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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125255391 | 12525539 | 1 | I | 20150908 | 20160620 | 20160705 | 20160705 | EXP | DE-BFARM-16201221 | DE-APOTEX-2016AP009646 | APOTEX | 0.00 | M | Y | 2.47000 | KG | 20160705 | CN | GB | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125255391 | 12525539 | 1 | SS | OLANZAPINE APOTEX | OLANZAPINE | 1 | Transplacental | 10 MG, QD | 2600 | MG | 0 | 10 | MG | TABLET | QD | ||||
| 125255391 | 12525539 | 2 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | 40 MG, QD | 2800 | MG | Y | U | 20031 | 40 | MG | TABLET | QD | ||
| 125255391 | 12525539 | 3 | SS | RISPERIDON | RISPERIDONE | 1 | Transplacental | 1 MG, QD | 260 | MG | 0 | 1 | MG | QD | |||||
| 125255391 | 12525539 | 4 | SS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 50 MG, QD | 9450 | MG | U | 0 | 50 | MG | QD | ||||
| 125255391 | 12525539 | 5 | C | VITAVERLAN | 2 | Transplacental | 0.4 MG, QD | 0 | .4 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125255391 | 12525539 | 1 | Schizophrenia |
| 125255391 | 12525539 | 2 | Schizophrenia |
| 125255391 | 12525539 | 3 | Schizophrenia |
| 125255391 | 12525539 | 4 | Schizophrenia |
| 125255391 | 12525539 | 5 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125255391 | 12525539 | CA |
| 125255391 | 12525539 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125255391 | 12525539 | Atrial septal defect | |
| 125255391 | 12525539 | Drug withdrawal syndrome neonatal | |
| 125255391 | 12525539 | Foetal exposure during pregnancy | |
| 125255391 | 12525539 | Small for dates baby | |
| 125255391 | 12525539 | Ventricular septal defect |
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 |
|---|---|---|---|---|---|---|
| 125255391 | 12525539 | 1 | 20141222 | 20150908 | 0 | |
| 125255391 | 12525539 | 2 | 20141222 | 20150302 | 0 | |
| 125255391 | 12525539 | 3 | 20141222 | 20150908 | 0 | |
| 125255391 | 12525539 | 4 | 20150303 | 20150908 | 0 |