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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126976652 | 12697665 | 2 | F | 20160712 | 20160830 | 20160830 | 20160906 | EXP | PHHY2016MX108715 | NOVARTIS | 8.96 | YR | F | Y | 25.00000 | KG | 20160906 | MD | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126976652 | 12697665 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | 2.5 ML, Q12H (10MG/KG/DAY) | N | 21285 | 2.5 | ML | SUSPENSION | Q12H | |||||
| 126976652 | 12697665 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | 5 ML, Q12H (20MG/KG/DAY) | N | 21285 | 5 | ML | SUSPENSION | Q12H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126976652 | 12697665 | 1 | Partial seizures |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126976652 | 12697665 | HO |
| 126976652 | 12697665 | LT |
| 126976652 | 12697665 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126976652 | 12697665 | Acinetobacter infection | |
| 126976652 | 12697665 | Arthralgia | |
| 126976652 | 12697665 | Conjunctival hyperaemia | |
| 126976652 | 12697665 | Conjunctivitis | |
| 126976652 | 12697665 | Dysphagia | |
| 126976652 | 12697665 | Headache | |
| 126976652 | 12697665 | Malaise | |
| 126976652 | 12697665 | Mucosal inflammation | |
| 126976652 | 12697665 | Necrosis | |
| 126976652 | 12697665 | Nikolsky's sign | |
| 126976652 | 12697665 | Oral disorder | |
| 126976652 | 12697665 | Pain | |
| 126976652 | 12697665 | Pruritus | |
| 126976652 | 12697665 | Pseudomonal sepsis | |
| 126976652 | 12697665 | Pyrexia | |
| 126976652 | 12697665 | Rash macular | |
| 126976652 | 12697665 | Rash papular | |
| 126976652 | 12697665 | Sepsis | |
| 126976652 | 12697665 | Skin discolouration | |
| 126976652 | 12697665 | Skin exfoliation | |
| 126976652 | 12697665 | Stevens-Johnson syndrome |
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 |
|---|---|---|---|---|---|---|
| 126976652 | 12697665 | 1 | 20160625 | 0 |