Table 4 Adverse events; safety set
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) |