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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126341001 | 12634100 | 1 | I | 20160803 | 20160808 | 20160808 | EXP | PHHY2016BR108386 | NOVARTIS | 0.00 | F | Y | 84.00000 | KG | 20160808 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126341001 | 12634100 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 126341001 | 12634100 | 2 | C | DIPIRONA | METAMIZOLE | 1 | Unknown | UNK, PRN | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126341001 | 12634100 | 1 | Osteoporosis |
| 126341001 | 12634100 | 2 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126341001 | 12634100 | HO |
| 126341001 | 12634100 | OT |
| 126341001 | 12634100 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126341001 | 12634100 | Bone disorder | |
| 126341001 | 12634100 | Nephrolithiasis | |
| 126341001 | 12634100 | Pain in extremity | |
| 126341001 | 12634100 | Spinal disorder | |
| 126341001 | 12634100 | Urinary tract infection | |
| 126341001 | 12634100 | White blood cell count increased |
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 |
|---|---|---|---|---|---|---|
| 126341001 | 12634100 | 1 | 2013 | 0 |