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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125818363 | 12581836 | 3 | F | 2004 | 20160829 | 20160722 | 20160905 | EXP | DE-UCBSA-2016015624 | UCB | 0.00 | A | F | Y | 0.00000 | 20160905 | OT | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125818363 | 12581836 | 1 | PS | Levetiracetam UCB | LEVETIRACETAM | 1 | UNK | U | U | 21035 | |||||||||
| 125818363 | 12581836 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 750 MG, 2X/DAY (BID) | Y | U | 21035 | 750 | MG | BID | |||||
| 125818363 | 12581836 | 3 | C | ZONEGRAN | ZONISAMIDE | 1 | 500 MG | U | 0 | ||||||||||
| 125818363 | 12581836 | 4 | C | ZONEGRAN | ZONISAMIDE | 1 | DOSE REDUCED | U | 0 | ||||||||||
| 125818363 | 12581836 | 5 | C | VALPROATE | VALPROIC ACID | 1 | 1200 MG | 0 | |||||||||||
| 125818363 | 12581836 | 6 | C | Brivaracetam | BRIVARACETAM | 1 | 100 MG DAILY | 0 | |||||||||||
| 125818363 | 12581836 | 7 | C | Brivaracetam | BRIVARACETAM | 1 | 200 MG DAILY | 0 | |||||||||||
| 125818363 | 12581836 | 8 | C | Convulex | VALPROIC ACID | 1 | Oral | 300 MG, (FREQUENCY : 2) | U | 0 | 300 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125818363 | 12581836 | 1 | Epilepsy |
| 125818363 | 12581836 | 2 | Epilepsy |
| 125818363 | 12581836 | 3 | Epilepsy |
| 125818363 | 12581836 | 5 | Epilepsy |
| 125818363 | 12581836 | 6 | Epilepsy |
| 125818363 | 12581836 | 8 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125818363 | 12581836 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125818363 | 12581836 | Aura | |
| 125818363 | 12581836 | Complex partial seizures | |
| 125818363 | 12581836 | Generalised tonic-clonic seizure | |
| 125818363 | 12581836 | Nervousness | |
| 125818363 | 12581836 | 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 |
|---|---|---|---|---|---|---|
| 125818363 | 12581836 | 2 | 2004 | 2007 | 0 | |
| 125818363 | 12581836 | 8 | 2003 | 0 |