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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117051535 | 11705153 | 5 | F | 20150416 | 20160628 | 20151106 | 20160705 | EXP | US-ASTELLAS-2015US040202 | ASTELLAS | 70.00 | YR | M | Y | 114.00000 | KG | 20160705 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117051535 | 11705153 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 160 MG DAILY DOSE, UNKNOWN FREQ. | 15840 | MG | Y | 203415 | 160 | MG | CAPSULE | QD | |||
| 117051535 | 11705153 | 2 | SS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 160 MG DAILY DOSE, UNKNOWN FREQ. | 15840 | MG | 203415 | 160 | MG | CAPSULE | QD | ||||
| 117051535 | 11705153 | 3 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 1000 MG DAILY DOSE, UNKNOWN FREQ. | 99000 | MG | U | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | |||
| 117051535 | 11705153 | 4 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 1000 MG DAILY DOSE, UNKNOWN FREQ. | 99000 | MG | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||
| 117051535 | 11705153 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 10 MG DAILY DOSE, UNKNOWN FREQ. | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 117051535 | 11705153 | 6 | SS | Atorvastatin | ATORVASTATIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 7 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 8 | SS | CALCIUM +D /00944201/ | CALCIUM CARBONATECHOLECALCIFEROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 9 | SS | DENOSUMAB | DENOSUMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 10 | SS | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 11 | SS | ENALAPRIL | ENALAPRIL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 12 | SS | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 13 | SS | HUMALOG | INSULIN LISPRO | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 14 | SS | LANTUS | INSULIN GLARGINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 15 | SS | ZOLADEX | GOSERELIN ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 16 | SS | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 17 | SS | COREG | CARVEDILOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 18 | SS | EXENATIDE | EXENATIDE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 117051535 | 11705153 | 19 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117051535 | 11705153 | 1 | Prostate cancer metastatic |
| 117051535 | 11705153 | 3 | Prostate cancer metastatic |
| 117051535 | 11705153 | 5 | Prostate cancer metastatic |
| 117051535 | 11705153 | 6 | Product used for unknown indication |
| 117051535 | 11705153 | 7 | Product used for unknown indication |
| 117051535 | 11705153 | 8 | Product used for unknown indication |
| 117051535 | 11705153 | 9 | Product used for unknown indication |
| 117051535 | 11705153 | 10 | Product used for unknown indication |
| 117051535 | 11705153 | 11 | Product used for unknown indication |
| 117051535 | 11705153 | 13 | Product used for unknown indication |
| 117051535 | 11705153 | 14 | Product used for unknown indication |
| 117051535 | 11705153 | 15 | Product used for unknown indication |
| 117051535 | 11705153 | 16 | Product used for unknown indication |
| 117051535 | 11705153 | 17 | Product used for unknown indication |
| 117051535 | 11705153 | 18 | Product used for unknown indication |
| 117051535 | 11705153 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117051535 | 11705153 | HO |
| 117051535 | 11705153 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117051535 | 11705153 | Acute kidney injury | |
| 117051535 | 11705153 | Cardiac failure congestive | |
| 117051535 | 11705153 | Cholecystitis acute | |
| 117051535 | 11705153 | Pancreatitis acute |
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 |
|---|---|---|---|---|---|---|
| 117051535 | 11705153 | 1 | 20150108 | 20150715 | 0 | |
| 117051535 | 11705153 | 2 | 20150806 | 0 | ||
| 117051535 | 11705153 | 3 | 20150108 | 20150715 | 0 | |
| 117051535 | 11705153 | 4 | 20150806 | 0 | ||
| 117051535 | 11705153 | 5 | 20150108 | 0 |