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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126050322 | 12605032 | 2 | F | 20160802 | 20160728 | 20160805 | EXP | PHHY2016VE103730 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160806 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126050322 | 12605032 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 2400 MG, QD | 21014 | 2400 | MG | TABLET | QD | ||||||
| 126050322 | 12605032 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1500 MG, QD | 21014 | 1500 | MG | TABLET | QD | ||||||
| 126050322 | 12605032 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1200 MG, QD | 21014 | 1200 | MG | TABLET | QD | ||||||
| 126050322 | 12605032 | 4 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 26 CM3, QD | U | 0 | SUSPENSION | QD | |||||||
| 126050322 | 12605032 | 5 | C | FENOBARBITAL | PHENOBARBITAL | 1 | Unknown | 100 MG, QD | U | 0 | 100 | MG | QD | ||||||
| 126050322 | 12605032 | 6 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126050322 | 12605032 | 1 | Epilepsy |
| 126050322 | 12605032 | 4 | Epilepsy |
| 126050322 | 12605032 | 5 | Epilepsy |
| 126050322 | 12605032 | 6 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126050322 | 12605032 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126050322 | 12605032 | Fall | |
| 126050322 | 12605032 | General physical health deterioration | |
| 126050322 | 12605032 | Seizure | |
| 126050322 | 12605032 | Wrong technique in product usage process |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |