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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126427522 | 12642752 | 2 | F | 201606 | 20160920 | 20160811 | 20160928 | EXP | US-AMGEN-USASP2016101360 | AMGEN | 66.00 | YR | E | M | Y | 0.00000 | 20160928 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126427522 | 12642752 | 1 | PS | XGEVA | DENOSUMAB | 1 | Subcutaneous | 120 MG, QMO | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | /month | |||||
| 126427522 | 12642752 | 2 | SS | XGEVA | DENOSUMAB | 1 | Subcutaneous | UNK | Y | 125320 | SOLUTION FOR INJECTION | ||||||||
| 126427522 | 12642752 | 3 | SS | ENZALUTAMIDE | ENZALUTAMIDE | 1 | Oral | 160 MG, QD | 0 | 160 | MG | QD | |||||||
| 126427522 | 12642752 | 4 | SS | ABIRATERONE | ABIRATERONE | 1 | Oral | 1000 MG, QD | 0 | 1000 | MG | QD | |||||||
| 126427522 | 12642752 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5 MG, BID | 0 | 5 | MG | BID | |||||||
| 126427522 | 12642752 | 6 | C | CALCIUM | CALCIUM | 1 | 0 | ||||||||||||
| 126427522 | 12642752 | 7 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126427522 | 12642752 | 1 | Metastases to bone |
| 126427522 | 12642752 | 3 | Hormone-refractory prostate cancer |
| 126427522 | 12642752 | 4 | Hormone-refractory prostate cancer |
| 126427522 | 12642752 | 5 | Hormone-refractory prostate cancer |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126427522 | 12642752 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126427522 | 12642752 | Abdominal pain | |
| 126427522 | 12642752 | Back pain | |
| 126427522 | 12642752 | Constipation | |
| 126427522 | 12642752 | Dehydration | |
| 126427522 | 12642752 | Hypocalcaemia | |
| 126427522 | 12642752 | Hypophagia | |
| 126427522 | 12642752 | Malaise | |
| 126427522 | 12642752 | Nausea | |
| 126427522 | 12642752 | Paraesthesia | |
| 126427522 | 12642752 | Respiratory disorder |
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 |
|---|---|---|---|---|---|---|
| 126427522 | 12642752 | 2 | 20160630 | 0 | ||
| 126427522 | 12642752 | 3 | 20160311 | 0 | ||
| 126427522 | 12642752 | 4 | 20160311 | 0 | ||
| 126427522 | 12642752 | 5 | 20160311 | 0 |