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 all other drugs by disproportionality analysis
| Adverse events description | N | PRR | ROR | IC | Drug labels | ||||
|---|---|---|---|---|---|---|---|---|---|
| KR | US | EU | AUS | JP | |||||
| Rash | 474 | 2.69 | 2.86 | 1.42 | Y | Y | Y | Y | Y |
| Acneiform dermatitis | 322 | 52.79 | 56.22 | 5.60 | Y | Y | Y | Y | Y |
| Anorexia | 182 | 2.28 | 2.33 | 1.19 | Y | Y | Y | Y | Y |
| Stomatitis | 145 | 5.50 | 5.63 | 2.45 | Y | Y | Y | Y | Y |
| Asthenia | 131 | 2.41 | 2.44 | 1.26 | Y | Y | Y | Y | Y |
| Skin disorder | 108 | 20.32 | 20.73 | 4.30 | Y | Y | Y | Y | Y |
| Leucopenia | 91 | 2.27 | 2.29 | 1.18 | Y | N | Y | N | N |
| Rigors | 68 | 3.65 | 3.68 | 1.86 | Y | Y | Y | Y | N |
| Mucositis nose | 68 | 6.89 | 6.97 | 2.77 | Y | Y | Y | Y | Y |
| Nail disorder | 62 | 11.16 | 11.28 | 3.46 | Y | Y | Y | Y | Y |
| Pain | 49 | 2.78 | 2.80 | 1.47 | Y | Y | Y | Y | Y |
| Rash erythematous | 43 | 3.31 | 3.33 | 1.72 | N | Y | N | Y | N |
| Anaphylactic reaction | 40 | 5.10 | 5.13 | 2.34 | Y | Y | Y | Y | Y |
| Dysphagia | 37 | 9.00 | 9.06 | 3.15 | Y | N | Y | Y | N |
| Skin reaction localized | 34 | 7.85 | 7.89 | 2.96 | Y | Y | Y | Y | Y |
| Paronychia | 28 | 7.78 | 7.82 | 2.94 | Y | Y | Y | Y | Y |
| Skin exfoliation | 27 | 4.81 | 4.83 | 2.26 | Y | Y | Y | Y | Y |
| Skin dry | 23 | 4.56 | 4.58 | 2.18 | Y | Y | Y | Y | Y |
| Dermatitis | 22 | 3.88 | 3.90 | 1.95 | Y | Y | Y | Y | Y |
| Flushing | 22 | 2.09 | 2.09 | 1.06 | Y | Y | N | N | N |
| Skin discoloration | 21 | 4.01 | 4.02 | 2.00 | Y | N | N | N | N |
| Sputum increased | 21 | 2.61 | 2.61 | 1.38 | Y | N | N | N | N |
| Hyperkeratosis | 19 | 8.34 | 8.37 | 3.04 | N | N | N | N | N |
| Cachexia | 18 | 2.62 | 2.62 | 1.39 | Y | N | N | N | N |
| Death | 16 | 3.82 | 3.83 | 1.93 | Y | Y | Y | Y | Y |
| Rash maculo-papular | 15 | 4.16 | 4.17 | 2.05 | N | Y | N | N | N |
| Hypomagnesaemia | 15 | 5.26 | 5.27 | 2.39 | Y | Y | Y | Y | Y |
| Tenesmus | 14 | 8.59 | 8.61 | 3.08 | N | N | N | N | N |
| Anaphylactic shock | 14 | 8.16 | 8.18 | 3.01 | Y | Y | Y | Y | Y |
| Phosphatase alkaline increased | 13 | 5.31 | 5.32 | 2.40 | N | Y | Y | N | N |
| Allergic reaction | 13 | 3.71 | 3.72 | 1.89 | Y | Y | Y | Y | Y |
| Neurologic disorder nos. | 12 | 24.98 | 25.04 | 4.59 | Y | Y | N | N | N |
| Dysphonia | 11 | 2.22 | 2.22 | 1.15 | Y | N | N | N | N |
| Rash pustular | 9 | 8.94 | 8.95 | 3.14 | Y | Y | N | N | Y |
| Lips dry | 9 | 6.48 | 6.49 | 2.68 | N | N | N | N | N |
| Respiratory insufficiency | 8 | 2.15 | 2.15 | 1.10 | N | N | N | N | N |
| Onycholysis | 8 | 33.20 | 33.24 | 4.98 | N | N | N | N | N |
| Glossitis | 7 | 4.39 | 4.39 | 2.13 | Y | Y | Y | Y | Y |
| Folliculitis | 6 | 4.02 | 4.03 | 2.00 | N | N | N | N | N |
| Neuralgia | 5 | 2.78 | 2.78 | 1.47 | N | N | N | N | N |
| Embolism pulmonary | 5 | 2.54 | 2.54 | 1.34 | Y | Y | Y | Y | Y |
| Purulent discharge | 5 | 18.69 | 18.70 | 4.18 | Y | Y | N | N | Y |
| Esophagitis | 4 | 2.77 | 2.77 | 1.46 | N | N | N | N | N |
| Coma hepatic | 4 | 3.43 | 3.43 | 1.77 | Y | N | N | N | N |
| LDH increased | 4 | 4.26 | 4.26 | 2.08 | Y | N | N | N | N |
| WBC abnormal nos.* | 4 | 37.03 | 37.05 | 5.13 | Y | Y | Y | N | N |
| Skin tightness | 4 | 38.20 | 38.23 | 5.17 | N | N | N | N | N |
| Seborrhea | 3 | 3.16 | 3.16 | 1.66 | N | N | N | N | N |
| Cheilitis | 3 | 3.25 | 3.25 | 1.69 | Y | Y | Y | Y | Y |
| Dehydration | 3 | 3.33 | 3.33 | 1.73 | Y | Y | Y | Y | Y |
| Disseminated intravascular coagulation | 3 | 5.73 | 5.73 | 2.51 | N | N | N | N | N |
| Tolerance | 3 | 45.12 | 45.15 | 5.39 | N | N | N | N | N |
| Throat tightness | 3 | 5.42 | 5.42 | 2.43 | N | N | N | N | N |