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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126967541 | 12696754 | 1 | I | 20160627 | 20160819 | 20160830 | 20160830 | EXP | DE-ROCHE-1819909 | ROCHE | 1.00 | DY | M | Y | 3.07000 | KG | 20160830 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126967541 | 12696754 | 1 | PS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | U | 13263 | ||||||||||
| 126967541 | 12696754 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126967541 | 12696754 | 1 | Product used for unknown indication |
| 126967541 | 12696754 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126967541 | 12696754 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126967541 | 12696754 | Atrial septal defect | |
| 126967541 | 12696754 | Drug withdrawal syndrome neonatal | |
| 126967541 | 12696754 | Foetal exposure during pregnancy | |
| 126967541 | 12696754 | Respiratory disorder neonatal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |