Table 4.
Placebo (N=51) | SPL 12.5 mg (N=27) | SPL 25 mg (N=26) | SPL 50 mg (N=25) | p-Values for Event Rates |
||||||
---|---|---|---|---|---|---|---|---|---|---|
Pts w/event No. (%) |
Events per pt-year |
Pts w/event No. (%) |
Events per pt-year |
Pts w/event No. (%) |
Events per pt-year |
Pts w/event No. (%) |
Events per pt-year |
Trend | Combined SPL vs Placebo |
|
Breast enlargement or tenderness | 2 (3.9) | 0.05 | 0 (0.0) | 0.00 | 1 (3.8) | 0.06 | 2 (8.0) | 0.11 | 0.7 | 0.9 |
Rash | 2 (3.9) | 0.05 | 1 (3.7) | 0.05 | 1 (3.8) | 0.06 | 2 (8.0) | 0.11 | 0.3 | <0.001 |
Nausea | 6 (11.8) | 0.16 | 8 (29.6) | 0.48 | 4 (15.4) | 0.23 | 1 (4.0) | 0.05 | 0.2 | 0.01 |
Vomiting | 5 (9.8) | 0.13 | 7 (25.9) | 0.42 | 2 (7.7) | 0.40 | 1 (4.0) | 0.11 | 0.8 | 0.1 |
Diarrhea | 5 (9.8) | 0.24 | 4 (14.8) | 0.21 | 5 (19.2) | 0.40 | 3 (12.0) | 0.21 | 0.7 | 0.8 |
Anorexia | 0 (0.0) | 0.00 | 0 (0.0) | 0.00 | 1 (3.8) | 0.06 | 0 (0.0) | 0.00 | 0.2 | 0.9 |
Constipation | 2 (3.9) | 0.05 | 1 (3.7) | 0.05 | 1 (3.8) | 0.28 | 0 (0.0) | 0.00 | 0.03 | <0.001 |
Any gastrointestinal symptoms | 11 (21.6) | 0.45 | 11 (40.7) | 0.79 | 8 (30.8) | 1.14 | 4 (16.0) | 0.32 | 0.6 | 0.1 |
Serious adverse eventa | 27 (52.9) | 1.79 | 13 (48.1) | 1.43 | 13 (50.0) | 2.68 | 12 (48.0) | 2.26 | 0.2 | 0.5 |
Serious adverse events include any adverse event that: is fatal or result in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, results in congenital anomalies or birth defects or is considered an important medical event Abbreviation: SPL, spironolactone; pt, patient