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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127171771 | 12717177 | 1 | I | 20160113 | 20160503 | 20160906 | 20160906 | EXP | US-ASTELLAS-2016US017646 | ASTELLAS | 72.00 | YR | M | Y | 103.00000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127171771 | 12717177 | 1 | PS | Enzalutamide | ENZALUTAMIDE | 1 | Oral | 12480 | MG | Y | 43626-5 | 203415 | 160 | MG | FORMULATION UNKNOWN | QD | |||
| 127171771 | 12717177 | 2 | SS | LEUPROLIDE ACETATE. | LEUPROLIDE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | 0 | FORMULATION UNKNOWN | |||||||||
| 127171771 | 12717177 | 3 | C | FLOMAX | TAMSULOSIN HYDROCHLORIDE | 1 | Oral | 0.4 MG, ONCE DAILY | U | 0 | .4 | MG | FORMULATION UNKNOWN | QD | |||||
| 127171771 | 12717177 | 4 | C | LOSARTAN. | LOSARTAN | 1 | Oral | U | 0 | 50 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127171771 | 12717177 | 5 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Oral | U | 0 | 500 | MG | FORMULATION UNKNOWN | BID | ||||||
| 127171771 | 12717177 | 6 | C | DENOSUMAB | DENOSUMAB | 1 | Subcutaneous | U | 0 | 120 | MG | FORMULATION UNKNOWN | |||||||
| 127171771 | 12717177 | 7 | C | LUPRON | LEUPROLIDE ACETATE | 1 | Intramuscular | 22.5 MG, EVERY 3 MONTHS | U | 0 | 22.5 | MG | INJECTION | ||||||
| 127171771 | 12717177 | 8 | C | ASPIRIN. | ASPIRIN | 1 | Oral | U | 0 | 81 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127171771 | 12717177 | 9 | C | NTG | NITROGLYCERIN | 1 | Sublingual | 0.4 MG, AS NEEDED | U | 0 | .4 | MG | FORMULATION UNKNOWN | ||||||
| 127171771 | 12717177 | 10 | C | WELLBUTRIN | BUPROPION HYDROCHLORIDE | 1 | Oral | U | 0 | 300 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127171771 | 12717177 | 11 | C | NAPROXEN. | NAPROXEN | 1 | Oral | 220 MG, 1-2 TIMES/WEEK,AS NEEDED | U | 0 | 220 | MG | FORMULATION UNKNOWN | ||||||
| 127171771 | 12717177 | 12 | C | METOPROLOL. | METOPROLOL | 1 | Oral | U | 0 | 50 | MG | FORMULATION UNKNOWN | QD | ||||||
| 127171771 | 12717177 | 13 | C | CARAFATE | SUCRALFATE | 1 | Oral | 480 | G | U | 0 | 1 | G | FORMULATION UNKNOWN | QID | ||||
| 127171771 | 12717177 | 14 | C | ESOMEPRAZOLE | ESOMEPRAZOLE | 1 | Oral | 1240 | MG | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127171771 | 12717177 | 1 | Prostate cancer metastatic |
| 127171771 | 12717177 | 2 | Hormone therapy |
| 127171771 | 12717177 | 3 | Product used for unknown indication |
| 127171771 | 12717177 | 4 | Product used for unknown indication |
| 127171771 | 12717177 | 5 | Product used for unknown indication |
| 127171771 | 12717177 | 6 | Product used for unknown indication |
| 127171771 | 12717177 | 7 | Product used for unknown indication |
| 127171771 | 12717177 | 8 | Product used for unknown indication |
| 127171771 | 12717177 | 9 | Product used for unknown indication |
| 127171771 | 12717177 | 10 | Product used for unknown indication |
| 127171771 | 12717177 | 11 | Product used for unknown indication |
| 127171771 | 12717177 | 12 | Product used for unknown indication |
| 127171771 | 12717177 | 13 | Product used for unknown indication |
| 127171771 | 12717177 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127171771 | 12717177 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127171771 | 12717177 | Angina pectoris |
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 |
|---|---|---|---|---|---|---|
| 127171771 | 12717177 | 1 | 20151028 | 20160113 | 0 | |
| 127171771 | 12717177 | 2 | 20141020 | 0 | ||
| 127171771 | 12717177 | 3 | 20150814 | 0 | ||
| 127171771 | 12717177 | 4 | 201501 | 0 | ||
| 127171771 | 12717177 | 5 | 201501 | 0 | ||
| 127171771 | 12717177 | 6 | 20141212 | 0 | ||
| 127171771 | 12717177 | 7 | 20141121 | 0 | ||
| 127171771 | 12717177 | 8 | 20151203 | 0 | ||
| 127171771 | 12717177 | 9 | 20151201 | 0 | ||
| 127171771 | 12717177 | 10 | 20150917 | 0 | ||
| 127171771 | 12717177 | 11 | 20140424 | 0 | ||
| 127171771 | 12717177 | 12 | 20151201 | 0 | ||
| 127171771 | 12717177 | 13 | 20150818 | 20151215 | 0 | |
| 127171771 | 12717177 | 14 | 20151113 | 20151213 | 0 |