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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111144303 | 11114430 | 3 | F | 201406 | 20160726 | 20150515 | 20160802 | EXP | DK-DKMA-EFO11980 | PHHY2015DK058062 | NOVARTIS | 64.15 | YR | F | Y | 60.00000 | KG | 20160802 | OT | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 111144303 | 11114430 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, (5MG/100ML), UNK | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 111144303 | 11114430 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | 21817 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 111144303 | 11114430 | 1 | Osteoporosis |
| 111144303 | 11114430 | 2 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 111144303 | 11114430 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 111144303 | 11114430 | Eye pain | |
| 111144303 | 11114430 | Ocular hyperaemia | |
| 111144303 | 11114430 | Osteonecrosis of jaw | |
| 111144303 | 11114430 | Pain | |
| 111144303 | 11114430 | Scleritis |
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 |
|---|---|---|---|---|---|---|
| 111144303 | 11114430 | 1 | 20140514 | 0 |