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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123281333 | 12328133 | 3 | F | 20160402 | 20160705 | 20160503 | 20160711 | EXP | US-BAYER-2016-067296 | BAYER | 75.00 | YR | E | M | Y | 0.00000 | 20160711 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123281333 | 12328133 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | 5600 | MG | Y | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||
| 123281333 | 12328133 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, QD | 5600 | MG | Y | 21923 | 200 | MG | FILM-COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123281333 | 12328133 | 1 | Hepatocellular carcinoma |
| 123281333 | 12328133 | 2 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123281333 | 12328133 | OT |
| 123281333 | 12328133 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123281333 | 12328133 | Abdominal pain upper | |
| 123281333 | 12328133 | Blood pressure increased | |
| 123281333 | 12328133 | Confusional state | |
| 123281333 | 12328133 | Decreased appetite | |
| 123281333 | 12328133 | Dehydration | |
| 123281333 | 12328133 | Diarrhoea | |
| 123281333 | 12328133 | Extrasystoles | |
| 123281333 | 12328133 | Fatigue | |
| 123281333 | 12328133 | Hallucination | |
| 123281333 | 12328133 | Pain | |
| 123281333 | 12328133 | Tremor | |
| 123281333 | 12328133 | Tumour marker increased |
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 |
|---|---|---|---|---|---|---|
| 123281333 | 12328133 | 1 | 20160331 | 20160406 | 0 | |
| 123281333 | 12328133 | 2 | 20160511 | 20160623 | 0 |