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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86156472 | 8615647 | 2 | F | 20160825 | 20120614 | 20160831 | EXP | US-AMGEN-USASP2012022923 | AMGEN | DRAUPADI B. TALREJA. SEVERE HYPOCALCEMIA FOLLOWING A SINGLE INJECTION OF DENOSUMAB IN A PATIENT WITH RENAL IMPAIRMENT. JOURNAL OF DRUG ASSESSMENT. 2012;1:30-33 | 68.00 | YR | E | F | Y | 0.00000 | 20160831 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 86156472 | 8615647 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q6MO | U | 125320 | 60 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 86156472 | 8615647 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 86156472 | 8615647 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 86156472 | 8615647 | Chills | |
| 86156472 | 8615647 | Hypocalcaemia | |
| 86156472 | 8615647 | Pain | |
| 86156472 | 8615647 | Productive cough | |
| 86156472 | 8615647 | Pyrexia | |
| 86156472 | 8615647 | Swelling | |
| 86156472 | 8615647 | Tenderness |
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 |
|---|---|---|---|---|---|---|
| 86156472 | 8615647 | 1 | 20101013 | 0 |