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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125780301 | 12578030 | 1 | I | 2016 | 20160715 | 20160721 | 20160721 | EXP | US-UCBSA-2016026791 | UCB | 0.00 | F | Y | 52.00000 | KG | 20160721 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125780301 | 12578030 | 1 | PS | VIMPAT | LACOSAMIDE | 1 | 200 MG, ONCE DAILY (QD) | 22253 | 200 | MG | QD | ||||||||
| 125780301 | 12578030 | 2 | SS | VIMPAT | LACOSAMIDE | 1 | 200 MG, 2X/DAY (BID) | 22253 | 200 | MG | BID | ||||||||
| 125780301 | 12578030 | 3 | SS | VIMPAT | LACOSAMIDE | 1 | 300 MG, 2X/DAY (BID) | 22253 | 300 | MG | BID | ||||||||
| 125780301 | 12578030 | 4 | SS | ZONISAMIDE. | ZONISAMIDE | 1 | 200 MG | U | U | 0 | |||||||||
| 125780301 | 12578030 | 5 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | 500 MG PER DAY | Y | U | 0 | |||||||||
| 125780301 | 12578030 | 6 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | 1000 MG PER DAY | Y | U | 0 | |||||||||
| 125780301 | 12578030 | 7 | C | LEVETIRACETAM. | LEVETIRACETAM | 1 | 25000 MG PER DAY | Y | U | 0 | |||||||||
| 125780301 | 12578030 | 8 | C | LAMICTAL | LAMOTRIGINE | 1 | UNK | Y | U | 0 | |||||||||
| 125780301 | 12578030 | 9 | C | ATIVAN | LORAZEPAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125780301 | 12578030 | 1 | Seizure |
| 125780301 | 12578030 | 2 | Status epilepticus |
| 125780301 | 12578030 | 3 | Off label use |
| 125780301 | 12578030 | 4 | Product used for unknown indication |
| 125780301 | 12578030 | 5 | Product used for unknown indication |
| 125780301 | 12578030 | 8 | Product used for unknown indication |
| 125780301 | 12578030 | 9 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125780301 | 12578030 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125780301 | 12578030 | Balance disorder | |
| 125780301 | 12578030 | Complex partial seizures | |
| 125780301 | 12578030 | Diplopia | |
| 125780301 | 12578030 | Fatigue | |
| 125780301 | 12578030 | Feeling abnormal | |
| 125780301 | 12578030 | Gait disturbance | |
| 125780301 | 12578030 | Hypersomnia | |
| 125780301 | 12578030 | Off label use | |
| 125780301 | 12578030 | Overdose | |
| 125780301 | 12578030 | 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 |
|---|---|---|---|---|---|---|
| 125780301 | 12578030 | 1 | 201602 | 2016 | 0 | |
| 125780301 | 12578030 | 2 | 201603 | 2016 | 0 | |
| 125780301 | 12578030 | 3 | 201606 | 0 | ||
| 125780301 | 12578030 | 4 | 201606 | 0 | ||
| 125780301 | 12578030 | 5 | 201504 | 0 | ||
| 125780301 | 12578030 | 6 | 201601 | 2016 | 0 | |
| 125780301 | 12578030 | 7 | 201603 | 201606 | 0 | |
| 125780301 | 12578030 | 8 | 201606 | 0 |