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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125735612 | 12573561 | 2 | F | 2015 | 20160830 | 20160720 | 20160910 | EXP | JP-UCBSA-2015027166 | UCB | 7.64 | YR | M | Y | 25.50000 | KG | 20160910 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125735612 | 12573561 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 250 MG, ONCE DAILY (QD) | 1000 | MG | Y | U | 21035 | 250 | MG | DRY SYRUP | QD | ||
| 125735612 | 12573561 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 250 MG, 2X/DAY (BID) | 1000 | MG | Y | U | 21035 | 250 | MG | DRY SYRUP | BID | ||
| 125735612 | 12573561 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 375 MG, 2X/DAY (BID) | 1000 | MG | Y | U | 21035 | 375 | MG | DRY SYRUP | BID | ||
| 125735612 | 12573561 | 4 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 500 MG, 2X/DAY (BID) | 1000 | MG | Y | U | 21035 | 500 | MG | DRY SYRUP | BID | ||
| 125735612 | 12573561 | 5 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 350 MG, 2X/DAY (BID) | 1000 | MG | Y | U | 21035 | 350 | MG | DRY SYRUP | BID | ||
| 125735612 | 12573561 | 6 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Oral | 175 MG, 2X/DAY (BID) | 1000 | MG | Y | U | 21035 | 175 | MG | DRY SYRUP | BID | ||
| 125735612 | 12573561 | 7 | C | TEGRETOL | CARBAMAZEPINE | 1 | 250 MG, DAILY | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125735612 | 12573561 | 1 | Complex partial seizures |
| 125735612 | 12573561 | 7 | Complex partial seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125735612 | 12573561 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125735612 | 12573561 | Abnormal behaviour | |
| 125735612 | 12573561 | Agitation | |
| 125735612 | 12573561 | Psychogenic seizure | |
| 125735612 | 12573561 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125735612 | 12573561 | 1 | 20150403 | 20150421 | 0 | |
| 125735612 | 12573561 | 2 | 20150422 | 20150425 | 0 | |
| 125735612 | 12573561 | 3 | 20150426 | 20150428 | 0 | |
| 125735612 | 12573561 | 4 | 20150429 | 20150512 | 0 | |
| 125735612 | 12573561 | 5 | 20150513 | 20150616 | 0 | |
| 125735612 | 12573561 | 6 | 20150617 | 20150623 | 0 | |
| 125735612 | 12573561 | 7 | 20160525 | 0 |