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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124036722 | 12403672 | 2 | F | 20160122 | 20160629 | 20160525 | 20160705 | EXP | PHHY2016IT070373 | NOVARTIS | 19.65 | YR | M | Y | 0.00000 | 20160705 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124036722 | 12403672 | 1 | PS | TEGRETOL | CARBAMAZEPINE | 1 | Oral | 1200 MG, QD | Y | 16608 | 1200 | MG | QD | ||||||
| 124036722 | 12403672 | 2 | C | DEPAKIN | VALPROATE SODIUM | 1 | Oral | 100 MG, UNK | Y | 0 | 100 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124036722 | 12403672 | 1 | Epilepsy |
| 124036722 | 12403672 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124036722 | 12403672 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124036722 | 12403672 | Hepatic steatosis | |
| 124036722 | 12403672 | Hepatomegaly | |
| 124036722 | 12403672 | Rash | |
| 124036722 | 12403672 | Toxic skin eruption | |
| 124036722 | 12403672 | Transaminases increased |
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 |
|---|---|---|---|---|---|---|
| 124036722 | 12403672 | 1 | 20151221 | 20160125 | 0 | |
| 124036722 | 12403672 | 2 | 20160122 | 20160126 | 0 |