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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126761131 | 12676113 | 1 | I | 201605 | 20160817 | 20160823 | 20160823 | EXP | PHHY2016BR114507 | NOVARTIS | 48.39 | YR | F | Y | 55.00000 | KG | 20160823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126761131 | 12676113 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 126761131 | 12676113 | 2 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Unknown | UNK UNK, QMO | U | 0 | SOLUTION FOR INFUSION | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126761131 | 12676113 | 1 | Osteoporosis |
| 126761131 | 12676113 | 2 | Bone disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126761131 | 12676113 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126761131 | 12676113 | Body surface area decreased | |
| 126761131 | 12676113 | Gait disturbance | |
| 126761131 | 12676113 | Muscle atrophy | |
| 126761131 | 12676113 | Neuropathy peripheral | |
| 126761131 | 12676113 | Spinal fracture | |
| 126761131 | 12676113 | Spinal pain |
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 |
|---|---|---|---|---|---|---|
| 126761131 | 12676113 | 2 | 201601 | 0 |