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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887621 | 12588762 | 1 | I | 201605 | 20160606 | 20160725 | 20160725 | PER | US-JNJFOC-20160607842 | JANSSEN | 84.00 | YR | E | M | Y | 79.38000 | KG | 20160725 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125887621 | 12588762 | 1 | PS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | UNKNOWN | 19872 | UNSPECIFIED | |||||||
| 125887621 | 12588762 | 2 | SS | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | U | UNKNOWN | 19872 | UNSPECIFIED | |||||||
| 125887621 | 12588762 | 3 | C | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 0 | 1000 | MG | TABLET | QD | |||||||
| 125887621 | 12588762 | 4 | C | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 5 | MG | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125887621 | 12588762 | 2 | Bone pain |
| 125887621 | 12588762 | 3 | Prostate cancer metastatic |
| 125887621 | 12588762 | 4 | Prostate cancer metastatic |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125887621 | 12588762 | Off label use | |
| 125887621 | 12588762 | Product use issue | |
| 125887621 | 12588762 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 125887621 | 12588762 | 2 | 201605 | 0 | ||
| 125887621 | 12588762 | 3 | 20160216 | 20160509 | 0 | |
| 125887621 | 12588762 | 4 | 20160216 | 20160509 | 0 |