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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127513341 | 12751334 | 1 | I | 20160411 | 20160701 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US025947 | ASTELLAS | 86.83 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127513341 | 12751334 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 1543982PC | 203415 | 160 | MG | CAPSULE | QD | ||||||
| 127513341 | 12751334 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | 203415 | CAPSULE | |||||||||||
| 127513341 | 12751334 | 3 | SS | XARELTO | RIVAROXABAN | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127513341 | 12751334 | 4 | SS | WARFARIN | WARFARIN | 1 | Unknown | UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127513341 | 12751334 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127513341 | 12751334 | 6 | C | TOPROL XL | METOPROLOL SUCCINATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127513341 | 12751334 | 1 | Prostate cancer metastatic |
| 127513341 | 12751334 | 2 | Metastases to bone |
| 127513341 | 12751334 | 3 | Product used for unknown indication |
| 127513341 | 12751334 | 4 | Product used for unknown indication |
| 127513341 | 12751334 | 5 | Product used for unknown indication |
| 127513341 | 12751334 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127513341 | 12751334 | Arthralgia | |
| 127513341 | 12751334 | Asthenia | |
| 127513341 | 12751334 | Headache | |
| 127513341 | 12751334 | Incorrect product storage | |
| 127513341 | 12751334 | Musculoskeletal discomfort | |
| 127513341 | 12751334 | Musculoskeletal stiffness | |
| 127513341 | 12751334 | Pain |
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 |
|---|---|---|---|---|---|---|
| 127513341 | 12751334 | 1 | 20160225 | 0 |