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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127814531 | 12781453 | 1 | I | 20160919 | 20160926 | 20160926 | EXP | PHHY2016BR130281 | NOVARTIS | 0.00 | F | Y | 58.50000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127814531 | 12781453 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 5 MG, Q12MO (BETWEEN JUN AND JUL) | D | 21817 | 5 | MG | SOLUTION FOR INJECTION | ||||||
| 127814531 | 12781453 | 2 | SS | METICORTEN | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 127814531 | 12781453 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | 2.5 MG, UNK | 0 | 2.5 | MG | ||||||||
| 127814531 | 12781453 | 4 | SS | REUQUINOL | HYDROXYCHLOROQUINE SULFATE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127814531 | 12781453 | 1 | Osteoporosis |
| 127814531 | 12781453 | 2 | Product used for unknown indication |
| 127814531 | 12781453 | 3 | Product used for unknown indication |
| 127814531 | 12781453 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127814531 | 12781453 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127814531 | 12781453 | Arthralgia | |
| 127814531 | 12781453 | Decreased immune responsiveness | |
| 127814531 | 12781453 | Joint swelling | |
| 127814531 | 12781453 | Pain | |
| 127814531 | 12781453 | Rheumatoid arthritis |
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 |
|---|---|---|---|---|---|---|
| 127814531 | 12781453 | 1 | 2015 | 0 |