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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127365622 | 12736562 | 2 | F | 20160120 | 20160912 | 20160913 | 20160915 | EXP | PHJP2016JP001877 | NOVARTIS | 1.00 | DY | M | Y | 2.20000 | KG | 20160915 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127365622 | 12736562 | 1 | PS | TEGRETOL | CARBAMAZEPINE | 1 | Transplacental | MOTHER DOSE: 600 MG DAILY (200 MG IN MORNING, 400 MG IN EVENING) | 16608 | TABLET | |||||||||
| 127365622 | 12736562 | 2 | SS | E KEPPRA | LEVETIRACETAM | 1 | Transplacental | (MOTHER DOSE: 1000 MG, BID) | 0 | TABLET | |||||||||
| 127365622 | 12736562 | 3 | C | FOLIAMIN | FOLIC ACID | 1 | Transplacental | MOTHER DOSE: 0.5 MG | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127365622 | 12736562 | 1 | Foetal exposure during pregnancy |
| 127365622 | 12736562 | 2 | Foetal exposure during pregnancy |
| 127365622 | 12736562 | 3 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127365622 | 12736562 | CA |
| 127365622 | 12736562 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127365622 | 12736562 | Aplasia | |
| 127365622 | 12736562 | Congenital nail disorder | |
| 127365622 | 12736562 | Drug withdrawal syndrome neonatal | |
| 127365622 | 12736562 | Foetal exposure during pregnancy | |
| 127365622 | 12736562 | Low birth weight baby | |
| 127365622 | 12736562 | Tachypnoea | |
| 127365622 | 12736562 | Tremor |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |