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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125271123 | 12527112 | 3 | F | 20160707 | 20160726 | 20160705 | 20160728 | EXP | US-GLAXOSMITHKLINE-US2016GSK094515 | GLAXOSMITHKLINE | 47.23 | YR | M | Y | 86.62000 | KG | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125271123 | 12527112 | 1 | PS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 200 MG, UNK | 20241 | 200 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125271123 | 12527112 | 1 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125271123 | 12527112 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125271123 | 12527112 | Disorientation | |
| 125271123 | 12527112 | Drug dose omission | |
| 125271123 | 12527112 | Impaired driving ability | |
| 125271123 | 12527112 | Loss of consciousness | |
| 125271123 | 12527112 | Memory impairment | |
| 125271123 | 12527112 | Seizure | |
| 125271123 | 12527112 | Somnolence |
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 |
|---|---|---|---|---|---|---|
| 125271123 | 12527112 | 1 | 20140404 | 20160706 | 0 |