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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112375363 | 11237536 | 3 | F | 20150312 | 20160809 | 20150703 | 20160815 | PER | PHEH2015US003015 | NOVARTIS | 40.24 | YR | F | Y | 0.00000 | 20160815 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112375363 | 11237536 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | U | 22334 | 10 | MG | TABLET | QD | |||||
| 112375363 | 11237536 | 2 | C | FOLIC ACID. | FOLIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 112375363 | 11237536 | 3 | C | TROKENDI | TOPIRAMATE | 1 | Unknown | U | 0 | ||||||||||
| 112375363 | 11237536 | 4 | C | VIMPAT | LACOSAMIDE | 1 | Unknown | U | 0 | ||||||||||
| 112375363 | 11237536 | 5 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112375363 | 11237536 | 1 | Angiomyolipoma |
| 112375363 | 11237536 | 2 | Product used for unknown indication |
| 112375363 | 11237536 | 3 | Product used for unknown indication |
| 112375363 | 11237536 | 4 | Product used for unknown indication |
| 112375363 | 11237536 | 5 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112375363 | 11237536 | Candida infection | |
| 112375363 | 11237536 | Cognitive disorder | |
| 112375363 | 11237536 | Dysphemia | |
| 112375363 | 11237536 | Ear pain | |
| 112375363 | 11237536 | Eating disorder | |
| 112375363 | 11237536 | Oropharyngeal pain | |
| 112375363 | 11237536 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 112375363 | 11237536 | 1 | 20140114 | 0 |