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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125241162 | 12524116 | 2 | F | 20150519 | 20160718 | 20160704 | 20160802 | EXP | 364487 | IT-ACCORD-042035 | ACCORD | FOIS C, RASSU AL, MANDIA D, SECHI E, DONEDDU PE, SECHI G. PARADOXICAL EFFECT OF LEVETIRACETAM IN NEWLY DIAGNOSED TYPE II FOCAL CORTICAL DYSPLASIA. CLIN NEUROPHARMACOL. 2016 JUL 12. | 18.00 | YR | M | Y | 70.00000 | KG | 20160802 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125241162 | 12524116 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | INITIAL TITRATION OF THE DRUG FROM DOSE OF 500 MG/DIE TO THE DOSE OF 1000 MG/DIE. | Y | 90843 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125241162 | 12524116 | 1 | Partial seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125241162 | 12524116 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125241162 | 12524116 | Epilepsy | |
| 125241162 | 12524116 | Paradoxical drug reaction |
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 |
|---|---|---|---|---|---|---|
| 125241162 | 12524116 | 1 | 20150519 | 20150529 | 0 |