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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123844502 | 12384450 | 2 | F | 2016 | 20160520 | 20160519 | 20160819 | PER | US-JNJFOC-20160500769 | JANSSEN | 91.17 | YR | E | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123844502 | 12384450 | 1 | PS | ZYTIGA | ABIRATERONE ACETATE | 1 | Oral | REGIMEN #1 | U | U | 202379 | TABLET | |||||||
| 123844502 | 12384450 | 2 | SS | XTANDI | ENZALUTAMIDE | 1 | Oral | REGIMEN #1 | U | 0 | 160 | MG | CAPSULE | QD | |||||
| 123844502 | 12384450 | 3 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | REGIMEN #1 | U | 0 | 5 | MG | UNSPECIFIED | BID | |||||
| 123844502 | 12384450 | 4 | C | PLAVIX | CLOPIDOGREL BISULFATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 123844502 | 12384450 | 5 | C | MIRALAX | POLYETHYLENE GLYCOL 3350 | 1 | Unknown | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123844502 | 12384450 | 1 | Product used for unknown indication |
| 123844502 | 12384450 | 2 | Hormone-refractory prostate cancer |
| 123844502 | 12384450 | 3 | Product used for unknown indication |
| 123844502 | 12384450 | 5 | Constipation |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123844502 | 12384450 | Blood bilirubin abnormal | |
| 123844502 | 12384450 | Blood glucose abnormal | |
| 123844502 | 12384450 | Confusional state | |
| 123844502 | 12384450 | Constipation | |
| 123844502 | 12384450 | Diarrhoea | |
| 123844502 | 12384450 | Fatigue | |
| 123844502 | 12384450 | Feeling abnormal | |
| 123844502 | 12384450 | Head discomfort | |
| 123844502 | 12384450 | Prostatic specific antigen increased | |
| 123844502 | 12384450 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 123844502 | 12384450 | 1 | 20160211 | 0 | ||
| 123844502 | 12384450 | 2 | 20160211 | 20160406 | 0 | |
| 123844502 | 12384450 | 3 | 20160211 | 0 |