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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111817032 | 11181703 | 2 | F | 20150311 | 20160302 | 20150611 | 20160915 | PER | US-ASTELLAS-2015US008789 | ASTELLAS | 66.48 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111817032 | 11181703 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Unknown | 203415 | 160 | MG | CAPSULE | QD | |||||||
| 111817032 | 11181703 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | 203415 | CAPSULE | |||||||||||
| 111817032 | 11181703 | 3 | SS | XGEVA | DENOSUMAB | 1 | Unknown | UNK, MONTHLY | U | 0 | FORMULATION UNKNOWN | /month | |||||||
| 111817032 | 11181703 | 4 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK, OTHER (ONCE IN 6 MONTHS) | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111817032 | 11181703 | 1 | Prostate cancer metastatic |
| 111817032 | 11181703 | 2 | Hormone-refractory prostate cancer |
| 111817032 | 11181703 | 3 | Product used for unknown indication |
| 111817032 | 11181703 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111817032 | 11181703 | Fatigue | |
| 111817032 | 11181703 | Nasopharyngitis | |
| 111817032 | 11181703 | Prostatic specific antigen abnormal | |
| 111817032 | 11181703 | Seasonal allergy |
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 |
|---|---|---|---|---|---|---|
| 111817032 | 11181703 | 1 | 20141230 | 0 |