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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294492 | 12529449 | 2 | F | 2016 | 20160715 | 20160706 | 20160722 | EXP | US-AMGEN-USASP2016083267 | AMGEN | 59.00 | YR | A | F | Y | 0.00000 | 20160722 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125294492 | 12529449 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q6MO | 125320 | 60 | MG | SOLUTION FOR INJECTION | |||||||
| 125294492 | 12529449 | 2 | C | SIMVASTATIN. | SIMVASTATIN | 1 | 5 MG, UNK | 0 | 5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125294492 | 12529449 | 1 | Osteoporosis postmenopausal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125294492 | 12529449 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125294492 | 12529449 | Cystitis haemorrhagic | |
| 125294492 | 12529449 | Hypercholesterolaemia | |
| 125294492 | 12529449 | Systemic infection | |
| 125294492 | 12529449 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 125294492 | 12529449 | 1 | 20160208 | 20160208 | 0 |