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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125259271 | 12525927 | 1 | I | 2016 | 20160530 | 20160705 | 20160705 | EXP | JP-UCBSA-2016020436 | UCB | 72.11 | YR | M | Y | 0.00000 | 20160705 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125259271 | 12525927 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Intravenous drip | 500 MG, 2X/DAY (BID) | 13000 | MG | U | 21035 | 500 | MG | BID | ||||
| 125259271 | 12525927 | 2 | C | Sulbacillin | AMPICILLIN SODIUMSULBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 6 G DAILY | U | 0 | |||||||||
| 125259271 | 12525927 | 3 | C | Flumarin | FLOMOXEF SODIUM | 1 | Intravenous (not otherwise specified) | 2 G DAILY | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125259271 | 12525927 | 1 | Generalised tonic-clonic seizure |
| 125259271 | 12525927 | 2 | Product used for unknown indication |
| 125259271 | 12525927 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125259271 | 12525927 | LT |
| 125259271 | 12525927 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125259271 | 12525927 | Asphyxia | |
| 125259271 | 12525927 | Hypernatraemia | |
| 125259271 | 12525927 | Hypoxic-ischaemic encephalopathy | |
| 125259271 | 12525927 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 125259271 | 12525927 | 1 | 20160210 | 20160222 | 0 | |
| 125259271 | 12525927 | 2 | 20160210 | 20160223 | 0 | |
| 125259271 | 12525927 | 3 | 20160224 | 20160225 | 0 |