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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124196874 | 12419687 | 4 | F | 2013 | 20160808 | 20160531 | 20160812 | EXP | US-GLAXOSMITHKLINE-US2016GSK076388 | GLAXOSMITHKLINE | 0.00 | M | Y | 93.88000 | KG | 20160812 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124196874 | 12419687 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 100 MG UNK, U | U | 20241 | TABLET | ||||||||
| 124196874 | 12419687 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | UNK, U | U | 0 | |||||||||
| 124196874 | 12419687 | 3 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Oral | UNK, U 100 MG TABLETS | U | 0 | PROLONGED-RELEASE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124196874 | 12419687 | 1 | Seizure |
| 124196874 | 12419687 | 2 | Seizure |
| 124196874 | 12419687 | 3 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124196874 | 12419687 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124196874 | 12419687 | Ageusia | |
| 124196874 | 12419687 | Anosmia | |
| 124196874 | 12419687 | Disorientation | |
| 124196874 | 12419687 | Drug ineffective | |
| 124196874 | 12419687 | Emergency care | |
| 124196874 | 12419687 | Generalised tonic-clonic seizure | |
| 124196874 | 12419687 | Loss of consciousness | |
| 124196874 | 12419687 | Myocardial infarction | |
| 124196874 | 12419687 | Somnolence | |
| 124196874 | 12419687 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124196874 | 12419687 | 2 | 20150824 | 0 | ||
| 124196874 | 12419687 | 3 | 20140519 | 0 |