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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126557211 | 12655721 | 1 | I | 20160801 | 20160816 | 20160816 | EXP | JP-CONCORDIA PHARMACEUTICALS INC.-CO-ZO-JP-2016-086 | CONCORDIA | KAWAMURA. ^STUDY OF PREGNANCY AND DELIVERY IN WOMAN WITH EPILEPSY^. BRAIN AND DEVELOPMENT. 2016;48:S300. | 0.00 | UNK | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126557211 | 12655721 | 1 | PS | ZONISAMIDE. | ZONISAMIDE | 1 | Transplacental | 0 | 150 | MG | |||||||||
| 126557211 | 12655721 | 2 | SS | SODIUM VALPROATE | VALPROATE SODIUM | 1 | Transplacental | 0 | 900 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126557211 | 12655721 | 1 | Foetal exposure during pregnancy |
| 126557211 | 12655721 | 2 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126557211 | 12655721 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126557211 | 12655721 | Foetal exposure during pregnancy | |
| 126557211 | 12655721 | Intellectual disability | |
| 126557211 | 12655721 | Spina bifida |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |