Table 4.
Adverse events | Experimental group | Control group | Analysis method | Heterogeneity | Odds Ratio (OR) | 95% CI | P-value | |
---|---|---|---|---|---|---|---|---|
No. of patients (n) | No. of patients (n) | I2 (%) | P-value | |||||
Nausea, vomiting | 452 | 437 | Fixed | 37 | 0.09 | 0.55 | 0.41 to 0.74 | <0.0001 |
Nausea, vomiting I+II | 292 | 279 | Fixed | 0 | 0.50 | 0.83 | 0.59 to 1.16 | 0.27 |
Nausea, vomiting III+IV | 292 | 279 | Fixed | 4 | 0.41 | 0.41 | 0.23 to 0.75 | 0.003 |
Diarrhea | 395 | 379 | Fixed | 0 | 0.88 | 0.65 | 0.46 to 0.90 | 0.010 |
Diarrhea I+II | 235 | 221 | Fixed | 0 | 0.69 | 0.84 | 0.56 to 1.27 | 0.41 |
Diarrhea III+IV | 235 | 221 | Fixed | 0 | 1.00 | 0.27 | 0.10 to 0.75 | 0.01 |
Leucopenia | 420 | 429 | Fixed | 34 | 0.13 | 0.62 | 0.47 to 0.82 | 0.0008 |
Leucopenia I+II | 250 | 238 | Fixed | 0 | 0.86 | 0.57 | 0.39 to 0.83 | 0.003 |
Leucopenia III+IV | 250 | 238 | Fixed | 0 | 0.77 | 0.36 | 0.17 to 0.75 | 0.007 |
Thrombocytopenia | 178 | 178 | Fixed | 0 | 0.81 | 0.69 | 0.44 to 1.11 | 0.13 |
Thrombocytopenia I+II | 178 | 178 | Fixed | 0 | 0.84 | 0.70 | 0.43 to 1.13 | 0.14 |
Thrombocytopenia III+IV | 178 | 178 | Fixed | 0 | 0.83 | 0.91 | 0.39 to 2.14 | 0.83 |
Hepatotoxicity | 193 | 193 | Random | 56 | 0.04 | 0.53 | 0.24 to 1.16 | 0.11 |
Hepatotoxicity I+II | 193 | 193 | Fixed | 26 | 0.24 | 0.61 | 0.38 to 0.97 | 0.04 |
Hepatotoxicity III+IV | 193 | 193 | Fixed | 0 | 0.70 | 0.14 | 0.02 to 0.81 | 0.03 |
Nephrotoxicity | 117 | 107 | Fixed | 0 | 0.77 | 0.56 | 0.16 to 1.95 | 0.36 |
Nephrotoxicity I+II | 117 | 107 | Fixed | 0 | 0.54 | 0.63 | 0.16 to 2.46 | 0.51 |
Nephrotoxicity III+IV | 117 | 107 | Fixed | 0.32 | 0.01 to 8.24 | 0.49 | ||
Oral mucositis | 235 | 233 | Random | 64 | 0.010 | 0.62 | 0.28 to 1.34 | 0.22 |
Oral mucositis I+II | 179 | 178 | Fixed | 44 | 0.13 | 1.08 | 0.68 to 1.72 | 0.74 |
Oral mucositis III+IV | 179 | 178 | Fixed | 0 | 0.58 | 0.54 | 0.15 to 1.96 | 0.35 |
Alopecia | 133 | 130 | Fixed | 0 | 0.58 | 0.61 | 0.24 to 1.56 | 0.30 |
Alopecia I+II | 133 | 130 | Fixed | 0 | 0.93 | 0.93 | 0.48 to 1.81 | 0.83 |
Alopecia III+IV | 133 | 130 | Fixed | 0 | 0.97 | 0.72 | 0.30 to 1.75 | 0.47 |
Hand foot syndrome | 334 | 356 | Fixed | 0 | 0.52 | 0.57 | 0.41 to 0.79 | 0.0007 |
Hand foot syndrome I+II | 92 | 92 | Fixed | 12 | 0.32 | 0.64 | 0.33 to 1.24 | 0.18 |
Hand foot syndrome III+IV | 92 | 92 | Fixed | 0.48 | 0.04 to 5.63 | 0.56 | ||
Anemia | 292 | 291 | Fixed | 0 | 0.91 | 0.69 | 0.48 to 0.99 | 0.05 |
Anemia I+II | 186 | 187 | Fixed | 0 | 0.65 | 0.92 | 0.60 to 1.42 | 0.71 |
Anemia III+IV | 186 | 187 | Fixed | 0 | 0.87 | 0.34 | 0.12 to 0.96 | 0.04 |
Gastrointestinal adverse effects | 277 | 295 | Random | 57 | 0.04 | 0.56 | 0.32 to 1.00 | 0.05 |
Gastrointestinal adverse effects I+II | 71 | 72 | Fixed | 0 | 0.75 | 0.71 | 0.35 to 1.42 | 0.33 |
Gastrointestinal adverse effects III+IV | 71 | 72 | Fixed | 0.39 | 0.09 to 1.60 | 0.19 | ||
Peripheral neurotoxicity | 265 | 263 | Fixed | 0 | 0.59 | 0.32 | 0.20 to 0.50 | <0.00001 |
Peripheral neurotoxicity I+II | 103 | 104 | Fixed | 29 | 0.24 | 0.52 | 0.26 to 1.03 | 0.06 |
Peripheral neurotoxicity III+IV | 103 | 104 | Fixed | 0 | 0.53 | 0.58 | 0.21 to 1.63 | 0.30 |
Neutropenia | 55 | 55 | Fixed | 0 | 0.98 | 0.45 | 0.14 to 1.42 | 0.17 |
Neutropenia I+II | 55 | 55 | Fixed | 0 | 0.35 | 0.93 | 0.44 to 1.96 | 0.85 |
Neutropenia III+IV | 55 | 55 | Fixed | 0 | 0.40 | 0.73 | 0.34 to 1.59 | 0.43 |
Myelosuppression | 94 | 90 | Random | 80 | 0.03 | 0.38 | 0.08 to 1.84 | 0.23 |
Myelosuppression I+II | 58 | 58 | Fixed | 1.09 | 0.48 to 2.49 | 0.83 | ||
Myelosuppression III+IV | 58 | 58 | Fixed | 0.24 | 0.03 to 2.19 | 0.20 |
Notes: Control group, chemotherapy alone group; Experimental group, chemotherapy and cinobufotalin combined group.