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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125709421 | 12570942 | 1 | I | 20160711 | 20160719 | 20160719 | EXP | US-AMGEN-USASP2016089890 | AMGEN | 59.00 | YR | A | F | Y | 0.00000 | 20160719 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125709421 | 12570942 | 1 | PS | PROLIA | DENOSUMAB | 1 | Unknown | UNK | U | 125320 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125709421 | 12570942 | 1 | Osteoporosis postmenopausal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125709421 | 12570942 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125709421 | 12570942 | Alopecia | |
| 125709421 | 12570942 | Arthralgia | |
| 125709421 | 12570942 | Back pain | |
| 125709421 | 12570942 | Bone pain | |
| 125709421 | 12570942 | General physical health deterioration | |
| 125709421 | 12570942 | Local swelling | |
| 125709421 | 12570942 | Nail disorder | |
| 125709421 | 12570942 | Pruritus | |
| 125709421 | 12570942 | Stomatitis | |
| 125709421 | 12570942 | Swelling | |
| 125709421 | 12570942 | Swelling face | |
| 125709421 | 12570942 | Tearfulness | |
| 125709421 | 12570942 | White blood cell count abnormal |
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 |
|---|---|---|---|---|---|---|
| 125709421 | 12570942 | 1 | 20160305 | 0 |