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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124127943 | 12412794 | 3 | F | 20160705 | 20160527 | 20160708 | EXP | US-PFIZER INC-2016244581 | PFIZER | 70.00 | YR | M | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124127943 | 12412794 | 1 | PS | TOVIAZ | FESOTERODINE FUMARATE | 1 | 8 MG, 1X/DAY | 22030 | 8 | MG | MODIFIED-RELEASE TABLET | QD | |||||||
| 124127943 | 12412794 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG (4X40MG), 1X/DAY AT NIGHT | 0 | 160 | MG | CAPSULE | QD | ||||||
| 124127943 | 12412794 | 3 | SS | XTANDI | ENZALUTAMIDE | 1 | 160 MG, 1X/DAY (AT NIGHT) | 0 | 160 | MG | CAPSULE | QD | |||||||
| 124127943 | 12412794 | 4 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | 160 MG, 1X/DAY | 0 | 160 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124127943 | 12412794 | 1 | Pollakiuria |
| 124127943 | 12412794 | 2 | Prostate cancer |
| 124127943 | 12412794 | 3 | Prostatic specific antigen increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124127943 | 12412794 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124127943 | 12412794 | Decreased appetite | |
| 124127943 | 12412794 | Dysphonia | |
| 124127943 | 12412794 | Fatigue | |
| 124127943 | 12412794 | Insomnia | |
| 124127943 | 12412794 | Oropharyngeal pain | |
| 124127943 | 12412794 | Pain | |
| 124127943 | 12412794 | 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 |
|---|---|---|---|---|---|---|
| 124127943 | 12412794 | 2 | 20160116 | 20160307 | 0 | |
| 124127943 | 12412794 | 3 | 201603 | 0 | ||
| 124127943 | 12412794 | 4 | 20160116 | 20160307 | 0 |