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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128003271 | 12800327 | 1 | I | 201411 | 20160922 | 20160930 | 20160930 | PER | US-LUNDBECK-DKLU2020008 | LUNDBECK | 53.09 | YR | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 128003271 | 12800327 | 1 | PS | ONFI | CLOBAZAM | 1 | Unknown | 202067 | 5 | MG | TABLET | QD | |||||||
| 128003271 | 12800327 | 2 | SS | ONFI | CLOBAZAM | 1 | Unknown | 202067 | 10 | MG | TABLET | QD | |||||||
| 128003271 | 12800327 | 3 | SS | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | 0 | ||||||||||
| 128003271 | 12800327 | 4 | SS | KEPPRA | LEVETIRACETAM | 1 | Unknown | U | 0 | ||||||||||
| 128003271 | 12800327 | 5 | C | VIMPAT | LACOSAMIDE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 128003271 | 12800327 | 1 | Epilepsy |
| 128003271 | 12800327 | 3 | Product used for unknown indication |
| 128003271 | 12800327 | 4 | Product used for unknown indication |
| 128003271 | 12800327 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 128003271 | 12800327 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 128003271 | 12800327 | Anxiety | |
| 128003271 | 12800327 | Depressed mood | |
| 128003271 | 12800327 | Drug level increased | |
| 128003271 | 12800327 | Gait disturbance | |
| 128003271 | 12800327 | Insomnia | |
| 128003271 | 12800327 | Irritability | |
| 128003271 | 12800327 | Memory impairment | |
| 128003271 | 12800327 | Nightmare | |
| 128003271 | 12800327 | Seizure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |