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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116504847 | 11650484 | 7 | F | 20151014 | 20160801 | 20151021 | 20160804 | PER | PHEH2015US020953 | NOVARTIS | 42.48 | YR | F | Y | 58.00000 | KG | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116504847 | 11650484 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | QD | |||||||
| 116504847 | 11650484 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 22334 | 10 | MG | QD | |||||||
| 116504847 | 11650484 | 3 | SS | AFINITOR | EVEROLIMUS | 1 | 22334 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116504847 | 11650484 | 1 | Angiomyolipoma |
| 116504847 | 11650484 | 2 | Astrocytoma, low grade |
| 116504847 | 11650484 | 3 | Tuberous sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116504847 | 11650484 | Basophil count increased | |
| 116504847 | 11650484 | Contusion | |
| 116504847 | 11650484 | Eosinophil count increased | |
| 116504847 | 11650484 | Hypocalcaemia | |
| 116504847 | 11650484 | Kidney small | |
| 116504847 | 11650484 | Menorrhagia | |
| 116504847 | 11650484 | Menstruation irregular | |
| 116504847 | 11650484 | Mucosal inflammation | |
| 116504847 | 11650484 | Rash | |
| 116504847 | 11650484 | Stomatitis | |
| 116504847 | 11650484 | Vitamin D 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 |
|---|---|---|---|---|---|---|
| 116504847 | 11650484 | 1 | 20150907 | 0 | ||
| 116504847 | 11650484 | 2 | 20160403 | 0 |