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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126689265 | 12668926 | 5 | F | 20160701 | 20160907 | 20160819 | 20160921 | EXP | DK-ASTELLAS-2016US026562 | ASTELLAS | 62.00 | YR | M | Y | 109.00000 | KG | 20160921 | CN | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126689265 | 12668926 | 1 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Unknown | 75520 | MG | Y | 0 | 160 | MG | FORMULATION UNKNOWN | QD | ||||
| 126689265 | 12668926 | 2 | SS | PLACEBO | UNSPECIFIED INGREDIENT | 1 | Unknown | 75520 | MG | Y | 0 | 160 | MG | FORMULATION UNKNOWN | QD | ||||
| 126689265 | 12668926 | 3 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 472000 | MG | Y | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||
| 126689265 | 12668926 | 4 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 472000 | MG | Y | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||
| 126689265 | 12668926 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 4720 | MG | Y | 0 | 5 | MG | FORMULATION UNKNOWN | BID | ||||
| 126689265 | 12668926 | 6 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 40640 | MG | D | 203415 | 160 | MG | CAPSULE | QD | ||||
| 126689265 | 12668926 | 7 | C | PANTOPRAZOL | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 126689265 | 12668926 | 8 | C | PROLIA | DENOSUMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 126689265 | 12668926 | 9 | C | UNIKALK PLUS | 2 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | ||||||||
| 126689265 | 12668926 | 10 | C | ELIGARD | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | INJECTION | |||||||
| 126689265 | 12668926 | 11 | C | Atorvastatin | ATORVASTATIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 126689265 | 12668926 | 12 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 126689265 | 12668926 | 13 | C | IMADRAX | AMOXICILLIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 126689265 | 12668926 | 14 | C | MULTIVITAMIN /07504101/ | VITAMINS | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 126689265 | 12668926 | 15 | C | NITROFURANTOIN. | NITROFURANTOIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126689265 | 12668926 | 1 | Prostate cancer |
| 126689265 | 12668926 | 3 | Prostate cancer |
| 126689265 | 12668926 | 5 | Prostate cancer |
| 126689265 | 12668926 | 6 | Prostate cancer |
| 126689265 | 12668926 | 7 | Product used for unknown indication |
| 126689265 | 12668926 | 8 | Product used for unknown indication |
| 126689265 | 12668926 | 9 | Product used for unknown indication |
| 126689265 | 12668926 | 10 | Product used for unknown indication |
| 126689265 | 12668926 | 11 | Product used for unknown indication |
| 126689265 | 12668926 | 12 | Product used for unknown indication |
| 126689265 | 12668926 | 13 | Product used for unknown indication |
| 126689265 | 12668926 | 14 | Product used for unknown indication |
| 126689265 | 12668926 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126689265 | 12668926 | HO |
| 126689265 | 12668926 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126689265 | 12668926 | Acute kidney injury | |
| 126689265 | 12668926 | Hypercalcaemia |
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 |
|---|---|---|---|---|---|---|
| 126689265 | 12668926 | 1 | 20150318 | 20160704 | 0 | |
| 126689265 | 12668926 | 2 | 20160711 | 20160722 | 0 | |
| 126689265 | 12668926 | 3 | 20150318 | 20160704 | 0 | |
| 126689265 | 12668926 | 4 | 20160711 | 20160722 | 0 | |
| 126689265 | 12668926 | 5 | 20150318 | 20160704 | 0 | |
| 126689265 | 12668926 | 6 | 20140707 | 20150317 | 0 | |
| 126689265 | 12668926 | 7 | 20120903 | 0 | ||
| 126689265 | 12668926 | 8 | 20140307 | 0 | ||
| 126689265 | 12668926 | 9 | 20130826 | 20160610 | 0 | |
| 126689265 | 12668926 | 10 | 20130826 | 0 | ||
| 126689265 | 12668926 | 11 | 20131216 | 0 | ||
| 126689265 | 12668926 | 12 | 20160424 | 0 | ||
| 126689265 | 12668926 | 13 | 20160525 | 20160601 | 0 | |
| 126689265 | 12668926 | 14 | 201308 | 0 | ||
| 126689265 | 12668926 | 15 | 20160616 | 20160701 | 0 |