| |
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.
