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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124479933 | 12447993 | 3 | F | 20151110 | 20160817 | 20160608 | 20160823 | EXP | JP-BAYER-2015-482128 | BAYER | 70.00 | YR | E | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124479933 | 12447993 | 1 | PS | NEXAVAR | SORAFENIB | 1 | Oral | UNK | 21923 | FILM-COATED TABLET | |||||||||
| 124479933 | 12447993 | 2 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 1 TABLETS TWICE | 21923 | FILM-COATED TABLET | BID | ||||||||
| 124479933 | 12447993 | 3 | SS | NEXAVAR | SORAFENIB | 1 | Oral | 2 TABLETS TWICE, BID | 21923 | FILM-COATED TABLET | BID | ||||||||
| 124479933 | 12447993 | 4 | C | TRAZENTA | LINAGLIPTIN | 1 | Oral | DAILY DOSE 5 MG | 0 | 5 | MG | TABLET | |||||||
| 124479933 | 12447993 | 5 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Oral | DAILY DOSE 5 MG | 0 | 5 | MG | ||||||||
| 124479933 | 12447993 | 6 | C | LIVALO | PITAVASTATIN CALCIUM | 1 | Oral | DAILY DOSE 2 MG | 0 | 2 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124479933 | 12447993 | 1 | Hepatic cancer |
| 124479933 | 12447993 | 2 | Hepatic cirrhosis |
| 124479933 | 12447993 | 3 | Hepatic cancer |
| 124479933 | 12447993 | 4 | Diabetes mellitus |
| 124479933 | 12447993 | 5 | Hypertension |
| 124479933 | 12447993 | 6 | Hyperlipidaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124479933 | 12447993 | LT |
| 124479933 | 12447993 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124479933 | 12447993 | Acute pulmonary oedema | |
| 124479933 | 12447993 | Blood pressure decreased | |
| 124479933 | 12447993 | Gastrointestinal haemorrhage | |
| 124479933 | 12447993 | Haemoptysis | |
| 124479933 | 12447993 | Interstitial lung disease | |
| 124479933 | 12447993 | Melaena | |
| 124479933 | 12447993 | Off label use | |
| 124479933 | 12447993 | Platelet count decreased | |
| 124479933 | 12447993 | Pulmonary alveolar haemorrhage | |
| 124479933 | 12447993 | Pyrexia | |
| 124479933 | 12447993 | Respiratory failure |
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 |
|---|---|---|---|---|---|---|
| 124479933 | 12447993 | 1 | 20150703 | 0 | ||
| 124479933 | 12447993 | 2 | 20151022 | 20151028 | 0 | |
| 124479933 | 12447993 | 3 | 20151029 | 20151105 | 0 |