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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125571284 | 12557128 | 4 | F | 20160610 | 20160913 | 20160714 | 20160916 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN098243 | GLAXOSMITHKLINE | 27.00 | YR | F | Y | 0.00000 | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125571284 | 12557128 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 25 MG, QD | 1025 | MG | Y | 20241 | 25 | MG | TABLET | QD | |||
| 125571284 | 12557128 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 50 MG, QD | 1025 | MG | Y | 20241 | 50 | MG | TABLET | QD | |||
| 125571284 | 12557128 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG, QD | 1025 | MG | Y | 20241 | 100 | MG | TABLET | QD | |||
| 125571284 | 12557128 | 4 | C | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | 200 MG, 1D | 0 | 200 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125571284 | 12557128 | 1 | Bipolar disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125571284 | 12557128 | HO |
| 125571284 | 12557128 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125571284 | 12557128 | Drug reaction with eosinophilia and systemic symptoms | |
| 125571284 | 12557128 | Rash |
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 |
|---|---|---|---|---|---|---|
| 125571284 | 12557128 | 1 | 20160407 | 20160420 | 0 | |
| 125571284 | 12557128 | 2 | 20160421 | 20160505 | 0 | |
| 125571284 | 12557128 | 3 | 20160506 | 0 | ||
| 125571284 | 12557128 | 4 | 20160530 | 201606 | 0 |