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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126614831 | 12661483 | 1 | I | 20160809 | 20160817 | 20160817 | EXP | DE-MYLANLABS-2016M1033574 | MYLAN | 0.00 | Y | 0.00000 | 20160817 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126614831 | 12661483 | 1 | PS | LEVETIRACETAM. | LEVETIRACETAM | 1 | Transmammary | UNK (DOSAGE INCREASE FROM 2X2000MG/D TO 2X2250MG/D) | U | 76919 | |||||||||
| 126614831 | 12661483 | 2 | SS | LAMICTAL | LAMOTRIGINE | 1 | Transmammary | 50 MG, BID (100 [MG/D ]) | 0 | 50 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126614831 | 12661483 | 1 | Epilepsy |
| 126614831 | 12661483 | 2 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126614831 | 12661483 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126614831 | 12661483 | Dehydration | |
| 126614831 | 12661483 | Exposure during breast feeding | |
| 126614831 | 12661483 | Foetal exposure during pregnancy | |
| 126614831 | 12661483 | Gastrooesophageal reflux disease | |
| 126614831 | 12661483 | Selective eating disorder |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |