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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125442482 | 12544248 | 2 | F | 201211 | 20160701 | 20160711 | 20160712 | EXP | NO-NOMAADVRE-RELISSO-2016-22274 | PHHY2016NO091477 | SANDOZ | 82.00 | YR | F | Y | 0.00000 | 20160712 | OT | NO | NO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125442482 | 12544248 | 1 | PS | ALENDRONIC ACID | ALENDRONIC ACID | 1 | Oral | 70 MG, QW | Y | 75871 | 70 | MG | /wk | ||||||
| 125442482 | 12544248 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous drip | 1 DF, 1 INFUSION PER YEAR | U | 0 | 1 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125442482 | 12544248 | 1 | Osteoporosis |
| 125442482 | 12544248 | 2 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125442482 | 12544248 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125442482 | 12544248 | Osteitis | |
| 125442482 | 12544248 | Osteonecrosis of jaw |
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 |
|---|---|---|---|---|---|---|
| 125442482 | 12544248 | 1 | 2008 | 0 | ||
| 125442482 | 12544248 | 2 | 2008 | 0 |