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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122196962 | 12219696 | 2 | F | 20150303 | 20160817 | 20160330 | 20160819 | PER | PHEH2015US006963 | NOVARTIS | 3.64 | YR | M | Y | 0.00000 | 20160819 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122196962 | 12219696 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 9 MG, QD | 22334 | 9 | MG | QD | |||||||
| 122196962 | 12219696 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 12 MG, QD | 22334 | 12 | MG | QD | |||||||
| 122196962 | 12219696 | 3 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | U | 0 | ||||||||||
| 122196962 | 12219696 | 4 | C | OMEGA 3 | OMEGA-3 FATTY ACIDS | 1 | Unknown | U | 0 | ||||||||||
| 122196962 | 12219696 | 5 | C | ONFI | CLOBAZAM | 1 | Unknown | U | 0 | ||||||||||
| 122196962 | 12219696 | 6 | C | VITAMINS NOS | VITAMINS | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122196962 | 12219696 | 1 | Ganglioglioma |
| 122196962 | 12219696 | 3 | Product used for unknown indication |
| 122196962 | 12219696 | 4 | Product used for unknown indication |
| 122196962 | 12219696 | 5 | Product used for unknown indication |
| 122196962 | 12219696 | 6 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122196962 | 12219696 | Decreased appetite | |
| 122196962 | 12219696 | Drug level decreased | |
| 122196962 | 12219696 | Oral pain | |
| 122196962 | 12219696 | Wrong technique in product usage process |
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 |
|---|---|---|---|---|---|---|
| 122196962 | 12219696 | 1 | 20140113 | 0 | ||
| 122196962 | 12219696 | 2 | 201603 | 0 |