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Table 4 Adverse events; safety set

From: Lanthanum carbonate versus placebo for management of hyperphosphatemia in patients undergoing peritoneal dialysis: a subgroup analysis of a phase 2 randomized controlled study of dialysis patients

  Dose-titration phase (n= 39) Parallel-group phase
Lanthanum carbonate (n= 10) Placebo (n= 11)
Patients with any AE, n (%) 34 (87.2) 7 (70.0) 8 (72.7)
Total AEs, n 82 14 19
Patients withdrawing because of an AE, n (%) 5 (12.8) 1 (9.1)
Gastrointestinal AEs by preferred term, n (%) 20 (51.3)a 3 (30.0)a 3 (27.3)a
  Abdominal distress 1 (2.6)
  Bloating 2 (5.1)
  Constipation 1 (2.6) 1 (10.0) 1 (9.1)
  Dental disorder 1 (10.0)
  Diarrhea 3 (7.7) 1 (9.1)
  Flatulence 2 (5.1) 1 (9.1)
  Indigestion 1 (9.1)
  Mouth ulceration 1 (2.6)
  Nausea 9 (23.1) 1 (9.1)
  Peritonitis 2 (5.1)
  Stools loose 1 (10.0)
  Vomiting 10 (25.6) 1 (10.0) 1 (9.1)
  1. aSome patients reported more than one gastrointestinal adverse event.
  2. AE: adverse events.
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