TABLE 3.
Clinical adverse events
| Adverse event | No. (%) of patients
|
P value | ||
|---|---|---|---|---|
| Total | QSP group (n = 94) | M group (n = 93) | ||
| Any side effect | 120 (64.2) | 59 (62.8) | 61 (65.6) | NSa |
| Nausea | 33 (17.6) | 20 (21.3) | 13 (14) | NS |
| Vomiting | 74 (39.6) | 42 (44.7) | 32 (34.4) | NS |
| Diarrhea | 11 (5.9) | 4 (4.3) | 7 (7.5) | NS |
| Any GIb disturbance | 95 (50.8) | 52 (55.3) | 43 (46.2) | NS |
| Sleep disturbance | 34 (18.2) | 9 (9.6) | 25 (26.9) | 0.02 (OR = 3.47; CI = 1.42-8.71) |
| Anxiety | 5 (2.7) | 1 (1) | 1 (4.3) | NS |
| Dizziness | 31 (16.6) | 13 (13.8) | 18 (19.4) | NS |
| Any CNS disturbance | 36 (19.3) | 9 (9.6) | 27 (29) | <0.001 (OR = 3.86; CI = 1.59-9.93) |
| Tinnitus | 16 (8.6) | 14 (14.9) | 2 (2.2) | 0.02 (OR = 0.13; CI = 0.02-0.61) |
a
NS, not significant.
b
GI, gastrointestinal.