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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121433612 | 12143361 | 2 | F | 20150416 | 20160623 | 20160304 | 20160701 | EXP | JP-AMGEN-JPNNI2016027188 | AMGEN | 0.00 | E | F | Y | 46.00000 | KG | 20160630 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121433612 | 12143361 | 1 | PS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG, UNK | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 2 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 3 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 4 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 5 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 6 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 7 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 8 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 9 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 10 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 11 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 12 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 13 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 14 | SS | denosumab | DENOSUMAB | 1 | Subcutaneous | 120 MG | U | 125320 | 120 | MG | SOLUTION FOR INJECTION | ||||||
| 121433612 | 12143361 | 15 | SS | FLUOROURACIL. | FLUOROURACIL | 1 | Unknown | UNK | 0 | ||||||||||
| 121433612 | 12143361 | 16 | SS | EPIRUBICIN HYDROCHLORIDE. | EPIRUBICIN HYDROCHLORIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 121433612 | 12143361 | 17 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | 0 | ||||||||||
| 121433612 | 12143361 | 18 | C | DENOTAS | CALCIUM CARBONATECHOLECALCIFEROLMAGNESIUM CARBONATE | 1 | Oral | 2 DF, QD | 0 | 2 | DF | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121433612 | 12143361 | 1 | Metastases to bone |
| 121433612 | 12143361 | 15 | Product used for unknown indication |
| 121433612 | 12143361 | 16 | Product used for unknown indication |
| 121433612 | 12143361 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121433612 | 12143361 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121433612 | 12143361 | Interstitial lung disease | |
| 121433612 | 12143361 | Pneumonia |
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 |
|---|---|---|---|---|---|---|
| 121433612 | 12143361 | 1 | 20140128 | 0 | ||
| 121433612 | 12143361 | 2 | 20140305 | 0 | ||
| 121433612 | 12143361 | 3 | 20140401 | 0 | ||
| 121433612 | 12143361 | 4 | 20140501 | 0 | ||
| 121433612 | 12143361 | 5 | 20140529 | 0 | ||
| 121433612 | 12143361 | 6 | 20140626 | 0 | ||
| 121433612 | 12143361 | 7 | 20140724 | 0 | ||
| 121433612 | 12143361 | 8 | 20140821 | 0 | ||
| 121433612 | 12143361 | 9 | 20140918 | 0 | ||
| 121433612 | 12143361 | 10 | 20141016 | 0 | ||
| 121433612 | 12143361 | 11 | 20141113 | 0 | ||
| 121433612 | 12143361 | 12 | 20141211 | 0 | ||
| 121433612 | 12143361 | 13 | 20150115 | 0 | ||
| 121433612 | 12143361 | 14 | 20150303 | 0 | ||
| 121433612 | 12143361 | 15 | 20150115 | 0 | ||
| 121433612 | 12143361 | 16 | 20150115 | 0 | ||
| 121433612 | 12143361 | 17 | 20150115 | 0 | ||
| 121433612 | 12143361 | 18 | 20140128 | 0 |