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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125248032 | 12524803 | 2 | F | 201512 | 20160926 | 20160704 | 20160929 | EXP | PHHY2016BR090350 | NOVARTIS | 63.64 | YR | F | Y | 89.00000 | KG | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125248032 | 12524803 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | D | 21817 | 5 | MG | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125248032 | 12524803 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125248032 | 12524803 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125248032 | 12524803 | Arthralgia | |
| 125248032 | 12524803 | Confusional state | |
| 125248032 | 12524803 | Facial paralysis | |
| 125248032 | 12524803 | Hypertension | |
| 125248032 | 12524803 | Joint injury | |
| 125248032 | 12524803 | Lower limb fracture | |
| 125248032 | 12524803 | Oedema peripheral | |
| 125248032 | 12524803 | Osteoporosis | |
| 125248032 | 12524803 | Synovial cyst |
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 |
|---|---|---|---|---|---|---|
| 125248032 | 12524803 | 1 | 201502 | 0 |