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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115035836 | 11503583 | 6 | F | 201507 | 20160816 | 20150914 | 20160823 | EXP | US-ASTELLAS-2015US026523 | ASTELLAS | 74.80 | YR | M | Y | 0.00000 | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115035836 | 11503583 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1494229PCA/1526650PC/1539683PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 115035836 | 11503583 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1543982PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 115035836 | 11503583 | 3 | SS | XGEVA | DENOSUMAB | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 115035836 | 11503583 | 4 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115035836 | 11503583 | 1 | Prostate cancer |
| 115035836 | 11503583 | 2 | Plasma cell myeloma |
| 115035836 | 11503583 | 3 | Product used for unknown indication |
| 115035836 | 11503583 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115035836 | 11503583 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115035836 | 11503583 | Asthenia | |
| 115035836 | 11503583 | Blood urine present | |
| 115035836 | 11503583 | Constipation | |
| 115035836 | 11503583 | Decreased appetite | |
| 115035836 | 11503583 | Depression | |
| 115035836 | 11503583 | Eating disorder | |
| 115035836 | 11503583 | Fatigue | |
| 115035836 | 11503583 | Flatulence | |
| 115035836 | 11503583 | Hot flush | |
| 115035836 | 11503583 | Hyperhidrosis | |
| 115035836 | 11503583 | Malignant neoplasm progression | |
| 115035836 | 11503583 | Paraesthesia | |
| 115035836 | 11503583 | Rhinorrhoea | |
| 115035836 | 11503583 | Tongue disorder | |
| 115035836 | 11503583 | Urinary bladder haemorrhage | |
| 115035836 | 11503583 | 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 |
|---|---|---|---|---|---|---|
| 115035836 | 11503583 | 3 | 201606 | 0 |