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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 76655805 | 7665580 | 5 | F | 20090821 | 20160724 | 20101112 | 20160801 | EXP | LB-SANOFI-AVENTIS-2010SA067000 | AVENTIS | 62.00 | YR | A | M | Y | 70.50000 | KG | 20160801 | MD | LB | LB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 76655805 | 7665580 | 1 | PS | ELOXATIN | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | UNK | 21759 | 150 | MG | QD | |||||||
| 76655805 | 7665580 | 2 | SS | ELOXATIN | OXALIPLATIN | 1 | Intravenous (not otherwise specified) | 21759 | 150 | MG | |||||||||
| 76655805 | 7665580 | 3 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | UNK | 0 | 750 | MG | QD | |||||||
| 76655805 | 7665580 | 4 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | UNK | 0 | 300 | MG | ||||||||
| 76655805 | 7665580 | 5 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous (not otherwise specified) | UNK | 0 | 2250 | MG | QD | |||||||
| 76655805 | 7665580 | 6 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | UNK | 0 | 300 | MG | ||||||||
| 76655805 | 7665580 | 7 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | Intravenous (not otherwise specified) | UNK | 0 | 400 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 76655805 | 7665580 | 1 | Colorectal cancer |
| 76655805 | 7665580 | 2 | Colorectal cancer |
| 76655805 | 7665580 | 3 | Colorectal cancer |
| 76655805 | 7665580 | 4 | Colorectal cancer |
| 76655805 | 7665580 | 5 | Colorectal cancer |
| 76655805 | 7665580 | 6 | Colorectal cancer |
| 76655805 | 7665580 | 7 | Colorectal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 76655805 | 7665580 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 76655805 | 7665580 | Atrial fibrillation | |
| 76655805 | 7665580 | Diarrhoea | |
| 76655805 | 7665580 | Nausea | |
| 76655805 | 7665580 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 76655805 | 7665580 | 1 | 20100215 | 0 | ||
| 76655805 | 7665580 | 2 | 20090817 | 20090817 | 0 | |
| 76655805 | 7665580 | 3 | 20100215 | 0 | ||
| 76655805 | 7665580 | 4 | 20090817 | 20090817 | 0 | |
| 76655805 | 7665580 | 6 | 20090817 | 20090817 | 0 | |
| 76655805 | 7665580 | 7 | 20100215 | 0 |