PT | SOC | Freq | ROR(95%CI) | IC(IC025) |
---|---|---|---|---|
Lenvatinib | ||||
Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 116 | 61.82(51.2-74.64) | 5.85(4.18) |
Cerebral haemorrhage | Nervous system disorders | 114 | 4.83(4.01–5.8) | 2.26(0.6) |
Oesophageal varices haemorrhage | Gastrointestinal disorders | 79 | 57.2(45.55–71.83) | 5.75(4.08) |
Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 43 | 3.33(2.47–4.49) | 1.73(0.06) |
Gastric haemorrhage | Gastrointestinal disorders | 34 | 4.58(3.27–6.42) | 2.19(0.52) |
Arterial haemorrhage | Vascular disorders | 31 | 39.6(27.63–56.77) | 5.24(3.58) |
Mouth haemorrhage | Gastrointestinal disorders | 22 | 4.59(3.02–6.97) | 2.19(0.52) |
Tracheal haemorrhage | Injury, poisoning and procedural complications | 20 | 101.74(64.03-161.65) | 6.51(4.83) |
Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 19 | 4.02(2.56–6.32) | 2(0.34) |
Duodenal ulcer haemorrhage | Gastrointestinal disorders | 17 | 9.44(5.86–15.23) | 3.23(1.56) |
Haemobilia | Hepatobiliary disorders | 17 | 60.57(37.05–99.01) | 5.83(4.15) |
Intra-abdominal haemorrhage | Gastrointestinal disorders | 15 | 10.17(6.11–16.92) | 3.33(1.66) |
Gastric ulcer haemorrhage | Gastrointestinal disorders | 14 | 4.06(2.4–6.86) | 2.01(0.35) |
Hepatic haemorrhage | Hepatobiliary disorders | 12 | 25.26(14.23–44.84) | 4.62(2.95) |
Oesophageal haemorrhage | Gastrointestinal disorders | 11 | 12.62(6.96–22.88) | 3.64(1.97) |
Cerebellar haemorrhage | Nervous system disorders | 8 | 7.78(3.88–15.6) | 2.95(1.28) |
Diverticulum intestinal haemorrhagic | Gastrointestinal disorders | 8 | 4.11(2.05–8.23) | 2.03(0.37) |
Adrenal haemorrhage | Endocrine disorders | 6 | 16.44(7.33–36.88) | 4.01(2.34) |
Gastric varices haemorrhage | Gastrointestinal disorders | 6 | 24.78(11.01–55.79) | 4.59(2.92) |
Thalamus haemorrhage | Nervous system disorders | 6 | 8.71(3.9-19.47) | 3.11(1.44) |
Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 5 | 19.64(8.09–47.64) | 4.27(2.59) |
Small intestinal haemorrhage | Gastrointestinal disorders | 5 | 3.64(1.51–8.77) | 1.86(0.19) |
Venous haemorrhage | Vascular disorders | 4 | 16.84(6.26–45.28) | 4.05(2.37) |
Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | 4 | 4.69(1.75–12.52) | 2.22(0.55) |
Respiratory tract haemorrhage | Respiratory, thoracic and mediastinal disorders | 4 | 9.05(3.38–24.22) | 3.16(1.49) |
Tongue haemorrhage | Gastrointestinal disorders | 4 | 5.32(1.99–14.23) | 2.41(0.74) |
Haemorrhagic cerebral infarction | Nervous system disorders | 3 | 7.78(2.5-24.26) | 2.95(1.28) |
Haemorrhagic tumour necrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 | 131.95(39.21-444.08) | 6.84(5.08) |
Bronchial haemorrhage | Respiratory, thoracic and mediastinal disorders | 3 | 12.45(3.98–38.91) | 3.62(1.94) |
Brain stem haemorrhage | Nervous system disorders | 3 | 5.1(1.64–15.88) | 2.34(0.67) |
Putamen haemorrhage | Nervous system disorders | 3 | 13.4(4.28–41.9) | 3.72(2.05) |
Pembrolizumab | ||||
Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 66 | 11.43(8.94–14.62) | 3.46(1.8) |
Small intestinal haemorrhage | Gastrointestinal disorders | 18 | 4.45(2.79–7.09) | 2.14(0.47) |
Enterocolitis haemorrhagic | Gastrointestinal disorders | 12 | 4.62(2.61–8.18) | 2.19(0.52) |
Gastritis haemorrhagic | Gastrointestinal disorders | 10 | 3.39(1.82–6.32) | 1.75(0.08) |
Adrenal haemorrhage | Endocrine disorders | 6 | 5.52(2.46–12.37) | 2.44(0.77) |
Haemobilia | Hepatobiliary disorders | 4 | 4.54(1.69–12.19) | 2.17(0.49) |
Tracheal haemorrhage | Injury, poisoning and procedural complications | 3 | 4.66(1.49–14.58) | 2.2(0.52) |
Intracranial tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 | 3.92(1.25–12.24) | 1.96(0.28) |
Stomatitis haemorrhagic | Gastrointestinal disorders | 3 | 12.65(3.98–40.18) | 3.61(1.91) |
Spinal cord haemorrhage | Nervous system disorders | 3 | 3.34(1.07–10.43) | 1.73(0.05) |
Combination therapy | ||||
Cerebral haemorrhage | Nervous system disorders | 41 | 3.8(2.79–5.16) | 1.92(0.25) |
Upper gastrointestinal haemorrhage | Gastrointestinal disorders | 33 | 5.61(3.98–7.9) | 2.48(0.82) |
Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 31 | 34.49(24.17–49.21) | 5.08(3.41) |
Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | 14 | 6.51(3.85-11) | 2.7(1.03) |
Haemorrhagic stroke | Nervous system disorders | 14 | 5.56(3.29–9.4) | 2.47(0.8) |
Gastric haemorrhage | Gastrointestinal disorders | 13 | 3.84(2.23–6.61) | 1.94(0.27) |
Subarachnoid haemorrhage | Nervous system disorders | 11 | 3.42(1.9–6.19) | 1.77(0.11) |
Mouth haemorrhage | Gastrointestinal disorders | 9 | 4.11(2.14–7.9) | 2.04(0.37) |
Oesophageal varices haemorrhage | Gastrointestinal disorders | 6 | 8.99(4.03–20.06) | 3.16(1.49) |
Renal haemorrhage | Renal and urinary disorders | 5 | 7.59(3.15–18.26) | 2.92(1.25) |
Large intestinal haemorrhage | Gastrointestinal disorders | 5 | 7.04(2.93–16.94) | 2.81(1.14) |
Small intestinal haemorrhage | Gastrointestinal disorders | 5 | 8.01(3.33–19.28) | 3(1.33) |
Intra-abdominal haemorrhage | Gastrointestinal disorders | 4 | 5.91(2.21–15.76) | 2.56(0.89) |
Oesophageal haemorrhage | Gastrointestinal disorders | 3 | 7.48(2.41–23.25) | 2.9(1.23) |
Tracheal haemorrhage | Injury, poisoning and procedural complications | 3 | 30.52(9.76–95.5) | 4.91(3.23) |
Pharyngeal haemorrhage | Respiratory, thoracic and mediastinal disorders | 3 | 7.71(2.48–23.97) | 2.94(1.27) |
Stoma site haemorrhage | Injury, poisoning and procedural complications | 3 | 4.6(1.48–14.29) | 2.2(0.53) |
Spinal cord haemorrhage | Nervous system disorders | 3 | 21.88(7.01–68.3) | 4.44(2.76) |
Hepatic haemorrhage | Hepatobiliary disorders | 3 | 13.58(4.36–42.28) | 3.75(2.08) |
Brain stem haemorrhage | Nervous system disorders | 3 | 11.22(3.61–34.9) | 3.48(1.81) |