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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126364171 | 12636417 | 1 | I | 201406 | 20160731 | 20160809 | 20160809 | EXP | NZ-AMGEN-NZLSP2016101036 | AMGEN | IAN R. REID, SONAKSHI SHARMA, RAMANAMMA KALLURU ET AL.. TREATMENT OF PAGET^S DISEASE OF BONE WITH DENOSUMAB: CASE REPORT AND LITERATURE REVIEW.. CALCIFIED TISSUE INTERNATIONAL. 2016;99:322-325 | 75.00 | YR | E | F | Y | 0.00000 | 20160809 | OT | NZ | NZ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126364171 | 12636417 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, UNK | U | 125320 | 60 | MG | SOLUTION FOR INJECTION | ||||||
| 126364171 | 12636417 | 2 | SS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, UNK | U | 125320 | 60 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126364171 | 12636417 | 1 | Osteitis deformans |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126364171 | 12636417 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126364171 | 12636417 | Blood alkaline phosphatase increased | |
| 126364171 | 12636417 | Headache | |
| 126364171 | 12636417 | Hypoacusis | |
| 126364171 | 12636417 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 126364171 | 12636417 | 1 | 201303 | 0 | ||
| 126364171 | 12636417 | 2 | 201503 | 0 |