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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457861 | 12645786 | 1 | I | 2015 | 20151222 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2015-005177 | ENDO | 59.00 | YR | M | Y | 0.00000 | 20160811 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457861 | 12645786 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | U | 40256 | UNKNOWN | |||||||||
| 126457861 | 12645786 | 2 | SS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | U | 40256 | UNKNOWN | |||||||||
| 126457861 | 12645786 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | U | 0 | CAPSULE | |||||||||
| 126457861 | 12645786 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | U | 0 | 160 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126457861 | 12645786 | 1 | Product used for unknown indication |
| 126457861 | 12645786 | 3 | Prostate cancer |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126457861 | 12645786 | Chromaturia | |
| 126457861 | 12645786 | Genital infection male | |
| 126457861 | 12645786 | Genital rash | |
| 126457861 | 12645786 | Nausea | |
| 126457861 | 12645786 | Peripheral swelling | |
| 126457861 | 12645786 | Rash pustular | |
| 126457861 | 12645786 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |