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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123509782 | 12350978 | 2 | F | 20160129 | 20160926 | 20160510 | 20160930 | EXP | US-ASTELLAS-2016US017569 | ASTELLAS | 81.49 | YR | M | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123509782 | 12350978 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 43626-8 | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | ||||||
| 123509782 | 12350978 | 2 | SS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | 0 | 1000 | MG | FORMULATION UNKNOWN | QD | |||||||
| 123509782 | 12350978 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 0 | 5 | MG | FORMULATION UNKNOWN | BID | |||||||
| 123509782 | 12350978 | 4 | SS | METOPROLOL. | METOPROLOL | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 123509782 | 12350978 | 5 | SS | NORVASC | AMLODIPINE BESYLATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 123509782 | 12350978 | 6 | C | XGEVA | DENOSUMAB | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 123509782 | 12350978 | 7 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 123509782 | 12350978 | 8 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 123509782 | 12350978 | 9 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | D | U | 0 | FORMULATION UNKNOWN | |||||||
| 123509782 | 12350978 | 10 | C | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, EVERY 3 MONTHS | D | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123509782 | 12350978 | 1 | Hormone-refractory prostate cancer |
| 123509782 | 12350978 | 2 | Hormone-refractory prostate cancer |
| 123509782 | 12350978 | 3 | Hormone-refractory prostate cancer |
| 123509782 | 12350978 | 4 | Product used for unknown indication |
| 123509782 | 12350978 | 5 | Product used for unknown indication |
| 123509782 | 12350978 | 6 | Product used for unknown indication |
| 123509782 | 12350978 | 7 | Product used for unknown indication |
| 123509782 | 12350978 | 8 | Product used for unknown indication |
| 123509782 | 12350978 | 9 | Product used for unknown indication |
| 123509782 | 12350978 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123509782 | 12350978 | OT |
| 123509782 | 12350978 | LT |
| 123509782 | 12350978 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123509782 | 12350978 | Confusional state | |
| 123509782 | 12350978 | Dizziness | |
| 123509782 | 12350978 | Dysarthria | |
| 123509782 | 12350978 | Fatigue | |
| 123509782 | 12350978 | Headache | |
| 123509782 | 12350978 | Hip fracture | |
| 123509782 | 12350978 | Hypertension | |
| 123509782 | 12350978 | Hypertensive encephalopathy | |
| 123509782 | 12350978 | Muscular weakness | |
| 123509782 | 12350978 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 123509782 | 12350978 | 1 | 20150601 | 0 | ||
| 123509782 | 12350978 | 2 | 20150601 | 0 | ||
| 123509782 | 12350978 | 3 | 20150601 | 0 |