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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122859864 | 12285986 | 4 | F | 20160411 | 20160725 | 20160420 | 20160727 | PER | PHEH2016US009077 | NOVARTIS | 33.81 | YR | F | Y | 0.00000 | 20160727 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122859864 | 12285986 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD (DAILY) | 22334 | 5 | MG | TABLET | QD | ||||||
| 122859864 | 12285986 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | 22334 | TABLET | |||||||||||
| 122859864 | 12285986 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | 22334 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122859864 | 12285986 | 1 | Angiomyolipoma |
| 122859864 | 12285986 | 2 | Benign renal neoplasm |
| 122859864 | 12285986 | 3 | Astrocytoma, low grade |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122859864 | 12285986 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122859864 | 12285986 | Feeding disorder | |
| 122859864 | 12285986 | Oral pain | |
| 122859864 | 12285986 | Speech disorder | |
| 122859864 | 12285986 | Stomatitis | |
| 122859864 | 12285986 | 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 |
|---|---|---|---|---|---|---|
| 122859864 | 12285986 | 1 | 20160307 | 0 |