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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113278472 | 11327847 | 2 | F | 2014 | 20160815 | 20150731 | 20160823 | EXP | US-BAYER-2014-129099 | BAYER | 74.00 | YR | E | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113278472 | 11327847 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | 21923 | 400 | MG | FILM-COATED TABLET | BID | ||||||
| 113278472 | 11327847 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | AH00GH3 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 113278472 | 11327847 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, QD | 21923 | 400 | MG | FILM-COATED TABLET | QD | ||||||
| 113278472 | 11327847 | 4 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | 21923 | 400 | MG | FILM-COATED TABLET | BID | ||||||
| 113278472 | 11327847 | 5 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, QD | 21923 | 200 | MG | FILM-COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113278472 | 11327847 | 1 | Hepatocellular carcinoma |
| 113278472 | 11327847 | 2 | Metastases to bone |
| 113278472 | 11327847 | 3 | Metastases to bone marrow |
| 113278472 | 11327847 | 4 | Hepatocellular carcinoma |
| 113278472 | 11327847 | 5 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113278472 | 11327847 | HO |
| 113278472 | 11327847 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113278472 | 11327847 | Alopecia | |
| 113278472 | 11327847 | Blister | |
| 113278472 | 11327847 | Diarrhoea | |
| 113278472 | 11327847 | Drug dose omission | |
| 113278472 | 11327847 | Dry skin | |
| 113278472 | 11327847 | Dysphonia | |
| 113278472 | 11327847 | Exostosis | |
| 113278472 | 11327847 | Hepatocellular carcinoma | |
| 113278472 | 11327847 | Hyperkeratosis | |
| 113278472 | 11327847 | Hypoaesthesia | |
| 113278472 | 11327847 | Limb discomfort | |
| 113278472 | 11327847 | Metastases to spine | |
| 113278472 | 11327847 | Mobility decreased | |
| 113278472 | 11327847 | Muscle spasms | |
| 113278472 | 11327847 | Neuralgia | |
| 113278472 | 11327847 | Neuropathy peripheral | |
| 113278472 | 11327847 | Pain in extremity | |
| 113278472 | 11327847 | Pain of skin | |
| 113278472 | 11327847 | Peripheral venous disease | |
| 113278472 | 11327847 | Pruritus | |
| 113278472 | 11327847 | Rash | |
| 113278472 | 11327847 | Rash pruritic | |
| 113278472 | 11327847 | Skin lesion excision | |
| 113278472 | 11327847 | Spinal cord compression | |
| 113278472 | 11327847 | Stomatitis | |
| 113278472 | 11327847 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 113278472 | 11327847 | 1 | 20140805 | 0 | ||
| 113278472 | 11327847 | 3 | 201601 | 2016 | 0 | |
| 113278472 | 11327847 | 4 | 2016 | 2016 | 0 | |
| 113278472 | 11327847 | 5 | 20160513 | 0 |