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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125394821 | 12539482 | 1 | I | 20160619 | 20160624 | 20160708 | 20160708 | EXP | DE-AUROBINDO-AUR-APL-2016-08506 | AUROBINDO | 0.00 | Y | 0.00000 | 20160708 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125394821 | 12539482 | 1 | PS | Simvastatin 20mg | SIMVASTATIN | 1 | Transplacental | 20 MG, DAILY | U | 77691 | 20 | MG | |||||||
| 125394821 | 12539482 | 2 | SS | LEPONEX | CLOZAPINE | 1 | Transplacental | 300 MG, DAILY | U | 0 | 300 | MG | |||||||
| 125394821 | 12539482 | 3 | SS | ZIPRASIDONE. | ZIPRASIDONE | 1 | Transplacental | 80 MG, TWO TIMES A DAY | U | 0 | 80 | MG | BID | ||||||
| 125394821 | 12539482 | 4 | SS | INSIDON | OPIPRAMOL HYDROCHLORIDE | 1 | Transplacental | 100 MG, 3 TIMES A DAY | 65700 | MG | U | 0 | 100 | MG | TID | ||||
| 125394821 | 12539482 | 5 | SS | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Transplacental | 20 MG, DAILY | U | 0 | 20 | MG | |||||||
| 125394821 | 12539482 | 6 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Transplacental | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125394821 | 12539482 | 1 | Product used for unknown indication |
| 125394821 | 12539482 | 2 | Schizophrenia |
| 125394821 | 12539482 | 3 | Schizophrenia |
| 125394821 | 12539482 | 4 | Anxiety disorder |
| 125394821 | 12539482 | 5 | Product used for unknown indication |
| 125394821 | 12539482 | 6 | Schizophrenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125394821 | 12539482 | CA |
| 125394821 | 12539482 | HO |
| 125394821 | 12539482 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125394821 | 12539482 | Abnormal palmar/plantar creases | |
| 125394821 | 12539482 | Developmental delay | |
| 125394821 | 12539482 | Dysmorphism | |
| 125394821 | 12539482 | Foetal exposure during pregnancy | |
| 125394821 | 12539482 | Hyperbilirubinaemia neonatal | |
| 125394821 | 12539482 | Hypotonia neonatal | |
| 125394821 | 12539482 | Neonatal respiratory distress syndrome | |
| 125394821 | 12539482 | Premature baby | |
| 125394821 | 12539482 | Selective eating disorder |
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 |
|---|---|---|---|---|---|---|
| 125394821 | 12539482 | 2 | 20141112 | 20150619 | 0 | |
| 125394821 | 12539482 | 4 | 20141112 | 20150619 | 0 | |
| 125394821 | 12539482 | 5 | 20141112 | 20150619 | 0 |