Table 3.
Adverse drug events of the patients
| Adverse drug events | Melatonin Group (n = 109) | Control Group (n = 117) | P value |
|---|---|---|---|
| QTc interval prolongation | 16(14.7) | 11(9.4) | 0.305 |
| Cerebral hemorrhage | 14(12.8) | 6(5.1) | 0.059 |
| Dizziness | 12(11) | 3(2.6) | 0.014 |
| Stroke | 9(8.3) | 21(17.9) | 0.048 |
| Myopathy | 12(11) | 15(12.8) | 0.688 |
| Palpitations | 16(14.7) | 21(17.9) | 0.591 |
| Tremor | 17(15.6) | 8(6.8) | 0.054 |
| Gastrointestinal hemorrhage | 7(6.4) | 19(16.2) | 0.023 |
| Intestinal cramps | 5(4.6) | 8(6.8) | 0.573 |
| MI | 12(11) | 11(9.4) | 0.826 |
| Rash | 28(25.7) | 18(15.4) | 0.069 |
| Hematuria | 8(7.3) | 25(21.4) | 0.004 |
Values were expressed as n (%). Comparison between groups was performed using Fisher’s exact test. Data were collected within period of randomization. The events were studied in the intent-to-treat population