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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124071697 | 12407169 | 7 | F | 2016 | 20160913 | 20160526 | 20160922 | EXP | US-BAYER-2016-092292 | BAYER | 61.00 | YR | A | M | Y | 0.00000 | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124071697 | 12407169 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | 400 MG, QD (EVERY BED TIME) | 21923 | 400 | MG | FILM-COATED TABLET | QD | ||||||
| 124071697 | 12407169 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 200 MG, QD | 21923 | 200 | MG | FILM-COATED TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124071697 | 12407169 | 1 | Hepatocellular carcinoma |
| 124071697 | 12407169 | 2 | Metastases to liver |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124071697 | 12407169 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124071697 | 12407169 | Abdominal distension | |
| 124071697 | 12407169 | Abdominal pain | |
| 124071697 | 12407169 | Asthenia | |
| 124071697 | 12407169 | Blood bilirubin increased | |
| 124071697 | 12407169 | Confusional state | |
| 124071697 | 12407169 | Constipation | |
| 124071697 | 12407169 | Cough | |
| 124071697 | 12407169 | Decreased appetite | |
| 124071697 | 12407169 | Erythema | |
| 124071697 | 12407169 | Fatigue | |
| 124071697 | 12407169 | Feeling abnormal | |
| 124071697 | 12407169 | Gait disturbance | |
| 124071697 | 12407169 | Gastrooesophageal reflux disease | |
| 124071697 | 12407169 | Hepatic function abnormal | |
| 124071697 | 12407169 | Hepatocellular carcinoma | |
| 124071697 | 12407169 | Infected dermal cyst | |
| 124071697 | 12407169 | Insomnia | |
| 124071697 | 12407169 | Oedema peripheral | |
| 124071697 | 12407169 | Poor quality sleep | |
| 124071697 | 12407169 | Tongue discolouration | |
| 124071697 | 12407169 | Tumour marker increased | |
| 124071697 | 12407169 | Vomiting | |
| 124071697 | 12407169 | 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 |
|---|---|---|---|---|---|---|
| 124071697 | 12407169 | 1 | 20160507 | 20160524 | 0 | |
| 124071697 | 12407169 | 2 | 20160525 | 20160707 | 0 |