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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121337804 | 12133780 | 4 | F | 20160209 | 20160712 | 20160301 | 20160722 | EXP | JP-AMGEN-JPNCT2016025313 | AMGEN | 74.00 | YR | E | M | Y | 51.00000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121337804 | 12133780 | 1 | PS | panitumumab | PANITUMUMAB | 1 | Intravenous drip | 6 MG/KG, Q2WK | 12 | MG/KG | Y | 125147 | 6 | MG/KG | SOLUTION FOR INJECTION | QOW | |||
| 121337804 | 12133780 | 2 | SS | panitumumab | PANITUMUMAB | 1 | Intravenous (not otherwise specified) | 4.8 MG/KG, Q2WK | 12 | MG/KG | Y | 125147 | 4.8 | MG/KG | SOLUTION FOR INJECTION | QOW | |||
| 121337804 | 12133780 | 3 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, Q2WK | U | 0 | 400 | MG/M**2 | QOW | ||||||
| 121337804 | 12133780 | 4 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, Q2WEEKS | U | 0 | 2400 | MG/M**2 | QOW | ||||||
| 121337804 | 12133780 | 5 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous bolus | 200 MG/M2, Q2WK | U | 0 | 200 | MG/M**2 | QOW | ||||||
| 121337804 | 12133780 | 6 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2000 MG/M2, Q2WK | U | 0 | 2000 | MG/M**2 | QOW | ||||||
| 121337804 | 12133780 | 7 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85 MG/M2, Q2WEEKS | 170 | MG/M2 | U | 0 | 85 | MG/M**2 | QOW | ||||
| 121337804 | 12133780 | 8 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 65 MG/M2, Q2WEEKS | 170 | MG/M2 | U | 0 | 65 | MG/M**2 | QOW | ||||
| 121337804 | 12133780 | 9 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 2.5 MG, UNK | U | 0 | 2.5 | MG | |||||||
| 121337804 | 12133780 | 10 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 400 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 121337804 | 12133780 | 11 | C | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, Q2WEEKS | 400 | MG/M2 | U | 0 | 200 | MG/M**2 | QOW | ||||
| 121337804 | 12133780 | 12 | C | AMLODIPINE /00972402/ | AMLODIPINE BESYLATE | 1 | Oral | 5 MG, UNK | U | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121337804 | 12133780 | 1 | Rectal cancer |
| 121337804 | 12133780 | 3 | Rectal cancer |
| 121337804 | 12133780 | 7 | Rectal cancer |
| 121337804 | 12133780 | 9 | Diabetes mellitus |
| 121337804 | 12133780 | 10 | Rectal cancer |
| 121337804 | 12133780 | 12 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121337804 | 12133780 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121337804 | 12133780 | Anaemia | |
| 121337804 | 12133780 | Decreased appetite | |
| 121337804 | 12133780 | Dermatitis acneiform | |
| 121337804 | 12133780 | Diarrhoea | |
| 121337804 | 12133780 | Hypoglycaemia | |
| 121337804 | 12133780 | Malaise | |
| 121337804 | 12133780 | Neutrophil count decreased | |
| 121337804 | 12133780 | 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 |
|---|---|---|---|---|---|---|
| 121337804 | 12133780 | 1 | 20160127 | 20160210 | 0 | |
| 121337804 | 12133780 | 2 | 20160316 | 20160413 | 0 | |
| 121337804 | 12133780 | 3 | 20160127 | 20160210 | 0 | |
| 121337804 | 12133780 | 4 | 20160127 | 20160210 | 0 | |
| 121337804 | 12133780 | 5 | 20160316 | 20160413 | 0 | |
| 121337804 | 12133780 | 6 | 20160316 | 20160413 | 0 | |
| 121337804 | 12133780 | 7 | 20160127 | 20160210 | 0 | |
| 121337804 | 12133780 | 8 | 20160316 | 20160413 | 0 | |
| 121337804 | 12133780 | 10 | 20160127 | 20160210 | 0 | |
| 121337804 | 12133780 | 11 | 20160316 | 20160413 | 0 |