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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125229941 | 12522994 | 1 | I | 20160623 | 20160628 | 20160701 | 20160701 | PER | PHEH2016US016461 | NOVARTIS | 36.61 | YR | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125229941 | 12522994 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG/KG, QD(ONCE DAILY) | 22334 | 7.5 | MG/KG | TABLET | QD | ||||||
| 125229941 | 12522994 | 2 | C | MULTIVITAMINS | VITAMINS | 1 | Unknown | U | 0 | ||||||||||
| 125229941 | 12522994 | 3 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 125229941 | 12522994 | 4 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Unknown | U | 0 | ||||||||||
| 125229941 | 12522994 | 5 | C | FLEXERIL | CYCLOBENZAPRINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 125229941 | 12522994 | 6 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125229941 | 12522994 | 1 | Angiomyolipoma |
| 125229941 | 12522994 | 2 | Product used for unknown indication |
| 125229941 | 12522994 | 3 | Product used for unknown indication |
| 125229941 | 12522994 | 4 | Product used for unknown indication |
| 125229941 | 12522994 | 5 | Product used for unknown indication |
| 125229941 | 12522994 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125229941 | 12522994 | Headache |
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 |
|---|---|---|---|---|---|---|
| 125229941 | 12522994 | 1 | 20160623 | 0 |