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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127489981 | 12748998 | 1 | I | 20160322 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US010852 | ASTELLAS | 0.00 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
127489981 | 12748998 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 00469-0125-99 | 203415 | 160 | MG | CAPSULE | QD | |||||
127489981 | 12748998 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 203415 | 160 | MG | CAPSULE | QD | ||||||
127489981 | 12748998 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 203415 | 120 | MG | CAPSULE | QD | |||||||
127489981 | 12748998 | 4 | SS | LUPRON | LEUPROLIDE ACETATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | INJECTION | ||||||||
127489981 | 12748998 | 5 | C | AMLODIPINE BESYLATE. | AMLODIPINE BESYLATE | 1 | Unknown | U | 0 | 60 | MG | FORMULATION UNKNOWN | |||||||
127489981 | 12748998 | 6 | C | CARVEDILOL. | CARVEDILOL | 1 | Unknown | U | 0 | 3.2 | MG | FORMULATION UNKNOWN | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
127489981 | 12748998 | 1 | Prostate cancer |
127489981 | 12748998 | 4 | Product used for unknown indication |
127489981 | 12748998 | 5 | Hypertension |
127489981 | 12748998 | 6 | Hypertension |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
127489981 | 12748998 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
127489981 | 12748998 | Blood pressure increased | |
127489981 | 12748998 | Blood pressure systolic increased | |
127489981 | 12748998 | Decreased appetite | |
127489981 | 12748998 | Fatigue | |
127489981 | 12748998 | Hot flush | |
127489981 | 12748998 | Oedema peripheral |
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 |
---|---|---|---|---|---|---|
127489981 | 12748998 | 1 | 20160302 | 0 | ||
127489981 | 12748998 | 2 | 20160314 | 0 | ||
127489981 | 12748998 | 4 | 20151104 | 0 |