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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124998912 | 12499891 | 2 | F | 20160118 | 20160727 | 20160627 | 20160808 | EXP | CO-UCBSA-2016006729 | UCB | 52.00 | YR | M | Y | 80.00000 | KG | 20160808 | CN | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124998912 | 12499891 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 3000 MG, ONCE DAILY (QD); 6 DF OF 500 MG | Y | 178115 | 21035 | 3000 | MG | FILM-COATED TABLET | QD | ||||
| 124998912 | 12499891 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 500 MG, ONCE DAILY (QD) | Y | 21035 | 500 | MG | FILM-COATED TABLET | QD | |||||
| 124998912 | 12499891 | 3 | C | ASPIRIN. | ASPIRIN | 1 | UNK, ONCE DAILY (QD) | U | 0 | TABLET | QD | ||||||||
| 124998912 | 12499891 | 4 | C | ESZOPICLONE. | ESZOPICLONE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 124998912 | 12499891 | 5 | C | ESZOPICLONE. | ESZOPICLONE | 1 | UNK | Y | 0 | TABLET | |||||||||
| 124998912 | 12499891 | 6 | C | Lamotrigina | LAMOTRIGINE | 1 | 200 MG PER DAY | 0 | |||||||||||
| 124998912 | 12499891 | 7 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.5 MG | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124998912 | 12499891 | 1 | Epilepsy |
| 124998912 | 12499891 | 3 | Cardiac disorder |
| 124998912 | 12499891 | 4 | Insomnia |
| 124998912 | 12499891 | 6 | Product used for unknown indication |
| 124998912 | 12499891 | 7 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124998912 | 12499891 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124998912 | 12499891 | Amnesia | |
| 124998912 | 12499891 | Anxiety | |
| 124998912 | 12499891 | Bipolar I disorder | |
| 124998912 | 12499891 | Depression | |
| 124998912 | 12499891 | Disturbance in attention | |
| 124998912 | 12499891 | Drug prescribing error | |
| 124998912 | 12499891 | Headache | |
| 124998912 | 12499891 | Insomnia | |
| 124998912 | 12499891 | Petit mal epilepsy | |
| 124998912 | 12499891 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 124998912 | 12499891 | 1 | 20151220 | 0 | ||
| 124998912 | 12499891 | 2 | 201602 | 0 | ||
| 124998912 | 12499891 | 4 | 20160120 | 2016 | 0 | |
| 124998912 | 12499891 | 5 | 2016 | 2016 | 0 | |
| 124998912 | 12499891 | 6 | 20160613 | 0 |