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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125527791 | 12552779 | 1 | I | 20160705 | 20160713 | 20160713 | EXP | US-LUNDBECK-DKLU2016106 | LUNDBECK | 0.00 | F | Y | 0.00000 | 20160713 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125527791 | 12552779 | 1 | PS | ONFI | CLOBAZAM | 1 | Unknown | 203993 | 1 | ML | ORAL SUSPENSION | BID | |||||||
125527791 | 12552779 | 2 | SS | ONFI | CLOBAZAM | 1 | Unknown | 203993 | 3 | ML | ORAL SUSPENSION | BID | |||||||
125527791 | 12552779 | 3 | SS | ONFI | CLOBAZAM | 1 | 203993 | ||||||||||||
125527791 | 12552779 | 4 | SS | DEPAKOTE | DIVALPROEX SODIUM | 1 | Unknown | 0 | |||||||||||
125527791 | 12552779 | 5 | C | KEPPRA | LEVETIRACETAM | 1 | Unknown | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125527791 | 12552779 | 1 | Idiopathic generalised epilepsy |
125527791 | 12552779 | 2 | Epilepsy |
125527791 | 12552779 | 3 | Status epilepticus |
125527791 | 12552779 | 4 | Product used for unknown indication |
125527791 | 12552779 | 5 | Product used for unknown indication |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125527791 | 12552779 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125527791 | 12552779 | Aggression | |
125527791 | 12552779 | Atonic seizures | |
125527791 | 12552779 | Mood altered | |
125527791 | 12552779 | Myoclonus | |
125527791 | 12552779 | Seizure | |
125527791 | 12552779 | Urinary incontinence |
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 |
---|---|---|---|---|---|---|
125527791 | 12552779 | 1 | 20160523 | 0 |