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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123904912 | 12390491 | 2 | F | 20160830 | 20160520 | 20160907 | EXP | US-LUNDBECK-DKLU2012890 | LUNDBECK | 0.00 | F | Y | 0.00000 | 20160907 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123904912 | 12390491 | 1 | PS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 10 | MG | TABLET | BID | |||||||
| 123904912 | 12390491 | 2 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | TABLET | ||||||||||
| 123904912 | 12390491 | 3 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 5 | MG | TABLET | BID | |||||||
| 123904912 | 12390491 | 4 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 20 | MG | TABLET | QD | |||||||
| 123904912 | 12390491 | 5 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 10 | MG | TABLET | QD | |||||||
| 123904912 | 12390491 | 6 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 10 | MG | TABLET | QD | |||||||
| 123904912 | 12390491 | 7 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 20 | MG | TABLET | QD | |||||||
| 123904912 | 12390491 | 8 | SS | ONFI | CLOBAZAM | 1 | Oral | HS | 202067 | 20 | MG | TABLET | QD | ||||||
| 123904912 | 12390491 | 9 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | U | 0 | .5 | MG | TABLET | TID | ||||||
| 123904912 | 12390491 | 10 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | U | 0 | .25 | MG | TABLET | TID | ||||||
| 123904912 | 12390491 | 11 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | U | 0 | .25 | MG | TABLET | QD | ||||||
| 123904912 | 12390491 | 12 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | U | 0 | .5 | MG | TABLET | QD | ||||||
| 123904912 | 12390491 | 13 | SS | CLONAZEPAM. | CLONAZEPAM | 1 | Oral | U | 0 | .75 | MG | TABLET | QD | ||||||
| 123904912 | 12390491 | 14 | C | ZONEGRAN | ZONISAMIDE | 1 | Oral | 0 | 100 | MG | CAPSULE | ||||||||
| 123904912 | 12390491 | 15 | C | ZONEGRAN | ZONISAMIDE | 1 | Oral | 0 | 200 | MG | CAPSULE | QD | |||||||
| 123904912 | 12390491 | 16 | C | ZONEGRAN | ZONISAMIDE | 1 | Oral | 0 | 300 | MG | CAPSULE | QD | |||||||
| 123904912 | 12390491 | 17 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 0 | 1000 | MG | TABLET | QD | |||||||
| 123904912 | 12390491 | 18 | C | KEPPRA | LEVETIRACETAM | 1 | Oral | 0 | 1500 | MG | TABLET | QD | |||||||
| 123904912 | 12390491 | 19 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 1 | MG | TABLET | Q12H | |||||||
| 123904912 | 12390491 | 20 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 2000 | IU | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123904912 | 12390491 | 1 | Epilepsy |
| 123904912 | 12390491 | 2 | Seizure |
| 123904912 | 12390491 | 9 | Epilepsy |
| 123904912 | 12390491 | 14 | Epilepsy |
| 123904912 | 12390491 | 17 | Epilepsy |
| 123904912 | 12390491 | 19 | Product used for unknown indication |
| 123904912 | 12390491 | 20 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123904912 | 12390491 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123904912 | 12390491 | Depressed mood | |
| 123904912 | 12390491 | Fatigue | |
| 123904912 | 12390491 | Somnolence | |
| 123904912 | 12390491 | 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 |
|---|---|---|---|---|---|---|
| 123904912 | 12390491 | 2 | 201604 | 0 |