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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126136741 | 12613674 | 1 | I | 20160613 | 20160802 | 20160802 | PER | US-MYLANLABS-2016M1024837 | MYLAN | 0.00 | M | Y | 0.00000 | 20160802 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126136741 | 12613674 | 1 | PS | VALSARTAN. | VALSARTAN | 1 | UNK | U | U | 90866 | |||||||||
| 126136741 | 12613674 | 2 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | UNK | U | U | 0 | |||||||||
| 126136741 | 12613674 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, QD | N | 1526646PC | 0 | 160 | MG | CAPSULE | QD | ||||
| 126136741 | 12613674 | 4 | SS | BICALUTAMIDE. | BICALUTAMIDE | 1 | UNK | U | U | UNK | 0 | ||||||||
| 126136741 | 12613674 | 5 | SS | ZYTIGA | ABIRATERONE ACETATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126136741 | 12613674 | 1 | Hypertension |
| 126136741 | 12613674 | 2 | Hypertension |
| 126136741 | 12613674 | 3 | Prostate cancer |
| 126136741 | 12613674 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126136741 | 12613674 | Anxiety | |
| 126136741 | 12613674 | Asthenia | |
| 126136741 | 12613674 | Back pain | |
| 126136741 | 12613674 | Blood pressure increased | |
| 126136741 | 12613674 | Head discomfort | |
| 126136741 | 12613674 | Tinnitus |
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 |
|---|---|---|---|---|---|---|
| 126136741 | 12613674 | 3 | 20160426 | 20160428 | 0 |