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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125877701 | 12587770 | 1 | I | 20160509 | 20160512 | 20160725 | 20160725 | EXP | DE-ASTELLAS-2016US019082 | ASTELLAS | 0.00 | M | Y | 105.00000 | KG | 20160725 | CN | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125877701 | 12587770 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 29120 | MG | Y | N | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | |||
| 125877701 | 12587770 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 29120 | MG | U | N | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | |||
| 125877701 | 12587770 | 3 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 0 | 4 | MG | FORMULATION UNKNOWN | /month | |||||||
| 125877701 | 12587770 | 4 | C | PROFACT | BUSERELIN ACETATE | 1 | Subcutaneous | 9.45 MG, /QUARTER | U | 0 | 9.45 | MG | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125877701 | 12587770 | 1 | Prostate cancer |
| 125877701 | 12587770 | 3 | Metastases to bone |
| 125877701 | 12587770 | 4 | Prostate cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125877701 | 12587770 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125877701 | 12587770 | Musculoskeletal stiffness | |
| 125877701 | 12587770 | Neck pain | |
| 125877701 | 12587770 | Necrosis | |
| 125877701 | 12587770 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 125877701 | 12587770 | 1 | 20151110 | 20160509 | 0 | |
| 125877701 | 12587770 | 2 | 201606 | 0 | ||
| 125877701 | 12587770 | 3 | 20120301 | 0 | ||
| 125877701 | 12587770 | 4 | 20120301 | 0 |