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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126435863 | 12643586 | 3 | F | 201602 | 20160829 | 20160811 | 20160901 | EXP | PHHY2016BR108912 | NOVARTIS | 11.80 | MON | M | Y | 11.50000 | KG | 20160901 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126435863 | 12643586 | 1 | PS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 60 MG/ML, UNK | H6998 | 21285 | SUSPENSION | ||||||||
| 126435863 | 12643586 | 2 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | Oral | 1.5 ML, BID | H6998 | 21285 | 1.5 | ML | SUSPENSION | BID | |||||
| 126435863 | 12643586 | 3 | SS | TRILEPTAL | OXCARBAZEPINE | 1 | 21285 | SUSPENSION | |||||||||||
| 126435863 | 12643586 | 4 | C | PROVANCE | 2 | Unknown | U | 0 | CHEWABLE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126435863 | 12643586 | 1 | Seizure |
| 126435863 | 12643586 | 2 | Epilepsy |
| 126435863 | 12643586 | 3 | Meningitis viral |
| 126435863 | 12643586 | 4 | Dysbacteriosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126435863 | 12643586 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126435863 | 12643586 | Abdominal pain | |
| 126435863 | 12643586 | Anger | |
| 126435863 | 12643586 | Crying | |
| 126435863 | 12643586 | Erythema | |
| 126435863 | 12643586 | Expired product administered | |
| 126435863 | 12643586 | Flatulence | |
| 126435863 | 12643586 | Head banging | |
| 126435863 | 12643586 | Insomnia | |
| 126435863 | 12643586 | Nervousness | |
| 126435863 | 12643586 | Pain | |
| 126435863 | 12643586 | Product colour issue | |
| 126435863 | 12643586 | Pyrexia | |
| 126435863 | 12643586 | Rhinitis | |
| 126435863 | 12643586 | Toxicity to various agents |
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 |
|---|---|---|---|---|---|---|
| 126435863 | 12643586 | 1 | 201512 | 0 | ||
| 126435863 | 12643586 | 2 | 20160803 | 0 |