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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115524933 | 11552493 | 3 | F | 201305 | 20160822 | 20150925 | 20160829 | EXP | DK-DKMA-ADR 23147270 | PHHY2015DK111579 | NOVARTIS | 75.00 | YR | M | Y | 0.00000 | 20160829 | OT | DK | DK |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115524933 | 11552493 | 1 | PS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 1 DF, UNK | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 115524933 | 11552493 | 2 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 1 DF, UNK | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 115524933 | 11552493 | 3 | SS | ACLASTA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 1 DF, UNK | 21817 | 1 | DF | SOLUTION FOR INJECTION | |||||||
| 115524933 | 11552493 | 4 | C | METHOTREXATE. | METHOTREXATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115524933 | 11552493 | 1 | Osteoporosis |
| 115524933 | 11552493 | 4 | Rheumatic disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115524933 | 11552493 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115524933 | 11552493 | Exposed bone in jaw | |
| 115524933 | 11552493 | Impaired healing | |
| 115524933 | 11552493 | Mastication disorder | |
| 115524933 | 11552493 | Oral infection | |
| 115524933 | 11552493 | Osteomyelitis | |
| 115524933 | 11552493 | Osteonecrosis of jaw | |
| 115524933 | 11552493 | Pain in jaw | |
| 115524933 | 11552493 | Sequestrectomy | |
| 115524933 | 11552493 | Swelling |
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 |
|---|---|---|---|---|---|---|
| 115524933 | 11552493 | 1 | 20110525 | 0 | ||
| 115524933 | 11552493 | 2 | 20120521 | 0 | ||
| 115524933 | 11552493 | 3 | 20130603 | 0 |