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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110451615 | 11045161 | 5 | F | 20150107 | 20160809 | 20150417 | 20160819 | EXP | JP-AMGEN-JPNNI2015027179 | AMGEN | 72.00 | YR | E | M | Y | 70.30000 | KG | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110451615 | 11045161 | 1 | PS | VECTIBIX | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WEEKS | 42 | MG/KG | Y | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | |||
| 110451615 | 11045161 | 2 | SS | VECTIBIX | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WEEKS | 42 | MG/KG | Y | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | |||
| 110451615 | 11045161 | 3 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, Q2WK | 19600 | MG/M2 | U | 0 | 400 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 4 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, Q2WEEKS | 19600 | MG/M2 | U | 0 | 2400 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 5 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, Q2WK | 19600 | MG/M2 | U | 0 | 400 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 6 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, Q2WEEKS | 19600 | MG/M2 | U | 0 | 2400 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 7 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85 MG/M2, Q2WEEKS | 107.746002 | MG/M2 | U | 0 | 85 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 8 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 1400 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 9 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 1400 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 110451615 | 11045161 | 10 | C | FAMOTIDINE. | FAMOTIDINE | 1 | Oral | 40 MG, UNK | U | 0 | 40 | MG | |||||||
| 110451615 | 11045161 | 11 | C | CILNIDIPINE | CILNIDIPINE | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG | |||||||
| 110451615 | 11045161 | 12 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Oral | 990 MG, UNK | U | 0 | 990 | MG | |||||||
| 110451615 | 11045161 | 13 | C | LOSARTAN POTASSIUM. | LOSARTAN POTASSIUM | 1 | Oral | 25 MG, UNK | U | 0 | 25 | MG | |||||||
| 110451615 | 11045161 | 14 | C | PRAVASTATIN SODIUM. | PRAVASTATIN SODIUM | 1 | Oral | 10 MG, UNK | U | 0 | 10 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110451615 | 11045161 | 1 | Colon cancer |
| 110451615 | 11045161 | 3 | Colon cancer |
| 110451615 | 11045161 | 7 | Colon cancer |
| 110451615 | 11045161 | 8 | Colon cancer |
| 110451615 | 11045161 | 10 | Prophylaxis |
| 110451615 | 11045161 | 11 | Hypertension |
| 110451615 | 11045161 | 12 | Constipation |
| 110451615 | 11045161 | 13 | Hypertension |
| 110451615 | 11045161 | 14 | Hyperlipidaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110451615 | 11045161 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110451615 | 11045161 | Epistaxis | |
| 110451615 | 11045161 | Fatigue | |
| 110451615 | 11045161 | Flank pain | |
| 110451615 | 11045161 | Paronychia | |
| 110451615 | 11045161 | Peripheral sensory neuropathy | |
| 110451615 | 11045161 | Pyrexia | |
| 110451615 | 11045161 | Rash | |
| 110451615 | 11045161 | 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 |
|---|---|---|---|---|---|---|
| 110451615 | 11045161 | 1 | 20150107 | 20150401 | 0 | |
| 110451615 | 11045161 | 2 | 20150422 | 20150422 | 0 | |
| 110451615 | 11045161 | 3 | 20150107 | 20150401 | 0 | |
| 110451615 | 11045161 | 4 | 20150107 | 20150404 | 0 | |
| 110451615 | 11045161 | 5 | 20150422 | 20150422 | 0 | |
| 110451615 | 11045161 | 6 | 20150422 | 20150422 | 0 | |
| 110451615 | 11045161 | 7 | 20150107 | 20150318 | 0 | |
| 110451615 | 11045161 | 8 | 20150107 | 20150401 | 0 | |
| 110451615 | 11045161 | 9 | 20150422 | 20150422 | 0 |