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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126159441 | 12615944 | 1 | I | 20160608 | 20160725 | 20160802 | 20160802 | EXP | DE-MYLANLABS-2016M1030925 | MYLAN | 0.00 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126159441 | 12615944 | 1 | PS | VALPROIC ACID. | VALPROIC ACID | 1 | Transplacental | 300 MG, TID (900 [MG/D ]) | 243000 | MG | U | 77567 | 300 | MG | TID | ||||
126159441 | 12615944 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Transplacental | 100 MG, BID (200 [MG/D ]) | 54000 | MG | U | 0 | 100 | MG | BID |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126159441 | 12615944 | 1 | Epilepsy |
126159441 | 12615944 | 2 | Epilepsy |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126159441 | 12615944 | CA |
126159441 | 12615944 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126159441 | 12615944 | Foetal exposure during pregnancy | |
126159441 | 12615944 | Hypospadias | |
126159441 | 12615944 | Large for dates baby |
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 |
---|---|---|---|---|---|---|
126159441 | 12615944 | 1 | 20150913 | 20160608 | 0 | |
126159441 | 12615944 | 2 | 20150913 | 20160608 | 0 |