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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123180493 | 12318049 | 3 | F | 201604 | 20160907 | 20160429 | 20160914 | EXP | US-BAYER-2016-068644 | BAYER | 60.00 | YR | A | M | Y | 78.69000 | KG | 20160914 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123180493 | 12318049 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | BXH8GZ1 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 123180493 | 12318049 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | BXH8GZ1 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 123180493 | 12318049 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | BXH8GZ3 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 123180493 | 12318049 | 4 | SS | NEXAVAR | SORAFENIB | 1 | UNK | BXH9XU3 | 21923 | FILM-COATED TABLET | |||||||||
| 123180493 | 12318049 | 5 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | BXH8GZ3 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 123180493 | 12318049 | 6 | C | FUROSEMIDE. | FUROSEMIDE | 1 | 0 | ||||||||||||
| 123180493 | 12318049 | 7 | C | SPIRONOLACTONE. | SPIRONOLACTONE | 1 | 0 | ||||||||||||
| 123180493 | 12318049 | 8 | C | ENTECAVIR. | ENTECAVIR | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123180493 | 12318049 | 1 | Hepatocellular carcinoma |
| 123180493 | 12318049 | 2 | Hepatocellular carcinoma |
| 123180493 | 12318049 | 3 | Hepatocellular carcinoma |
| 123180493 | 12318049 | 4 | Hepatocellular carcinoma |
| 123180493 | 12318049 | 5 | Hepatocellular carcinoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123180493 | 12318049 | OT |
| 123180493 | 12318049 | HO |
| 123180493 | 12318049 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123180493 | 12318049 | Blood pressure increased | |
| 123180493 | 12318049 | Confusional state | |
| 123180493 | 12318049 | Death | |
| 123180493 | 12318049 | Disorientation | |
| 123180493 | 12318049 | Hypocoagulable state | |
| 123180493 | 12318049 | Rectal haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 123180493 | 12318049 | 1 | 20160302 | 0 | ||
| 123180493 | 12318049 | 2 | 20160328 | 0 | ||
| 123180493 | 12318049 | 3 | 20160328 | 201606 | 0 | |
| 123180493 | 12318049 | 5 | 201603 | 201606 | 0 |