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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127163961 | 12716396 | 1 | I | 20151109 | 20160823 | 20160906 | 20160906 | EXP | IT-MINISAL02-371945 | IT-TEVA-688726ACC | TEVA | 60.93 | YR | F | Y | 0.00000 | 20160903 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127163961 | 12716396 | 1 | PS | ZOLEDRONIC ACID | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | U | 202472 | 4 | MG | ||||||||
| 127163961 | 12716396 | 2 | SS | DENOSUMAB | DENOSUMAB | 1 | Y | 0 | 120 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127163961 | 12716396 | 1 | Metastasis |
| 127163961 | 12716396 | 2 | Metastases to bone |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127163961 | 12716396 | DS |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127163961 | 12716396 | Dysaesthesia | |
| 127163961 | 12716396 | Fistula | |
| 127163961 | 12716396 | Mouth 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 |
|---|---|---|---|---|---|---|
| 127163961 | 12716396 | 1 | 20140901 | 20150101 | 0 | |
| 127163961 | 12716396 | 2 | 20150102 | 0 |