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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107593344 | 10759334 | 4 | F | 20140929 | 20160802 | 20150203 | 20160809 | EXP | DK-DKMA-EFO10834 | PHHY2015DK009715 | NOVARTIS | 53.00 | YR | F | Y | 59.00000 | KG | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107593344 | 10759334 | 1 | PS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | 21223 | 4 | MG | ||||||||
| 107593344 | 10759334 | 2 | SS | XGEVA | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | 0 | 120 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107593344 | 10759334 | 1 | Metastases to bone |
| 107593344 | 10759334 | 2 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107593344 | 10759334 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107593344 | 10759334 | Exposed bone in jaw | |
| 107593344 | 10759334 | Osteolysis | |
| 107593344 | 10759334 | 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 |
|---|---|---|---|---|---|---|
| 107593344 | 10759334 | 1 | 20120307 | 20160714 | 0 | |
| 107593344 | 10759334 | 2 | 20130614 | 0 |