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. 2016 Jun 23;11(9):1597–1605. doi: 10.2215/CJN.09050815

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 (%).

a

As judged by the investigator.

b

Pneumonia (placebo: n=1), urinary tract infection (tenapanor: n=1), and syncope in combination with humerus fracture (tenapanor: n=1).

c

Any adverse event reported by at least two participants.

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