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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116652748 | 11665274 | 8 | F | 20150908 | 20160621 | 20151027 | 20160701 | EXP | JP-AMGEN-JPNCT2015112690 | AMGEN | 71.00 | YR | E | M | Y | 0.00000 | 20160630 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116652748 | 11665274 | 1 | PS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WEEKS | 12 | MG/KG | Y | Y | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 116652748 | 11665274 | 2 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WEEKS | 12 | MG/KG | Y | Y | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 116652748 | 11665274 | 3 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 4.8 MG/KG, Q2WEEKS | 12 | MG/KG | Y | Y | 125147 | 4.8 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 116652748 | 11665274 | 4 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 3.6 MG/KG, Q2WK | 12 | MG/KG | Y | Y | 125147 | 3.6 | MG/KG | SOLUTION FOR INJECTION | QOW | ||
| 116652748 | 11665274 | 5 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 400 MG/M2, Q2WK | 5600 | MG/M2 | U | 0 | 400 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 6 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, Q2WEEKS | 5600 | MG/M2 | U | 0 | 2400 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 7 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous bolus | 200 MG/M2, Q2WEEKS | 5600 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 8 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2000 MG/M2, Q2WEEKS | 5600 | MG/M2 | U | 0 | 2000 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 9 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85 MG/M2, Q2WEEKS | 170 | MG/M2 | U | 0 | 85 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 10 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 65 MG/M2, Q2WEEKS | 170 | MG/M2 | U | 0 | 65 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 11 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 400 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 116652748 | 11665274 | 12 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 400 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116652748 | 11665274 | 1 | Colon cancer |
| 116652748 | 11665274 | 5 | Colon cancer |
| 116652748 | 11665274 | 9 | Colon cancer |
| 116652748 | 11665274 | 11 | Colon cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116652748 | 11665274 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116652748 | 11665274 | Diarrhoea | |
| 116652748 | 11665274 | Dry skin | |
| 116652748 | 11665274 | Fatigue | |
| 116652748 | 11665274 | Hypomagnesaemia | Hypomagnesaemia |
| 116652748 | 11665274 | Nausea | |
| 116652748 | 11665274 | Neuropathy peripheral | |
| 116652748 | 11665274 | Neutrophil count decreased | |
| 116652748 | 11665274 | Paronychia | |
| 116652748 | 11665274 | Pyrexia | |
| 116652748 | 11665274 | Rash | |
| 116652748 | 11665274 | Stomatitis | |
| 116652748 | 11665274 | Vomiting | |
| 116652748 | 11665274 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 116652748 | 11665274 | 1 | 20150903 | 20150916 | 0 | |
| 116652748 | 11665274 | 2 | 20151007 | 20151104 | 0 | |
| 116652748 | 11665274 | 3 | 20151216 | 20160210 | 0 | |
| 116652748 | 11665274 | 4 | 20160309 | 20160511 | 0 | |
| 116652748 | 11665274 | 5 | 20150903 | 20150916 | 0 | |
| 116652748 | 11665274 | 6 | 20150903 | 20150916 | 0 | |
| 116652748 | 11665274 | 7 | 20151007 | 20160511 | 0 | |
| 116652748 | 11665274 | 8 | 20151007 | 20160511 | 0 | |
| 116652748 | 11665274 | 9 | 20150903 | 20150916 | 0 | |
| 116652748 | 11665274 | 10 | 20151007 | 20160224 | 0 | |
| 116652748 | 11665274 | 11 | 20150903 | 20150916 | 0 | |
| 116652748 | 11665274 | 12 | 20151007 | 20160511 | 0 |