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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126103772 | 12610377 | 2 | F | 20120429 | 20160921 | 20160801 | 20160926 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN084104 | GLAXOSMITHKLINE | 36.25 | YR | F | Y | 48.00000 | KG | 20160926 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126103772 | 12610377 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QOD | 325 | MG | Y | 20241 | 25 | MG | TABLET | QOD | |||
| 126103772 | 12610377 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, 1D | 325 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 126103772 | 12610377 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, 1D | 325 | MG | Y | 20241 | 50 | MG | TABLET | QD | |||
| 126103772 | 12610377 | 4 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 200 MG, BID | 2200 | MG | 0 | 200 | MG | BID | |||||
| 126103772 | 12610377 | 5 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 200 MG, QD | 2200 | MG | 0 | 200 | MG | QD | |||||
| 126103772 | 12610377 | 6 | SS | DEPAKENE | VALPROIC ACID | 1 | Oral | 200 MG, BID | 2200 | MG | 0 | 200 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126103772 | 12610377 | 1 | Epilepsy |
| 126103772 | 12610377 | 2 | Convulsion prophylaxis |
| 126103772 | 12610377 | 4 | Epilepsy |
| 126103772 | 12610377 | 5 | Convulsion prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126103772 | 12610377 | OT |
| 126103772 | 12610377 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126103772 | 12610377 | Ageusia | |
| 126103772 | 12610377 | Blister | |
| 126103772 | 12610377 | Epidermal necrosis | |
| 126103772 | 12610377 | Erythema multiforme | |
| 126103772 | 12610377 | Generalised erythema | |
| 126103772 | 12610377 | Hypophagia | |
| 126103772 | 12610377 | Lip erosion | |
| 126103772 | 12610377 | Lymphadenopathy | |
| 126103772 | 12610377 | Mouth haemorrhage | |
| 126103772 | 12610377 | Nasal mucosal erosion | |
| 126103772 | 12610377 | Oedema mucosal | |
| 126103772 | 12610377 | Oral mucosa erosion | |
| 126103772 | 12610377 | Pigmentation disorder | |
| 126103772 | 12610377 | Pruritus | |
| 126103772 | 12610377 | Pyrexia | |
| 126103772 | 12610377 | Rash generalised | |
| 126103772 | 12610377 | Scab | |
| 126103772 | 12610377 | Skin exfoliation | |
| 126103772 | 12610377 | Stevens-Johnson syndrome | |
| 126103772 | 12610377 | Strangury | |
| 126103772 | 12610377 | Vulvar erosion |
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 |
|---|---|---|---|---|---|---|
| 126103772 | 12610377 | 1 | 20120327 | 20120408 | 0 | |
| 126103772 | 12610377 | 2 | 20120410 | 20120423 | 0 | |
| 126103772 | 12610377 | 3 | 20120424 | 20120507 | 0 | |
| 126103772 | 12610377 | 4 | 201201 | 20120417 | 0 | |
| 126103772 | 12610377 | 5 | 20120418 | 20120508 | 0 | |
| 126103772 | 12610377 | 6 | 20120509 | 20130415 | 0 |