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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044951 | 12604495 | 1 | I | 20160520 | 20160725 | 20160728 | 20160728 | EXP | IT-MINISAL02-368599 | IT-MYLANLABS-2016M1030944 | MYLAN | 0.00 | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126044951 | 12604495 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 1000 MG, QD | Y | 76919 | 1000 | MG | TABLET | QD | |||||
| 126044951 | 12604495 | 2 | C | DINTOINA | PHENYTOIN SODIUM | 1 | Oral | 200 MG, UNK | 0 | 200 | MG | COATED TABLET | |||||||
| 126044951 | 12604495 | 3 | C | VIMPAT | LACOSAMIDE | 1 | Oral | 400 MG, UNK | 0 | 400 | MG | FILM-COATED TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126044951 | 12604495 | 1 | Lennox-Gastaut syndrome |
| 126044951 | 12604495 | 2 | Lennox-Gastaut syndrome |
| 126044951 | 12604495 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126044951 | 12604495 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126044951 | 12604495 | Drug ineffective | |
| 126044951 | 12604495 | 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 |
|---|---|---|---|---|---|---|
| 126044951 | 12604495 | 1 | 20160520 | 20160520 | 0 |