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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127539401 | 12753940 | 1 | I | 20160729 | 20160908 | 20160916 | 20160916 | EXP | FR-UCBSA-2016034983 | UCB | 39.75 | YR | M | Y | 0.00000 | 20160916 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127539401 | 12753940 | 1 | PS | VIMPAT | LACOSAMIDE | 1 | Oral | 200 MG, 2X/DAY (BID) | 22253 | 200 | MG | FILM-COATED TABLET | BID | ||||||
| 127539401 | 12753940 | 2 | SS | VIMPAT | LACOSAMIDE | 1 | 400 MG, TOTAL | 22253 | 400 | MG | FILM-COATED TABLET | 1X | |||||||
| 127539401 | 12753940 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | 300 MG IN THE MORNING AND 600 MG IN THE EVENING, 2X/DAY (BID) | Y | U | 0 | FILM-COATED TABLET | BID | |||||||
| 127539401 | 12753940 | 4 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 900 MG, TOTAL | Y | U | 0 | 900 | MG | FILM-COATED TABLET | 1X |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127539401 | 12753940 | 1 | Epilepsy |
| 127539401 | 12753940 | 3 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127539401 | 12753940 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127539401 | 12753940 | Diplopia | |
| 127539401 | 12753940 | Dizziness | |
| 127539401 | 12753940 | Hyponatraemia | |
| 127539401 | 12753940 | Nausea | |
| 127539401 | 12753940 | Overdose | |
| 127539401 | 12753940 | 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 |
|---|---|---|---|---|---|---|
| 127539401 | 12753940 | 2 | 20160729 | 20160729 | 0 | |
| 127539401 | 12753940 | 4 | 20160729 | 20160729 | 0 |