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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604581 | 12660458 | 1 | I | 2016 | 20160805 | 20160817 | 20160817 | EXP | JP-UCBSA-2016030809 | UCB | 14.44 | YR | M | Y | 47.00000 | KG | 20160817 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126604581 | 12660458 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 250 MG, ONCE DAILY (QD) | 35250 | MG | U | 21035 | 250 | MG | QD | ||||
| 126604581 | 12660458 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 250 MG, 2X/DAY (BID) | 35250 | MG | U | 21035 | 250 | MG | BID | ||||
| 126604581 | 12660458 | 3 | C | DEPAKENE | VALPROIC ACID | 1 | Oral | 400 MG, UNK | U | 0 | 400 | MG | |||||||
| 126604581 | 12660458 | 4 | C | DEPAKENE | VALPROIC ACID | 1 | Oral | 600 MG, UNK | U | 0 | 600 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126604581 | 12660458 | 1 | Partial seizures with secondary generalisation |
| 126604581 | 12660458 | 3 | Partial seizures with secondary generalisation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126604581 | 12660458 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126604581 | 12660458 | Headache | |
| 126604581 | 12660458 | Off label use | |
| 126604581 | 12660458 | Withdrawal syndrome |
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 |
|---|---|---|---|---|---|---|
| 126604581 | 12660458 | 1 | 20160201 | 20160207 | 0 | |
| 126604581 | 12660458 | 2 | 20160208 | 20160414 | 0 | |
| 126604581 | 12660458 | 3 | 20160414 | 20160420 | 0 | |
| 126604581 | 12660458 | 4 | 20160421 | 0 |