Table 3.
Top 10 adverse effects (grade 3–5).
| Grade 3–5 adverse effects | Twice-daily arm (event/total) | Once-daily arm (event/total) | The incidence of adverse effects (%)a | RR (95% CI) | P-value | Heterogeneity | |
|---|---|---|---|---|---|---|---|
| I2 (%) | P-value | ||||||
| Total | 255/336 | 230/335 | 72.28 | 1.17 [0.80, 1.72] | 0.42 | 87 | 0.005 |
| Myelotoxicityb | 179/206 | 173/203 | 86.06 | 1.02 [0.94, 1.10] | 0.63 | - | - |
| Leukopenia | 340/409 | 334/419 | 81.40 | 1.04 [0.98, 1.11] | 0.23 | 0 | 0.61 |
| Neutropenia | 422/545 | 395/550 | 74.61 | 1.06 [0.95, 1.17] | 0.30 | 57 | 0.1 |
| Thrombocytopenia | 129/409 | 155/419 | 34.30 | 0.86 [0.72, 1.03] | 0.10 | 24 | 0.27 |
| Esophagitis | 157/675 | 121/691 | 20.35 | 1.39 [0.91, 2.11] | 0.13 | 67 | 0.002 |
| Anemia | 109/675 | 100/682 | 15.40 | 1.10[0.86, 1.40] | 0.46 | 11 | 0.34 |
| Infection | 91/675 | 97/682 | 13.71 | 0.99[0.77, 1.26] | 0.93 | 0 | 0.72 |
| Nausea | 45/396 | 48/395 | 11.76 | 0.94[0.60, 1.37] | 0.74 | 0 | 0.70 |
| Fatigue | 31/266 | 31/263 | 11.72 | 0.99 [0.62, 1.58] | 0.96 | - | - |
| Vomiting | 52/602 | 50/598 | 8.50 | 1.04[0.72, 1.50] | 0.85 | 0 | 0.84 |
RR, risk ratio; CI, confidence interval.
a
Event (twice-daily arm + once-daily arm)/Total (twice-daily arm + once-daily arm).
b
Myelotoxicity was defined as any decrease in marrow-derived cells in the peripheral-blood counts.