Person who experienced the adverse event (patient)
| Event ID | CASE | I F COD | FOLL SEQ | IMAGE | EVENT DT | MFR DT | FDA DT | REPT COD | MFR NUM | MFR SNDR | AGE | AGE COD | GNDR COD | E SUB | WT | WT COD | REPT DT | OCCP COD | DEATH DT | TO MFR | CONFID | REPORTER COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6138790 | 6957017 | I | 6138790-2 | 20081018 | 20090323 | 20090331 | EXP | PHHY2009FR11215 | NOVARTIS PHARMACEUTICALS CORP. | 47 | F | Y | 20090331 | OT | FRANCE |
Drug(s) used by person
| Event ID | DRUG SEQ | ROLE COD | DRUGNAME | VAL VBM | ROUTE | DOSE VBM | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 6138790 | 1011359254 | PS | TEGRETOL | 1 | ORAL | 300 MG, BID | 016608 | ||||
| 6138790 | 1011359255 | SS | TRILEPTAL | 1 | 300 MG, UNK | ||||||
| 6138790 | 1011359256 | C | URBANYL | 2 | UNK | ||||||
| 6138790 | 1011359257 | C | BISOPROLOL | 2 | UNK | ||||||
| 6138790 | 1011359258 | C | CANDESARTAN CILEXETIL | 1 | 16 MG/DAY | ||||||
| 6138790 | 1011359259 | C | ENOXAPARIN SODIUM | 1 | 0.4 UNK, QD | ||||||
| 6138790 | 1011359260 | C | HYDROCORTISONE | 1 | INTRAVENOUS | 500 MG, QD |
Indications of drugs used
| Event ID | DRUG SEQ | INDI PT |
|---|---|---|
| 6138790 | 1011359254 | EPILEPSY |
| 6138790 | 1011359255 | EPILEPSY |
Outcome of event
| Event ID | OUTC COD |
|---|---|
| 6138790 | HO |
Reactions reported
| Event ID | PT |
|---|---|
| 6138790 | ASTHENIA |
| 6138790 | CEREBELLAR SYNDROME |
| 6138790 | DIPLOPIA |
| 6138790 | GAIT DISTURBANCE |
| 6138790 | OVERDOSE |
| 6138790 | STATUS EPILEPTICUS |
| 6138790 | STRESS |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|
| 6138790 | 1011359254 | 20081018 | |||
| 6138790 | 1011359260 | 20081018 | 20081021 | 4 | DAY |