Table 3.

Summary of adverse events in the randomized study population (Medical Dictionary for Regulatory Activities 18.1 English, classification)

Adverse EventsPlaceboSevelamer Carbonate
Serious adverse events011
 Related to investigational product00
  Cardiac disorders01 (9%)
   Myocardial infarction01
  Reproductive system and breast disorders01 (9%)
   Prostatitis01
  Renal and urinary disorders03 (27%)
   Acute renal disease01
   Urinary tract obstruction01
   Acute urinary retention01
  Nervous system disorders01 (9%)
   Headache01
  Gastrointestinal disorders01 (9%)
   Acute abdominal pain01
  Musculoskeletal and connective tissue disorders02 (18%)
   Rhabdomyolysis01
   Chest pain01
  Vascular disorders01 (9%)
   Hypertension01
  Injury, poisoning, and procedural complications01 (9%)
   Fall01
Nonserious adverse events1739
 Surgical and medical procedure0 (0%)1 (3%)
  Skin lesion excision01
 Skin and subcutaneous tissue disorders0 (0%)2 (5%)
  Dyshidrosis01
  Redness01
 Renal and urinary disorder1 (6%)1 (3%)
  Acute renal injury01
  Macroscopic hematuria10
 Nervous system disorder0 (0%)1 (3%)
  Vertigo01
 Gastrointestinal disorders4 (23%)17 (43%)
  Bloating11
  Gastroesophageal burning01
  Constipation04
  Diarrhea05
  Abdominal pain10
  Dysphagia01
  Nausea02
  Gastroesophageal reflux disease01
  Digestive disorder01
  Intestinal transit disorder10
  Vomiting11
 Musculoskeletal and connective tissue disorders3 (18%)2 (5%)
  Arm pain10
  Leg pain10
  Muscular pain01
  Weakness of lower extremities10
  Polyarthralgia01
 Respiratory, thoracic, and mediastinal conditions0 (0%)2 (5%)
  Breathlessness01
  Breathing difficult01
 Vascular disorders1 (6%)0 (0%)
  Orthostatic hypotension10
 Infections and infestations2 (12%)2 (5%)
  Cervical abscess01
  Dental infection10
  Urinary tract infection10
  Superinfection01
 Metabolism and nutrition disorders1 (6%)4 (10%)
  Gout attack01
  Hyperkaliemia03
  Hypertriglyceridemia10
 General disorders and administration site conditions5 (29%)6 (15%)
  Disease aggravation10
  Pain01
  Thoracic pain10
  Tiredness10
  Drug intolerance01
  Edema23
  Inflammatory reaction01
 Neoplasms: benign, malignant, and perinatal conditions0 (0%)1 (3%)
  Lipoma01