Table 5.
RR of high-grade AEs associated with regorafenib based on the subgroup analysis
| AEs | Prior MKI exposure (95% CI) | Tumor type (95% CI) | ||||
|---|---|---|---|---|---|---|
| Yes (2 trials) | No (4 trials) | P-value | CRC (2 trials) | Non-CRC (4 trials) | P-value | |
| Any AE | 3.58 (2.64–4.87) | 3.86 (2.92–5.11) | 0.73 | 3.86 (2.92–5.11) | 3.58 (2.64–4.87) | 0.73 |
| Clinical AE | ||||||
| Hand–foot skin reaction | 25.07 (5.01–125.38) | 34.44 (8.43–140.69) | 0.77 | 35.55 (7.13–177.11) | 26.05 (6.43–105.56) | 0.77 |
| Hypertension | 5.11 (2.51–10.40) | 6.77 (3.16–14.51) | 0.60 | 6.42 (2.35–17.59) | 5.63 (3.08–10.31) | 0.83 |
| Fatigue | 4.04 (1.34–12.16) | 1.55 (0.91–2.63) | 0.12 | 1.55 (0.91–2.63) | 4.04 (1.34–12.16) | 0.12 |
| Rash or desquamation | 3.53 (0.18–67.28) | 18.22 (2.51–132.21) | 0.36 | 18.22 (2.51–132.21) | 3.53 (0.18–67.28) | 0.36 |
| Diarrhea | 8.69 (1.16–64.80) | 4.86 (1.86–12.65) | 0.61 | 6.23 (1.94–20.06) | 4.73 (1.32–17.00) | 0.76 |
| Anorexia | 10.86 (0.64–184.42) | 1.06 (0.56–2.01) | 0.12 | 1.18 (0.51–2.74) | 1.67 (0.70–4.00) | 0.57 |
| Oral mucositis | 1.53 (0.31–7.51) | 12.99 (1.65–102.14) | 0.11 | 15.72 (0.94–261.60) | 2.74 (0.74–10.13) | 0.27 |
| Myalgia | 1.51 (0.06–36.60) | 1.68 (0.47–6.08) | 0.95 | 1.51 (0.06–36.61) | 1.68 (0.47–6.08) | 0.95 |
| Laboratory abnormalities | ||||||
| Increased AST | 0.98 (0.47–2.07) | 9.22 (1.25–68.19) | 0.04 | 8.56 (0.50–146.17) | 1.40 (0.70–2.80) | 0.22 |
| Hypophosphatemia | 9.29 (1.25–69.06) | 9.66 (3.03–30.78) | 0.97 | 9.60 (1.87–49.28) | 9.53 (2.68–33.89) | 0.99 |
| Hyperbilirubinemia | 3.23 (1.14–9.13) | 3.19 (0.95–10.68) | 0.99 | 3.19 (0.95–10.68) | 3.23 (1.14–9.13) | 0.99 |
| Increased ALT | 2.06 (0.44–9.63) | 2.55 (0.83–7.88) | 0.83 | 9.57 (0.57–162.00) | 1.65 (0.62–4.41) | 0.25 |
| Lipase increase | NA | 2.17 (0.42–11.10) | NA | 3.00 (0.37–24.42) | 1.03 (0.07–16.27) | 0.55 |
| Thrombocytopenia | 8.79 (0.51–151.57) | 5.61 (1.28–24.61) | 0.78 | 6.23 (1.19–32.72) | 6.36 (0.75–54.06) | 0.99 |
| Anemia | 3.10 (0.38–25.54) | 6.70 (1.50–29.96) | 0.56 | 8.60 (1.15–64.34) | 3.54 (0.78–16.04) | 0.49 |
Abbreviations: AE/s, adverse event/s; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CRC, colorectal cancer; MKI, multikinase inhibitor; NA, not applicable; RR, relative risk.