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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117952453 | 11795245 | 3 | F | 20160905 | 20160923 | 20151202 | 20160928 | EXP | US-GLAXOSMITHKLINE-US2015GSK170901 | GLAXOSMITHKLINE | 54.17 | YR | F | Y | 0.00000 | 20160928 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117952453 | 11795245 | 1 | PS | LAMOTRIGINE. | LAMOTRIGINE | 1 | 200 MG, UNK | U | 20241 | 200 | MG | TABLET | |||||||
| 117952453 | 11795245 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | 200 MG, BID | UNKNOWN | 20241 | 200 | MG | TABLET | BID | |||||
| 117952453 | 11795245 | 3 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117952453 | 11795245 | 1 | Seizure |
| 117952453 | 11795245 | 2 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117952453 | 11795245 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117952453 | 11795245 | Abnormal dreams | |
| 117952453 | 11795245 | Affect lability | |
| 117952453 | 11795245 | Aggression | |
| 117952453 | 11795245 | Brain injury | |
| 117952453 | 11795245 | Diarrhoea | |
| 117952453 | 11795245 | Drug ineffective | |
| 117952453 | 11795245 | Emotional distress | |
| 117952453 | 11795245 | Fall | |
| 117952453 | 11795245 | Headache | |
| 117952453 | 11795245 | Irritability | |
| 117952453 | 11795245 | Limb injury | |
| 117952453 | 11795245 | Nausea | |
| 117952453 | 11795245 | Nightmare | |
| 117952453 | 11795245 | Oropharyngeal pain | |
| 117952453 | 11795245 | Pain | |
| 117952453 | 11795245 | Product substitution issue | |
| 117952453 | 11795245 | Rhinorrhoea | |
| 117952453 | 11795245 | Rib fracture | |
| 117952453 | 11795245 | Seizure | |
| 117952453 | 11795245 | Sleep terror | |
| 117952453 | 11795245 | Sneezing | |
| 117952453 | 11795245 | Suicidal behaviour | |
| 117952453 | 11795245 | Suicidal ideation | |
| 117952453 | 11795245 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 117952453 | 11795245 | 1 | 20151115 | 0 | ||
| 117952453 | 11795245 | 2 | 1999 | 0 |