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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114548393 | 11454839 | 3 | F | 20150513 | 20160705 | 20150903 | 20160708 | EXP | PHEH2015US017036 | NOVARTIS | 25.05 | YR | F | Y | 39.91000 | KG | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114548393 | 11454839 | 1 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | UNK UNK, QD | 0 | QD | |||||||||
| 114548393 | 11454839 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 10 MG, QD | 0 | 10 | MG | QD | |||||||
| 114548393 | 11454839 | 3 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | Y | 21014 | ||||||||||
| 114548393 | 11454839 | 4 | C | TOPAMAX | TOPIRAMATE | 1 | Unknown | U | 0 | ||||||||||
| 114548393 | 11454839 | 5 | C | ONFI | CLOBAZAM | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114548393 | 11454839 | 1 | Angiomyolipoma |
| 114548393 | 11454839 | 3 | Product used for unknown indication |
| 114548393 | 11454839 | 4 | Product used for unknown indication |
| 114548393 | 11454839 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114548393 | 11454839 | HO |
| 114548393 | 11454839 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114548393 | 11454839 | Confusional state | |
| 114548393 | 11454839 | Dyskinesia | |
| 114548393 | 11454839 | Head discomfort | |
| 114548393 | 11454839 | Muscle rigidity | |
| 114548393 | 11454839 | Muscle spasms | |
| 114548393 | 11454839 | Seizure | |
| 114548393 | 11454839 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 114548393 | 11454839 | 1 | 20140303 | 0 | ||
| 114548393 | 11454839 | 2 | 20150722 | 0 |