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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125714263 | 12571426 | 3 | F | 20160128 | 20160909 | 20160719 | 20160916 | EXP | ID-BAYER-2016-020166 | BAYER | 77.00 | YR | E | M | Y | 0.00000 | 20160916 | CN | ID | ID |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125714263 | 12571426 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | Y | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 125714263 | 12571426 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 600 MG, QD | Y | 21923 | 600 | MG | FILM-COATED TABLET | QD | |||||
| 125714263 | 12571426 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, BID (2 X 200 MG) | Y | 21923 | 200 | MG | FILM-COATED TABLET | BID | |||||
| 125714263 | 12571426 | 4 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, QD | Y | 21923 | 200 | MG | FILM-COATED TABLET | QD | |||||
| 125714263 | 12571426 | 5 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, BID (2 X 200 MG) | Y | 21923 | 200 | MG | FILM-COATED TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125714263 | 12571426 | 1 | Hepatocellular carcinoma |
| 125714263 | 12571426 | 2 | Hepatocellular carcinoma |
| 125714263 | 12571426 | 3 | Hepatocellular carcinoma |
| 125714263 | 12571426 | 4 | Hepatocellular carcinoma |
| 125714263 | 12571426 | 5 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125714263 | 12571426 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125714263 | 12571426 | Bedridden | |
| 125714263 | 12571426 | Gait disturbance | |
| 125714263 | 12571426 | Hyperkeratosis | |
| 125714263 | 12571426 | Off label use | |
| 125714263 | 12571426 | Pain in extremity | |
| 125714263 | 12571426 | Palmar-plantar erythrodysaesthesia syndrome | |
| 125714263 | 12571426 | Plantar erythema | |
| 125714263 | 12571426 | Skin exfoliation |
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 |
|---|---|---|---|---|---|---|
| 125714263 | 12571426 | 1 | 201512 | 20160128 | 0 | |
| 125714263 | 12571426 | 2 | 20160129 | 20160130 | 0 | |
| 125714263 | 12571426 | 3 | 2016 | 2016 | 0 | |
| 125714263 | 12571426 | 4 | 2016 | 2016 | 0 | |
| 125714263 | 12571426 | 5 | 2016 | 201606 | 0 |