Table 4.
Adverse events according to treatment group (safety population)
| PA21 | Sevelamer-HCl (n=26) | ||||||
|---|---|---|---|---|---|---|---|
| 1.25 g/d (n=26) | 5.0 g/d (n=26) | 7.5 g/d (n=25) | 10.0 g/d (n=27) | 12.5 g/d (n=24) | All (n=128) | ||
| Any adverse event | 14 (53.8) | 16 (61.5) | 13 (52.0) | 18 (66.7) | 17 (70.8) | 78 (60.9) | 15 (57.7) |
| Any severe adverse event | 2 (7.7) | 1 (3.8) | 0 | 1 (3.7) | 0 | 4 (3.1) | 1 (3.8) |
| Any serious adverse event | 2 (7.7) | 2 (7.7) | 1 (4.0) | 1 (3.7) | 2 (8.3) | 8 (6.3) | 2 (7.7) |
| Discontinuation of study or treatment due to adverse event | 5 (19.2) | 5 (19.2) | 4 (16.0) | 8 (29.6) | 5 (20.8) | 27 (21.1) | 6 (23.1) |
| Adverse eventsa | |||||||
| Hypophosphatemia | 2 (7.7) | 4 (15.4) | 2 (8.0) | 8 (29.6) | 7 (29.2) | 23 (18.0) | 3 (11.5) |
| Hyperphosphatemia | 5 (19.2) | 3 (11.5) | 1 (4.0) | 1 (3.7) | 0 | 10 (7.8) | 2 (7.7) |
| Hypercalcemia | 2 (7.7) | 2 (7.7) | 1 (4.0) | 1 (3.7) | 1 (4.2) | 7 (5.5) | 2 (7.7) |
| Discolored feces | 2 (7.7) | 3 (11.5) | 3 (12.0) | 4 (14.8) | 3 (12.5) | 15 (11.7) | 0 |
| Diarrhea | 1 (3.8) | 2 (7.7) | 2 (8.0) | 1 (3.7) | 1 (4.2) | 7 (5.5) | 3 (11.5) |
| Constipation | 0 | 1 (3.8) | 1 (4.0) | 2 (7.4) | 0 | 4 (3.1) | 0 |
| Vomiting | 0 | 2 (7.7) | 0 | 1 (3.7) | 0 | 3 (2.3) | 1 (3.8) |
| Muscle spasms | 1 (3.8) | 1 (3.8) | 2 (8.0) | 1 (3.7) | 3 (12.5) | 8 (6.3) | 0 |
| Pain in extremity | 1 (3.8) | 1 (3.8) | 1 (4.0) | 0 | 0 | 3 (2.3) | 1 (3.8) |
| Hypertension | 1 (3.8) | 0 | 2 (8.0) | 0 | 2 (8.3) | 5 (3.9) | 1 (3.8) |
| Hypotension | 0 | 1 (3.8) | 0 | 0 | 0 | 1 (0.8) | 3 (11.5) |
| Anemia | 0 | 0 | 3 (12.0) | 0 | 0 | 3 (2.3) | 0 |
Values are shown as n (%).
a
Any adverse event reported by >1 participant in any treatment group or >2 participants in the pooled PA21 group.