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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127807351 | 12780735 | 1 | I | 201606 | 20160919 | 20160926 | 20160926 | EXP | FR-JNJFOC-20160920363 | JANSSEN | 80.00 | YR | E | M | Y | 0.00000 | 20160926 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127807351 | 12780735 | 1 | PS | ZYTIGA | ABIRATERONE ACETATE | 1 | Oral | N | 202379 | 4 | DF | TABLET | QD | ||||||
| 127807351 | 12780735 | 2 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | 5 | MG | UNSPECIFIED | QD | ||||||
| 127807351 | 12780735 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | 10 | MG | UNSPECIFIED | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127807351 | 12780735 | 1 | Prostate cancer metastatic |
| 127807351 | 12780735 | 2 | Prostate cancer metastatic |
| 127807351 | 12780735 | 3 | Prostate cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127807351 | 12780735 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127807351 | 12780735 | Cellulitis | |
| 127807351 | 12780735 | Nausea | |
| 127807351 | 12780735 | Tooth abscess |
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 |
|---|---|---|---|---|---|---|
| 127807351 | 12780735 | 1 | 201603 | 0 | ||
| 127807351 | 12780735 | 2 | 201607 | 0 | ||
| 127807351 | 12780735 | 3 | 201603 | 201607 | 0 |