Table 3.
Summary of adverse events in the randomized study population (Medical Dictionary for Regulatory Activities 18.1 English, classification)
| Adverse Events | Placebo | Sevelamer Carbonate |
|---|---|---|
| Serious adverse events | 0 | 11 |
| Related to investigational product | 0 | 0 |
| Cardiac disorders | 0 | 1 (9%) |
| Myocardial infarction | 0 | 1 |
| Reproductive system and breast disorders | 0 | 1 (9%) |
| Prostatitis | 0 | 1 |
| Renal and urinary disorders | 0 | 3 (27%) |
| Acute renal disease | 0 | 1 |
| Urinary tract obstruction | 0 | 1 |
| Acute urinary retention | 0 | 1 |
| Nervous system disorders | 0 | 1 (9%) |
| Headache | 0 | 1 |
| Gastrointestinal disorders | 0 | 1 (9%) |
| Acute abdominal pain | 0 | 1 |
| Musculoskeletal and connective tissue disorders | 0 | 2 (18%) |
| Rhabdomyolysis | 0 | 1 |
| Chest pain | 0 | 1 |
| Vascular disorders | 0 | 1 (9%) |
| Hypertension | 0 | 1 |
| Injury, poisoning, and procedural complications | 0 | 1 (9%) |
| Fall | 0 | 1 |
| Nonserious adverse events | 17 | 39 |
| Surgical and medical procedure | 0 (0%) | 1 (3%) |
| Skin lesion excision | 0 | 1 |
| Skin and subcutaneous tissue disorders | 0 (0%) | 2 (5%) |
| Dyshidrosis | 0 | 1 |
| Redness | 0 | 1 |
| Renal and urinary disorder | 1 (6%) | 1 (3%) |
| Acute renal injury | 0 | 1 |
| Macroscopic hematuria | 1 | 0 |
| Nervous system disorder | 0 (0%) | 1 (3%) |
| Vertigo | 0 | 1 |
| Gastrointestinal disorders | 4 (23%) | 17 (43%) |
| Bloating | 1 | 1 |
| Gastroesophageal burning | 0 | 1 |
| Constipation | 0 | 4 |
| Diarrhea | 0 | 5 |
| Abdominal pain | 1 | 0 |
| Dysphagia | 0 | 1 |
| Nausea | 0 | 2 |
| Gastroesophageal reflux disease | 0 | 1 |
| Digestive disorder | 0 | 1 |
| Intestinal transit disorder | 1 | 0 |
| Vomiting | 1 | 1 |
| Musculoskeletal and connective tissue disorders | 3 (18%) | 2 (5%) |
| Arm pain | 1 | 0 |
| Leg pain | 1 | 0 |
| Muscular pain | 0 | 1 |
| Weakness of lower extremities | 1 | 0 |
| Polyarthralgia | 0 | 1 |
| Respiratory, thoracic, and mediastinal conditions | 0 (0%) | 2 (5%) |
| Breathlessness | 0 | 1 |
| Breathing difficult | 0 | 1 |
| Vascular disorders | 1 (6%) | 0 (0%) |
| Orthostatic hypotension | 1 | 0 |
| Infections and infestations | 2 (12%) | 2 (5%) |
| Cervical abscess | 0 | 1 |
| Dental infection | 1 | 0 |
| Urinary tract infection | 1 | 0 |
| Superinfection | 0 | 1 |
| Metabolism and nutrition disorders | 1 (6%) | 4 (10%) |
| Gout attack | 0 | 1 |
| Hyperkaliemia | 0 | 3 |
| Hypertriglyceridemia | 1 | 0 |
| General disorders and administration site conditions | 5 (29%) | 6 (15%) |
| Disease aggravation | 1 | 0 |
| Pain | 0 | 1 |
| Thoracic pain | 1 | 0 |
| Tiredness | 1 | 0 |
| Drug intolerance | 0 | 1 |
| Edema | 2 | 3 |
| Inflammatory reaction | 0 | 1 |
| Neoplasms: benign, malignant, and perinatal conditions | 0 (0%) | 1 (3%) |
| Lipoma | 0 | 1 |