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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114471715 | 11447171 | 5 | F | 20150321 | 20160630 | 20150902 | 20160707 | EXP | PHJP2015JP014783 | NOVARTIS | 45.85 | YR | F | Y | 58.00000 | KG | 20160708 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114471715 | 11447171 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 200 | MG | 22334 | 10 | MG | TABLET | QD | ||||
| 114471715 | 11447171 | 2 | SS | AROMASIN | EXEMESTANE | 1 | Oral | 25 MG, QD | 2800 | MG | 0 | 25 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114471715 | 11447171 | 1 | Breast cancer metastatic |
| 114471715 | 11447171 | 2 | Breast cancer metastatic |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114471715 | 11447171 | DE |
| 114471715 | 11447171 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114471715 | 11447171 | Decreased appetite | |
| 114471715 | 11447171 | Glossitis | |
| 114471715 | 11447171 | Malaise | |
| 114471715 | 11447171 | Malignant neoplasm progression | |
| 114471715 | 11447171 | Oropharyngeal pain | |
| 114471715 | 11447171 | Platelet count decreased | |
| 114471715 | 11447171 | Pyrexia | |
| 114471715 | 11447171 | Renal disorder | |
| 114471715 | 11447171 | Stomatitis | |
| 114471715 | 11447171 | Urine output 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 |
|---|---|---|---|---|---|---|
| 114471715 | 11447171 | 1 | 20150302 | 20150321 | 0 | |
| 114471715 | 11447171 | 2 | 20150302 | 20150621 | 0 |