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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126421292 | 12642129 | 2 | F | 20160816 | 20160810 | 20160822 | EXP | PHHY2016BR108393 | NOVARTIS | 0.00 | M | Y | 60.00000 | KG | 20160822 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126421292 | 12642129 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1.5 DF, QD (0.5 IN THE MORNING, 0.5 IN THE AFTERNOON AND 0.5 AT NIGHT) 300 MG CONCENTRATION | 21014 | 1.5 | DF | TABLET | QD | ||||||
| 126421292 | 12642129 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1 DF (600 MG CONCENTRATION), UNK | 21014 | 1 | DF | TABLET | |||||||
| 126421292 | 12642129 | 3 | SS | OXCARBAZEPINA | OXCARBAZEPINE | 1 | Oral | 2.5 DF, QD (1 IN THE MORNING, HALF AT LUNCH TIME AND AT NIGHT) | 0 | 2.5 | DF | TABLET | QD | ||||||
| 126421292 | 12642129 | 4 | C | GARDENAL//PHENOBARBITAL | PHENOBARBITAL | 1 | Oral | 1 DF, QD | 0 | 1 | DF | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126421292 | 12642129 | 1 | Seizure |
| 126421292 | 12642129 | 3 | Seizure |
| 126421292 | 12642129 | 4 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126421292 | 12642129 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126421292 | 12642129 | Condition aggravated | |
| 126421292 | 12642129 | Dysphagia | |
| 126421292 | 12642129 | Petit mal epilepsy | |
| 126421292 | 12642129 | Respiratory arrest | |
| 126421292 | 12642129 | Seizure | |
| 126421292 | 12642129 | 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
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126421292 | 12642129 | 2 | 201608 | 0 | ||
| 126421292 | 12642129 | 3 | 2008 | 0 |