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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125613072 | 12561307 | 2 | F | 20160515 | 20160712 | 20160715 | 20160722 | EXP | PT-SUNOVION-2016SUN001701 | SUNOVION | 0.00 | Y | 0.00000 | 20160722 | CN | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125613072 | 12561307 | 1 | PS | Zebinix | ESLICARBAZEPINE ACETATE | 1 | Oral | UNK UNK, QD | Y | 22416 | TABLET | QD | |||||||
125613072 | 12561307 | 2 | SS | Zebinix | ESLICARBAZEPINE ACETATE | 1 | Oral | 800 MG, QD | Y | 22416 | 800 | MG | TABLET | QD | |||||
125613072 | 12561307 | 3 | SS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 1400 MG, QD | 0 | 1400 | MG | QD | |||||||
125613072 | 12561307 | 4 | C | KEPPRA | LEVETIRACETAM | 1 | 3000 MG, QD | 0 | 3000 | MG | QD |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125613072 | 12561307 | 1 | Epilepsy |
125613072 | 12561307 | 3 | Epilepsy |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125613072 | 12561307 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125613072 | 12561307 | Delirium | |
125613072 | 12561307 | Rash |
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 |
---|---|---|---|---|---|---|
125613072 | 12561307 | 1 | 20160314 | 2016 | 0 | |
125613072 | 12561307 | 2 | 201605 | 20160519 | 0 |