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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393671 | 12539367 | 1 | I | 20160624 | 20160708 | 20160708 | EXP | DE-AUROBINDO-AUR-APL-2016-08815 | AUROBINDO | 0.00 | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125393671 | 12539367 | 1 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | UNK | U | 77206 | |||||||||
| 125393671 | 12539367 | 2 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Transplacental | U | 0 | ||||||||||
| 125393671 | 12539367 | 3 | C | VOMEX A | DIMENHYDRINATE | 1 | Transplacental | U | 0 | ||||||||||
| 125393671 | 12539367 | 4 | C | MISOPROSTOL. | MISOPROSTOL | 1 | Transplacental | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125393671 | 12539367 | 1 | Anxiety disorder |
| 125393671 | 12539367 | 2 | Pyrexia |
| 125393671 | 12539367 | 3 | Vomiting |
| 125393671 | 12539367 | 4 | Labour induction |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125393671 | 12539367 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125393671 | 12539367 | Bradycardia | |
| 125393671 | 12539367 | Cardiomegaly | |
| 125393671 | 12539367 | Foetal exposure during pregnancy | |
| 125393671 | 12539367 | Hypospadias | |
| 125393671 | 12539367 | Micrognathia | |
| 125393671 | 12539367 | Retrognathia | |
| 125393671 | 12539367 | Talipes | |
| 125393671 | 12539367 | Vitello-intestinal duct remnant |
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 |
|---|---|---|---|---|---|---|
| 125393671 | 12539367 | 1 | 20151127 | 20151111 | 0 |