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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127496411 | 12749641 | 1 | I | 201605 | 20160428 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US016775 | ASTELLAS | 83.78 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127496411 | 12749641 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | N | 1526646PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127496411 | 12749641 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 127496411 | 12749641 | 3 | SS | VALSARTAN. | VALSARTAN | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127496411 | 12749641 | 4 | SS | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127496411 | 12749641 | 5 | SS | BICALUTAMIDE. | BICALUTAMIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127496411 | 12749641 | 6 | SS | ZYTIGA | ABIRATERONE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127496411 | 12749641 | 1 | Prostate cancer |
| 127496411 | 12749641 | 2 | Prostate cancer metastatic |
| 127496411 | 12749641 | 3 | Hypertension |
| 127496411 | 12749641 | 4 | Hypertension |
| 127496411 | 12749641 | 5 | Product used for unknown indication |
| 127496411 | 12749641 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127496411 | 12749641 | Anxiety | |
| 127496411 | 12749641 | Asthenia | |
| 127496411 | 12749641 | Back pain | |
| 127496411 | 12749641 | Blood pressure increased | |
| 127496411 | 12749641 | Drug ineffective | |
| 127496411 | 12749641 | Head discomfort | |
| 127496411 | 12749641 | 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 |
|---|---|---|---|---|---|---|
| 127496411 | 12749641 | 1 | 20160426 | 20160428 | 0 | |
| 127496411 | 12749641 | 2 | 20160606 | 0 |