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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83112014 | 8311201 | 4 | F | 201106 | 20160719 | 20111227 | 20160725 | EXP | JP-BAYER-2011-053260 | BAYER | 77.00 | YR | E | F | Y | 0.00000 | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 83112014 | 8311201 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | DAILY DOSE 400 MG | 21923 | 400 | MG | FILM-COATED TABLET | |||||||
| 83112014 | 8311201 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | DAILY DOSE 600 MG | 21923 | 600 | MG | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 83112014 | 8311201 | 1 | Renal cell carcinoma |
| 83112014 | 8311201 | 2 | Renal cell carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 83112014 | 8311201 | DE |
| 83112014 | 8311201 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 83112014 | 8311201 | Abdominal pain | |
| 83112014 | 8311201 | Intestinal haemorrhage | |
| 83112014 | 8311201 | Intestinal ischaemia | |
| 83112014 | 8311201 | Malaise | |
| 83112014 | 8311201 | Pneumatosis intestinalis | |
| 83112014 | 8311201 | Portal venous gas | |
| 83112014 | 8311201 | Renal impairment | |
| 83112014 | 8311201 | Thrombocytopenia | |
| 83112014 | 8311201 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 83112014 | 8311201 | 1 | 20110523 | 201106 | 0 | |
| 83112014 | 8311201 | 2 | 201106 | 201106 | 0 |