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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125555981 | 12555598 | 1 | I | 2015 | 20160711 | 20160714 | 20160714 | EXP | PHHY2016VE096275 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125555981 | 12555598 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 2.5 CM3, QD | 21285 | SUSPENSION | QD | ||||||||
| 125555981 | 12555598 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 10 CM3, QD (6%) (5CM3 EVERY DOSE | 21285 | SUSPENSION | QD | ||||||||
| 125555981 | 12555598 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | UNK | 21285 | SUSPENSION | |||||||||
| 125555981 | 12555598 | 4 | C | CEBION | 2 | Unknown | 1 OT, QD | U | 0 | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125555981 | 12555598 | 1 | Seizure |
| 125555981 | 12555598 | 4 | Feeding disorder |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125555981 | 12555598 | HO |
| 125555981 | 12555598 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125555981 | 12555598 | Asthenia | |
| 125555981 | 12555598 | Fall | |
| 125555981 | 12555598 | Grip strength decreased | |
| 125555981 | 12555598 | Hemiparesis | |
| 125555981 | 12555598 | Paraesthesia | |
| 125555981 | 12555598 | Posture abnormal | |
| 125555981 | 12555598 | 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 |
|---|---|---|---|---|---|---|
| 125555981 | 12555598 | 1 | 2014 | 0 |