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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127519371 | 12751937 | 1 | I | 201511 | 20151130 | 20160915 | 20160915 | PER | US-ASTELLAS-2015US045200 | ASTELLAS | 75.70 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127519371 | 12751937 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Unknown | 160 MG (4 X 40 MG), ONCE DAILY | 1507024PCC,1516825PC,1521458PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127519371 | 12751937 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | 203415 | CAPSULE | |||||||||||
| 127519371 | 12751937 | 3 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | UNK UNK, EVERY 03 MONTHS | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127519371 | 12751937 | 1 | Hormone-refractory prostate cancer |
| 127519371 | 12751937 | 2 | Metastases to bone |
| 127519371 | 12751937 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127519371 | 12751937 | Asthenia | |
| 127519371 | 12751937 | Back pain | |
| 127519371 | 12751937 | Fatigue | |
| 127519371 | 12751937 | Headache | |
| 127519371 | 12751937 | Hot flush | |
| 127519371 | 12751937 | Malaise | |
| 127519371 | 12751937 | Neck pain |
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 |
|---|---|---|---|---|---|---|
| 127519371 | 12751937 | 1 | 20151031 | 0 | ||
| 127519371 | 12751937 | 3 | 20151020 | 0 |