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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124195003 | 12419500 | 3 | F | 2013 | 20160509 | 20160531 | 20160701 | EXP | CZ-JNJFOC-20160510069 | JANSSEN | 67.00 | YR | E | M | Y | 0.00000 | 20160701 | MD | CZ | CZ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124195003 | 12419500 | 1 | PS | ABIRATERONE ACETATE | ABIRATERONE ACETATE | 1 | Oral | Y | N | 202379 | 1000 | MG | TABLET | ||||||
| 124195003 | 12419500 | 2 | SS | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | U | 0 | 4 | MG | UNKNOWN | |||||||
| 124195003 | 12419500 | 3 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | Y | 0 | 75 | MG/M**2 | UNKNOWN | |||||||
| 124195003 | 12419500 | 4 | SS | DOCETAXEL. | DOCETAXEL | 1 | Unknown | Y | 0 | 75 | MG/M**2 | UNKNOWN | |||||||
| 124195003 | 12419500 | 5 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 5 | MG | UNSPECIFIED | ||||||||
| 124195003 | 12419500 | 6 | C | RAMIPRIL. | RAMIPRIL | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124195003 | 12419500 | 1 | Prostate cancer metastatic |
| 124195003 | 12419500 | 2 | Product used for unknown indication |
| 124195003 | 12419500 | 3 | Product used for unknown indication |
| 124195003 | 12419500 | 4 | Product used for unknown indication |
| 124195003 | 12419500 | 5 | Prostate cancer metastatic |
| 124195003 | 12419500 | 6 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124195003 | 12419500 | DE |
| 124195003 | 12419500 | HO |
| 124195003 | 12419500 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124195003 | 12419500 | Altered state of consciousness | |
| 124195003 | 12419500 | Bladder tamponade | |
| 124195003 | 12419500 | Bone pain | |
| 124195003 | 12419500 | Hepatorenal failure | |
| 124195003 | 12419500 | Hypertension | |
| 124195003 | 12419500 | Liver function test increased | |
| 124195003 | 12419500 | Malignant neoplasm progression |
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 |
|---|---|---|---|---|---|---|
| 124195003 | 12419500 | 1 | 201303 | 201406 | 0 | |
| 124195003 | 12419500 | 2 | 2014 | 0 | ||
| 124195003 | 12419500 | 3 | 201204 | 2012 | 0 | |
| 124195003 | 12419500 | 4 | 2014 | 0 | ||
| 124195003 | 12419500 | 5 | 2013 | 0 |