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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125019483 | 12501948 | 3 | F | 20160415 | 20160817 | 20160627 | 20160824 | EXP | US-BAYER-2016-076022 | BAYER | 85.00 | YR | E | M | Y | 0.00000 | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125019483 | 12501948 | 1 | PS | XOFIGO | RADIUM RA-223 DICHLORIDE | 1 | Intravenous (not otherwise specified) | 104 ?CI, ONCE | Y | ET10376A | 203971 | 104 | UCI | INJECTION | 1X | ||||
| 125019483 | 12501948 | 2 | SS | XOFIGO | RADIUM RA-223 DICHLORIDE | 1 | Y | 203971 | INJECTION | ||||||||||
| 125019483 | 12501948 | 3 | C | DURAGESIC | FENTANYL | 1 | 50 ?G, UNK | 0 | 50 | UG | |||||||||
| 125019483 | 12501948 | 4 | C | DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 125019483 | 12501948 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125019483 | 12501948 | 1 | Hormone-refractory prostate cancer |
| 125019483 | 12501948 | 2 | Metastases to bone |
| 125019483 | 12501948 | 3 | Pain |
| 125019483 | 12501948 | 4 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125019483 | 12501948 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125019483 | 12501948 | Contusion | |
| 125019483 | 12501948 | Laboratory test abnormal | |
| 125019483 | 12501948 | Lymphocyte count decreased | |
| 125019483 | 12501948 | Neutrophil count decreased | |
| 125019483 | 12501948 | Pollakiuria | |
| 125019483 | 12501948 | Red blood cell count decreased | |
| 125019483 | 12501948 | Skin fragility | |
| 125019483 | 12501948 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 125019483 | 12501948 | 1 | 20160325 | 20160325 | 0 |