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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457621 | 12645762 | 1 | I | 20151030 | 20160129 | 20160811 | 20160811 | PER | US-ENDO PHARMACEUTICALS INC.-2016-001182 | ENDO | 79.40 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126457621 | 12645762 | 1 | PS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | U | 40256 | UNKNOWN | BID | ||||||||
| 126457621 | 12645762 | 2 | SS | PREDNISONE TABLETS | PREDNISONE | 1 | Unknown | U | 40256 | UNKNOWN | QD | ||||||||
| 126457621 | 12645762 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 1521457PC | 0 | 160 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126457621 | 12645762 | 1 | Product used for unknown indication |
| 126457621 | 12645762 | 3 | Prostate cancer |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126457621 | 12645762 | Cough | |
| 126457621 | 12645762 | Fall | |
| 126457621 | 12645762 | Insomnia | |
| 126457621 | 12645762 | Nasal congestion | |
| 126457621 | 12645762 | Non-cardiac chest pain |
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 |
|---|---|---|---|---|---|---|
| 126457621 | 12645762 | 1 | 2016 | 0 | ||
| 126457621 | 12645762 | 2 | 2016 | 0 | ||
| 126457621 | 12645762 | 3 | 20151021 | 0 |