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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125451282 | 12545128 | 2 | F | 2016 | 20160810 | 20160711 | 20160818 | EXP | US-AMGEN-USASP2016087674 | AMGEN | 62.00 | YR | A | F | Y | 73.92000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125451282 | 12545128 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q6MO | U | 125320 | 60 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125451282 | 12545128 | 1 | Osteoporosis postmenopausal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125451282 | 12545128 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125451282 | 12545128 | Abasia | |
| 125451282 | 12545128 | Arthralgia | |
| 125451282 | 12545128 | Back pain | |
| 125451282 | 12545128 | Influenza like illness | |
| 125451282 | 12545128 | Mobility decreased | |
| 125451282 | 12545128 | Musculoskeletal discomfort | |
| 125451282 | 12545128 | Nausea | |
| 125451282 | 12545128 | Pain | |
| 125451282 | 12545128 | Pain in extremity | |
| 125451282 | 12545128 | Sleep disorder | |
| 125451282 | 12545128 | Spinal pain |
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 |
|---|---|---|---|---|---|---|
| 125451282 | 12545128 | 1 | 20160415 | 0 |