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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115079583 | 11507958 | 3 | F | 2013 | 20160712 | 20150915 | 20160715 | EXP | PHHY2015BR110017 | NOVARTIS | 39.13 | YR | F | Y | 67.00000 | KG | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115079583 | 11507958 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 115079583 | 11507958 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | 21817 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115079583 | 11507958 | 1 | Osteoporosis |
| 115079583 | 11507958 | 2 | Bone density decreased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115079583 | 11507958 | OT |
| 115079583 | 11507958 | LT |
| 115079583 | 11507958 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115079583 | 11507958 | Bone infarction | |
| 115079583 | 11507958 | Coma | |
| 115079583 | 11507958 | Concomitant disease aggravated | |
| 115079583 | 11507958 | Feeding disorder | |
| 115079583 | 11507958 | Malaise | |
| 115079583 | 11507958 | Osteonecrosis | |
| 115079583 | 11507958 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 115079583 | 11507958 | 1 | 2009 | 0 |