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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127852521 | 12785252 | 1 | I | 2016 | 20160808 | 20160927 | 20160927 | EXP | US-BAYER-2016-156075 | BAYER | 62.00 | YR | A | M | Y | 0.00000 | 20160927 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127852521 | 12785252 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, BID | BXH9XU3 | 21923 | 400 | MG | FILM-COATED TABLET | BID | |||||
| 127852521 | 12785252 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, QD | BXH9XU3 | 21923 | 200 | MG | FILM-COATED TABLET | QD | |||||
| 127852521 | 12785252 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, BID | 21923 | 200 | MG | FILM-COATED TABLET | BID | ||||||
| 127852521 | 12785252 | 4 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, BID | BXH8GZ1 | 21923 | 200 | MG | FILM-COATED TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127852521 | 12785252 | 1 | Renal cancer |
| 127852521 | 12785252 | 2 | Hepatocellular carcinoma |
| 127852521 | 12785252 | 3 | Renal cancer |
| 127852521 | 12785252 | 4 | Renal cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127852521 | 12785252 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127852521 | 12785252 | Abdominal distension | |
| 127852521 | 12785252 | Ascites | |
| 127852521 | 12785252 | Asthenia | |
| 127852521 | 12785252 | Blood sodium decreased | |
| 127852521 | 12785252 | Constipation | |
| 127852521 | 12785252 | Discomfort | |
| 127852521 | 12785252 | Dyspnoea exertional | |
| 127852521 | 12785252 | Fatigue | |
| 127852521 | 12785252 | Feeling hot | |
| 127852521 | 12785252 | Hyperhidrosis | |
| 127852521 | 12785252 | Laboratory test abnormal | |
| 127852521 | 12785252 | Metastases to abdominal cavity | |
| 127852521 | 12785252 | Nausea | |
| 127852521 | 12785252 | Somnolence | |
| 127852521 | 12785252 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127852521 | 12785252 | 1 | 20160806 | 2016 | 0 | |
| 127852521 | 12785252 | 2 | 2016 | 0 | ||
| 127852521 | 12785252 | 3 | 2016 | 2016 | 0 | |
| 127852521 | 12785252 | 4 | 2016 | 0 |