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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124508203 | 12450820 | 3 | F | 20151216 | 20160628 | 20160609 | 20160710 | EXP | PHHY2016NL077219 | NOVARTIS | 71.98 | YR | F | Y | 0.00000 | 20160711 | MD | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124508203 | 12450820 | 1 | PS | ZOMETA | ZOLEDRONIC ACID | 1 | Intravenous (not otherwise specified) | 4 MG,/100 ML, ONCE PER 26 WEEKS | U | S0106, S0149, S0318 | 21223 | 4 | MG | SOLUTION FOR INFUSION | |||||
| 124508203 | 12450820 | 2 | C | LETROZOLE. | LETROZOLE | 1 | Unknown | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124508203 | 12450820 | 1 | Breast cancer metastatic |
| 124508203 | 12450820 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124508203 | 12450820 | OT |
| 124508203 | 12450820 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124508203 | 12450820 | Breast cancer recurrent | |
| 124508203 | 12450820 | Inappropriate schedule of drug administration | |
| 124508203 | 12450820 | Lymphadenopathy | |
| 124508203 | 12450820 | Metastases to lymph nodes | |
| 124508203 | 12450820 | Thrombosis |
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 |
|---|---|---|---|---|---|---|
| 124508203 | 12450820 | 1 | 20141229 | 0 |