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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127489501 | 12748950 | 1 | I | 20160405 | 20160318 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US010441 | ASTELLAS | 92.01 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127489501 | 12748950 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG (40 MG X 4 CAPSULES), ONCE DAILY | U | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127489501 | 12748950 | 2 | SS | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | CAPSULE |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127489501 | 12748950 | 1 | Prostate cancer |
| 127489501 | 12748950 | 2 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127489501 | 12748950 | Asthenia | |
| 127489501 | 12748950 | Contusion | |
| 127489501 | 12748950 | Fall | |
| 127489501 | 12748950 | Fatigue | |
| 127489501 | 12748950 | Gastrooesophageal reflux disease | |
| 127489501 | 12748950 | Musculoskeletal stiffness | |
| 127489501 | 12748950 | 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 |
|---|---|---|---|---|---|---|
| 127489501 | 12748950 | 1 | 20160226 | 0 |