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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127477751 | 12747775 | 1 | I | 20160206 | 20160915 | 20160915 | PER | US-ASTELLAS-2016US004634 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127477751 | 12747775 | 1 | PS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG (4 X 40 MG), ONCE DAILY | U | 203415 | 160 | MG | CAPSULE | QD | |||||
| 127477751 | 12747775 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Unknown | 203415 | 160 | MG | CAPSULE | QD | |||||||
| 127477751 | 12747775 | 3 | SS | TOVIAZ | FESOTERODINE FUMARATE | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 127477751 | 12747775 | 4 | SS | TOVIAZ | FESOTERODINE FUMARATE | 1 | Unknown | 0 | 8 | MG | FORMULATION UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127477751 | 12747775 | 1 | Prostate cancer |
| 127477751 | 12747775 | 2 | Prostatic specific antigen increased |
| 127477751 | 12747775 | 3 | Pollakiuria |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127477751 | 12747775 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127477751 | 12747775 | Appetite disorder | |
| 127477751 | 12747775 | Dysphonia | |
| 127477751 | 12747775 | Fatigue | |
| 127477751 | 12747775 | Insomnia | |
| 127477751 | 12747775 | Oropharyngeal pain | |
| 127477751 | 12747775 | Pain | |
| 127477751 | 12747775 | Restless legs syndrome |
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 |
|---|---|---|---|---|---|---|
| 127477751 | 12747775 | 1 | 20160116 | 20160307 | 0 | |
| 127477751 | 12747775 | 2 | 201603 | 0 |