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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120899196 | 12089919 | 6 | F | 20151229 | 20160803 | 20160218 | 20160809 | EXP | US-BAYER-2016-004810 | BAYER | 65.00 | YR | E | M | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120899196 | 12089919 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID (2 TABLETS TWICE A DAY UPON PHYSICIAN'S ORDER) | BXH4C76 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 120899196 | 12089919 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID (2 TABLETS TWICE A DAY UPON PHYSICIAN'S ORDER) | BXH5XH2 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 120899196 | 12089919 | 3 | C | LACTULOSE. | LACTULOSE | 1 | 10G/15 | 0 | |||||||||||
| 120899196 | 12089919 | 4 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 | ||||||||||||
| 120899196 | 12089919 | 5 | C | RIFAXIMIN | RIFAXIMIN | 1 | UNK | 0 | |||||||||||
| 120899196 | 12089919 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 40MG/4ML | 0 | |||||||||||
| 120899196 | 12089919 | 7 | C | PANTOPRAZOLE SODIUM. | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 120899196 | 12089919 | 8 | C | SPIRONOLACTONE W/HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDESPIRONOLACTONE | 1 | 25/25 | 0 | |||||||||||
| 120899196 | 12089919 | 9 | C | SUCRALFAT | SUCRALFATE | 1 | 1G/10ML | 0 | |||||||||||
| 120899196 | 12089919 | 10 | C | SOFOSBUVIR | SOFOSBUVIR | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120899196 | 12089919 | 1 | Hepatocellular carcinoma |
| 120899196 | 12089919 | 2 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120899196 | 12089919 | HO |
| 120899196 | 12089919 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120899196 | 12089919 | Abdominal distension | |
| 120899196 | 12089919 | Abdominal pain upper | |
| 120899196 | 12089919 | Blood creatinine increased | |
| 120899196 | 12089919 | Cardiac disorder | |
| 120899196 | 12089919 | Death | |
| 120899196 | 12089919 | Dehydration | |
| 120899196 | 12089919 | Diplopia | |
| 120899196 | 12089919 | Dizziness | |
| 120899196 | 12089919 | Dysphonia | |
| 120899196 | 12089919 | Glycosylated haemoglobin increased | |
| 120899196 | 12089919 | Pneumonia | |
| 120899196 | 12089919 | Pruritus | |
| 120899196 | 12089919 | Pruritus generalised | |
| 120899196 | 12089919 | Rash vesicular | |
| 120899196 | 12089919 | Transfusion | |
| 120899196 | 12089919 | 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 |
|---|---|---|---|---|---|---|
| 120899196 | 12089919 | 1 | 20151219 | 0 | ||
| 120899196 | 12089919 | 2 | 2016 | 0 |