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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122683973 | 12268397 | 3 | F | 20150820 | 20160802 | 20160414 | 20160808 | EXP | US-JNJFOC-20160406420 | JANSSEN | 76.00 | YR | E | M | Y | 79.00000 | KG | 20160808 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122683973 | 12268397 | 1 | PS | ZYTIGA | ABIRATERONE ACETATE | 1 | Oral | U | U | 202379 | 1000 | MG | TABLET | QD | |||||
| 122683973 | 12268397 | 2 | SS | NAPROSYN | NAPROXEN | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 122683973 | 12268397 | 3 | SS | ASPIRIN. | ASPIRIN | 1 | Unknown | U | 0 | UNSPECIFIED | |||||||||
| 122683973 | 12268397 | 4 | SS | ENZALUTAMIDE | ENZALUTAMIDE | 1 | Oral | 0 | 160 | MG | CAPSULE | QD | |||||||
| 122683973 | 12268397 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | 5 | MG | UNSPECIFIED | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122683973 | 12268397 | 1 | Prostate cancer metastatic |
| 122683973 | 12268397 | 2 | Product used for unknown indication |
| 122683973 | 12268397 | 3 | Product used for unknown indication |
| 122683973 | 12268397 | 4 | Prostate cancer metastatic |
| 122683973 | 12268397 | 5 | Prostate cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122683973 | 12268397 | OT |
| 122683973 | 12268397 | HO |
| 122683973 | 12268397 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122683973 | 12268397 | Anaemia | |
| 122683973 | 12268397 | Encephalopathy | |
| 122683973 | 12268397 | Gastric haemorrhage | |
| 122683973 | 12268397 | Haematuria | |
| 122683973 | 12268397 | Hydronephrosis | |
| 122683973 | 12268397 | Klebsiella bacteraemia | |
| 122683973 | 12268397 | Muscular weakness | |
| 122683973 | 12268397 | Nephrolithiasis | |
| 122683973 | 12268397 | Urinary tract infection | |
| 122683973 | 12268397 | Urinary tract obstruction |
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 |
|---|---|---|---|---|---|---|
| 122683973 | 12268397 | 1 | 20150513 | 20160112 | 0 | |
| 122683973 | 12268397 | 4 | 20150513 | 20160113 | 0 | |
| 122683973 | 12268397 | 5 | 20150513 | 20160128 | 0 |