Table 3.
Number of Patients With a Given Type and Grade of Adverse Eventa
Calcium Carbonate | Placebo | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
(n = 95) | (n = 99) | |||||||||||||
Grade | Grade | |||||||||||||
Adverse Event | Unk | 0 | 1 | 2 | 3 | 4 | 5 | Unk | 0 | 1 | 2 | 3 | 4 | 5 |
Allergy/hypersensitivity | 0 | 98 | 0 | 1 | 0 | 0 | 0 | 0 | 101 | 0 | 0 | 0 | 0 | 0 |
Bilirubin increase | 0 | 94 | 4 | 0 | 1 | 0 | 0 | 0 | 92 | 8 | 1 | 0 | 0 | 0 |
Constipation/bowel obstruction | 0 | 80 | 14 | 4 | 1 | 0 | 0 | 0 | 83 | 11 | 7 | 0 | 0 | 0 |
Creatinine increase | 0 | 96 | 3 | 0 | 0 | 0 | 0 | 0 | 95 | 5 | 1 | 0 | 0 | 0 |
Diarrhea without colostomy | 1 | 95 | 1 | 1 | 1 | 0 | 0 | 0 | 100 | 0 | 0 | 1 | 0 | 0 |
Dyspnea | 0 | 98 | 0 | 1 | 0 | 0 | 0 | 0 | 101 | 0 | 0 | 0 | 0 | 0 |
Hypercalcemia | 0 | 97 | 1 | 0 | 0 | 1 | 0 | 0 | 99 | 2 | 0 | 0 | 0 | 0 |
Nausea | 1 | 96 | 1 | 1 | 0 | 0 | 0 | 0 | 99 | 1 | 1 | 0 | 0 | 0 |
Proteinuria | 0 | 99 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 1 | 0 | 0 | 0 |
SGOT (AST) increase | 0 | 99 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 1 | 0 | 0 | 0 |
SGPT (ALT) increase | 0 | 99 | 0 | 0 | 0 | 0 | 0 | 0 | 100 | 0 | 1 | 0 | 0 | 0 |
Weight gain | 0 | 98 | 0 | 1 | 0 | 0 | 0 | 0 | 101 | 0 | 0 | 0 | 0 | 0 |
Maximum Grade Any Adverse Event (N) | 2 | 65 | 20 | 8 | 3 | 1 | 0 | 0 | 61 | 29 | 10 | 1 | 0 | 0 |
Adverse events unlikely or not related to treatment excluded adverse events with no entries for grades 2 to 5 have been suppressed.