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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127162661 | 12716266 | 1 | I | 20160321 | 20160901 | 20160906 | 20160906 | EXP | PHHY2016BR121796 | NOVARTIS | 89.25 | YR | F | Y | 45.00000 | KG | 20160906 | MD | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127162661 | 12716266 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 127162661 | 12716266 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 21817 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127162661 | 12716266 | 1 | Osteoporosis |
| 127162661 | 12716266 | 2 | Bone disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127162661 | 12716266 | DS |
| 127162661 | 12716266 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127162661 | 12716266 | Fall | |
| 127162661 | 12716266 | Spinal fracture |
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 |
|---|---|---|---|---|---|---|
| 127162661 | 12716266 | 1 | 20130129 | 0 | ||
| 127162661 | 12716266 | 2 | 20150331 | 20150331 | 0 |