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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114200652 | 11420065 | 2 | F | 20160916 | 20150826 | 20160921 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN053666 | GLAXOSMITHKLINE | OTANI H, YAMAZAKI E, YOSHIMURA M, SHIGEMATSU H, HIYOSHI T, TERADA K, ET AL.. LAMOTRIGINE AND PREGNANCY: CHANGES OF SERUM CONCENTRATION AND SEIZURE FREQUENCY. THE 9TH TOKAI AND HOKURIKU REGIONAL MEETING OF THE JAPAN EPILEPSY SOCIETY. 2016;6 | 0.00 | F | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114200652 | 11420065 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 400 MG, 1D | D | 20241 | 400 | MG | TABLET | QD | |||||
| 114200652 | 11420065 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 500 MG, 1D | D | 20241 | 500 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114200652 | 11420065 | 1 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114200652 | 11420065 | DE |
| 114200652 | 11420065 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114200652 | 11420065 | Drug level decreased | |
| 114200652 | 11420065 | Exposure during pregnancy | |
| 114200652 | 11420065 | Maternal death affecting foetus | |
| 114200652 | 11420065 | Seizure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |