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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126740022 | 12674002 | 2 | F | 20150826 | 20160815 | 20160822 | 20160826 | EXP | DE-BFARM-16268404 | DE-UCBSA-2016031573 | UCB | -0.73 | YR | F | Y | 4.20000 | KG | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126740022 | 12674002 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transplacental | UNK | U | 21035 | |||||||||
| 126740022 | 12674002 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transmammary | 2X2000 MD/DAY | U | 21035 | BID | ||||||||
| 126740022 | 12674002 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transmammary | 2X2250MG /DAY | U | 21035 | BID | ||||||||
| 126740022 | 12674002 | 4 | SS | LAMICTAL | LAMOTRIGINE | 1 | Transplacental | 100 MG/DAY | U | 0 | |||||||||
| 126740022 | 12674002 | 5 | SS | LAMICTAL | LAMOTRIGINE | 1 | Transmammary | 50 MG, 2X/DAY (BID) | U | 0 | 50 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126740022 | 12674002 | 1 | Epilepsy |
| 126740022 | 12674002 | 4 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126740022 | 12674002 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126740022 | 12674002 | Dehydration | |
| 126740022 | 12674002 | Exposure during breast feeding | |
| 126740022 | 12674002 | Foetal exposure during pregnancy | |
| 126740022 | 12674002 | Gastrooesophageal reflux disease | |
| 126740022 | 12674002 | Selective eating disorder | |
| 126740022 | 12674002 | Urinary tract infection | |
| 126740022 | 12674002 | Weight gain poor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126740022 | 12674002 | 1 | 20150826 | 20160517 | 0 | |
| 126740022 | 12674002 | 2 | 2016 | 2016 | 0 | |
| 126740022 | 12674002 | 3 | 2016 | 0 | ||
| 126740022 | 12674002 | 4 | 20150826 | 20160517 | 0 | |
| 126740022 | 12674002 | 5 | 2016 | 0 |