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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125745062 | 12574506 | 2 | F | 20150424 | 20160809 | 20160720 | 20160816 | EXP | JP-GLAXOSMITHKLINE-JP2016JPN101463 | GLAXOSMITHKLINE | 16.18 | YR | M | Y | 62.00000 | KG | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125745062 | 12574506 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 200 MG, 1D | 65200 | MG | Y | 20241 | 200 | MG | TABLET | QD | |||
| 125745062 | 12574506 | 2 | C | MYSTAN | CLOBAZAM | 1 | 10 MG, 1D | 0 | 10 | MG | QD | ||||||||
| 125745062 | 12574506 | 3 | C | MYSTAN | CLOBAZAM | 1 | 35 MG, 1D | 0 | 35 | MG | QD | ||||||||
| 125745062 | 12574506 | 4 | C | E KEPPRA | LEVETIRACETAM | 1 | 3000 MG, 1D | 0 | 3000 | MG | QD | ||||||||
| 125745062 | 12574506 | 5 | C | DEPAKENE | VALPROIC ACID | 1 | 600 MG, 1D | 0 | 600 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125745062 | 12574506 | 1 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125745062 | 12574506 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125745062 | 12574506 | Arrhythmia | |
| 125745062 | 12574506 | Fall | |
| 125745062 | 12574506 | Sinus node dysfunction |
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 |
|---|---|---|---|---|---|---|
| 125745062 | 12574506 | 1 | 20150123 | 20160105 | 0 |