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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126169491 | 12616949 | 1 | I | 20160328 | 20160803 | 20160803 | PER | JP-LUPIN PHARMACEUTICALS INC.-2016-01359 | LUPIN | SHIMAKAWA S, YOSHIKAWA S, FUKUI M, NOMURA S, TANABE T, TAMAI H. CLINICAL FEATURES OF LONG-TERM LOW-DOSE LEVETIRACETAM TREATMENT FOR EPILEPSY. PEDIATRICS INTERNATIONAL. 2016;58(1):40-44. | 39.00 | YR | M | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126169491 | 12616949 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | UNKNOWN | 78154 | 500 | MG | ||||||||
| 126169491 | 12616949 | 2 | C | VALPROIC ACID. | VALPROIC ACID | 1 | Unknown | 0 | |||||||||||
| 126169491 | 12616949 | 3 | C | PHENYTOIN. | PHENYTOIN | 1 | Unknown | 0 | |||||||||||
| 126169491 | 12616949 | 4 | C | Clobazam | CLOBAZAM | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126169491 | 12616949 | 1 | Generalised tonic-clonic seizure |
| 126169491 | 12616949 | 2 | Product used for unknown indication |
| 126169491 | 12616949 | 3 | Product used for unknown indication |
| 126169491 | 12616949 | 4 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126169491 | 12616949 | Somnolence |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |