Table 3.
Summary of adverse events (outpatient cohort)
Adverse Event Category | Tenapanor, n=37 | Placebo, n=35 |
---|---|---|
At least one adverse event | 33 (89.2) | 25 (71.4) |
Treatment–related adverse eventa | 17 (45.9) | 4 (11.4) |
Serious adverse eventb | 2 (5.4) | 1 (2.9) |
Adverse event leading to discontinuation | 1 (2.7) | 0 |
Adverse event by system organ class (preferred term)c | ||
Gastrointestinal disorders | 23 (62.2) | 7 (20.0) |
Diarrhea | 21 (56.8) | 3 (8.6) |
Nausea | 4 (10.8) | 3 (8.6) |
Abdominal pain | 1 (2.7) | 1 (2.9) |
Vomiting | 1 (2.7) | 1 (2.9) |
Investigations | 7 (18.9) | 6 (17.1) |
Blood carbon dioxide decreased | 2 (5.4) | 2 (5.7) |
Blood parathyroid hormone increased | 1 (2.7) | 2 (5.7) |
Blood potassium increased | 1 (2.7) | 1 (2.9) |
Blood sodium decreased | 2 (5.4) | 0 |
Musculoskeletal and connective tissue disorders | 6 (16.2) | 7 (20.0) |
Muscle spasms | 6 (16.2) | 5 (14.3) |
Vascular disorders | 6 (16.2) | 6 (17.1) |
Hypotension | 5 (13.5) | 6 (17.1) |
Metabolism and nutrition disorders | 6 (16.2) | 4 (11.4) |
Hyperkalemia | 3 (8.1) | 0 |
Hyperphosphatemia | 2 (5.4) | 2 (5.7) |
Metabolic acidosis | 1 (2.7) | 1 (2.9) |
Hypocalcemia | 0 | 2 (5.7) |
Injury, poisoning, and procedural complications | 5 (13.5) | 5 (14.3) |
Procedural hypotension | 4 (10.8) | 3 (8.6) |
General disorders and administration site conditions | 5 (13.5) | 4 (11.4) |
Chest pain | 2 (5.4) | 1 (2.9) |
Catheter site pain | 2 (5.4) | 0 |
Malaise | 1 (2.7) | 3 (8.6) |
Nervous system disorders | 5 (13.5) | 3 (8.6) |
Dizziness | 3 (8.1) | 2 (5.7) |
Headache | 1 (2.7) | 1 (2.9) |
Respiratory, thoracic, and mediastinal disorders | 2 (5.4) | 2 (5.7) |
Dyspnea | 2 (5.4) | 0 |
Cardiac disorders | 2 (5.4) | 1 (2.9) |
Cardiac failure congestive | 1 (2.7) | 1 (2.9) |
Values are n (%).
As judged by the investigator.
Pneumonia (placebo: n=1), urinary tract infection (tenapanor: n=1), and syncope in combination with humerus fracture (tenapanor: n=1).
Any adverse event reported by at least two participants.