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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125218551 | 12521855 | 1 | I | 20160509 | 20160622 | 20160701 | 20160701 | EXP | US-TEVA-672839USA | TEVA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125218551 | 12521855 | 1 | PS | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 1 MILLIGRAM DAILY; | Y | 74569 | .5 | MG | BID | ||||||
| 125218551 | 12521855 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 600 MILLIGRAM DAILY; | U | 76420 | 300 | MG | TABLET | BID | |||||
| 125218551 | 12521855 | 3 | I | SABRIL | VIGABATRIN | 1 | Unknown | 3000 MILLIGRAM DAILY; | U | 0 | 1500 | MG | TABLET | BID | |||||
| 125218551 | 12521855 | 4 | I | SABRIL | VIGABATRIN | 1 | U | 0 | 1000 | MG | TABLET | ||||||||
| 125218551 | 12521855 | 5 | SS | FELBATOL | FELBAMATE | 1 | Unknown | 1200 MILLIGRAM DAILY; | U | 0 | 400 | MG | TABLET | TID | |||||
| 125218551 | 12521855 | 6 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | 3000 MILLIGRAM DAILY; | Y | 0 | 1500 | MG | TABLET | BID | |||||
| 125218551 | 12521855 | 7 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | Y | 0 | 500 | MG | TABLET | |||||||
| 125218551 | 12521855 | 8 | SS | VIMPAT | LACOSAMIDE | 1 | Unknown | 400 MILLIGRAM DAILY; | U | 0 | 200 | MG | TABLET | BID | |||||
| 125218551 | 12521855 | 9 | C | AMITIZA | LUBIPROSTONE | 1 | 0 | 24 | UG | CAPSULE | |||||||||
| 125218551 | 12521855 | 10 | C | DIASTAT ACUDIAL | DIAZEPAM | 1 | 0 | 20 | MG | GEL | |||||||||
| 125218551 | 12521855 | 11 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 0.9 PERCENT INJECTION 2 ML | 0 | .9 | PCT | INJECTION | ||||||||
| 125218551 | 12521855 | 12 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Unknown | 0 | 20 | MEQ | |||||||||
| 125218551 | 12521855 | 13 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 20 MEQ/100ML | 0 | 20 | MEQ | ||||||||
| 125218551 | 12521855 | 14 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Unknown | 0 | 40 | MEQ | |||||||||
| 125218551 | 12521855 | 15 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Unknown | 0 | 40 | MEQ | |||||||||
| 125218551 | 12521855 | 16 | C | LOVENOX | ENOXAPARIN SODIUM | 1 | 0 | 40 | MG | INJECTION | |||||||||
| 125218551 | 12521855 | 17 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | IN DEXTROSE 5 PERCENT 100 ML IVPB | 0 | 1 | G | ||||||||
| 125218551 | 12521855 | 18 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | 0 | 2 | G | |||||||||
| 125218551 | 12521855 | 19 | C | DEXTROSE AND SODIUM CHLORIDE INJECTION | 2 | Intravenous (not otherwise specified) | DEXTROSE 5 PERCENT WITH SOCIUM CHLORIDE 0.45 PERCENT | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125218551 | 12521855 | 1 | Seizure |
| 125218551 | 12521855 | 2 | Seizure |
| 125218551 | 12521855 | 3 | Generalised tonic-clonic seizure |
| 125218551 | 12521855 | 5 | Seizure |
| 125218551 | 12521855 | 6 | Seizure |
| 125218551 | 12521855 | 8 | Seizure |
| 125218551 | 12521855 | 9 | Product used for unknown indication |
| 125218551 | 12521855 | 10 | Product used for unknown indication |
| 125218551 | 12521855 | 11 | Product used for unknown indication |
| 125218551 | 12521855 | 16 | Product used for unknown indication |
| 125218551 | 12521855 | 17 | Product used for unknown indication |
| 125218551 | 12521855 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125218551 | 12521855 | HO |
| 125218551 | 12521855 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125218551 | 12521855 | Chills | |
| 125218551 | 12521855 | Drug ineffective | |
| 125218551 | 12521855 | Fatigue | |
| 125218551 | 12521855 | Overdose | |
| 125218551 | 12521855 | Potentiating drug interaction | |
| 125218551 | 12521855 | Pyrexia | |
| 125218551 | 12521855 | Sedation | |
| 125218551 | 12521855 | Seizure | |
| 125218551 | 12521855 | Tremor | |
| 125218551 | 12521855 | 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 |
|---|---|---|---|---|---|---|
| 125218551 | 12521855 | 3 | 201509 | 201509 | 0 |