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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126010652 | 12601065 | 2 | F | 20150519 | 20160721 | 20160728 | 20160804 | EXP | IT-LUPIN PHARMACEUTICALS INC.-2016-03011 | LUPIN | UNPREDICTABLE SEIZURE-WORSENING INDUCED BY LEVETIRACETAM MONOTHERAPY IN A PATIENT WITH FOCAL CORTICAL DYSPLASIA TYPE II. EUROPEAN JOURNAL OF NEUROLOGY. 2016;23(2):172-173. | 18.00 | YR | M | Y | 70.00000 | KG | 20160804 | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126010652 | 12601065 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | Y | UNKNOWN | 78154 | 500 | MG | QD | ||||||
| 126010652 | 12601065 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | DOSE INCREASED | Y | UNKNOWN | 78154 | ||||||||
| 126010652 | 12601065 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | Y | UNKNOWN | 78154 | 250 | MG | BID | ||||||
| 126010652 | 12601065 | 4 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | Y | UNKNOWN | 78154 | 500 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126010652 | 12601065 | 1 | Partial seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126010652 | 12601065 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126010652 | 12601065 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126010652 | 12601065 | 1 | 20150519 | 0 |