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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125292001 | 12529200 | 1 | I | 20160628 | 20160705 | 20160705 | EXP | FR-JNJFOC-20160626337 | JANSSEN | MONTASTRUC F, SALVO F, ARNAUD M, BEGAUD B, PARIENTE A. SIGNAL OF GASTROINTESTINAL CONGENITAL MALFORMATIONS WITH ANTIPSYCHOTICS AFTER MINIMISING COMPETITION BIAS: A DISPROPORTIONALITY ANALYSIS USING DATA FROM VIGIBASE. DRUG SAFETY 09-MAR-2016;39 (7):689-696. | 0.00 | Y | 0.00000 | 20160705 | OT | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125292001 | 12529200 | 1 | PS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | U | U | 20272 | UNSPECIFIED | ||||||||
| 125292001 | 12529200 | 2 | SS | HALOPERIDOL. | HALOPERIDOL | 1 | Transplacental | U | U | 15923 | UNSPECIFIED | ||||||||
| 125292001 | 12529200 | 3 | SS | TROPATEPINE | TROPATEPINE | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 125292001 | 12529200 | 4 | SS | FENFLURAMINE | FENFLURAMINE | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 125292001 | 12529200 | 5 | SS | PYRIDOXINE | PYRIDOXINE | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 125292001 | 12529200 | 6 | SS | AMPICILLIN | AMPICILLIN | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 125292001 | 12529200 | 7 | SS | PARACETAMOL | ACETAMINOPHEN | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 125292001 | 12529200 | 8 | SS | DOXYLAMINE | DOXYLAMINE | 1 | Transplacental | U | 0 | UNSPECIFIED | |||||||||
| 125292001 | 12529200 | 9 | SS | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Transplacental | U | 0 | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125292001 | 12529200 | 1 | Product used for unknown indication |
| 125292001 | 12529200 | 2 | Product used for unknown indication |
| 125292001 | 12529200 | 3 | Product used for unknown indication |
| 125292001 | 12529200 | 4 | Product used for unknown indication |
| 125292001 | 12529200 | 5 | Product used for unknown indication |
| 125292001 | 12529200 | 6 | Product used for unknown indication |
| 125292001 | 12529200 | 7 | Product used for unknown indication |
| 125292001 | 12529200 | 8 | Product used for unknown indication |
| 125292001 | 12529200 | 9 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125292001 | 12529200 | OT |
| 125292001 | 12529200 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125292001 | 12529200 | Anorectal disorder | |
| 125292001 | 12529200 | Cleft lip and palate | |
| 125292001 | 12529200 | Cleft palate | |
| 125292001 | 12529200 | Congenital anomaly | |
| 125292001 | 12529200 | Congenital jaw malformation | |
| 125292001 | 12529200 | Congenital oesophageal anomaly | |
| 125292001 | 12529200 | Foetal exposure during pregnancy | |
| 125292001 | 12529200 | Gastrointestinal malformation | |
| 125292001 | 12529200 | Heart disease congenital | |
| 125292001 | 12529200 | Hypertelorism of orbit |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |