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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125026695 | 12502669 | 5 | F | 201604 | 20160805 | 20160628 | 20160811 | EXP | FR-AMGEN-FRASP2016081337 | AMGEN | 74.00 | YR | E | F | Y | 65.00000 | KG | 20160811 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125026695 | 12502669 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | UNK | U | 125320 | SOLUTION FOR INJECTION | ||||||||
| 125026695 | 12502669 | 2 | SS | PROLIA | DENOSUMAB | 1 | U | 125320 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125026695 | 12502669 | 1 | Osteoporosis postmenopausal |
| 125026695 | 12502669 | 2 | Osteoporotic fracture |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125026695 | 12502669 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125026695 | 12502669 | Cholestasis | |
| 125026695 | 12502669 | Hepatocellular injury | |
| 125026695 | 12502669 | Musculoskeletal pain | |
| 125026695 | 12502669 | Nausea | |
| 125026695 | 12502669 | Oedema | |
| 125026695 | 12502669 | Pain | |
| 125026695 | 12502669 | Rash | |
| 125026695 | 12502669 | Renal cyst | |
| 125026695 | 12502669 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125026695 | 12502669 | 1 | 20160405 | 0 |