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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127040981 | 12704098 | 1 | I | 20160829 | 20160831 | 20160831 | EXP | PHHY2016BR118973 | NOVARTIS | 9.00 | YR | M | Y | 32.00000 | KG | 20160831 | MD | BR | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127040981 | 12704098 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Unknown | UNK, QD | 21014 | QD | |||||||||
| 127040981 | 12704098 | 2 | SS | DEPAKINE | VALPROATE SODIUM | 1 | Oral | QD | 0 | TABLET | QD | ||||||||
| 127040981 | 12704098 | 3 | SS | DEPAKINE | VALPROATE SODIUM | 1 | Oral | QD | 0 | SOLUTION | QD | ||||||||
| 127040981 | 12704098 | 4 | C | FRISIUM | CLOBAZAM | 1 | Oral | UNK UNK, QD | 0 | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127040981 | 12704098 | 1 | Seizure |
| 127040981 | 12704098 | 2 | Seizure |
| 127040981 | 12704098 | 3 | Seizure |
| 127040981 | 12704098 | 4 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127040981 | 12704098 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127040981 | 12704098 | Adverse drug reaction | |
| 127040981 | 12704098 | Drug intolerance | |
| 127040981 | 12704098 | Pleural effusion | |
| 127040981 | 12704098 | 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 |