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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125429071 | 12542907 | 1 | I | 20160628 | 20160710 | 20160710 | EXP | IT-TEVA-673639ACC | TEVA | CASSINA M,DILAGHI A,DI GIANANTONIO E,CESARI E,DE SANTIS M,MANNAIONI G. PREGNANCY OUTCOME IN WOMEN EXPOSED TO ANTIEPILEPTIC DRUGS:TERATOGENIC ROLE OF MATERNAL EPILEPSY AND ITS PHARMACOLOGIC TREATMENT. REPROD TOXICOL. 2013 APR 13;50-57. | 0.00 | F | Y | 0.00000 | 20160710 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125429071 | 12542907 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transplacental | 2000 MILLIGRAM DAILY; | U | 78101 | 2000 | MG | QD |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125429071 | 12542907 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125429071 | 12542907 | Cleft palate | |
| 125429071 | 12542907 | Foetal exposure during pregnancy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |