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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604512 | 12660451 | 2 | F | 2016 | 20160809 | 20160817 | 20160817 | EXP | JP-BAYER-2016-142044 | BAYER | 60.00 | YR | A | F | Y | 59.00000 | KG | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604512 | 12660451 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG DAILY, BID | 21923 | 400 | MG | FILM-COATED TABLET | |||||||
| 126604512 | 12660451 | 2 | SS | LUNESTA | ESZOPICLONE | 1 | Oral | DAILY DOSE 2 MG | 0 | 2 | MG | TABLET | |||||||
| 126604512 | 12660451 | 3 | C | URSODEOXYCHOLIC ACID | URSODIOL | 1 | Oral | DAILY DOSE 600 MG | 0 | 600 | MG | TABLET | |||||||
| 126604512 | 12660451 | 4 | C | BARACLUDE | ENTECAVIR | 1 | Oral | DAILY DOSE .5 MG | 0 | .5 | MG | TABLET | |||||||
| 126604512 | 12660451 | 5 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | Oral | DAILY DOSE 25 MG | 0 | 25 | MG | TABLET | |||||||
| 126604512 | 12660451 | 6 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | Oral | DAILY DOSE 750 MG | 0 | 750 | MG | TABLET | |||||||
| 126604512 | 12660451 | 7 | C | LANSOPRAZOLE. | LANSOPRAZOLE | 1 | Oral | DAILY DOSE 30 MG | 0 | 30 | MG | ||||||||
| 126604512 | 12660451 | 8 | C | RIZABEN | TRANILAST | 1 | Oral | DAILY DOSE 300 MG | 0 | 300 | MG | CAPSULE | |||||||
| 126604512 | 12660451 | 9 | C | HIRUDOID | GLYCOSAMINOGLYCANS | 1 | Topical | UNK | 0 | OINTMENT |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126604512 | 12660451 | 1 | Hepatocellular carcinoma |
| 126604512 | 12660451 | 2 | Insomnia |
| 126604512 | 12660451 | 3 | Hepatic function abnormal |
| 126604512 | 12660451 | 4 | Hepatitis B |
| 126604512 | 12660451 | 5 | Ascites |
| 126604512 | 12660451 | 6 | Constipation |
| 126604512 | 12660451 | 7 | Gastric ulcer |
| 126604512 | 12660451 | 9 | Drug toxicity prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126604512 | 12660451 | DE |
| 126604512 | 12660451 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126604512 | 12660451 | Altered state of consciousness | |
| 126604512 | 12660451 | Gastrointestinal haemorrhage | |
| 126604512 | 12660451 | Haematemesis | |
| 126604512 | 12660451 | Hepatic function abnormal | |
| 126604512 | 12660451 | Jaundice | |
| 126604512 | 12660451 | Melaena | |
| 126604512 | 12660451 | Pyrexia | |
| 126604512 | 12660451 | Rash |
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 |
|---|---|---|---|---|---|---|
| 126604512 | 12660451 | 1 | 20160702 | 20160716 | 0 | |
| 126604512 | 12660451 | 2 | 20160716 | 0 | ||
| 126604512 | 12660451 | 3 | 2016 | 0 | ||
| 126604512 | 12660451 | 4 | 20071025 | 20160716 | 0 | |
| 126604512 | 12660451 | 5 | 20160716 | 0 | ||
| 126604512 | 12660451 | 6 | 20160716 | 0 | ||
| 126604512 | 12660451 | 7 | 20160716 | 0 | ||
| 126604512 | 12660451 | 8 | 20160716 | 0 | ||
| 126604512 | 12660451 | 9 | 20160716 | 0 |