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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107254073 | 10725407 | 3 | F | 20141222 | 20160906 | 20150121 | 20160912 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN004095 | GLAXOSMITHKLINE | 48.00 | YR | F | Y | 0.00000 | 20160912 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 107254073 | 10725407 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QOD | Y | 20241 | 25 | MG | TABLET | QOD | |||||
| 107254073 | 10725407 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | Y | 20241 | 25 | MG | TABLET | QD | |||||
| 107254073 | 10725407 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | Y | 20241 | 50 | MG | TABLET | QD | |||||
| 107254073 | 10725407 | 4 | C | SELENICA-R | VALPROATE SODIUM | 1 | 600 MG, QD | 1508400 | MG | 0 | 600 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 107254073 | 10725407 | 1 | Epilepsy |
| 107254073 | 10725407 | 2 | Convulsion prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 107254073 | 10725407 | HO |
| 107254073 | 10725407 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 107254073 | 10725407 | Drug eruption | |
| 107254073 | 10725407 | Enanthema | |
| 107254073 | 10725407 | Erythema multiforme | |
| 107254073 | 10725407 | Mucosal erosion | |
| 107254073 | 10725407 | Peripheral swelling | |
| 107254073 | 10725407 | Swelling face | |
| 107254073 | 10725407 | Urticaria |
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 |
|---|---|---|---|---|---|---|
| 107254073 | 10725407 | 1 | 20141112 | 20141124 | 0 | |
| 107254073 | 10725407 | 2 | 20141125 | 20141207 | 0 | |
| 107254073 | 10725407 | 3 | 20141208 | 20141222 | 0 | |
| 107254073 | 10725407 | 4 | 20080203 | 20141222 | 0 |