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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112241622 | 11224162 | 2 | F | 20140915 | 20160801 | 20150629 | 20160808 | EXP | DK-DKMA-EFO12272 | DK-AMGEN-DNKSP2015061727 | AMGEN | 63.00 | YR | A | F | Y | 0.00000 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112241622 | 11224162 | 1 | PS | XGEVA | DENOSUMAB | 1 | Subcutaneous | 120 MG | 125320 | 120 | MG | UNKNOWN FORMULATION | |||||||
| 112241622 | 11224162 | 2 | SS | XGEVA | DENOSUMAB | 1 | 125320 | UNKNOWN FORMULATION | |||||||||||
| 112241622 | 11224162 | 3 | SS | BONDRONAT | IBANDRONIC ACID | 1 | Oral | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 112241622 | 11224162 | 4 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | U | 0 | 4 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112241622 | 11224162 | 1 | Metastases to bone |
| 112241622 | 11224162 | 2 | Metastases to bone |
| 112241622 | 11224162 | 3 | Metastases to bone |
| 112241622 | 11224162 | 4 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112241622 | 11224162 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112241622 | 11224162 | Exposed bone in jaw | |
| 112241622 | 11224162 | Osteonecrosis of jaw | |
| 112241622 | 11224162 | Pain in jaw | |
| 112241622 | 11224162 | Sequestrectomy | |
| 112241622 | 11224162 | Tooth extraction |
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 |
|---|---|---|---|---|---|---|
| 112241622 | 11224162 | 1 | 20130417 | 0 | ||
| 112241622 | 11224162 | 3 | 20080701 | 20130101 | 0 | |
| 112241622 | 11224162 | 4 | 20130122 | 20130417 | 0 |