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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126087191 | 12608719 | 1 | I | 20160715 | 20160729 | 20160729 | EXP | FR-LUNDBECK-DKLU2017239 | LUNDBECK | DE LUCIA S, PICHARD S, ILEA A, GRENECHE M, FRANCOIS L, DELANOE C. AN UNFORTUNATE CHALLENGE: KETOGENIC DIET FOR THE TREATMENT OF LENNOX-GASTAUT SYNDROME IN TYROSINEMIA TYPE 1.. EUROPEAN JOURNAL OF PAEDIATRIC NEUROLOGY. 2016;20:674-677. | 26.00 | MON | F | Y | 0.00000 | 20160729 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126087191 | 12608719 | 1 | PS | Clobazam | CLOBAZAM | 1 | Unknown | 202067 | |||||||||||
| 126087191 | 12608719 | 2 | SS | VALPROATE SALT NOT SPECIFIED | VALPROATE SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 126087191 | 12608719 | 3 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | 0 | |||||||||||
| 126087191 | 12608719 | 4 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | 0 | QD | ||||||||||
| 126087191 | 12608719 | 5 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | U | 0 | ||||||||||
| 126087191 | 12608719 | 6 | SS | RUFINAMIDE | RUFINAMIDE | 1 | Unknown | 0 | |||||||||||
| 126087191 | 12608719 | 7 | C | NITISINONE | NITISINONE | 1 | Unknown | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126087191 | 12608719 | 1 | Lennox-Gastaut syndrome |
| 126087191 | 12608719 | 2 | Lennox-Gastaut syndrome |
| 126087191 | 12608719 | 3 | Lennox-Gastaut syndrome |
| 126087191 | 12608719 | 4 | Lennox-Gastaut syndrome |
| 126087191 | 12608719 | 5 | Lennox-Gastaut syndrome |
| 126087191 | 12608719 | 6 | Lennox-Gastaut syndrome |
| 126087191 | 12608719 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126087191 | 12608719 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126087191 | 12608719 | Cognitive disorder | |
| 126087191 | 12608719 | Fatigue | |
| 126087191 | 12608719 | Hepatomegaly | |
| 126087191 | 12608719 | Lennox-Gastaut syndrome |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |