pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
Detected signals and signal information of cetuximab in the drug labels of 5 countries compared with cancer immunotherapeutic and targeted therapeutic agents by disproportionality analysis
| Adverse events description | N | PRR | ROR | IC | Drug labels | ||||
|---|---|---|---|---|---|---|---|---|---|
| KR | US | EU | AUS | JP | |||||
| Acne | 322 | 7.62 | 8.06 | 2.36 | Y | Y | Y | Y | Y |
| Skin disorder | 108 | 3.98 | 4.05 | 1.71 | Y | Y | Y | Y | Y |
| Mucositis nose | 68 | 3.25 | 3.28 | 1.48 | Y | Y | Y | Y | Y |
| Nail disorder | 62 | 6.47 | 6.53 | 2.21 | Y | Y | Y | Y | Y |
| Hypotension | 49 | 3.37 | 3.39 | 1.52 | Y | Y | Y | Y | Y |
| Anaphylactic reaction | 40 | 21.21 | 21.37 | 3.10 | Y | Y | Y | Y | Y |
| Dysphagia | 37 | 9.81 | 9.87 | 2.58 | Y | N | Y | Y | N |
| Skin reaction localized | 34 | 2.96 | 2.98 | 1.37 | Y | Y | Y | Y | Y |
| Dermatitis | 22 | 3.78 | 3.80 | 1.65 | Y | Y | Y | Y | Y |
| Flushing | 22 | 2.39 | 2.40 | 1.12 | Y | Y | N | N | N |
| Sputum increased | 21 | 3.47 | 3.48 | 1.56 | Y | N | N | N | N |
| Hiccup | 17 | 3.33 | 3.34 | 1.51 | Y | N | N | N | N |
| Hypomagnesaemia | 15 | 38.18 | 38.29 | 3.36 | Y | Y | Y | Y | Y |
| Tenesmus | 14 | 11.14 | 11.16 | 2.68 | N | N | N | N | N |
| Anaphylactic shock | 14 | 35.63 | 35.73 | 3.34 | Y | Y | Y | Y | Y |
| Phosphatase alkaline increased | 13 | 3.76 | 3.77 | 1.65 | N | Y | N | N | N |
| Allergic reaction | 13 | 5.91 | 5.92 | 2.12 | Y | Y | Y | Y | Y |
| Neurologic disorder nose | 12 | 3.92 | 3.92 | 1.69 | Y | Y | N | N | N |
| Rash pustular | 9 | 4.24 | 4.25 | 1.78 | Y | Y | N | N | Y |
| Lips dry | 9 | 6.74 | 6.75 | 2.25 | N | N | N | N | N |
| Thirst | 8 | 5.99 | 6.00 | 2.14 | N | N | N | N | N |
| Respiratory insufficiency | 8 | 2.83 | 2.83 | 1.32 | Y | N | N | Y | Y |
| Onycholysis | 8 | 5.36 | 5.37 | 2.02 | N | N | N | N | N |
| Stupor | 6 | 3.64 | 3.64 | 1.61 | Y | Y | N | Y | Y |
| Circulatory failure | 5 | 3.54 | 3.54 | 1.58 | Y | Y | Y | Y | Y |
| Purulent discharge | 5 | 5.30 | 5.31 | 2.01 | Y | Y | N | N | Y |
| Drug hypersensitivity syndrome | 5 | 3.35 | 3.35 | 1.52 | Y | Y | Y | Y | Y |
| Eye pain | 4 | 3.18 | 3.18 | 1.46 | Y | N | Y | Y | N |
| Respiratory disorder | 4 | 3.39 | 3.40 | 1.53 | Y | Y | Y | Y | Y |
| WBC abnormal nose | 4 | 7.27 | 7.28 | 2.32 | Y | N | Y | N | N |
| Seborrhea | 3 | 5.45 | 5.46 | 2.04 | N | N | N | N | N |
| Disseminated intravascular coagulation | 3 | 38.18 | 38.20 | 3.36 | N | N | N | N | N |
| Tolerance | 3 | 3.82 | 3.82 | 1.66 | N | N | N | N | N |
PRR, proportional reporting ratio; ROR, reporting odds ratio; IC, information component; WBC, white blood cell; KR, Korea; US, the United States; EU, the European Union; AUS, Australia; JP, Japan