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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126444432 | 12644443 | 2 | F | 20160809 | 20160811 | 20160816 | EXP | PHHY2016VE109832 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160816 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126444432 | 12644443 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | QD STRENGTH: 300 MG | 21014 | QD | |||||||||
| 126444432 | 12644443 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 2550 MG, QD (900 MG IN THE MORNING, 750 MG AT 2 P.M AND 900 MG AT 9 P.M) | 21014 | 2550 | MG | QD | |||||||
| 126444432 | 12644443 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 600 MG, QD (STRENGTH: 600 MG) | 21014 | 600 | MG | QD | |||||||
| 126444432 | 12644443 | 4 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 42.5 CM3, QD (15 CC IN THE MORNING, 12.5 CC AT MIDDAY AND 15 CC AT NIGHT) | 0 | SUSPENSION | QD | ||||||||
| 126444432 | 12644443 | 5 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | UNK UNK, QD | 0 | SUSPENSION | QD | ||||||||
| 126444432 | 12644443 | 6 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | 0 | SUSPENSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126444432 | 12644443 | 1 | Seizure |
| 126444432 | 12644443 | 2 | Cerebral disorder |
| 126444432 | 12644443 | 3 | Addison's disease |
| 126444432 | 12644443 | 4 | Seizure |
| 126444432 | 12644443 | 5 | Cerebral disorder |
| 126444432 | 12644443 | 6 | Addison's disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126444432 | 12644443 | OT |
| 126444432 | 12644443 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126444432 | 12644443 | Abasia | |
| 126444432 | 12644443 | Hypertension | |
| 126444432 | 12644443 | Hypokinesia | |
| 126444432 | 12644443 | Malaise | |
| 126444432 | 12644443 | Nephrolithiasis | |
| 126444432 | 12644443 | Product use issue | |
| 126444432 | 12644443 | Renal disorder | |
| 126444432 | 12644443 | Seizure | |
| 126444432 | 12644443 | Systemic lupus erythematosus |
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 |
|---|---|---|---|---|---|---|
| 126444432 | 12644443 | 5 | 2016 | 0 |