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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111822813 | 11182281 | 3 | F | 20150317 | 20160825 | 20150611 | 20160915 | PER | US-ASTELLAS-2015US009225 | ASTELLAS | 81.78 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111822813 | 11182281 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1507029PC/1521457PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 111822813 | 11182281 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 80 MG, ONCE DAILY (ONE DAY) | U | 203415 | 80 | MG | CAPSULE | QD | |||||
| 111822813 | 11182281 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 120 | MG | CAPSULE | QD | ||||||
| 111822813 | 11182281 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 203415 | 160 | MG | CAPSULE | QD | |||||||
| 111822813 | 11182281 | 5 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111822813 | 11182281 | 1 | Prostate cancer |
| 111822813 | 11182281 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111822813 | 11182281 | Back pain | |
| 111822813 | 11182281 | Blood pressure fluctuation | |
| 111822813 | 11182281 | Blood pressure increased | |
| 111822813 | 11182281 | Diarrhoea | |
| 111822813 | 11182281 | Fatigue | |
| 111822813 | 11182281 | Gynaecomastia | |
| 111822813 | 11182281 | Lacrimation increased | |
| 111822813 | 11182281 | Nail growth abnormal | |
| 111822813 | 11182281 | Nasal congestion | |
| 111822813 | 11182281 | Pain in extremity | |
| 111822813 | 11182281 | Productive cough | |
| 111822813 | 11182281 | Prostatic specific antigen increased | |
| 111822813 | 11182281 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 111822813 | 11182281 | 1 | 20150223 | 0 | ||
| 111822813 | 11182281 | 4 | 20160510 | 0 |