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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125392291 | 12539229 | 1 | I | 20160630 | 20160708 | 20160708 | EXP | PHHY2016BR092309 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160708 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125392291 | 12539229 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | UNK | 21817 | SOLUTION FOR INJECTION | |||||||||
| 125392291 | 12539229 | 2 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | TABLET | QD | ||||||
| 125392291 | 12539229 | 3 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | 1 DF, QD | 0 | 1 | DF | DROPS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125392291 | 12539229 | 1 | Product used for unknown indication |
| 125392291 | 12539229 | 2 | Gastric disorder |
| 125392291 | 12539229 | 3 | Bone disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125392291 | 12539229 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125392291 | 12539229 | Malaise | |
| 125392291 | 12539229 | Pneumonia | |
| 125392291 | 12539229 | Speech disorder |
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 |
|---|---|---|---|---|---|---|
| 125392291 | 12539229 | 1 | 20160530 | 0 |