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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124087613 | 12408761 | 3 | F | 201505 | 20160630 | 20160526 | 20160708 | EXP | JP-SA-2016SA098519 | AVENTIS | KANAKO TAKAI, ET AL. A CASE OF HEPATIC ENCEPHALOPATHY DEVELOPED AFTER FOLFOX ADMINISTRATION. JOURNAL OF JAPAN SURGICAL ASSOCIATION 2016;77(3):705. | 77.00 | YR | E | M | Y | 0.00000 | 20160708 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124087613 | 12408761 | 1 | PS | ELPLAT | OXALIPLATIN | 1 | Intravenous drip | IV INFUSION SOLUTION | UNKNOWN | 21759 | SOLUTION FOR INJECTION | QD | |||||||
| 124087613 | 12408761 | 2 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | U | UNK | 21759 | INJECTION | QD | |||||||
| 124087613 | 12408761 | 3 | SS | CALCIUM LEVOFOLINATE | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | IV INFUSION | U | UNK | 0 | INJECTION | QD | ||||||
| 124087613 | 12408761 | 4 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | IV BOLUS AND THEN CONTINOUS INFUSION | U | UNK | 0 | INJECTION | QD | ||||||
| 124087613 | 12408761 | 5 | SS | 5-FU | FLUOROURACIL | 1 | Intravenous bolus | IV BOLUS AND THEN CONTINOUS INFUSION | U | UNK | 0 | INJECTION | QOD | ||||||
| 124087613 | 12408761 | 6 | C | AVASTIN | BEVACIZUMAB | 1 | 0 | INJECTION | |||||||||||
| 124087613 | 12408761 | 7 | C | XELODA | CAPECITABINE | 1 | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124087613 | 12408761 | 1 | Rectal cancer |
| 124087613 | 12408761 | 2 | Rectal cancer |
| 124087613 | 12408761 | 3 | Rectal cancer |
| 124087613 | 12408761 | 4 | Rectal cancer |
| 124087613 | 12408761 | 5 | Rectal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124087613 | 12408761 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124087613 | 12408761 | Altered state of consciousness | |
| 124087613 | 12408761 | Hepatic encephalopathy | |
| 124087613 | 12408761 | Hyperammonaemia | |
| 124087613 | 12408761 | Palmar-plantar erythrodysaesthesia syndrome |
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 |
|---|---|---|---|---|---|---|
| 124087613 | 12408761 | 1 | 201411 | 201504 | 0 | |
| 124087613 | 12408761 | 2 | 201505 | 0 | ||
| 124087613 | 12408761 | 3 | 201505 | 201505 | 0 | |
| 124087613 | 12408761 | 4 | 201505 | 0 | ||
| 124087613 | 12408761 | 5 | 201505 | 0 | ||
| 124087613 | 12408761 | 6 | 201411 | 201505 | 0 | |
| 124087613 | 12408761 | 7 | 201411 | 201504 | 0 |