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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110025032 | 11002503 | 2 | F | 20150312 | 20160823 | 20150408 | 20160830 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN039669 | GLAXOSMITHKLINE | 20.00 | YR | F | Y | 0.00000 | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 110025032 | 11002503 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QOD | 550 | MG | Y | 20241 | 25 | MG | TABLET | QOD | |||
| 110025032 | 11002503 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 550 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 110025032 | 11002503 | 3 | C | DEPAKENE | VALPROIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 110025032 | 11002503 | 1 | Partial seizures |
| 110025032 | 11002503 | 2 | Seizure |
| 110025032 | 11002503 | 3 | Partial seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 110025032 | 11002503 | OT |
| 110025032 | 11002503 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 110025032 | 11002503 | Drug eruption | |
| 110025032 | 11002503 | Generalised erythema | |
| 110025032 | 11002503 | Lip swelling | |
| 110025032 | 11002503 | Papule | |
| 110025032 | 11002503 | Rash generalised | |
| 110025032 | 11002503 | Toxic skin eruption |
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 |
|---|---|---|---|---|---|---|
| 110025032 | 11002503 | 1 | 20150210 | 20150217 | 0 | |
| 110025032 | 11002503 | 2 | 20150218 | 20150314 | 0 |