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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116304253 | 11630425 | 3 | F | 20151001 | 20160809 | 20151014 | 20160816 | EXP | PHHY2015BR103929 | NOVARTIS | 84.04 | YR | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116304253 | 11630425 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Unknown | 5 MG, Q12MO | 21817 | 5 | MG | SOLUTION FOR INJECTION | |||||||
| 116304253 | 11630425 | 2 | SS | DEOCIL | KETOROLAC TROMETHAMINE | 1 | Unknown | 2 DF, AT NIGHT | Y | 0 | 2 | DF |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116304253 | 11630425 | 1 | Osteoporosis |
| 116304253 | 11630425 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116304253 | 11630425 | LT |
| 116304253 | 11630425 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116304253 | 11630425 | Anger | |
| 116304253 | 11630425 | Apparent death | |
| 116304253 | 11630425 | Arthritis | |
| 116304253 | 11630425 | Arthropathy | |
| 116304253 | 11630425 | Dizziness | |
| 116304253 | 11630425 | Emotional disorder | |
| 116304253 | 11630425 | Eye disorder | |
| 116304253 | 11630425 | Fall | |
| 116304253 | 11630425 | Fatigue | |
| 116304253 | 11630425 | Feeling hot | |
| 116304253 | 11630425 | Gait disturbance | |
| 116304253 | 11630425 | Head discomfort | |
| 116304253 | 11630425 | Malaise | |
| 116304253 | 11630425 | Osteoporosis | |
| 116304253 | 11630425 | Rib 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 |
|---|---|---|---|---|---|---|
| 116304253 | 11630425 | 1 | 201409 | 0 |