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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125219562 | 12521956 | 2 | F | 20160422 | 20160831 | 20160701 | 20160907 | EXP | US-ASTELLAS-2016US024879 | ASTELLAS | 66.64 | YR | M | Y | 111.00000 | KG | 20160907 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125219562 | 12521956 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 7040 | MG | Y | 43626-8 | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | |||
| 125219562 | 12521956 | 2 | SS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 7040 | MG | 43626-8 | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | ||||
| 125219562 | 12521956 | 3 | SS | ABIRATERONE | ABIRATERONE | 1 | Oral | 44000 | MG | Y | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||
| 125219562 | 12521956 | 4 | SS | ABIRATERONE | ABIRATERONE | 1 | Oral | 44000 | MG | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | |||||
| 125219562 | 12521956 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 440 | MG | Y | 0 | 5 | MG | FORMULATION UNKNOWN | BID | ||||
| 125219562 | 12521956 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 440 | MG | 0 | 5 | MG | FORMULATION UNKNOWN | BID | |||||
| 125219562 | 12521956 | 7 | SS | XGEVA | DENOSUMAB | 1 | Subcutaneous | Y | 0 | 120 | MG | FORMULATION UNKNOWN | /month | ||||||
| 125219562 | 12521956 | 8 | SS | XGEVA | DENOSUMAB | 1 | Subcutaneous | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125219562 | 12521956 | 9 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 125219562 | 12521956 | 10 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125219562 | 12521956 | 1 | Prostate cancer metastatic |
| 125219562 | 12521956 | 3 | Prostate cancer metastatic |
| 125219562 | 12521956 | 5 | Prostate cancer metastatic |
| 125219562 | 12521956 | 7 | Metastases to bone |
| 125219562 | 12521956 | 9 | Supplementation therapy |
| 125219562 | 12521956 | 10 | Supplementation therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125219562 | 12521956 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125219562 | 12521956 | Back pain | |
| 125219562 | 12521956 | Dehydration | |
| 125219562 | 12521956 | Hypocalcaemia |
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 |
|---|---|---|---|---|---|---|
| 125219562 | 12521956 | 1 | 20160311 | 20160428 | 0 | |
| 125219562 | 12521956 | 2 | 20160511 | 0 | ||
| 125219562 | 12521956 | 3 | 20160311 | 20160428 | 0 | |
| 125219562 | 12521956 | 4 | 20160511 | 0 | ||
| 125219562 | 12521956 | 5 | 20160311 | 20160428 | 0 | |
| 125219562 | 12521956 | 6 | 20160506 | 0 | ||
| 125219562 | 12521956 | 8 | 20160630 | 0 |