 30 mg Twice Daily Titration, n=71 3 mg Twice Daily, n=25 10 mg Twice Daily, n=23 30 mg Twice Daily Titration, n=34
RTP
 Any AE 39 (52.7) 51 (69.9) 49 (69.0)
  Treatment-related AE 24 (32.4) 38 (52.1) 33 (46.5)
  AE leading to study discontinuation 8 (10.8) 16 (21.9) 11 (15.5)
  AE leading to death 1 (1.4) 0 (0.0) 0 (0.0)
  SAE 11 (14.9) 5 (6.8) 5 (7.0)
 AEs by system organ classa
  Gastrointestinal disorders 24 (32.4) 35 (47.9) 40 (56.3)
  Infections and infestations 11 (14.9) 5 (6.8) 8 (11.3)
  Metabolism and nutrition disorders 4 (5.4) 10 (13.7) 9 (12.7)
  Injury, poisoning, and procedural complications 5 (6.8) 11 (15.1) 5 (7.0)
  General disorders and administration site conditions 7 (9.5) 5 (6.8) 3 (4.2)
  Respiratory, thoracic, and mediastinal disorders 3 (4.1) 3 (4.1) 5 (7.0)
  Skin and subcutaneous tissue disorders 3 (4.1) 4 (5.5) 2 (2.8)
  Cardiac disorders 3 (4.1) 2 (2.7) 3 (4.2)
  Vascular disorders 0 (0.0) 4 (5.5) 3 (4.2)
  Investigations 3 (4.1) 2 (2.7) 1 (1.4)
  Nervous system disorders 4 (5.4) 1 (1.4) 1 (1.4)
  Musculoskeletal and connective tissue disorders 2 (2.7) 1 (1.4) 2 (2.8)
  Blood and lymphatic system disorders 2 (2.7) 2 (2.7) 0 (0.0)
  Renal and urinary disorders 2 (2.7) 1 (1.4) 1 (1.4)
RWP
 Any AE 21 (25.6) 4 (16.0) 7 (30.4) 12 (35.3)
  Treatment-related AE 5 (6.1) 0 (0.0) 1 (4.3) 0 (0.0)
  AE leading to study discontinuation 5 (6.1) 0 (0.0) 1 (4.3) 1 (2.9)
  AE leading to death 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
  SAE 4 (4.9) 0 (0.0) 0 (0.0) 0 (0.0)
 AEs by system organ classa
  Metabolism and nutrition disorders 7 (8.5) 0 (0.0) 1 (4.3) 3 (8.8)
  Injury, poisoning, and procedural complications 4 (4.9) 2 (8.0) 0 (0.0) 2 (5.9)
  Infections and infestations 2 (2.4) 2 (8.0) 1 (4.3) 2 (5.9)
  Gastrointestinal disorders 4 (4.9) 0 (0.0) 0 (0.0) 2 (5.9)
  Investigations 2 (2.4) 1 (4.0) 0 (0.0) 2 (5.9)
  Respiratory, thoracic, and mediastinal disorders 1 (1.2) 1 (4.0) 3 (13.0) 0 (0.0)
  General disorders and administration site conditions 1 (1.2) 0 (0.0) 0 (0.0) 2 (5.9)
  Skin and subcutaneous tissue disorders 2 (2.4) 0 (0.0) 1 (4.3) 0 (0.0)
  Cardiac disorders 2 (2.4) 0 (0.0) 0 (0.0) 0 (0.0)

Data are number of patients experiencing AE (%). AE, adverse event; SAE, serious adverse event.

a

Data shown for system organ classes for which two or more patients in any group experienced an AE.