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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127000211 | 12700021 | 1 | I | 201505 | 20160818 | 20160830 | 20160830 | EXP | ID-UCBSA-2016032864 | UCB | 39.00 | YR | M | Y | 0.00000 | 20160830 | CN | ID | ID |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127000211 | 12700021 | 1 | PS | KEPPRA | LEVETIRACETAM | 1 | Oral | 250 MG, 2X/DAY (BID) | 186375 | 21035 | 250 | MG | FILM-COATED TABLET | BID | |||||
| 127000211 | 12700021 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | 500 MG, 2X/DAY (BID) | 21035 | 500 | MG | FILM-COATED TABLET | BID | |||||||
| 127000211 | 12700021 | 3 | SS | KEPPRA | LEVETIRACETAM | 1 | MISSED DOSE | 21035 | FILM-COATED TABLET | ||||||||||
| 127000211 | 12700021 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | 250 MG IN MORNING AND 500 MG IN EVENING, 2X/DAY (BID) | 21035 | FILM-COATED TABLET | BID | |||||||||
| 127000211 | 12700021 | 5 | SS | KEPPRA | LEVETIRACETAM | 1 | 250 MG, 2X/DAY (BID) | 21035 | 250 | MG | FILM-COATED TABLET | BID | |||||||
| 127000211 | 12700021 | 6 | SS | KEPPRA | LEVETIRACETAM | 1 | 500 MG, 2X/DAY (BID) | 21035 | 500 | MG | FILM-COATED TABLET | BID | |||||||
| 127000211 | 12700021 | 7 | SS | DILANTIN | PHENYTOIN | 1 | Oral | 100 MG, 3X/DAY (TID) | 0 | 100 | MG | TID | |||||||
| 127000211 | 12700021 | 8 | C | Frisium | CLOBAZAM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127000211 | 12700021 | 1 | Seizure |
| 127000211 | 12700021 | 7 | Seizure |
| 127000211 | 12700021 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127000211 | 12700021 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127000211 | 12700021 | Drug dependence | |
| 127000211 | 12700021 | Drug dose omission | |
| 127000211 | 12700021 | Headache | |
| 127000211 | 12700021 | Intentional product misuse | |
| 127000211 | 12700021 | Procedural pain | |
| 127000211 | 12700021 | Seizure | |
| 127000211 | 12700021 | Treatment noncompliance |
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 |
|---|---|---|---|---|---|---|
| 127000211 | 12700021 | 1 | 201505 | 2015 | 0 | |
| 127000211 | 12700021 | 2 | 201507 | 2016 | 0 | |
| 127000211 | 12700021 | 3 | 2016 | 2016 | 0 | |
| 127000211 | 12700021 | 4 | 2016 | 2016 | 0 | |
| 127000211 | 12700021 | 5 | 2016 | 2016 | 0 | |
| 127000211 | 12700021 | 6 | 2016 | 0 | ||
| 127000211 | 12700021 | 7 | 2014 | 0 | ||
| 127000211 | 12700021 | 8 | 201607 | 0 |