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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126289191 | 12628919 | 1 | I | 20160608 | 20160725 | 20160808 | 20160808 | EXP | DE-SUN PHARMACEUTICAL INDUSTRIES LTD-2016R1-121560 | RANBAXY | 1.00 | DY | M | Y | 3.99000 | KG | 20160808 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126289191 | 12628919 | 1 | PS | VALPROIC ACID. | VALPROIC ACID | 1 | Transplacental | 300 MG, TID | U | 91037 | 300 | MG | Q8H | ||||||
| 126289191 | 12628919 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Transplacental | 100 MG, BID | U | 0 | 100 | MG | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126289191 | 12628919 | 1 | Epilepsy |
| 126289191 | 12628919 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126289191 | 12628919 | CA |
| 126289191 | 12628919 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126289191 | 12628919 | Foetal exposure during pregnancy | |
| 126289191 | 12628919 | Hypospadias | |
| 126289191 | 12628919 | 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 |
|---|---|---|---|---|---|---|
| 126289191 | 12628919 | 1 | 20150913 | 20160608 | 0 | |
| 126289191 | 12628919 | 2 | 20150913 | 20160608 | 0 |