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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125796203 | 12579620 | 3 | F | 20130712 | 20160727 | 20160721 | 20160805 | EXP | GR-AMGEN-GRCSP2016000554 | AMGEN | 55.00 | YR | A | F | Y | 0.00000 | 20160805 | CN | GR | GR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125796203 | 12579620 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 125320 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125796203 | 12579620 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125796203 | 12579620 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125796203 | 12579620 | Arthralgia | |
| 125796203 | 12579620 | Dental caries | |
| 125796203 | 12579620 | Device failure | |
| 125796203 | 12579620 | Drug dose omission | |
| 125796203 | 12579620 | Erythema | |
| 125796203 | 12579620 | Gingival bleeding | |
| 125796203 | 12579620 | Myalgia | |
| 125796203 | 12579620 | Osteonecrosis of jaw | |
| 125796203 | 12579620 | Pain | |
| 125796203 | 12579620 | Peau d'orange | |
| 125796203 | 12579620 | Rash | |
| 125796203 | 12579620 | Skin disorder | |
| 125796203 | 12579620 | Skin ulcer haemorrhage |
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 |
|---|---|---|---|---|---|---|
| 125796203 | 12579620 | 1 | 2013 | 0 |