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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126084532 | 12608453 | 2 | F | 20160726 | 20160729 | 20160804 | EXP | FR-ABBVIE-16P-056-1688845-00 | ABBVIE | DE LUCIA S, PICHARD S, ILEA A, ET AL. 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 | 20160804 | OT | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126084532 | 12608453 | 1 | PS | VALPROATE SODIUM. | VALPROATE SODIUM | 1 | Unknown | U | UNKNOWN | 18082 | |||||||||
| 126084532 | 12608453 | 2 | SS | LAMOTRIGINE. | LAMOTRIGINE | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 126084532 | 12608453 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Unknown | UNKNOWN | 0 | 40 | MG/KG | QD | |||||||
| 126084532 | 12608453 | 4 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | U | UNKNOWN | 0 | |||||||||
| 126084532 | 12608453 | 5 | SS | CLOBAZAM | CLOBAZAM | 1 | Unknown | UNKNOWN | 0 | ||||||||||
| 126084532 | 12608453 | 6 | SS | RUFINAMIDE | RUFINAMIDE | 1 | Unknown | N | UNKNOWN | 0 | |||||||||
| 126084532 | 12608453 | 7 | C | NITISINONE | NITISINONE | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126084532 | 12608453 | 1 | Lennox-Gastaut syndrome |
| 126084532 | 12608453 | 2 | Lennox-Gastaut syndrome |
| 126084532 | 12608453 | 3 | Lennox-Gastaut syndrome |
| 126084532 | 12608453 | 4 | Lennox-Gastaut syndrome |
| 126084532 | 12608453 | 5 | Lennox-Gastaut syndrome |
| 126084532 | 12608453 | 6 | Lennox-Gastaut syndrome |
| 126084532 | 12608453 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126084532 | 12608453 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126084532 | 12608453 | Atonic seizures | |
| 126084532 | 12608453 | Cognitive disorder | |
| 126084532 | 12608453 | Condition aggravated | |
| 126084532 | 12608453 | Electroencephalogram abnormal | |
| 126084532 | 12608453 | Fatigue | |
| 126084532 | 12608453 | Hepatomegaly | |
| 126084532 | 12608453 | Lennox-Gastaut syndrome | |
| 126084532 | 12608453 | Petit mal epilepsy | |
| 126084532 | 12608453 | Status epilepticus | |
| 126084532 | 12608453 | Tonic convulsion | |
| 126084532 | 12608453 | Treatment failure | |
| 126084532 | 12608453 | Ultrasound scan abnormal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |