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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118072273 | 11807227 | 3 | F | 2015 | 20160926 | 20151207 | 20160930 | EXP | JP-JNJFOC-20151204313 | JANSSEN | 67.00 | YR | E | M | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118072273 | 11807227 | 1 | PS | ZYTIGA | ABIRATERONE ACETATE | 1 | Oral | U | U | 202379 | 1000 | MG | TABLET | QD | |||||
| 118072273 | 11807227 | 2 | SS | PREDONINE | PREDNISOLONEPREDNISOLONE ACETATEPREDNISOLONE SODIUM SUCCINATE | 1 | Oral | U | 0 | 5 | MG | UNSPECIFIED | BID | ||||||
| 118072273 | 11807227 | 3 | C | ZOLADEX | GOSERELIN ACETATE | 1 | Subcutaneous | D | 0 | 10.8 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118072273 | 11807227 | 1 | Hormone-refractory prostate cancer |
| 118072273 | 11807227 | 2 | Hormone-refractory prostate cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118072273 | 11807227 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118072273 | 11807227 | Diabetes mellitus | |
| 118072273 | 11807227 | Metastases to bone |
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 |
|---|---|---|---|---|---|---|
| 118072273 | 11807227 | 1 | 201503 | 201509 | 0 | |
| 118072273 | 11807227 | 2 | 201503 | 201509 | 0 |