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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115034332 | 11503433 | 2 | F | 201505 | 20151204 | 20150914 | 20160915 | PER | US-ASTELLAS-2015US024871 | ASTELLAS | 82.45 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115034332 | 11503433 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | Y | 1482441PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 115034332 | 11503433 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | 203415 | 2 | DF | CAPSULE | QD | |||||||
| 115034332 | 11503433 | 3 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | 10 | MG | FORMULATION UNKNOWN | QD | ||||||
| 115034332 | 11503433 | 4 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | U | 0 | 12.5 | MG | FORMULATION UNKNOWN | QD | ||||||
| 115034332 | 11503433 | 5 | C | NYSTATIN. | NYSTATIN | 1 | Unknown | 100000 U/GM, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 6 | C | GABAPENTIN. | GABAPENTIN | 1 | Unknown | U | 0 | 300 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 7 | C | ELIGARD | LEUPROLIDE ACETATE | 1 | Unknown | U | 0 | 30 | MG | INJECTION | |||||||
| 115034332 | 11503433 | 8 | C | LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 1 | Unknown | U | 0 | 10 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 9 | C | LOMOTIL | ATROPINE SULFATEDIPHENOXYLATE HYDROCHLORIDE | 1 | Unknown | U | 0 | 2.5 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 10 | C | MULTI VITAMINS + MINERALS | 2 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | |||||||||
| 115034332 | 11503433 | 11 | C | VITAMIN C | ASCORBIC ACID | 1 | Unknown | U | 0 | 250 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 12 | C | WARFARIN SODIUM. | WARFARIN SODIUM | 1 | Unknown | U | 0 | 5 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 13 | C | FISH OIL BURP LESS | 2 | Unknown | U | 0 | 1200 | MG | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 14 | C | AMIODARONE HCL | AMIODARONE HYDROCHLORIDE | 1 | Unknown | U | 0 | 200 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 15 | C | LEVOTHYROXINE SODIUM. | LEVOTHYROXINE SODIUM | 1 | Unknown | 0.75 MG, UNKNOWN FREQ. | U | 0 | .75 | MG | FORMULATION UNKNOWN | ||||||
| 115034332 | 11503433 | 16 | C | CALCIUM VITAMIN D | CALCIUMVITAMIN D | 1 | Unknown | 500-400 MG-UNIT, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 17 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | 0 | 500 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 18 | C | BIOFLEX /00808401/ | 2 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | |||||||||
| 115034332 | 11503433 | 19 | C | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Unknown | U | 0 | 10 | MG | FORMULATION UNKNOWN | |||||||
| 115034332 | 11503433 | 20 | C | AMOXICILLIN. | AMOXICILLIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 21 | C | FINASTERIDE. | FINASTERIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 22 | C | VIAGRA | SILDENAFIL CITRATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 23 | C | Tamsulosin | TAMSULOSIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 24 | C | PROSCAR | FINASTERIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 25 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 26 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 27 | C | SELENIUM | SELENIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 28 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 29 | C | SOTALOL HCL | SOTALOL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 30 | C | VITAMIN D /00107901/ | ERGOCALCIFEROL | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 31 | C | MULTAQ | DRONEDARONE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 32 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 115034332 | 11503433 | 33 | C | BYSTOLIC | NEBIVOLOL HYDROCHLORIDE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115034332 | 11503433 | 1 | Hormone-refractory prostate cancer |
| 115034332 | 11503433 | 3 | Product used for unknown indication |
| 115034332 | 11503433 | 5 | Product used for unknown indication |
| 115034332 | 11503433 | 6 | Product used for unknown indication |
| 115034332 | 11503433 | 7 | Product used for unknown indication |
| 115034332 | 11503433 | 8 | Product used for unknown indication |
| 115034332 | 11503433 | 9 | Product used for unknown indication |
| 115034332 | 11503433 | 10 | Product used for unknown indication |
| 115034332 | 11503433 | 11 | Product used for unknown indication |
| 115034332 | 11503433 | 12 | Product used for unknown indication |
| 115034332 | 11503433 | 13 | Product used for unknown indication |
| 115034332 | 11503433 | 14 | Product used for unknown indication |
| 115034332 | 11503433 | 15 | Product used for unknown indication |
| 115034332 | 11503433 | 16 | Product used for unknown indication |
| 115034332 | 11503433 | 17 | Product used for unknown indication |
| 115034332 | 11503433 | 18 | Product used for unknown indication |
| 115034332 | 11503433 | 19 | Product used for unknown indication |
| 115034332 | 11503433 | 20 | Product used for unknown indication |
| 115034332 | 11503433 | 21 | Product used for unknown indication |
| 115034332 | 11503433 | 22 | Product used for unknown indication |
| 115034332 | 11503433 | 23 | Product used for unknown indication |
| 115034332 | 11503433 | 24 | Product used for unknown indication |
| 115034332 | 11503433 | 25 | Product used for unknown indication |
| 115034332 | 11503433 | 26 | Product used for unknown indication |
| 115034332 | 11503433 | 27 | Product used for unknown indication |
| 115034332 | 11503433 | 28 | Product used for unknown indication |
| 115034332 | 11503433 | 29 | Product used for unknown indication |
| 115034332 | 11503433 | 30 | Product used for unknown indication |
| 115034332 | 11503433 | 31 | Product used for unknown indication |
| 115034332 | 11503433 | 32 | Product used for unknown indication |
| 115034332 | 11503433 | 33 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115034332 | 11503433 | Asthenia | |
| 115034332 | 11503433 | International normalised ratio abnormal | |
| 115034332 | 11503433 | Lethargy |
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 |
|---|---|---|---|---|---|---|
| 115034332 | 11503433 | 1 | 20150509 | 0 |