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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125293401 | 12529340 | 1 | I | 2016 | 20160630 | 20160705 | 20160705 | EXP | FR-UCBSA-2016024940 | UCB | 0.00 | M | Y | 0.00000 | 20160706 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125293401 | 12529340 | 1 | PS | VIMPAT | LACOSAMIDE | 1 | 400 MG, UNK | Y | U | 22253 | 400 | MG | |||||||
| 125293401 | 12529340 | 2 | SS | VIMPAT | LACOSAMIDE | 1 | Y | U | 22253 | ||||||||||
| 125293401 | 12529340 | 3 | SS | KEPPRA | LEVETIRACETAM | 1 | UNK | 0 | |||||||||||
| 125293401 | 12529340 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125293401 | 12529340 | 1 | Status epilepticus |
| 125293401 | 12529340 | 2 | Off label use |
| 125293401 | 12529340 | 3 | Status epilepticus |
| 125293401 | 12529340 | 4 | Off label use |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125293401 | 12529340 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125293401 | 12529340 | Hepatocellular injury | |
| 125293401 | 12529340 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125293401 | 12529340 | 1 | 2016 | 0 |