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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127105261 | 12710526 | 1 | I | 20160627 | 20160822 | 20160902 | 20160902 | EXP | DE-LUPIN PHARMACEUTICALS INC.-E2B_00006052 | LUPIN | 1.00 | DY | M | Y | 3.07000 | KG | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127105261 | 12710526 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNKNOWN | 77670 | 50 | MG | ||||||||
| 127105261 | 12710526 | 2 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNKNOWN | 77670 | 100 | MG | ||||||||
| 127105261 | 12710526 | 3 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | UNKNOWN | 0 | ||||||||||
| 127105261 | 12710526 | 4 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | UNKNOWN | 0 | ||||||||||
| 127105261 | 12710526 | 5 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | WEEK 37+2 UNTIL DELIVERY | UNKNOWN | 0 | 2 | MG | TID | ||||||
| 127105261 | 12710526 | 6 | C | Femibion | VITAMINS | 1 | Transplacental | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127105261 | 12710526 | 1 | Depression |
| 127105261 | 12710526 | 3 | Depression |
| 127105261 | 12710526 | 6 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127105261 | 12710526 | OT |
| 127105261 | 12710526 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127105261 | 12710526 | Atrial septal defect | |
| 127105261 | 12710526 | Drug withdrawal syndrome neonatal | |
| 127105261 | 12710526 | Foetal exposure during pregnancy | |
| 127105261 | 12710526 | 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 |
|---|---|---|---|---|---|---|
| 127105261 | 12710526 | 1 | 20151003 | 0 | ||
| 127105261 | 12710526 | 2 | 20160513 | 20160627 | 0 | |
| 127105261 | 12710526 | 3 | 20151003 | 0 | ||
| 127105261 | 12710526 | 4 | 20160428 | 20160526 | 0 | |
| 127105261 | 12710526 | 5 | 20160627 | 0 | ||
| 127105261 | 12710526 | 6 | 20151015 | 20160627 | 0 |