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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127543061 | 12754306 | 1 | I | 201605 | 20151215 | 20160915 | 20160915 | PER | US-ASTELLAS-2015US047232 | ASTELLAS | 64.57 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127543061 | 12754306 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1516824PC/1516825PC/1526650PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127543061 | 12754306 | 2 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
| 127543061 | 12754306 | 3 | SS | HYDROCODONE | HYDROCODONE | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127543061 | 12754306 | 1 | Prostate cancer |
| 127543061 | 12754306 | 2 | Product used for unknown indication |
| 127543061 | 12754306 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127543061 | 12754306 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127543061 | 12754306 | Abdominal discomfort | |
| 127543061 | 12754306 | Arthralgia | |
| 127543061 | 12754306 | Contusion | |
| 127543061 | 12754306 | Decreased appetite | |
| 127543061 | 12754306 | Diarrhoea | |
| 127543061 | 12754306 | Dysgeusia | |
| 127543061 | 12754306 | Fatigue | |
| 127543061 | 12754306 | Flatulence | |
| 127543061 | 12754306 | Frequent bowel movements | |
| 127543061 | 12754306 | Hypoaesthesia | |
| 127543061 | 12754306 | Joint swelling | |
| 127543061 | 12754306 | Malignant neoplasm progression | |
| 127543061 | 12754306 | Musculoskeletal stiffness | |
| 127543061 | 12754306 | Oedema peripheral | |
| 127543061 | 12754306 | Pain | |
| 127543061 | 12754306 | Peripheral swelling | |
| 127543061 | 12754306 | Photopsia | |
| 127543061 | 12754306 | Pollakiuria | |
| 127543061 | 12754306 | Pruritus | |
| 127543061 | 12754306 | Vision blurred | |
| 127543061 | 12754306 | Visual impairment | |
| 127543061 | 12754306 | Weight decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |