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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126031601 | 12603160 | 1 | I | 20160721 | 20160728 | 20160728 | EXP | PHHY2016US102628 | SANDOZ | STERGIOPOULOS K, SHIANG E, BENCH T. PREGNANCY IN PATIENTS WITH PRE EXISTING CARDIOMYOPATHIES. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY. 2011;58(4):337-50 | 0.00 | N | Y | 0.00000 | 20160728 | OT | US | US |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
126031601 | 12603160 | 1 | PS | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Transplacental | 83241 | |||||||||||
126031601 | 12603160 | 2 | SS | DIGOXIN. | DIGOXIN | 1 | Transplacental | 0 | |||||||||||
126031601 | 12603160 | 3 | SS | CARVEDILOL. | CARVEDILOL | 1 | Transplacental | 0 | |||||||||||
126031601 | 12603160 | 4 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Transplacental | 0 |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
126031601 | 12603160 | 1 | Foetal exposure during pregnancy |
126031601 | 12603160 | 2 | Foetal exposure during pregnancy |
126031601 | 12603160 | 3 | Foetal exposure during pregnancy |
126031601 | 12603160 | 4 | Foetal exposure during pregnancy |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
126031601 | 12603160 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
126031601 | 12603160 | Foetal exposure during pregnancy | |
126031601 | 12603160 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
no results found |
Therapies reported
no results found |