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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121050273 | 12105027 | 3 | F | 20130605 | 20160919 | 20160223 | 20160926 | PER | PHEH2013US014341 | NOVARTIS | 9.49 | YR | M | Y | 0.00000 | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121050273 | 12105027 | 1 | PS | AFINITOR | EVEROLIMUS | 1 | Oral | 5 MG, QD | 22334 | 5 | MG | TABLET | QD | ||||||
| 121050273 | 12105027 | 2 | SS | AFINITOR | EVEROLIMUS | 1 | Oral | 7.5 MG, QD | 22334 | 7.5 | MG | TABLET | QD | ||||||
| 121050273 | 12105027 | 3 | C | MULTI VITAMIN | VITAMINS | 1 | Unknown | U | 0 | ||||||||||
| 121050273 | 12105027 | 4 | C | VIMPAT | LACOSAMIDE | 1 | Oral | 50 MG (HALF TABLET IN MORNING AND HALF TABLET IN EVENING), DAILY | U | 0 | 50 | MG | TABLET | ||||||
| 121050273 | 12105027 | 5 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 5 ML, QD | U | 0 | 5 | ML | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121050273 | 12105027 | 1 | Astrocytoma, low grade |
| 121050273 | 12105027 | 3 | Product used for unknown indication |
| 121050273 | 12105027 | 4 | Seizure |
| 121050273 | 12105027 | 5 | Anxiety |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121050273 | 12105027 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121050273 | 12105027 | Abdominal discomfort | |
| 121050273 | 12105027 | Abdominal pain | |
| 121050273 | 12105027 | Abdominal pain upper | |
| 121050273 | 12105027 | Cough | |
| 121050273 | 12105027 | Diarrhoea | |
| 121050273 | 12105027 | Eye swelling | |
| 121050273 | 12105027 | Feeding disorder | |
| 121050273 | 12105027 | Impetigo | |
| 121050273 | 12105027 | Influenza | |
| 121050273 | 12105027 | Mouth ulceration | |
| 121050273 | 12105027 | Nasopharyngitis | |
| 121050273 | 12105027 | Pyrexia | |
| 121050273 | 12105027 | Sinusitis | |
| 121050273 | 12105027 | Staphylococcal skin infection | |
| 121050273 | 12105027 | Stomatitis | |
| 121050273 | 12105027 | Viral infection | |
| 121050273 | 12105027 | Vomiting | |
| 121050273 | 12105027 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 121050273 | 12105027 | 1 | 20130513 | 0 | ||
| 121050273 | 12105027 | 2 | 20130530 | 0 |