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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483771 | 12548377 | 1 | I | 201604 | 20160705 | 20160712 | 20160712 | EXP | US-AMGEN-USASL2016087631 | AMGEN | 67.00 | YR | E | F | Y | 0.00000 | 20160712 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125483771 | 12548377 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | 125320 | SOLUTION FOR INJECTION | |||||||||
| 125483771 | 12548377 | 2 | C | VITAMIN D | CHOLECALCIFEROL | 1 | 50000 UNIT, QMO | 0 | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125483771 | 12548377 | 1 | Osteopenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125483771 | 12548377 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125483771 | 12548377 | Back pain | |
| 125483771 | 12548377 | Bone prosthesis insertion | |
| 125483771 | 12548377 | Eczema | |
| 125483771 | 12548377 | Muscular weakness | |
| 125483771 | 12548377 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125483771 | 12548377 | 1 | 20160423 | 0 |