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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126631381 | 12663138 | 1 | I | 201604 | 20150820 | 20160818 | 20160818 | EXP | PHHY2015ZA100948 | NOVARTIS | 83.56 | YR | F | Y | 0.00000 | 20160818 | CN | COUNTRY NOT SPECIFIED | ZA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126631381 | 12663138 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | 1 DF (5 MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION | ||||||||
| 126631381 | 12663138 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 1 DF (5 MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 126631381 | 12663138 | 3 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 1 DF (5 MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 126631381 | 12663138 | 4 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 1 DF (5 MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 126631381 | 12663138 | 5 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 1 DF (5 MG/100 ML), Q12MO | 21817 | 1 | DF | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126631381 | 12663138 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126631381 | 12663138 | HO |
| 126631381 | 12663138 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126631381 | 12663138 | Fall | |
| 126631381 | 12663138 | Pelvi-ureteric obstruction | |
| 126631381 | 12663138 | Renal impairment | |
| 126631381 | 12663138 | Upper limb 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 |
|---|---|---|---|---|---|---|
| 126631381 | 12663138 | 1 | 2011 | 0 | ||
| 126631381 | 12663138 | 2 | 2012 | 0 | ||
| 126631381 | 12663138 | 3 | 2013 | 0 | ||
| 126631381 | 12663138 | 4 | 2014 | 0 | ||
| 126631381 | 12663138 | 5 | 2015 | 2015 | 0 |