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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126912691 | 12691269 | 1 | I | 20160627 | 20160818 | 20160826 | 20160826 | EXP | DE-MYLANLABS-2016M1035649 | MYLAN | 0.00 | Y | 0.00000 | 20160826 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126912691 | 12691269 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNK (100 [MG/D (50 MG) ]/ SINCE 13.05.2016: 100 MG SERTRALINE) | 78626 | ||||||||||
| 126912691 | 12691269 | 2 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | UNK (8 [MG/D (-6 MG/D) ]/ FROM 28.04. UNTIL 26.05. 2016: 8 MG/D; WEEK 37+2 UNTIL DELIVERY3X2 MG/D) | 0 | ||||||||||
| 126912691 | 12691269 | 3 | C | FEMIBION /01597501/ | CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSFERROUS SUCCINATEMAGNESIUM HYDROXIDE | 1 | Transplacental | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126912691 | 12691269 | 1 | Depression |
| 126912691 | 12691269 | 2 | Depression |
| 126912691 | 12691269 | 3 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126912691 | 12691269 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126912691 | 12691269 | Atrial septal defect | |
| 126912691 | 12691269 | Drug withdrawal syndrome neonatal | |
| 126912691 | 12691269 | Foetal exposure during pregnancy | |
| 126912691 | 12691269 | Respiratory disorder neonatal |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 126912691 | 12691269 | 1 | 20151003 | 20160627 | 0 | |
| 126912691 | 12691269 | 2 | 20151003 | 20160627 | 0 | |
| 126912691 | 12691269 | 3 | 20151015 | 20160627 | 0 |