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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127644291 | 12764429 | 1 | I | 201606 | 20160627 | 20160920 | 20160920 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN091857 | GLAXOSMITHKLINE | 32.82 | YR | F | Y | 55.00000 | KG | 20160920 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127644291 | 12764429 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, 1D | 700 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 127644291 | 12764429 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, 1D | 700 | MG | Y | 20241 | 50 | MG | TABLET | QD | |||
| 127644291 | 12764429 | 3 | C | DEPAKENE | VALPROIC ACID | 1 | 400 MG, BID | 0 | 400 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127644291 | 12764429 | 1 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127644291 | 12764429 | HO |
| 127644291 | 12764429 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127644291 | 12764429 | Abnormal sensation in eye | |
| 127644291 | 12764429 | Asthenia | |
| 127644291 | 12764429 | Blister | |
| 127644291 | 12764429 | Cough | |
| 127644291 | 12764429 | Drug hypersensitivity | |
| 127644291 | 12764429 | Epidermal necrosis | |
| 127644291 | 12764429 | Erythema multiforme | |
| 127644291 | 12764429 | Erythema of eyelid | |
| 127644291 | 12764429 | Eye discharge | |
| 127644291 | 12764429 | Laryngeal ulceration | |
| 127644291 | 12764429 | Lip erosion | |
| 127644291 | 12764429 | Lymph node pain | |
| 127644291 | 12764429 | Malaise | |
| 127644291 | 12764429 | Mouth ulceration | |
| 127644291 | 12764429 | Nasal mucosal erosion | |
| 127644291 | 12764429 | Ocular hyperaemia | |
| 127644291 | 12764429 | Oral discomfort | |
| 127644291 | 12764429 | Oral mucosa erosion | |
| 127644291 | 12764429 | Oral pain | |
| 127644291 | 12764429 | Palmar erythema | |
| 127644291 | 12764429 | Plantar erythema | |
| 127644291 | 12764429 | Pyrexia | |
| 127644291 | 12764429 | Rash maculo-papular | |
| 127644291 | 12764429 | Rash papular | |
| 127644291 | 12764429 | Stevens-Johnson syndrome |
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 |
|---|---|---|---|---|---|---|
| 127644291 | 12764429 | 1 | 20160427 | 20160525 | 0 | |
| 127644291 | 12764429 | 2 | 20160526 | 20160607 | 0 |