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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124145542 | 12414554 | 2 | F | 20151222 | 20160715 | 20160528 | 20160722 | EXP | US-AMGEN-USASP2015139529 | AMGEN | 88.00 | YR | E | F | Y | 68.27000 | KG | 20160722 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124145542 | 12414554 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG, Q6MO | Y | 1063211 | 125320 | 60 | MG | SOLUTION FOR INJECTION | |||||
| 124145542 | 12414554 | 2 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | 50000 UNIT, 3 TIMES/WK | 0 | TIW |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124145542 | 12414554 | 1 | Osteoporosis postmenopausal |
| 124145542 | 12414554 | 2 | Vitamin D deficiency |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124145542 | 12414554 | HO |
| 124145542 | 12414554 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124145542 | 12414554 | Blood albumin decreased | |
| 124145542 | 12414554 | Blood sodium decreased | |
| 124145542 | 12414554 | Carbon dioxide decreased | |
| 124145542 | 12414554 | Fatigue | |
| 124145542 | 12414554 | Hypocalcaemia | |
| 124145542 | 12414554 | Hyponatraemia | |
| 124145542 | 12414554 | Lung hyperinflation | |
| 124145542 | 12414554 | Paranasal sinus discomfort | |
| 124145542 | 12414554 | Urinary tract disorder | |
| 124145542 | 12414554 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 124145542 | 12414554 | 1 | 20140523 | 0 |