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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126164821 | 12616482 | 1 | I | 20160608 | 20160726 | 20160802 | 20160802 | EXP | DE-ABBVIE-16P-062-1691549-00 | ABBVIE | 1.00 | DY | M | Y | 0.00000 | 20160802 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126164821 | 12616482 | 1 | PS | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | Transplacental | UNKNOWN | 18081 | ||||||||||
| 126164821 | 12616482 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Transplacental | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126164821 | 12616482 | 1 | Maternal exposure timing unspecified |
| 126164821 | 12616482 | 2 | Maternal exposure timing unspecified |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126164821 | 12616482 | OT |
| 126164821 | 12616482 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126164821 | 12616482 | Foetal exposure during pregnancy | |
| 126164821 | 12616482 | Hypospadias | |
| 126164821 | 12616482 | Large for dates baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |