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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125914511 | 12591451 | 1 | I | 20160706 | 20160726 | 20160726 | EXP | VE-UCBSA-2016025995 | UCB | 55.00 | YR | M | Y | 85.00000 | KG | 20160726 | CN | VE | VE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125914511 | 12591451 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | 500 MG IN MORNING AND 1000 MG IN THE NIGHT, 2X/DAY (BID) | N | U | 21035 | FILM-COATED TABLET | BID | |||||||
| 125914511 | 12591451 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | 1000 MG 2X/DAY (BID) | N | U | 21035 | 1000 | MG | FILM-COATED TABLET | BID | |||||
| 125914511 | 12591451 | 3 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | 150 MG | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125914511 | 12591451 | 1 | Seizure |
| 125914511 | 12591451 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125914511 | 12591451 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125914511 | 12591451 | Drug ineffective | |
| 125914511 | 12591451 | Hypoaesthesia | |
| 125914511 | 12591451 | Immobile | |
| 125914511 | 12591451 | Limb injury | |
| 125914511 | 12591451 | Seizure | |
| 125914511 | 12591451 | Therapy cessation |
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 |
|---|---|---|---|---|---|---|
| 125914511 | 12591451 | 1 | 2009 | 2009 | 0 | |
| 125914511 | 12591451 | 2 | 2009 | 0 |