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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269852 | 12626985 | 2 | F | 2009 | 20160804 | 20160805 | 20160810 | EXP | MX-UCBSA-2016029101 | UCB | 0.00 | F | Y | 11.00000 | KG | 20160810 | CN | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126269852 | 12626985 | 1 | PS | VIMPAT | LACOSAMIDE | 1 | Oral | 25 MG, 2X/DAY (BID) | U | U | UNK | 22253 | 25 | MG | FILM-COATED TABLET | BID | |||
| 126269852 | 12626985 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 2 ML, 3X/DAY (TID) | U | UNK | 0 | 2 | ML | ORAL SOLUTION | TID | ||||
| 126269852 | 12626985 | 3 | SS | KEPPRA | LEVETIRACETAM | 1 | U | 0 | ORAL SOLUTION | ||||||||||
| 126269852 | 12626985 | 4 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | 2.5 ML, 3X/DAY (TID) | U | 0 | 2.5 | ML | TID | |||||||
| 126269852 | 12626985 | 5 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 5 GTT, 3X/DAY (TID) | U | 0 | 5 | GTT | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126269852 | 12626985 | 1 | Holoprosencephaly |
| 126269852 | 12626985 | 2 | Holoprosencephaly |
| 126269852 | 12626985 | 3 | Off label use |
| 126269852 | 12626985 | 4 | Seizure |
| 126269852 | 12626985 | 5 | Sleep disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126269852 | 12626985 | DE |
| 126269852 | 12626985 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126269852 | 12626985 | Drug ineffective | |
| 126269852 | 12626985 | Off label use | |
| 126269852 | 12626985 | 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 |
|---|---|---|---|---|---|---|
| 126269852 | 12626985 | 1 | 2011 | 0 | ||
| 126269852 | 12626985 | 2 | 2009 | 2009 | 0 | |
| 126269852 | 12626985 | 4 | 200912 | 0 | ||
| 126269852 | 12626985 | 5 | 2011 | 0 |