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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125908152 | 12590815 | 2 | F | 20160711 | 20160726 | 20160726 | EXP | IT-CIPLA LTD.-2016IT09790 | CIPLA | CASSINA M, DILAGHI A, GIANANTONIO ED, CESARI E, SANTIS MD, MANNAIONI G ET AL.,. PREGNANCY OUTCOME IN WOMEN EXPOSED TO ANTIEPILEPTIC DRUGS: TERATOGENIC ROLE OF MATERNAL EPILEPSY AND ITS PHARMACOLOGIC TREATMENT. REPRODUCTIVE TOXICOLOGY. 2013;39:50 TO 57 | 0.00 | Y | 0.00000 | 20160726 | OT | IT | IT |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125908152 | 12590815 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNK | 77397 | ||||||||||
125908152 | 12590815 | 2 | SS | VALPROIC ACID. | VALPROIC ACID | 1 | Transplacental | UNK | 0 | ||||||||||
125908152 | 12590815 | 3 | SS | Niaprazine | NIAPRAZINE | 1 | Transplacental | UNK | 0 |
Indications of drugs used
no results found |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125908152 | 12590815 | CA |
125908152 | 12590815 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125908152 | 12590815 | Foetal exposure during pregnancy | |
125908152 | 12590815 | Ventricular septal defect |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |