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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127009192 | 12700919 | 2 | F | 20150904 | 20160831 | 20160830 | 20160904 | EXP | PHHY2015VE110440 | NOVARTIS | 10.58 | YR | M | Y | 30.00000 | KG | 20160905 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127009192 | 12700919 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 10 CM3, BID | 21285 | SUSPENSION | BID | ||||||||
| 127009192 | 12700919 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 18 CM3, QD | 21285 | SUSPENSION | QD | ||||||||
| 127009192 | 12700919 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1275 MG, QD (STRENGTH: 300 MG, 4 TABLETS AND AN EXTRA SMALL PIECE) | 0 | 1275 | MG | TABLET | QD | ||||||
| 127009192 | 12700919 | 4 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1275 MG, QD (STRENGTH: 600 MG, 2 TABLETS AND AN EXTRA SMALL PIECE) | 0 | 1275 | MG | TABLET | QD | ||||||
| 127009192 | 12700919 | 5 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | UNK UNK, BID | 0 | TABLET | BID | ||||||||
| 127009192 | 12700919 | 6 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 2 DF (300 MG TWO TABLETS IN THE MORNING AND 300 MG TWO TABLETS AT NIGHT), BID | 0 | 2 | DF | TABLET | BID | ||||||
| 127009192 | 12700919 | 7 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1200 MG, QD (300 MG) | 0 | 1200 | MG | TABLET | QD | ||||||
| 127009192 | 12700919 | 8 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1200 MG, QD (600 MG) | 0 | 1200 | MG | TABLET | QD | ||||||
| 127009192 | 12700919 | 9 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1350 MG, QD | 0 | 1350 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127009192 | 12700919 | 1 | Epilepsy |
| 127009192 | 12700919 | 3 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127009192 | 12700919 | HO |
| 127009192 | 12700919 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127009192 | 12700919 | Aphasia | |
| 127009192 | 12700919 | Blood bilirubin increased | |
| 127009192 | 12700919 | Blood disorder | |
| 127009192 | 12700919 | Decreased immune responsiveness | |
| 127009192 | 12700919 | Drug dependence | |
| 127009192 | 12700919 | Fall | |
| 127009192 | 12700919 | Gait disturbance | |
| 127009192 | 12700919 | Head injury | |
| 127009192 | 12700919 | Seizure | |
| 127009192 | 12700919 | Skin discolouration | |
| 127009192 | 12700919 | Somnolence | |
| 127009192 | 12700919 | Tremor | |
| 127009192 | 12700919 | 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 |
|---|---|---|---|---|---|---|
| 127009192 | 12700919 | 1 | 2005 | 0 | ||
| 127009192 | 12700919 | 2 | 20050727 | 0 | ||
| 127009192 | 12700919 | 5 | 201301 | 0 | ||
| 127009192 | 12700919 | 6 | 2013 | 0 |