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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126748491 | 12674849 | 1 | I | 20160627 | 20160808 | 20160822 | 20160822 | EXP | FR-CONCORDIA PHARMACEUTICALS INC.-CO-ZO-FR-2016-089 | CONCORDIA | 38.00 | YR | F | Y | 0.00000 | 20160822 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126748491 | 12674849 | 1 | PS | ZONEGRAN | ZONISAMIDE | 1 | Oral | UNKNOWN | Y | 0 | TABLET | ||||||||
| 126748491 | 12674849 | 2 | SS | ZONEGRAN | ZONISAMIDE | 1 | Oral | Y | 0 | 25 | MG | TABLET | BID | ||||||
| 126748491 | 12674849 | 3 | SS | VIMPAT | LACOSAMIDE | 1 | Oral | UNKNOWN | Y | 0 | |||||||||
| 126748491 | 12674849 | 4 | SS | VIMPAT | LACOSAMIDE | 1 | Oral | Y | 0 | 200 | MG | BID | |||||||
| 126748491 | 12674849 | 5 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | UNKNOWN | Y | 0 | |||||||||
| 126748491 | 12674849 | 6 | SS | LAMICTAL | LAMOTRIGINE | 1 | Oral | Y | 0 | 100 | MG | QID | |||||||
| 126748491 | 12674849 | 7 | SS | KEPPRA | LEVETIRACETAM | 1 | Oral | 0 | 500 | MG | BID | ||||||||
| 126748491 | 12674849 | 8 | C | HALDOL | HALOPERIDOL | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 126748491 | 12674849 | 9 | C | HEPT A MYL | HEPTAMINOL HYDROCHLORIDE | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 126748491 | 12674849 | 10 | C | DAFALGAN | ACETAMINOPHEN | 1 | Oral | UNKNOWN | 0 | ||||||||||
| 126748491 | 12674849 | 11 | C | URBANYL | CLOBAZAM | 1 | Oral | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126748491 | 12674849 | 1 | Epilepsy |
| 126748491 | 12674849 | 3 | Epilepsy |
| 126748491 | 12674849 | 5 | Epilepsy |
| 126748491 | 12674849 | 7 | Epilepsy |
| 126748491 | 12674849 | 8 | Product used for unknown indication |
| 126748491 | 12674849 | 9 | Product used for unknown indication |
| 126748491 | 12674849 | 10 | Product used for unknown indication |
| 126748491 | 12674849 | 11 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126748491 | 12674849 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126748491 | 12674849 | Coma | |
| 126748491 | 12674849 | Somnolence | |
| 126748491 | 12674849 | 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 |
|---|---|---|---|---|---|---|
| 126748491 | 12674849 | 1 | 20160627 | 201607 | 0 | |
| 126748491 | 12674849 | 2 | 201607 | 0 | ||
| 126748491 | 12674849 | 3 | 2013 | 20160626 | 0 | |
| 126748491 | 12674849 | 4 | 20160627 | 201607 | 0 | |
| 126748491 | 12674849 | 5 | 20160626 | 0 | ||
| 126748491 | 12674849 | 6 | 20160627 | 201607 | 0 | |
| 126748491 | 12674849 | 7 | 20160627 | 0 |