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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112397632 | 11239763 | 2 | F | 20150410 | 20160801 | 20150706 | 20160808 | EXP | DK-DKMA-EFO12566 | PHHY2015DK080206 | NOVARTIS | 64.19 | YR | M | Y | 72.00000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112397632 | 11239763 | 1 | PS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | 21223 | 4 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112397632 | 11239763 | 1 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112397632 | 11239763 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112397632 | 11239763 | Erythema | |
| 112397632 | 11239763 | Exposed bone in jaw | |
| 112397632 | 11239763 | Gingivitis | |
| 112397632 | 11239763 | Mouth swelling | |
| 112397632 | 11239763 | Osteonecrosis of jaw | |
| 112397632 | 11239763 | Sinusitis | |
| 112397632 | 11239763 | Soft tissue 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 |
|---|---|---|---|---|---|---|
| 112397632 | 11239763 | 1 | 20130508 | 20150324 | 0 |