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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124593142 | 12459314 | 2 | F | 201507 | 20160913 | 20160613 | 20160920 | EXP | FR-GLAXOSMITHKLINE-FR2016GSK082315 | GLAXOSMITHKLINE | 21.12 | YR | F | Y | 37.00000 | KG | 20160920 | CN | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124593142 | 12459314 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 200 MG, BID | Y | 20764 | 200 | MG | DISPERSIBLE TABLET | BID | |||||
| 124593142 | 12459314 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 125 MG, BID | Y | 20764 | 125 | MG | DISPERSIBLE TABLET | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124593142 | 12459314 | 1 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124593142 | 12459314 | HO |
| 124593142 | 12459314 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124593142 | 12459314 | Crying | |
| 124593142 | 12459314 | Drug level increased | |
| 124593142 | 12459314 | Feeling hot | |
| 124593142 | 12459314 | Gastrointestinal pain | |
| 124593142 | 12459314 | Head titubation | |
| 124593142 | 12459314 | Hyperacusis | |
| 124593142 | 12459314 | Hyperhidrosis | |
| 124593142 | 12459314 | Irritability | |
| 124593142 | 12459314 | Malabsorption | |
| 124593142 | 12459314 | Mydriasis | |
| 124593142 | 12459314 | Neurological symptom | |
| 124593142 | 12459314 | Nystagmus | |
| 124593142 | 12459314 | Photosensitivity reaction | |
| 124593142 | 12459314 | Pyrexia | |
| 124593142 | 12459314 | Trismus | |
| 124593142 | 12459314 | Urinary retention |
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 |
|---|---|---|---|---|---|---|
| 124593142 | 12459314 | 1 | 2004 | 0 |