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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124971093 | 12497109 | 3 | F | 20160823 | 20160624 | 20160825 | EXP | PHHY2016CA087019 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160825 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124971093 | 12497109 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, UNK | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 124971093 | 12497109 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 21817 | SOLUTION FOR INJECTION | ||||||||||
| 124971093 | 12497109 | 3 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 21817 | SOLUTION FOR INJECTION | ||||||||||
| 124971093 | 12497109 | 4 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | UNK MG, UNK | 21817 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124971093 | 12497109 | 1 | Osteoporosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124971093 | 12497109 | OT |
| 124971093 | 12497109 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124971093 | 12497109 | Intestinal perforation | |
| 124971093 | 12497109 | Malaise | |
| 124971093 | 12497109 | Peritonitis | |
| 124971093 | 12497109 | Pseudomonas infection | |
| 124971093 | 12497109 | Sepsis | |
| 124971093 | 12497109 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 124971093 | 12497109 | 1 | 20090923 | 0 | ||
| 124971093 | 12497109 | 2 | 20100823 | 0 | ||
| 124971093 | 12497109 | 3 | 20110818 | 0 | ||
| 124971093 | 12497109 | 4 | 20140904 | 0 |