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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124639792 | 12463979 | 2 | F | 2016 | 20160712 | 20160614 | 20160722 | EXP | US-BAYER-2016-061220 | BAYER | 60.00 | YR | A | F | Y | 88.50000 | KG | 20160722 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124639792 | 12463979 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, QD | 21923 | 400 | MG | FILM-COATED TABLET | QD | ||||||
| 124639792 | 12463979 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, QD | 21923 | 400 | MG | FILM-COATED TABLET | QD | ||||||
| 124639792 | 12463979 | 3 | C | SPIRONOLACTON | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 124639792 | 12463979 | 4 | C | NORCO | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | 0 | ||||||||||||
| 124639792 | 12463979 | 5 | C | ONDANSETRON | ONDANSETRON | 1 | 4 MG, Q8HR | 0 | 4 | MG | Q8H | ||||||||
| 124639792 | 12463979 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 124639792 | 12463979 | 7 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124639792 | 12463979 | 1 | Hepatocellular carcinoma |
| 124639792 | 12463979 | 2 | Hepatocellular carcinoma |
| 124639792 | 12463979 | 3 | Ascites |
| 124639792 | 12463979 | 4 | Arthritis |
| 124639792 | 12463979 | 5 | Nausea |
| 124639792 | 12463979 | 6 | Ascites |
| 124639792 | 12463979 | 7 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124639792 | 12463979 | OT |
| 124639792 | 12463979 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124639792 | 12463979 | Abdominal pain upper | |
| 124639792 | 12463979 | Alpha 1 foetoprotein abnormal | |
| 124639792 | 12463979 | Asthenia | |
| 124639792 | 12463979 | Drug dose omission | |
| 124639792 | 12463979 | Fall | |
| 124639792 | 12463979 | Fatigue | |
| 124639792 | 12463979 | Gastrointestinal haemorrhage | |
| 124639792 | 12463979 | Haemorrhage | |
| 124639792 | 12463979 | Haemorrhoidal haemorrhage | |
| 124639792 | 12463979 | Hepatic cirrhosis | |
| 124639792 | 12463979 | Incoherent | |
| 124639792 | 12463979 | Jaundice | |
| 124639792 | 12463979 | 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 |
|---|---|---|---|---|---|---|
| 124639792 | 12463979 | 1 | 20160211 | 201605 | 0 | |
| 124639792 | 12463979 | 2 | 2016 | 0 |