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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127470621 | 12747062 | 1 | I | 20050928 | 20150928 | 20160915 | 20160915 | PER | US-ASTELLAS-2015US035832 | ASTELLAS | 71.69 | YR | M | Y | 0.00000 | 20160915 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127470621 | 12747062 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Unknown | Y | 1516824PC/1494229PCA | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127470621 | 12747062 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | Y | 1516824PC/1494229PCA | 203415 | 80 | MG | CAPSULE | QD | |||||
| 127470621 | 12747062 | 3 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Unknown | UNK, UNKNOWN FREQ. | Y | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127470621 | 12747062 | 1 | Prostate cancer |
| 127470621 | 12747062 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127470621 | 12747062 | Activities of daily living impaired | |
| 127470621 | 12747062 | Arthralgia | |
| 127470621 | 12747062 | Asthenia | |
| 127470621 | 12747062 | Depression | |
| 127470621 | 12747062 | Dizziness | |
| 127470621 | 12747062 | Fall | |
| 127470621 | 12747062 | Headache | |
| 127470621 | 12747062 | Hot flush | |
| 127470621 | 12747062 | Muscular weakness | |
| 127470621 | 12747062 | Myalgia | |
| 127470621 | 12747062 | Peripheral swelling | |
| 127470621 | 12747062 | Somnolence | |
| 127470621 | 12747062 | Thinking abnormal | |
| 127470621 | 12747062 | Tremor | |
| 127470621 | 12747062 | Underdose | |
| 127470621 | 12747062 | Yawning |
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 |
|---|---|---|---|---|---|---|
| 127470621 | 12747062 | 2 | 2015 | 0 | ||
| 127470621 | 12747062 | 3 | 201510 | 0 |