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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126169593 | 12616959 | 3 | F | 201505 | 20160729 | 20160803 | 20160919 | EXP | IT-ALVOGEN-2016-ALVOGEN-026976 | ALVOGEN | FOIS C, RASSU AL, MANDIA D, SECHI E, DONEDDU PE, SECHI G. PARADOXICAL EFFECT OF LEVETIRACETAM IN NEWLY DIAGNOSED TYPE II FOCAL CORTICAL DYSPLASIA.CLINICAL NEUROPHARMACOLOGY. 2016 | 18.00 | YR | M | Y | 0.00000 | 20160919 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126169593 | 12616959 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 90906 | 250 | MG | BID | |||||||||
| 126169593 | 12616959 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Y | 90906 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126169593 | 12616959 | 1 | Product used for unknown indication |
| 126169593 | 12616959 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126169593 | 12616959 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126169593 | 12616959 | Paradoxical drug reaction | |
| 126169593 | 12616959 | Seizure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |