Table 2.
Incidence and RR of all-grade AEs resulting from regorafenib treatment
| AEs | No of studies | No of events/sample size | Incidence (95% CI) | I2 (%) | RR (95% CI) | P-value | ||
|---|---|---|---|---|---|---|---|---|
| Regorafenib | Placebo/control | Regorafenib | Placebo/control | |||||
| Any AE | 4 | 1,073/1,142 | 330/580 | 0.95 (0.92–0.97)a | 0.57 (0.48–0.65)a | 69 | 1.66 (1.45–1.91)a | <0.00001 |
| Clinical AE | ||||||||
| Hand–foot skin reaction | 5 | 638/1,231 | 45/672 | 0.54 (0.45–0.63)a | 0.07 (0.04–0.11)a | 54 | 7.42 (4.61–11.94) | <0.00001 |
| Fatigue | 4 | 421/1,142 | 131/580 | 0.32 (0.21–0.46)a | 0.21 (0.14–0.30)a | 0 | 1.63 (1.38–1.93) | <0.00001 |
| Diarrhea | 5 | 410/1,231 | 50/672 | 0.33 (0.27–0.40)a | 0.08 (0.06–0.10) | 0 | 4.51 (3.42–5.95) | <0.00001 |
| Hypertension | 5 | 353/1,231 | 48/672 | 0.31 (0.23–0.40)a | 0.08 (0.05–0.13)a | 0 | 4.12 (3.09–5.50) | <0.00001 |
| Voice changes | 2 | 161/632 | 16/319 | 0.19 (0.06–0.44)a | 0.05 (0.03–0.08) | 0 | 5.09 (3.10–8.34) | <0.00001 |
| Anorexia | 5 | 311/1,231 | 79/672 | 0.23 (0.16–0.32)a | 0.11 (0.06–0.18)a | 24 | 2.26 (1.80–2.84) | <0.00001 |
| Oral mucositis | 4 | 267/1,095 | 28/604 | 0.28 (0.16–0.44)a | 0.05 (0.03–0.10)a | 0 | 5.66 (3.87–8.29) | <0.00001 |
| Rash or desquamation | 3 | 166/768 | 13/387 | 0.17 (0.09–0.29)a | 0.04 (0.02–0.06) | 0 | 6.44 (3.72–11.17) | <0.00001 |
| Myalgia | 3 | 56/357 | 29/226 | 0.15 (0.05–0.37)a | 0.10 (0.03–0.31)a | 0 | 1.55 (1.04–2.32) | 0.03 |
| Hoarseness | 3 | 90/642 | 4/327 | 0.16 (0.09–0.27)a | 0.02 (0.004–0.08)a | 19 | 10.16 (4.00–25.78) | <0.00001 |
| Nausea | 3 | 133/1,006 | 47/512 | 0.13 (0.11–0.16) | 0.09 (0.07–0.12) | 0 | 1.44 (1.05–1.97) | 0.02 |
| Weight loss | 2 | 96/874 | 9/446 | 0.10 (0.05–0.19)a | 0.02 (0.01–0.04) | 0 | 5.43 (2.77–10.64) | <0.00001 |
| Alopecia | 2 | 67/632 | 2/319 | 0.13 (0.04–0.37)a | 0.008 (0.002–0.03) | 0 | 16.86 (4.17–68.14) | <0.0001 |
| Laboratory abnormalities | ||||||||
| Hyperbilirubinemia | 3 | 165/1,010 | 16/514 | 0.19 (0.09–0.37)a | 0.04 (0.02–0.08)a | 0 | 5.24 (3.19–8.63) | <0.00001 |
| Increased AST | 2 | 80/510 | 21/261 | 0.17 (0.09–0.30)a | 0.08 (0.05–0.12) | 0 | 1.94 (1.23–3.07) | 0.004 |
| Increased ALT | 2 | 61/510 | 13/261 | 0.14 (0.04–0.36)a | 0.05 (0.03–0.09) | 0 | 2.39 (1.34–4.25) | 0.003 |
Note:
a
The incidence or RR of AEs and 95% CI were calculated with a random effects model.
Abbreviations: AE/s, adverse event/s; ALT, alanine aminotransferase; AST, aspartate aminotransferase; RR, relative risk.