Table 4.

Adverse events according to treatment group (safety population)

PA21Sevelamer-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 event14 (53.8)16 (61.5)13 (52.0)18 (66.7)17 (70.8)78 (60.9)15 (57.7)
Any severe adverse event2 (7.7)1 (3.8)01 (3.7)04 (3.1)1 (3.8)
Any serious adverse event2 (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 event5 (19.2)5 (19.2)4 (16.0)8 (29.6)5 (20.8)27 (21.1)6 (23.1)
Adverse eventsa
 Hypophosphatemia2 (7.7)4 (15.4)2 (8.0)8 (29.6)7 (29.2)23 (18.0)3 (11.5)
 Hyperphosphatemia5 (19.2)3 (11.5)1 (4.0)1 (3.7)010 (7.8)2 (7.7)
 Hypercalcemia2 (7.7)2 (7.7)1 (4.0)1 (3.7)1 (4.2)7 (5.5)2 (7.7)
 Discolored feces2 (7.7)3 (11.5)3 (12.0)4 (14.8)3 (12.5)15 (11.7)0
 Diarrhea1 (3.8)2 (7.7)2 (8.0)1 (3.7)1 (4.2)7 (5.5)3 (11.5)
 Constipation01 (3.8)1 (4.0)2 (7.4)04 (3.1)0
 Vomiting02 (7.7)01 (3.7)03 (2.3)1 (3.8)
 Muscle spasms1 (3.8)1 (3.8)2 (8.0)1 (3.7)3 (12.5)8 (6.3)0
 Pain in extremity1 (3.8)1 (3.8)1 (4.0)003 (2.3)1 (3.8)
 Hypertension1 (3.8)02 (8.0)02 (8.3)5 (3.9)1 (3.8)
 Hypotension01 (3.8)0001 (0.8)3 (11.5)
 Anemia003 (12.0)003 (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.