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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127800471 | 12780047 | 1 | I | 20160916 | 20160926 | 20160926 | EXP | NL-MYLANLABS-2016M1040742 | MYLAN | NIJMAN TAJ, VAN VLIET EOG, NAAKTGEBOREN CA, OUDE RENGERINK K, DE LANGE TS, BAX CJ, ET AL. NIFEDIPINE VERSUS PLACEBO IN THE TREATMENT OF PRETERM PRELABOR RUPTURE OF MEMBRANES: A RANDOMIZED CONTROLLED TRIAL: ASSESSMENT OF PERINATAL OUTCOME BY USE OF TOCOLYSIS IN EARLY LABOR-APOSTEL IV TRIAL. EUR-J-OBSTET-GYNECOL-REPROD-BIOL 2016;205:79-84. | 0.00 | Y | 0.00000 | 20160926 | OT | NL | NL |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127800471 | 12780047 | 1 | PS | NIFEDIPINE. | NIFEDIPINE | 1 | D | U | 90649 | ||||||||||
| 127800471 | 12780047 | 2 | SS | MAGNESIUM | MAGNESIUM | 1 | D | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127800471 | 12780047 | 1 | Premature rupture of membranes |
| 127800471 | 12780047 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127800471 | 12780047 | DE |
| 127800471 | 12780047 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127800471 | 12780047 | Breech presentation | |
| 127800471 | 12780047 | Foetal exposure during pregnancy | |
| 127800471 | 12780047 | Low birth weight baby | |
| 127800471 | 12780047 | Necrotising enterocolitis neonatal | |
| 127800471 | 12780047 | Premature baby | |
| 127800471 | 12780047 | Septic shock |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |