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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124461913 | 12446191 | 3 | F | 2014 | 20160923 | 20160608 | 20160930 | EXP | US-UCBSA-2016020693 | UCB | 26.23 | YR | F | Y | 69.00000 | KG | 20160930 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124461913 | 12446191 | 1 | PS | VIMPAT | LACOSAMIDE | 1 | Oral | 50 MG, 2X/DAY (BID) | 1200 | MG | Y | 22253 | 50 | MG | FILM-COATED TABLET | BID | |||
| 124461913 | 12446191 | 2 | SS | VIMPAT | LACOSAMIDE | 1 | Oral | GRADUALLY INCREASED | 1200 | MG | Y | 22253 | FILM-COATED TABLET | ||||||
| 124461913 | 12446191 | 3 | SS | VIMPAT | LACOSAMIDE | 1 | Oral | 200 MG, 2X/DAY (BID) | 1200 | MG | Y | 22253 | 200 | MG | FILM-COATED TABLET | BID | |||
| 124461913 | 12446191 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 1500 MG, 2X/DAY (BID) | U | U | 0 | 1500 | MG | FILM-COATED TABLET | BID | ||||
| 124461913 | 12446191 | 5 | C | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 900 MG, 2X/DAY (BID) | U | 0 | 900 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124461913 | 12446191 | 1 | Partial seizures |
| 124461913 | 12446191 | 4 | Seizure |
| 124461913 | 12446191 | 5 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124461913 | 12446191 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124461913 | 12446191 | Aphasia | |
| 124461913 | 12446191 | Drug ineffective | |
| 124461913 | 12446191 | Muscle spasticity | |
| 124461913 | 12446191 | Musculoskeletal stiffness |
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 |
|---|---|---|---|---|---|---|
| 124461913 | 12446191 | 1 | 20140605 | 0 | ||
| 124461913 | 12446191 | 3 | 20150123 | 20150126 | 0 |