Table 2 The adverse event rates (grades 3 or more) and 95% confidence interval of fixed model and random model in single-arm trials
Model | Group by | All grade | ||||
|---|---|---|---|---|---|---|
Event rate (%) | Lower limit (%) | Upper limit (%) | Z-Value | p-Value | ||
Fixed | Abdominal distension | 1.3 | 0.2 | 8.6 | −4.303 | 0.000 |
Fixed | Abdominal pain | 1.1 | 0.4 | 2.8 | −9.443 | 0.000 |
Fixed | Alanine aminotransferase increased | 1.7 | 0.9 | 3.4 | −11.293 | 0.000 |
Fixed | Alopecia | 0.6 | 0.3 | 1.3 | −13.009 | 0.000 |
Fixed | Cholangitis | 5.5 | 1.8 | 15.9 | −4.765 | 0.000 |
Fixed | Constipation | 0.7 | 0.3 | 1.5 | −13.003 | 0.000 |
Fixed | Cough | 1.0 | 0.3 | 2.7 | −8.603 | 0.000 |
Fixed | Decreased lymphocyte count | 8.6 | 6.1 | 11.8 | −12.967 | 0.000 |
Fixed | Diarrhoea | 2.1 | 1.4 | 3.1 | −18.197 | 0.000 |
Fixed | Dizziness | 0.9 | 0.1 | 5.9 | −4.715 | 0.000 |
Fixed | Dysgeusia | 0.7 | 0.1 | 3.6 | −5.983 | 0.000 |
Fixed | Dyspnea | 1.9 | 0.3 | 12.0 | −3.933 | 0.000 |
Fixed | Ejection fraction decreased | 0.7 | 0.1 | 3.6 | −5.983 | 0.000 |
Fixed | Electrocardiogram QT prolonged | 1.2 | 0.3 | 4.5 | −6.236 | 0.000 |
Fixed | Epistaxis | 0.6 | 0.1 | 4.1 | −5.095 | 0.000 |
Fixed | Fatigue | 6.0 | 4.8 | 7.4 | −23.406 | 0.000 |
Fixed | Headache | 0.9 | 0.2 | 3.7 | − 6.546 | 0.000 |
Fixed | Hypoalbuminaemia | 2.1 | 0.7 | 5.7 | −7.141 | 0.000 |
Fixed | Hypokalaemia | 7.1 | 4.7 | 10.7 | −11.279 | 0.000 |
Fixed | Hyponatraemia | 4.2 | 1.9 | 9.0 | −7.481 | 0.000 |
Fixed | Increased alanine aminotransferase | 1.3 | 0.2 | 8.5 | −4.316 | 0.000 |
Fixed | Increased aspartate aminotransferase | 2.7 | 1.5 | 4.7 | −12.205 | 0.000 |
Fixed | Increased blood alkaline phosphatase | 3.8 | 0.8 | 17.0 | −3.843 | 0.000 |
Fixed | Increased blood bilirubin | 2.3 | 1.0 | 5.5 | −8.204 | 0.000 |
Fixed | Infusion-related reactions | 0.7 | 0.1 | 3.6 | −5.983 | 0.000 |
Fixed | Interstitial lung disease | 0.8 | 0.4 | 1.9 | −11.634 | 0.000 |
Fixed | Intestinal perforation | 3.8 | 0.2 | 40.3 | −2.232 | 0.026 |
Fixed | Malaise | 1.0 | 0.4 | 2.6 | −9.602 | 0.000 |
Fixed | Nasopharyngitis | 0.6 | 0.1 | 4.1 | −5.095 | 0.000 |
Fixed | Nausea | 5.8 | 4.7 | 7.2 | −23.716 | 0.000 |
Fixed | Neutropenia | 5.1 | 1.9 | 12.9 | −5.684 | 0.000 |
Fixed | Oedema | 0.8 | 0.2 | 3.0 | −6.832 | 0.000 |
Fixed | Pneumonitis | 1.9 | 0.8 | 4.2 | −9.203 | 0.000 |
Fixed | Pyrexia | 1.5 | 0.7 | 3.5 | −9.631 | 0.000 |
Fixed | Rush | 0.4 | 0.0 | 6.5 | −3.840 | 0.000 |
Fixed | Stomatitis | 1.3 | 0.4 | 4.5 | −6.745 | 0.000 |
Fixed | Upper respiratory tract infection | 1.3 | 0.2 | 8.6 | −4.303 | 0.000 |
Fixed | Vomiting | 2.5 | 1.8 | 3.6 | −19.390 | 0.000 |
Fixed | Weight decreased | 2.1 | 0.8 | 5.4 | −7.623 | 0.000 |
Random | Anemia | 15.0 | 9.6 | 22.8 | −6.654 | 0.000 |
Random | Decreased appetite | 3.3 | 1.5 | 6.9 | −8.426 | 0.000 |
Random | Decreased neutrophil count | 20.3 | 14.5 | 27.6 | −6.646 | 0.000 |
Random | Decreased platelet count | 8.6 | 6.4 | 11.5 | −14.412 | 0.000 |
Random | Decreased white blood cell count | 10.3 | 7.2 | 14.5 | −10.855 | 0.000 |