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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126586541 | 12658654 | 1 | I | 20160809 | 20160817 | 20160817 | EXP | CA-AMGEN-CANSP2016104016 | AMGEN | 86.00 | YR | E | F | Y | 72.00000 | KG | 20160817 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126586541 | 12658654 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 1 ML, Q12H | U | 125320 | 1 | ML | SOLUTION FOR INJECTION | BID | |||||
| 126586541 | 12658654 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126586541 | 12658654 | 1 | Osteoporosis |
| 126586541 | 12658654 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126586541 | 12658654 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126586541 | 12658654 | Arthritis | |
| 126586541 | 12658654 | Femur fracture | |
| 126586541 | 12658654 | Joint stiffness | |
| 126586541 | 12658654 | Multiple fractures | |
| 126586541 | 12658654 | Rotator cuff syndrome |
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 |
|---|---|---|---|---|---|---|
| 126586541 | 12658654 | 1 | 2015 | 0 | ||
| 126586541 | 12658654 | 2 | 2012 | 0 |