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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127266521 | 12726652 | 1 | I | 201406 | 20160831 | 20160908 | 20160908 | PER | US-LUNDBECK-DKLU2018852 | LUNDBECK | 18.03 | YR | M | Y | 0.00000 | 20160908 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127266521 | 12726652 | 1 | PS | ONFI | CLOBAZAM | 1 | Oral | 202067 | |||||||||||
| 127266521 | 12726652 | 2 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 30 | MG | QD | ||||||||
| 127266521 | 12726652 | 3 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | 40 | MG | QD | ||||||||
| 127266521 | 12726652 | 4 | SS | ONFI | CLOBAZAM | 1 | Oral | 202067 | |||||||||||
| 127266521 | 12726652 | 5 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | U | 0 | ||||||||||
| 127266521 | 12726652 | 6 | C | PERAMPANEL | PERAMPANEL | 1 | Unknown | 0 | |||||||||||
| 127266521 | 12726652 | 7 | C | LORAZEPAM. | LORAZEPAM | 1 | Unknown | 0 | |||||||||||
| 127266521 | 12726652 | 8 | C | LACOSAMIDE. | LACOSAMIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127266521 | 12726652 | 1 | Complex partial seizures |
| 127266521 | 12726652 | 5 | Product used for unknown indication |
| 127266521 | 12726652 | 6 | Product used for unknown indication |
| 127266521 | 12726652 | 7 | Product used for unknown indication |
| 127266521 | 12726652 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127266521 | 12726652 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127266521 | 12726652 | Abnormal behaviour | |
| 127266521 | 12726652 | Facial paralysis | |
| 127266521 | 12726652 | Fall | |
| 127266521 | 12726652 | Fatigue | |
| 127266521 | 12726652 | Influenza | |
| 127266521 | 12726652 | Irritability | |
| 127266521 | 12726652 | Sedation | |
| 127266521 | 12726652 | Seizure | |
| 127266521 | 12726652 | Somnolence | |
| 127266521 | 12726652 | Therapeutic response unexpected |
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 |
|---|---|---|---|---|---|---|
| 127266521 | 12726652 | 2 | 20141209 | 0 | ||
| 127266521 | 12726652 | 3 | 20141209 | 0 | ||
| 127266521 | 12726652 | 4 | 201604 | 0 |