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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126953122 | 12695312 | 2 | F | 20160902 | 20160829 | 20160916 | EXP | US-UCBSA-2016032553 | UCB | MCNALLY MA, JOHNSON J, HUISMAN TAGM, PORETTI A, BARANANO K, BASCHAT AA, ET AL. TREATMENT OF FETAL SEIZURES/ SCN8A EPILEPTIC ENCEPHALOPATHY: DETECTION OF FETAL SEIZURES GUIDES MULTIDISCIPLINARY APPROACH TO DIAGNOSIS AND TREATMENT. PEDIATRIC NEUROLOGY. 2016 | 0.00 | F | Y | 4.00000 | KG | 20160916 | MD | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126953122 | 12695312 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transplacental | 500 MG, 2X/DAY (BID) | U | U | 21035 | 500 | MG | BID | |||||
| 126953122 | 12695312 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transplacental | 500 MG, 3X/DAY (TID) | U | U | 21035 | 500 | MG | TID | |||||
| 126953122 | 12695312 | 3 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transplacental | 750 MG, 3X/DAY (TID) | U | U | 21035 | 750 | MG | TID | |||||
| 126953122 | 12695312 | 4 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | UNKNOWN DOSE INITIATED AFTER BIRTH | U | U | 21035 | |||||||||
| 126953122 | 12695312 | 5 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | UNKNOWN DOSE TITRATION | U | U | 21035 | |||||||||
| 126953122 | 12695312 | 6 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 60 MG/KG/DAY | U | U | 21035 | |||||||||
| 126953122 | 12695312 | 7 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | Intravenous (not otherwise specified) | 20 MG/KG | U | U | 0 | ||||||||
| 126953122 | 12695312 | 8 | C | PHENOBARBITAL. | PHENOBARBITAL | 1 | 6 MG/KG/DAY | U | U | 0 | 6 | MG/KG | |||||||
| 126953122 | 12695312 | 9 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | UNKNOWN | U | 0 | ||||||||||
| 126953122 | 12695312 | 10 | C | OXCARBAZEPINE. | OXCARBAZEPINE | 1 | TITRATED TO HIGH DOSE (80 MG/KG/DAY) | U | 0 | 80 | MG/KG | ||||||||
| 126953122 | 12695312 | 11 | C | PHENYTOIN. | PHENYTOIN | 1 | UNK | U | U | 0 | |||||||||
| 126953122 | 12695312 | 12 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | UNK | U | U | 0 | |||||||||
| 126953122 | 12695312 | 13 | C | LAMOTRIGINE. | LAMOTRIGINE | 1 | SLOWLY UPTITRATED TO 2 MG/KG/DAY | U | U | 0 | 2 | MG/KG | |||||||
| 126953122 | 12695312 | 14 | C | DIAZEPAM. | DIAZEPAM | 1 | Rectal | UNK | U | U | 0 | ||||||||
| 126953122 | 12695312 | 15 | C | INDOMETHACIN. | INDOMETHACIN | 1 | Transplacental | UNKNOWN DOSE | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126953122 | 12695312 | 1 | Seizure |
| 126953122 | 12695312 | 7 | Seizure |
| 126953122 | 12695312 | 9 | Seizure |
| 126953122 | 12695312 | 11 | Seizure |
| 126953122 | 12695312 | 12 | Seizure |
| 126953122 | 12695312 | 14 | Seizure |
| 126953122 | 12695312 | 15 | Polyhydramnios |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126953122 | 12695312 | OT |
| 126953122 | 12695312 | HO |
| 126953122 | 12695312 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126953122 | 12695312 | Cardiomegaly | |
| 126953122 | 12695312 | Congenital multiplex arthrogryposis | |
| 126953122 | 12695312 | Deformity of orbit | |
| 126953122 | 12695312 | Foetal exposure during pregnancy | |
| 126953122 | 12695312 | Foetal macrosomia | |
| 126953122 | 12695312 | Generalised oedema | |
| 126953122 | 12695312 | Hand deformity | |
| 126953122 | 12695312 | High arched palate | |
| 126953122 | 12695312 | Hypotonia | |
| 126953122 | 12695312 | Joint contracture | |
| 126953122 | 12695312 | Low set ears | |
| 126953122 | 12695312 | Nervous system disorder | |
| 126953122 | 12695312 | Oxygen saturation decreased | |
| 126953122 | 12695312 | Seizure | |
| 126953122 | 12695312 | Tachycardia | |
| 126953122 | 12695312 | Tardive dyskinesia | |
| 126953122 | 12695312 | Tonic convulsion |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |