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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124318944 | 12431894 | 4 | F | 20160509 | 20160909 | 20160603 | 20160916 | EXP | PHEH2016US013336 | NOVARTIS | 88.53 | YR | F | Y | 0.00000 | 20160916 | CN | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124318944 | 12431894 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Unknown | 10 MG, QD | Y | 22334 | 10 | MG | TABLET | QD | |||||
| 124318944 | 12431894 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | 10 MG, QOD | Y | 22334 | 10 | MG | TABLET | ||||||
| 124318944 | 12431894 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | Unknown | 5 MG, QD | Y | 22334 | 5 | MG | TABLET | QD | |||||
| 124318944 | 12431894 | 4 | SS | AROMASIN | EXEMESTANE | 1 | Unknown | 25 MG, QD | 0 | 25 | MG | QD | |||||||
| 124318944 | 12431894 | 5 | C | ARIMIDEX | ANASTROZOLE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124318944 | 12431894 | 1 | Breast cancer metastatic |
| 124318944 | 12431894 | 4 | Breast cancer metastatic |
| 124318944 | 12431894 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124318944 | 12431894 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124318944 | 12431894 | Arthritis | |
| 124318944 | 12431894 | Atrial fibrillation | |
| 124318944 | 12431894 | Body height decreased | |
| 124318944 | 12431894 | Cough | |
| 124318944 | 12431894 | Dizziness | |
| 124318944 | 12431894 | Feeling abnormal | |
| 124318944 | 12431894 | Head discomfort | |
| 124318944 | 12431894 | Joint swelling | |
| 124318944 | 12431894 | Oedema peripheral | |
| 124318944 | 12431894 | Peripheral swelling | |
| 124318944 | 12431894 | Platelet count decreased | |
| 124318944 | 12431894 | Sneezing | |
| 124318944 | 12431894 | Somnolence | |
| 124318944 | 12431894 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 124318944 | 12431894 | 1 | 20160426 | 0 | ||
| 124318944 | 12431894 | 3 | 20160621 | 0 |