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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126156202 | 12615620 | 2 | F | 20160801 | 20160802 | 20160811 | EXP | US-CONCORDIA PHARMACEUTICALS INC.-GSH201608-003924 | CONCORDIA | STERGIOPOULOS K,SHIANG E,BENCH T. PREGNANCY IN PATIENTS WITH PRE EXISTING CARDIOMYOPATHIES. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2011;58(4):337-350. | 0.00 | N | Y | 0.00000 | 20160811 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126156202 | 12615620 | 1 | SS | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Transplacental | 0 | |||||||||||
| 126156202 | 12615620 | 2 | PS | DIGOXIN. | DIGOXIN | 1 | Transplacental | 20405 | |||||||||||
| 126156202 | 12615620 | 3 | SS | CARVEDILOL. | CARVEDILOL | 1 | Transplacental | 0 | |||||||||||
| 126156202 | 12615620 | 4 | SS | FUROSEMIDE. | FUROSEMIDE | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126156202 | 12615620 | 1 | Foetal exposure during pregnancy |
| 126156202 | 12615620 | 2 | Foetal exposure during pregnancy |
| 126156202 | 12615620 | 3 | Foetal exposure during pregnancy |
| 126156202 | 12615620 | 4 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126156202 | 12615620 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126156202 | 12615620 | Foetal exposure during pregnancy | |
| 126156202 | 12615620 | Premature baby |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |