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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215372 | 12521537 | 2 | F | 20160406 | 20160810 | 20160701 | 20160817 | EXP | US-ASTELLAS-2016US024753 | ASTELLAS | 91.00 | YR | M | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125215372 | 12521537 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 3520 | MG | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | |||||
| 125215372 | 12521537 | 2 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 21000 | MG | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | |||||
| 125215372 | 12521537 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 220 | MG | 0 | 5 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125215372 | 12521537 | 1 | Prostate cancer metastatic |
| 125215372 | 12521537 | 2 | Prostate cancer metastatic |
| 125215372 | 12521537 | 3 | Prostate cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125215372 | 12521537 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125215372 | 12521537 | Atrial fibrillation | |
| 125215372 | 12521537 | Cardiac failure congestive | |
| 125215372 | 12521537 | Dizziness | |
| 125215372 | 12521537 | Dyspnoea | |
| 125215372 | 12521537 | Muscular weakness | |
| 125215372 | 12521537 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 125215372 | 12521537 | 1 | 20160316 | 20160406 | 0 | |
| 125215372 | 12521537 | 2 | 20160316 | 20160405 | 0 | |
| 125215372 | 12521537 | 3 | 20160316 | 20160406 | 0 |