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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127064091 | 12706409 | 1 | I | 20160627 | 20160818 | 20160901 | 20160901 | EXP | DE-AUROBINDO-AUR-APL-2016-10834 | AUROBINDO | 1.00 | DY | M | Y | 3.70000 | KG | 20160901 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127064091 | 12706409 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 100 MG, UNK | U | 77206 | 100 | MG | |||||||
| 127064091 | 12706409 | 2 | SS | DIAZEPAM. | DIAZEPAM | 1 | Transplacental | 8 (MG/D (6 MG/D)) | U | 0 | |||||||||
| 127064091 | 12706409 | 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 |
|---|---|---|---|
| 127064091 | 12706409 | 1 | Depression |
| 127064091 | 12706409 | 2 | Depression |
| 127064091 | 12706409 | 3 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127064091 | 12706409 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127064091 | 12706409 | Atrial septal defect | |
| 127064091 | 12706409 | Diarrhoea | |
| 127064091 | 12706409 | Drug withdrawal syndrome neonatal | |
| 127064091 | 12706409 | Foetal exposure during pregnancy | |
| 127064091 | 12706409 | Hypertonia | |
| 127064091 | 12706409 | Myoclonus | |
| 127064091 | 12706409 | Oxygen saturation decreased | |
| 127064091 | 12706409 | Respiratory disorder neonatal | |
| 127064091 | 12706409 | Sneezing | |
| 127064091 | 12706409 | Tachypnoea | |
| 127064091 | 12706409 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 127064091 | 12706409 | 1 | 20151003 | 20160627 | 0 | |
| 127064091 | 12706409 | 2 | 20151003 | 20160627 | 0 | |
| 127064091 | 12706409 | 3 | 20151015 | 20160627 | 0 |