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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125893682 | 12589368 | 2 | F | 2015 | 20160719 | 20160725 | 20160729 | EXP | DE-UCBSA-2016027543 | UCB | 0.00 | E | M | Y | 0.00000 | 20160729 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125893682 | 12589368 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 4 G, UNK | 21035 | 4 | G | |||||||||
| 125893682 | 12589368 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | UPTITRATED DOSE | 21035 | |||||||||||
| 125893682 | 12589368 | 3 | C | HYDROCHLOROTHIAZIDE. | HYDROCHLOROTHIAZIDE | 1 | UNK | Y | U | 0 | |||||||||
| 125893682 | 12589368 | 4 | C | LORAZEPAM. | LORAZEPAM | 1 | 2 MG | 0 | |||||||||||
| 125893682 | 12589368 | 5 | C | PHENYTOIN. | PHENYTOIN | 1 | UNK | 0 | |||||||||||
| 125893682 | 12589368 | 6 | C | Clobazam | CLOBAZAM | 1 | UNK | 0 | |||||||||||
| 125893682 | 12589368 | 7 | C | LACOSAMIDE. | LACOSAMIDE | 1 | UNK | Y | 0 | ||||||||||
| 125893682 | 12589368 | 8 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | UNK | U | U | 0 | |||||||||
| 125893682 | 12589368 | 9 | C | PREGABALIN. | PREGABALIN | 1 | UNK | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125893682 | 12589368 | 1 | Status epilepticus |
| 125893682 | 12589368 | 2 | Off label use |
| 125893682 | 12589368 | 3 | Product used for unknown indication |
| 125893682 | 12589368 | 4 | Product used for unknown indication |
| 125893682 | 12589368 | 5 | Product used for unknown indication |
| 125893682 | 12589368 | 6 | Product used for unknown indication |
| 125893682 | 12589368 | 7 | Product used for unknown indication |
| 125893682 | 12589368 | 8 | Product used for unknown indication |
| 125893682 | 12589368 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125893682 | 12589368 | HO |
| 125893682 | 12589368 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125893682 | 12589368 | Formication | |
| 125893682 | 12589368 | Hyponatraemia | |
| 125893682 | 12589368 | Multiple-drug resistance | |
| 125893682 | 12589368 | Off label use | |
| 125893682 | 12589368 | Seizure | |
| 125893682 | 12589368 | Status epilepticus |
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 |
|---|---|---|---|---|---|---|
| 125893682 | 12589368 | 1 | 201508 | 201508 | 0 | |
| 125893682 | 12589368 | 2 | 201508 | 0 | ||
| 125893682 | 12589368 | 8 | 201509 | 0 |