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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127720301 | 12772030 | 1 | I | 20160203 | 20160503 | 20160922 | 20160922 | EXP | US-ASTELLAS-2016US017743 | ASTELLAS | 69.00 | YR | M | Y | 172.00000 | KG | 20160922 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127720301 | 12772030 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 82880 | MG | D | 43626-5 | 203415 | 160 | MG | CAPSULE | QD | |||
| 127720301 | 12772030 | 2 | SS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 82880 | MG | D | 43626-5 | 203415 | 160 | MG | CAPSULE | QD | |||
| 127720301 | 12772030 | 3 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 517000 | MG | D | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||
| 127720301 | 12772030 | 4 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 517000 | MG | D | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | ||||
| 127720301 | 12772030 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5170 | MG | 0 | 5 | MG | FORMULATION UNKNOWN | BID | |||||
| 127720301 | 12772030 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5170 | MG | D | 0 | 5 | MG | FORMULATION UNKNOWN | QD | ||||
| 127720301 | 12772030 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 5170 | MG | D | 0 | 5 | MG | FORMULATION UNKNOWN | BID | ||||
| 127720301 | 12772030 | 8 | C | LISINOPRIL. | LISINOPRIL | 1 | Unknown | D | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD | |||||
| 127720301 | 12772030 | 9 | C | SIMVASTATIN. | SIMVASTATIN | 1 | Unknown | D | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | |||||
| 127720301 | 12772030 | 10 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | D | U | 0 | 81 | MG | FORMULATION UNKNOWN | QD | |||||
| 127720301 | 12772030 | 11 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | D | U | 0 | 800 | MG | FORMULATION UNKNOWN | QD | |||||
| 127720301 | 12772030 | 12 | C | NIFEDIPINE. | NIFEDIPINE | 1 | Unknown | D | U | 0 | 60 | MG | FORMULATION UNKNOWN | BID | |||||
| 127720301 | 12772030 | 13 | C | TRIAMTERENE AND HYDROCHLOROTHIAZIDE | HYDROCHLOROTHIAZIDETRIAMTERENE | 1 | Unknown | 37.5 MG/ 25 MG ONCE DAILY | D | U | 0 | FORMULATION UNKNOWN | QD | ||||||
| 127720301 | 12772030 | 14 | C | CYMBALTA | DULOXETINE HYDROCHLORIDE | 1 | Unknown | D | U | 0 | 30 | MG | FORMULATION UNKNOWN | QD | |||||
| 127720301 | 12772030 | 15 | C | ALEVE | NAPROXEN SODIUM | 1 | Unknown | D | U | 0 | 200 | MG | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127720301 | 12772030 | 1 | Hormone-refractory prostate cancer |
| 127720301 | 12772030 | 3 | Hormone-refractory prostate cancer |
| 127720301 | 12772030 | 5 | Hormone-refractory prostate cancer |
| 127720301 | 12772030 | 8 | Product used for unknown indication |
| 127720301 | 12772030 | 9 | Product used for unknown indication |
| 127720301 | 12772030 | 10 | Product used for unknown indication |
| 127720301 | 12772030 | 11 | Product used for unknown indication |
| 127720301 | 12772030 | 12 | Product used for unknown indication |
| 127720301 | 12772030 | 13 | Product used for unknown indication |
| 127720301 | 12772030 | 14 | Product used for unknown indication |
| 127720301 | 12772030 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127720301 | 12772030 | HO |
| 127720301 | 12772030 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127720301 | 12772030 | Acute kidney injury | |
| 127720301 | 12772030 | Hypokalaemia | |
| 127720301 | 12772030 | Nausea | |
| 127720301 | 12772030 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127720301 | 12772030 | 1 | 20140903 | 20160202 | 0 | |
| 127720301 | 12772030 | 2 | 20160206 | 20160226 | 0 | |
| 127720301 | 12772030 | 3 | 20140903 | 20160201 | 0 | |
| 127720301 | 12772030 | 4 | 20160206 | 20160225 | 0 | |
| 127720301 | 12772030 | 5 | 20140903 | 20160201 | 0 | |
| 127720301 | 12772030 | 6 | 20160204 | 20160205 | 0 | |
| 127720301 | 12772030 | 7 | 20160206 | 20160226 | 0 | |
| 127720301 | 12772030 | 8 | 20130708 | 0 | ||
| 127720301 | 12772030 | 9 | 20121018 | 0 | ||
| 127720301 | 12772030 | 10 | 2010 | 0 | ||
| 127720301 | 12772030 | 11 | 2010 | 0 | ||
| 127720301 | 12772030 | 13 | 20120928 | 0 | ||
| 127720301 | 12772030 | 14 | 20070124 | 0 | ||
| 127720301 | 12772030 | 15 | 20150625 | 0 |