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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113595494 | 11359549 | 4 | F | 20150730 | 20160804 | 20150807 | 20160809 | PER | PHEH2015US014903 | NOVARTIS | 17.41 | YR | F | Y | 0.00000 | 20160809 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113595494 | 11359549 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | 22334 | 7.5 | MG | TABLET | QD | ||||||
| 113595494 | 11359549 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | TABLET | QD | ||||||
| 113595494 | 11359549 | 3 | C | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113595494 | 11359549 | 1 | Astrocytoma, low grade |
| 113595494 | 11359549 | 3 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113595494 | 11359549 | Central nervous system lesion | |
| 113595494 | 11359549 | Drug level decreased | |
| 113595494 | 11359549 | Stomatitis | |
| 113595494 | 11359549 | Swelling face |
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 |
|---|---|---|---|---|---|---|
| 113595494 | 11359549 | 1 | 20150626 | 0 | ||
| 113595494 | 11359549 | 2 | 20150730 | 0 |