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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126011831 | 12601183 | 1 | I | 20160601 | 20160728 | 20160728 | EXP | US-ACTAVIS-2016-12101 | ACTAVIS | CHAPUY CI, SAHAI I, SHARMA R, ZHU AX, KOZYREVA ON. HYPERAMMONEMIC ENCEPHALOPATHY ASSOCIATED WITH FIBROLAMELLAR HEPATOCELLULAR CARCINOMA: CASE REPORT, LITERATURE REVIEW, AND PROPOSED TREATMENT ALGORITHM. ONCOLOGIST. 2016;21(4):514-20. | 31.00 | YR | M | Y | 0.00000 | 20160728 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126011831 | 12601183 | 1 | PS | Gemcitabine (ATLLC) | GEMCITABINE HYDROCHLORIDE | 1 | Unknown | 1000 MG/M2, 1/TWO WEEKS | Y | UNCONFIRMED | 79160 | 1000 | MG/M**2 | UNK | QOW | ||||
| 126011831 | 12601183 | 2 | SS | ELOXATIN | OXALIPLATIN | 1 | Unknown | 100 MG/M2, 1/TWO WEEKS | Y | UNCONFIRMED | 0 | 100 | MG/M**2 | UNK | QOW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126011831 | 12601183 | 1 | Hepatocellular carcinoma |
| 126011831 | 12601183 | 2 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126011831 | 12601183 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126011831 | 12601183 | Hyperammonaemic encephalopathy | |
| 126011831 | 12601183 | Hypersensitivity |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |