Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123861304 | 12386130 | 4 | F | 20160802 | 20160519 | 20160813 | EXP | JP-AMGEN-JPNCT2015141456 | AMGEN | 0.00 | M | Y | 80.10000 | KG | 20160813 | MD | JP | JP |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123861304 | 12386130 | 1 | PS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 480 MG, Q2WK | Y | 125147 | 480 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 123861304 | 12386130 | 2 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 480 MG, Q2WK | Y | 125147 | 480 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 123861304 | 12386130 | 3 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 480 MG, Q2WK | Y | 125147 | 480 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 123861304 | 12386130 | 4 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 4.8 MG/KG, Q2WK | Y | 125147 | 4.8 | MG/KG | SOLUTION FOR INJECTION | QOW | |||||
| 123861304 | 12386130 | 5 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 160 MG, Q2WEEKS | U | 0 | 160 | MG | QOW | ||||||
| 123861304 | 12386130 | 6 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 160 MG, Q2WEEKS | U | 0 | 160 | MG | QOW | ||||||
| 123861304 | 12386130 | 7 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 65 MG/M2, Q2WEEKS | U | 0 | 65 | MG/M**2 | QOW | ||||||
| 123861304 | 12386130 | 8 | C | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 50 MG/M2, Q2WEEKS | U | 0 | 50 | MG/M**2 | QOW | ||||||
| 123861304 | 12386130 | 9 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 375 MG, Q2WEEKS | U | 0 | 375 | MG | QOW | ||||||
| 123861304 | 12386130 | 10 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 375 MG, Q2WEEKS | U | 0 | 375 | MG | QOW | ||||||
| 123861304 | 12386130 | 11 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | UNK, Q2WEEKS | U | 0 | QOW | ||||||||
| 123861304 | 12386130 | 12 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 750 MG, Q2WEEKS | U | 0 | 750 | MG | QOW | ||||||
| 123861304 | 12386130 | 13 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 4600 MG, Q2WEEKS | U | 0 | 4600 | MG | QOW | ||||||
| 123861304 | 12386130 | 14 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 750 MG, Q2WEEKS | U | 0 | 750 | MG | QOW | ||||||
| 123861304 | 12386130 | 15 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 4600 MG, Q2WEEKS | U | 0 | 4600 | MG | QOW | ||||||
| 123861304 | 12386130 | 16 | C | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | 200 MG/M2, Q2WK | U | 0 | 200 | MG/M**2 | QOW | ||||||
| 123861304 | 12386130 | 17 | C | 5-FU | FLUOROURACIL | 1 | Intravenous drip | 2000 MG/M2, Q2WEEKS | U | 0 | 2000 | MG/M**2 | QOW | ||||||
| 123861304 | 12386130 | 18 | C | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 4600 MG, Q2WEEKS | U | 0 | 4600 | MG | QOW | ||||||
| 123861304 | 12386130 | 19 | C | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 4600 MG, Q2WEEKS | U | 0 | 4600 | MG | QOW | ||||||
| 123861304 | 12386130 | 20 | C | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2000 MG/M2, Q2WEEKS | U | 0 | 2000 | MG/M**2 | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123861304 | 12386130 | 1 | Colon cancer |
| 123861304 | 12386130 | 5 | Colon cancer |
| 123861304 | 12386130 | 6 | Colon cancer |
| 123861304 | 12386130 | 9 | Colon cancer |
| 123861304 | 12386130 | 10 | Colon cancer |
| 123861304 | 12386130 | 12 | Colon cancer |
| 123861304 | 12386130 | 18 | Colon cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123861304 | 12386130 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123861304 | 12386130 | Alopecia | |
| 123861304 | 12386130 | Arthralgia | |
| 123861304 | 12386130 | Constipation | |
| 123861304 | 12386130 | Decreased appetite | |
| 123861304 | 12386130 | Dermatitis acneiform | |
| 123861304 | 12386130 | Diarrhoea | |
| 123861304 | 12386130 | Dry skin | |
| 123861304 | 12386130 | Dysgeusia | |
| 123861304 | 12386130 | Fatigue | |
| 123861304 | 12386130 | Myalgia | |
| 123861304 | 12386130 | Nausea | |
| 123861304 | 12386130 | Neutrophil count decreased | |
| 123861304 | 12386130 | Paronychia | |
| 123861304 | 12386130 | Peripheral sensory neuropathy | |
| 123861304 | 12386130 | Stomatitis |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 123861304 | 12386130 | 1 | 20151203 | 20160104 | 0 | |
| 123861304 | 12386130 | 2 | 20160127 | 20160127 | 0 | |
| 123861304 | 12386130 | 3 | 20160219 | 20160219 | 0 | |
| 123861304 | 12386130 | 4 | 20160304 | 0 | ||
| 123861304 | 12386130 | 5 | 20151203 | 20160104 | 0 | |
| 123861304 | 12386130 | 6 | 20160127 | 20160127 | 0 | |
| 123861304 | 12386130 | 7 | 20160219 | 20160415 | 0 | |
| 123861304 | 12386130 | 8 | 20160506 | 0 | ||
| 123861304 | 12386130 | 9 | 20151203 | 20160104 | 0 | |
| 123861304 | 12386130 | 10 | 20160127 | 20160127 | 0 | |
| 123861304 | 12386130 | 11 | 20160219 | 0 | ||
| 123861304 | 12386130 | 12 | 20151203 | 20160104 | 0 | |
| 123861304 | 12386130 | 13 | 20151203 | 20160104 | 0 | |
| 123861304 | 12386130 | 14 | 20160127 | 20160127 | 0 | |
| 123861304 | 12386130 | 15 | 20160127 | 20160127 | 0 | |
| 123861304 | 12386130 | 16 | 20160219 | 0 | ||
| 123861304 | 12386130 | 17 | 20160219 | 0 | ||
| 123861304 | 12386130 | 18 | 20151203 | 20160104 | 0 | |
| 123861304 | 12386130 | 19 | 20160127 | 20160127 | 0 | |
| 123861304 | 12386130 | 20 | 20160219 | 0 |