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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117770552 | 11777055 | 2 | F | 20151017 | 20160919 | 20151125 | 20160921 | PER | PHEH2015US024408 | NOVARTIS | 7.48 | YR | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117770552 | 11777055 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD (ONCE DAILY) | 360 | MG | Y | 22334 | 5 | MG | TABLET | QD | |||
| 117770552 | 11777055 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | 360 | MG | Y | 22334 | TABLET | ||||||||
| 117770552 | 11777055 | 3 | C | VIGABATRIN | VIGABATRIN | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 5 | C | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 6 | C | ZYRTEC | CETIRIZINE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 7 | C | TAURINE | TAURINE | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 8 | C | TRAZODONE | TRAZODONE HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 9 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 117770552 | 11777055 | 10 | C | SABRIL | VIGABATRIN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117770552 | 11777055 | 1 | Ganglioglioma |
| 117770552 | 11777055 | 2 | Astrocytoma, low grade |
| 117770552 | 11777055 | 3 | Product used for unknown indication |
| 117770552 | 11777055 | 4 | Product used for unknown indication |
| 117770552 | 11777055 | 5 | Seizure |
| 117770552 | 11777055 | 6 | Product used for unknown indication |
| 117770552 | 11777055 | 7 | Product used for unknown indication |
| 117770552 | 11777055 | 8 | Sleep disorder |
| 117770552 | 11777055 | 9 | Hypersensitivity |
| 117770552 | 11777055 | 10 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117770552 | 11777055 | Ear infection | |
| 117770552 | 11777055 | Hypersensitivity | |
| 117770552 | 11777055 | Malaise |
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 |
|---|---|---|---|---|---|---|
| 117770552 | 11777055 | 1 | 20150221 | 20150503 | 0 |