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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121787195 | 12178719 | 5 | F | 201602 | 20160810 | 20160315 | 20160817 | EXP | US-ASTELLAS-2015US040615 | ASTELLAS | 85.18 | YR | M | Y | 0.00000 | 20160817 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121787195 | 12178719 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | U | 1507024PCC, 1516825C, 1526650PC | 203415 | 160 | MG | CAPSULE | QD | |||||
| 121787195 | 12178719 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | 203415 | CAPSULE | |||||||||||
| 121787195 | 12178719 | 3 | SS | COUMADIN | WARFARIN SODIUM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121787195 | 12178719 | 1 | Neoplasm malignant |
| 121787195 | 12178719 | 2 | Prostate cancer |
| 121787195 | 12178719 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121787195 | 12178719 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121787195 | 12178719 | Arthralgia | |
| 121787195 | 12178719 | Arthritis | |
| 121787195 | 12178719 | Back pain | |
| 121787195 | 12178719 | Coordination abnormal | |
| 121787195 | 12178719 | Dry eye | |
| 121787195 | 12178719 | Eye disorder | |
| 121787195 | 12178719 | Fall | |
| 121787195 | 12178719 | Fatigue | |
| 121787195 | 12178719 | Heart rate irregular | |
| 121787195 | 12178719 | Hip deformity | |
| 121787195 | 12178719 | International normalised ratio decreased | |
| 121787195 | 12178719 | International normalised ratio fluctuation | |
| 121787195 | 12178719 | Micturition urgency | |
| 121787195 | 12178719 | Poor quality sleep | |
| 121787195 | 12178719 | 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 |
|---|---|---|---|---|---|---|
| 121787195 | 12178719 | 1 | 20151022 | 0 |