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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126907001 | 12690700 | 1 | I | 20160812 | 20160826 | 20160826 | EXP | AU-UNICHEM LABORATORIES LIMITED-UCM201608-000192 | UNICHEM | VAJDA F,GRAHAM J,ROTEN A,LANDER C,O^BRIEN T,EADIE M. TERATOGENICITY OF THE NEWER ANTIEPILEPTIC DRUGS - THE AUSTRALIAN EXPERIENCE. JOURNAL OF CLINICAL NEUROSCIENCE 2012;19:57-9. | 0.00 | Y | 0.00000 | 20160826 | OT | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126907001 | 12690700 | 1 | PS | TOPIRAMATE. | TOPIRAMATE | 1 | 90162 | ||||||||||||
| 126907001 | 12690700 | 2 | SS | LEVETIRACETAM. | LEVETIRACETAM | 1 | 0 |
Indications of drugs used
| no results found |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126907001 | 12690700 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126907001 | 12690700 | Atrial septal defect | |
| 126907001 | 12690700 | Foetal exposure during pregnancy | |
| 126907001 | 12690700 | Heart disease congenital |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |