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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126498642 | 12649864 | 2 | F | 201607 | 20160818 | 20160812 | 20160824 | EXP | PHHY2016BR087956 | NOVARTIS | 82.98 | YR | F | Y | 60.00000 | KG | 20160824 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126498642 | 12649864 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | SA822 | 22334 | 10 | MG | TABLET | QD | |||||
| 126498642 | 12649864 | 2 | SS | ZOMETA | ZOLEDRONIC ACID | 1 | Unknown | UNK OT, QMO | 0 | /month | |||||||||
| 126498642 | 12649864 | 3 | C | AROMASIN | EXEMESTANE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126498642 | 12649864 | 1 | Breast cancer metastatic |
| 126498642 | 12649864 | 2 | Metastases to bone |
| 126498642 | 12649864 | 3 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126498642 | 12649864 | DE |
| 126498642 | 12649864 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126498642 | 12649864 | Abdominal pain upper | |
| 126498642 | 12649864 | Bone disorder | |
| 126498642 | 12649864 | Death | |
| 126498642 | 12649864 | Decreased appetite | |
| 126498642 | 12649864 | Dysgeusia | |
| 126498642 | 12649864 | Dyspnoea | |
| 126498642 | 12649864 | Feeding disorder | |
| 126498642 | 12649864 | Feeling of body temperature change | |
| 126498642 | 12649864 | General physical health deterioration | |
| 126498642 | 12649864 | Malaise | |
| 126498642 | 12649864 | Mucosal inflammation | |
| 126498642 | 12649864 | Nausea | |
| 126498642 | 12649864 | Pneumonia | |
| 126498642 | 12649864 | Pyrexia | |
| 126498642 | 12649864 | Stomatitis | |
| 126498642 | 12649864 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 126498642 | 12649864 | 1 | 20160516 | 20160808 | 0 | |
| 126498642 | 12649864 | 2 | 20160516 | 0 |