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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120727702 | 12072770 | 2 | F | 20160119 | 20160708 | 20160212 | 20160718 | EXP | IT-AMGEN-ITASP2016016171 | AMGEN | 78.00 | YR | E | F | Y | 0.00000 | 20160717 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120727702 | 12072770 | 1 | PS | PROLIA | DENOSUMAB | 1 | Subcutaneous | 60 MG/ML, Q6MO(ANNUALLY) | 60 | MG | 125320 | 60 | MG | SOLUTION FOR INJECTION | |||||
| 120727702 | 12072770 | 2 | SS | ACTONEL | RISEDRONATE SODIUM | 1 | Oral | 150 MG, QMO | 2400 | MG | 0 | 150 | MG | /month | |||||
| 120727702 | 12072770 | 3 | C | LOBIVON | NEBIVOLOL HYDROCHLORIDE | 1 | 5 MG, UNK | 0 | 5 | MG | |||||||||
| 120727702 | 12072770 | 4 | C | NORVASC | AMLODIPINE BESYLATE | 1 | 10 MG, UNK | 0 | 10 | MG | |||||||||
| 120727702 | 12072770 | 5 | C | CALCIO SAVIO | 2 | 2500 MG, UNK | 0 | 2500 | MG | ||||||||||
| 120727702 | 12072770 | 6 | C | DIBASE | CHOLECALCIFEROL | 1 | 2.5 ML(25.000 UL), UNK | 0 | 2.5 | ML |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120727702 | 12072770 | 1 | Osteoporosis postmenopausal |
| 120727702 | 12072770 | 2 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120727702 | 12072770 | HO |
| 120727702 | 12072770 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120727702 | 12072770 | 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 |
|---|---|---|---|---|---|---|
| 120727702 | 12072770 | 1 | 20150402 | 20151002 | 0 | |
| 120727702 | 12072770 | 2 | 20131118 | 20150218 | 0 |