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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106345614 | 10634561 | 4 | F | 20150511 | 20160818 | 20141205 | 20160915 | PER | US-ASTELLAS-2014US012423 | ASTELLAS | 88.53 | YR | M | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 106345614 | 10634561 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, PER DAY | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 106345614 | 10634561 | 2 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, EVERY 3 MONTHS | U | 0 | INJECTION | ||||||||
| 106345614 | 10634561 | 3 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | Y | 0 | 2 | DF | FORMULATION UNKNOWN | QD | ||||||
| 106345614 | 10634561 | 4 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 5 | C | AVAPRO | IRBESARTAN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 6 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 7 | C | ANTIVERT | MECLIZINE HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 8 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 9 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 10 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 11 | C | IRON | IRON | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 12 | C | CALCIUM | CALCIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 13 | C | MAGNESIUM | MAGNESIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 14 | C | VITAMIN E /00110501/ | TOCOPHEROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 15 | C | GLUCOSAMINE | GLUCOSAMINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 106345614 | 10634561 | 16 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 106345614 | 10634561 | 1 | Prostate cancer |
| 106345614 | 10634561 | 2 | Product used for unknown indication |
| 106345614 | 10634561 | 3 | Product used for unknown indication |
| 106345614 | 10634561 | 4 | Product used for unknown indication |
| 106345614 | 10634561 | 5 | Product used for unknown indication |
| 106345614 | 10634561 | 6 | Product used for unknown indication |
| 106345614 | 10634561 | 7 | Product used for unknown indication |
| 106345614 | 10634561 | 8 | Product used for unknown indication |
| 106345614 | 10634561 | 9 | Product used for unknown indication |
| 106345614 | 10634561 | 10 | Product used for unknown indication |
| 106345614 | 10634561 | 11 | Product used for unknown indication |
| 106345614 | 10634561 | 12 | Product used for unknown indication |
| 106345614 | 10634561 | 13 | Product used for unknown indication |
| 106345614 | 10634561 | 14 | Product used for unknown indication |
| 106345614 | 10634561 | 15 | Product used for unknown indication |
| 106345614 | 10634561 | 16 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 106345614 | 10634561 | Balance disorder | |
| 106345614 | 10634561 | Decreased appetite | |
| 106345614 | 10634561 | Dizziness | |
| 106345614 | 10634561 | Faeces discoloured | |
| 106345614 | 10634561 | Fall | |
| 106345614 | 10634561 | Head injury | |
| 106345614 | 10634561 | Hypersensitivity | |
| 106345614 | 10634561 | Memory impairment | |
| 106345614 | 10634561 | Nasal pruritus | |
| 106345614 | 10634561 | Nausea | |
| 106345614 | 10634561 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 106345614 | 10634561 | 1 | 20140816 | 0 |