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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126893101 | 12689310 | 1 | I | 201502 | 20160822 | 20160826 | 20160826 | EXP | PHHY2016VE116791 | NOVARTIS | 8.94 | YR | M | Y | 28.00000 | KG | 20160826 | MD | VE | VE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126893101 | 12689310 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 20 CM3, QD | 21285 | SUSPENSION | QD | ||||||||
| 126893101 | 12689310 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | 21285 | SUSPENSION | |||||||||||
| 126893101 | 12689310 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1200 MG, QD (DOSAGE FORM STRENGTH: 300 MG) | 0 | 1200 | MG | QD | |||||||
| 126893101 | 12689310 | 4 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1200 MG, QD (DOSAGE FORM STRENGTH: 600 MG) | 0 | 1200 | MG | QD | |||||||
| 126893101 | 12689310 | 5 | C | PROVICAR//LEVOCARNITINE | 2 | Unknown | Y | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126893101 | 12689310 | 1 | Encephalopathy |
| 126893101 | 12689310 | 2 | Seizure |
| 126893101 | 12689310 | 3 | Encephalopathy |
| 126893101 | 12689310 | 4 | Seizure |
| 126893101 | 12689310 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126893101 | 12689310 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126893101 | 12689310 | Headache | |
| 126893101 | 12689310 | Product use issue | |
| 126893101 | 12689310 | Psychomotor hyperactivity | |
| 126893101 | 12689310 | Seizure |
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 |
|---|---|---|---|---|---|---|
| 126893101 | 12689310 | 3 | 201501 | 0 | ||
| 126893101 | 12689310 | 4 | 201501 | 0 |