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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114851344 | 11485134 | 4 | F | 20150702 | 20160815 | 20150909 | 20160818 | EXP | JP-GLAXOSMITHKLINE-JP2015JPN100008 | GLAXOSMITHKLINE | 74.37 | YR | F | Y | 51.00000 | KG | 20160818 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114851344 | 11485134 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QOD | 550 | MG | Y | 20241 | 25 | MG | TABLET | QOD | |||
| 114851344 | 11485134 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 550 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 114851344 | 11485134 | 3 | C | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | UNK | 0 | |||||||||||
| 114851344 | 11485134 | 4 | C | AMLODIN OD | AMLODIPINE BESYLATE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114851344 | 11485134 | 1 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 114851344 | 11485134 | OT |
| 114851344 | 11485134 | LT |
| 114851344 | 11485134 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114851344 | 11485134 | Blister | |
| 114851344 | 11485134 | Erythema of eyelid | |
| 114851344 | 11485134 | Eye discharge | |
| 114851344 | 11485134 | Generalised erythema | |
| 114851344 | 11485134 | Lip erosion | |
| 114851344 | 11485134 | Ocular hyperaemia | |
| 114851344 | 11485134 | Oral mucosa erosion | |
| 114851344 | 11485134 | Pyrexia | |
| 114851344 | 11485134 | Rash maculo-papular | |
| 114851344 | 11485134 | Scab | |
| 114851344 | 11485134 | Skin erosion | |
| 114851344 | 11485134 | Toxic epidermal necrolysis | |
| 114851344 | 11485134 | Visual acuity reduced | |
| 114851344 | 11485134 | Vulval disorder |
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 |
|---|---|---|---|---|---|---|
| 114851344 | 11485134 | 1 | 20120828 | 20120910 | 0 | |
| 114851344 | 11485134 | 2 | 20150610 | 20150704 | 0 | |
| 114851344 | 11485134 | 3 | 20141125 | 0 | ||
| 114851344 | 11485134 | 4 | 20100511 | 0 |