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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125475381 | 12547538 | 1 | I | 20160627 | 20160712 | 20160712 | EXP | IT-CIPLA LTD.-2016IT08400 | CIPLA | CASSINA M, DILAGHI A, DI GIANANTONIO E, CESARI E, DE SANTIS M, MANNAIONI G ET AL.,. PREGNANCY OUTCOME IN WOMEN EXPOSED TO ANTIEPILEPTIC DRUGS: TERATOGENIC ROLE OF MATERNAL EPILEPSY AND ITS PHARMACOLOGIC TREATMENT. REPROD TOXICOL. 2013;39:50-57 | 0.00 | Y | 0.00000 | 20160712 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125475381 | 12547538 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transplacental | UNK | 78234 | ||||||||||
| 125475381 | 12547538 | 2 | SS | CARBAMAZEPINE. | CARBAMAZEPINE | 1 | Transplacental | UNK | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125475381 | 12547538 | OT |
| 125475381 | 12547538 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125475381 | 12547538 | Foetal exposure during pregnancy | |
| 125475381 | 12547538 | Phalangeal hypoplasia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |