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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122446232 | 12244623 | 2 | F | 20150520 | 20160901 | 20160407 | 20160909 | EXP | JP-AMGEN-JPNNI2016043217 | AMGEN | 58.00 | YR | A | F | Y | 46.00000 | KG | 20160909 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122446232 | 12244623 | 1 | PS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 2 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 3 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 4 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 5 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 6 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 7 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 8 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 9 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 10 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 11 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 12 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 13 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 14 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | Y | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 122446232 | 12244623 | 15 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG, QD | 0 | 4 | MG | QD | |||||||
| 122446232 | 12244623 | 16 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | 2 DF, QD | 0 | 2 | DF | QD | |||||||
| 122446232 | 12244623 | 17 | C | TAMOXIFEN | TAMOXIFEN | 1 | Unknown | UNK | 0 | ||||||||||
| 122446232 | 12244623 | 18 | C | HERCEPTIN | TRASTUZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 122446232 | 12244623 | 19 | C | PERJETA | PERTUZUMAB | 1 | Unknown | UNK | 0 | ||||||||||
| 122446232 | 12244623 | 20 | C | DOCETAXEL. | DOCETAXEL | 1 | Unknown | UNK | 0 | ||||||||||
| 122446232 | 12244623 | 21 | C | DECADRON | DEXAMETHASONE | 1 | Oral | 8MG/DAY | 0 | 8 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122446232 | 12244623 | 1 | Metastases to bone |
| 122446232 | 12244623 | 15 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122446232 | 12244623 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122446232 | 12244623 | Hypocalcaemia | |
| 122446232 | 12244623 | 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 |
|---|---|---|---|---|---|---|
| 122446232 | 12244623 | 1 | 20131225 | 0 | ||
| 122446232 | 12244623 | 2 | 20140122 | 0 | ||
| 122446232 | 12244623 | 3 | 20140219 | 0 | ||
| 122446232 | 12244623 | 4 | 20140319 | 0 | ||
| 122446232 | 12244623 | 5 | 20140416 | 0 | ||
| 122446232 | 12244623 | 6 | 20140514 | 0 | ||
| 122446232 | 12244623 | 7 | 20110611 | 0 | ||
| 122446232 | 12244623 | 8 | 20141016 | 0 | ||
| 122446232 | 12244623 | 9 | 20141119 | 0 | ||
| 122446232 | 12244623 | 10 | 20141218 | 0 | ||
| 122446232 | 12244623 | 11 | 20150114 | 0 | ||
| 122446232 | 12244623 | 12 | 20150218 | 0 | ||
| 122446232 | 12244623 | 13 | 20150318 | 0 | ||
| 122446232 | 12244623 | 14 | 20150422 | 0 | ||
| 122446232 | 12244623 | 15 | 20150610 | 20151002 | 0 | |
| 122446232 | 12244623 | 16 | 20131225 | 0 | ||
| 122446232 | 12244623 | 17 | 20141017 | 20150519 | 0 | |
| 122446232 | 12244623 | 18 | 20150430 | 20151209 | 0 | |
| 122446232 | 12244623 | 19 | 20150430 | 20151209 | 0 | |
| 122446232 | 12244623 | 20 | 20150722 | 20151002 | 0 | |
| 122446232 | 12244623 | 21 | 20150723 | 20151004 | 0 |