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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112526287 | 11252628 | 7 | F | 201501 | 20160707 | 20150708 | 20160714 | EXP | US-GLAXOSMITHKLINE-US2015097950 | GLAXOSMITHKLINE | 54.11 | YR | F | Y | 0.00000 | 20160714 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112526287 | 11252628 | 1 | PS | LAMICTAL XR | LAMOTRIGINE | 1 | UNK | U | U | UNKNOWN | 22115 | PROLONGED-RELEASE TABLET | |||||||
| 112526287 | 11252628 | 2 | SS | LAMICTAL XR | LAMOTRIGINE | 1 | 200 MG, UNK | U | U | UNKNOWN | 22115 | 200 | MG | PROLONGED-RELEASE TABLET | |||||
| 112526287 | 11252628 | 3 | SS | LAMICTAL XR | LAMOTRIGINE | 1 | 200 MG, UNK | U | U | 92915 | 22115 | 200 | MG | PROLONGED-RELEASE TABLET | |||||
| 112526287 | 11252628 | 4 | SS | LAMICTAL XR | LAMOTRIGINE | 1 | UNK, U | U | U | 22115 | PROLONGED-RELEASE TABLET | ||||||||
| 112526287 | 11252628 | 5 | SS | LAMICTAL XR | LAMOTRIGINE | 1 | 200 MG UNK, U | U | U | 22115 | PROLONGED-RELEASE TABLET | ||||||||
| 112526287 | 11252628 | 6 | SS | LAMICTAL | LAMOTRIGINE | 1 | UNK | U | 012003101 | 0 | TABLET | ||||||||
| 112526287 | 11252628 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | UNK | U | 0 | ||||||||||
| 112526287 | 11252628 | 8 | C | TOPIRAMATE. | TOPIRAMATE | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112526287 | 11252628 | 1 | Seizure |
| 112526287 | 11252628 | 2 | Epilepsy |
| 112526287 | 11252628 | 6 | Seizure |
| 112526287 | 11252628 | 7 | Product used for unknown indication |
| 112526287 | 11252628 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112526287 | 11252628 | OT |
| 112526287 | 11252628 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112526287 | 11252628 | Amnesia | |
| 112526287 | 11252628 | Diplopia | |
| 112526287 | 11252628 | Drug ineffective | |
| 112526287 | 11252628 | Generalised tonic-clonic seizure | |
| 112526287 | 11252628 | Loss of consciousness | |
| 112526287 | 11252628 | Seizure cluster | |
| 112526287 | 11252628 | Tremor | |
| 112526287 | 11252628 | Vision blurred | |
| 112526287 | 11252628 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 112526287 | 11252628 | 1 | 20130116 | 0 | ||
| 112526287 | 11252628 | 2 | 20130429 | 0 | ||
| 112526287 | 11252628 | 3 | 20131030 | 0 | ||
| 112526287 | 11252628 | 6 | 2013 | 0 | ||
| 112526287 | 11252628 | 8 | 20140910 | 0 |