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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125222731 | 12522273 | 1 | I | 20160509 | 20160621 | 20160701 | 20160701 | EXP | US-UCBSA-2016024081 | UCB | 26.00 | YR | F | Y | 69.00000 | KG | 20160701 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125222731 | 12522273 | 1 | SS | KEPPRA | LEVETIRACETAM | 1 | 1500 MG 2 IN 1 D, | Y | U | 0 | FILM-COATED TABLET | ||||||||
| 125222731 | 12522273 | 2 | SS | KEPPRA | LEVETIRACETAM | 1 | 500 MG DAILY DOSE | Y | U | 0 | FILM-COATED TABLET | ||||||||
| 125222731 | 12522273 | 3 | PS | VIMPAT | LACOSAMIDE | 1 | 200 MG 2 IN 1 D | U | U | 22253 | FILM-COATED TABLET | ||||||||
| 125222731 | 12522273 | 4 | SS | SABRIL | VIGABATRIN | 1 | 1500 MG, 2 IN 1 D, 500 MG | U | U | 0 | TABLET | ||||||||
| 125222731 | 12522273 | 5 | SS | SABRIL | VIGABATRIN | 1 | 1000 MG DAILY DOSE | U | U | 0 | TABLET | ||||||||
| 125222731 | 12522273 | 6 | SS | FELBATOL | FELBAMATE | 1 | 400 MG 3 IN 1 D | U | U | 0 | TABLET | ||||||||
| 125222731 | 12522273 | 7 | SS | FELBATOL | FELBAMATE | 1 | READDED UNKNOWN DOSE | U | U | 0 | TABLET | ||||||||
| 125222731 | 12522273 | 8 | C | AMITIZA | LUBIPROSTONE | 1 | 24 MCG | U | U | 0 | CAPSULE | ||||||||
| 125222731 | 12522273 | 9 | C | DIASTAT ACUDIAL | DIAZEPAM | 1 | 20 MG | U | 0 | GEL | |||||||||
| 125222731 | 12522273 | 10 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 0.9 PERCENT INJECTION 2 ML | U | 0 | INJECTION | |||||||||
| 125222731 | 12522273 | 11 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 20 MILLIEQUIVALENTS | U | 0 | INJECTION | |||||||||
| 125222731 | 12522273 | 12 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 20 MEQ/100 ML | U | 0 | INJECTION | ||||||||
| 125222731 | 12522273 | 13 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 40 MILLIEQUIVALENTS | U | 0 | INJECTION | |||||||||
| 125222731 | 12522273 | 14 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 40 MILLIEQUIVALENTS | U | 0 | INJECTION | |||||||||
| 125222731 | 12522273 | 15 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | UNK | U | 0 | INJECTION | |||||||||
| 125222731 | 12522273 | 16 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | IN DEXTROSE 5 PERCENT 100 ML IVPB | U | 0 | |||||||||
| 125222731 | 12522273 | 17 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 125222731 | 12522273 | 18 | C | DEXTROSE AND SODIUM CHLORIDE | DEXTROSE MONOHYDRATESODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | DEXTROSE 5 % WITH SODIUM CHLORIDE 0.45 PERCENT | U | 0 | |||||||||
| 125222731 | 12522273 | 19 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | 300 MG 2 IN 1 D | U | 0 | TABLET | |||||||||
| 125222731 | 12522273 | 20 | C | CLONAZEPAM. | CLONAZEPAM | 1 | 0.5 MG 2 IN 1D | Y | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125222731 | 12522273 | 1 | Seizure |
| 125222731 | 12522273 | 3 | Seizure |
| 125222731 | 12522273 | 4 | Generalised tonic-clonic seizure |
| 125222731 | 12522273 | 6 | Seizure |
| 125222731 | 12522273 | 8 | Product used for unknown indication |
| 125222731 | 12522273 | 9 | Product used for unknown indication |
| 125222731 | 12522273 | 10 | Product used for unknown indication |
| 125222731 | 12522273 | 15 | Product used for unknown indication |
| 125222731 | 12522273 | 16 | Product used for unknown indication |
| 125222731 | 12522273 | 18 | Product used for unknown indication |
| 125222731 | 12522273 | 19 | Seizure |
| 125222731 | 12522273 | 20 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125222731 | 12522273 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125222731 | 12522273 | Chills | |
| 125222731 | 12522273 | Fatigue | |
| 125222731 | 12522273 | Overdose | |
| 125222731 | 12522273 | Pyrexia | |
| 125222731 | 12522273 | Sedation | |
| 125222731 | 12522273 | Seizure | |
| 125222731 | 12522273 | Tremor | |
| 125222731 | 12522273 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 125222731 | 12522273 | 4 | 201509 | 0 |