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) |
aSome patients reported more than one gastrointestinal adverse event.
AE: adverse events.