Adverse event | PRR | ROR(95%CI) | Number of report |
---|---|---|---|
Vascular disorders | |||
 Periphlebitis | 108.375 | 108.395(33.378, 352.0159) | 4 |
 Varicose vein ruptured | 41.407 | 41.425(20.432,, 83.98553) | 9 |
Skin and subcutaneous tissue disorders | |||
 Melanoderma | 76.2 | 76.237(37.474, 155.09632) | 5 |
Respiratory, thoracic and mediastinal disorders | |||
 Laryngeal necrosis | 365.765 | 365.868(103.237, 1296.6254) | 6 |
 Acquired tracheo-oesophageal fistula | 182.882 | 182.934(63.467, 527.2818) | 6 |
 Dysaesthesia pharynx | 156.756 | 156.823(67.871, 362.35614) | 9 |
Renal and urinary disorders | |||
 Ureteric fistula | 406.406 | 406.501(97.139, 1701.1043) | 5 |
 Glomerular vascular disorder | 365.765 | 366.283(207.98, 645.07720) | 30 |
Nervous system disorders | |||
 Secondary cerebellar degeneration | 58.1 | 58.071(21.895, 154.02121) | 5 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | |||
 Malignant glioma | 171 | 170.746(64.987, 448.61810) | 7 |
 Optic glioma | 155 | 155.275(79.438, 303.51222) | 14 |
Metabolism and nutrition disorders | |||
 Hyperamylasaemia | 11.2 | 11.213(4.115, 30.55387) | 4 |
Investigations | |||
 Transaminases | 112.543 | 112.575(42.784, 296.20913) | 6 |
 Prothrombin level decreased | 54.865 | 54.911(32.924, 91.57980) | 18 |
 Protein urine | 48.057 | 48.117(31.84, 72.715137) | 27 |
 Protein urine present | 47.01 | 47.314(39.438, 56.763721) | 190 |
 kL-6 increased | 46.446 | 46.455(15.945, 135.34621) | 4 |
Injury, poisoning and procedural complications | |||
 Stomal varices | 549 | 548.88(169.015, 1782.4994) | 9 |
 Anastomotic fistula | 457 | 457.53(193.96, 1079.2618) | 15 |
Infections and infestations | |||
 Suspected transmission of an infectious agent via product | 277 | 278.447(215.665, 359.506111) | 190 |
 Bacterial endophthalmitis | 106 | 106.068(50.478, 222.87923) | 10 |
Hepatobiliary disorders | |||
 Hepatic atrophy | 128 | 127.925(83.936, 194.96963) | 33 |
General disorders and administration site conditions | |||
 Acral peeling skin syndrome | 2926.12 | 2927.779(380.666, 22,518.1481) | 12 |
 Radiation interaction | 121.922 | 121.95(41.679, 356.82110) | 5 |
 Perforation | 58.465 | 58.577(41.648, 82.388171) | 41 |
Gastrointestinal disorders | |||
 Malignant gastrointestinal obstruction | 97.537 | 97.565(37.851, 251.48515) | 6 |
 Gastrointestinal perforation | 90.464 | 91.503(78.927,106.083655) | 243 |
 Rectourethral fistula | 87.087 | 87.107(31.372, 241.86214) | 5 |
 Tongue geographic | 53.341 | 53.358(23.549,120.90132) | 7 |
 Peritoneal disorder | 48.03 | 48.059(26.51,87.12266) | 13 |
Eye disorders | |||
 Ciliary hyperaemia | 243.843 | 244.108(136.931, 435.17123) | 23 |
 Retinal pigment epithelial tear | 131.02 | 131.242(87.513, 196.82167) | 36 |
Blood and lymphatic system disorders | |||
 Splenic artery thrombosis | 94.828 | 94.859(39.616, 227.13618) | 7 |
 Intravascular haemolysis | 45.285 | 45.312(25.065, 81.91470) | 13 |
 Microangiopathic haemolytic anaemia | 22.168 | 22.182(12.832, 38.342154) | 14 |
 Myelosuppression | 20.619 | 20.922(18.658,23.4623808) | 322 |
 Bone marrow failure | 19.597 | 19.95(17.991, 22.1244915) | 395 |
 Hypersplenism | 19.05 | 19.055(7.668, 47.34964) | 5 |
Surgical and medical procedures | |||
 Portal vein embolisation | 244 | 243.901(70.603, 842.5625) | 71 |
Product issues | |||
 Product contamination microbial | 22.5 | 22.546(13.716, 37.062184) | 17 |
Endocrine disorders | |||
 Primary adrenal insufficiency | 39.3 | 39.339(15.295, 101.17931) | 5 |
 Congenital, familial and genetic disorders | |||
 bRCA2 gene mutation | 65 | 65.037(21.583, 195.97615) | 4 |
Cardiac disorders | |||
 Cardiac ventricular thrombosis | 11.6 | 11.572(6.484, 20.651253) | 12 |