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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115033952 | 11503395 | 2 | F | 2015 | 20160713 | 20150914 | 20160915 | PER | US-ASTELLAS-2015US024392 | ASTELLAS | 69.98 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115033952 | 11503395 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 31360 | MG | U | 1507023PC | 203415 | 160 | MG | CAPSULE | QD | |||
| 115033952 | 11503395 | 2 | SS | XGEVA | DENOSUMAB | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 3 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 4 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | U | 0 | 40 | MG | FORMULATION UNKNOWN | QD | ||||||
| 115033952 | 11503395 | 5 | C | ZETIA | EZETIMIBE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 6 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 7 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 8 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 9 | C | OMEGA 3 /01333901/ | FISH OILTOCOPHEROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 10 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 11 | C | PROTONIX | PANTOPRAZOLE SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115033952 | 11503395 | 12 | C | ATENOLOL. | ATENOLOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115033952 | 11503395 | 1 | Prostate cancer |
| 115033952 | 11503395 | 2 | Product used for unknown indication |
| 115033952 | 11503395 | 3 | Product used for unknown indication |
| 115033952 | 11503395 | 4 | Blood cholesterol increased |
| 115033952 | 11503395 | 5 | Product used for unknown indication |
| 115033952 | 11503395 | 6 | Product used for unknown indication |
| 115033952 | 11503395 | 7 | Product used for unknown indication |
| 115033952 | 11503395 | 8 | Product used for unknown indication |
| 115033952 | 11503395 | 9 | Product used for unknown indication |
| 115033952 | 11503395 | 10 | Product used for unknown indication |
| 115033952 | 11503395 | 11 | Product used for unknown indication |
| 115033952 | 11503395 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115033952 | 11503395 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115033952 | 11503395 | Adverse event | |
| 115033952 | 11503395 | Bone pain | |
| 115033952 | 11503395 | Bursitis | |
| 115033952 | 11503395 | Decreased appetite | |
| 115033952 | 11503395 | Fatigue | |
| 115033952 | 11503395 | Gait disturbance | |
| 115033952 | 11503395 | Hot flush | |
| 115033952 | 11503395 | Liver disorder | |
| 115033952 | 11503395 | Malignant neoplasm progression | |
| 115033952 | 11503395 | Middle insomnia | |
| 115033952 | 11503395 | Nasopharyngitis | |
| 115033952 | 11503395 | Nausea | |
| 115033952 | 11503395 | Norovirus test positive | |
| 115033952 | 11503395 | Prostatic specific antigen increased | |
| 115033952 | 11503395 | 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 |
|---|---|---|---|---|---|---|
| 115033952 | 11503395 | 1 | 20150122 | 20160620 | 0 |