Table 2.
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.
Data shown for system organ classes for which two or more patients in any group experienced an AE.