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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125244641 | 12524464 | 1 | I | 20150908 | 20160620 | 20160704 | 20160704 | EXP | DE-LUPIN PHARMACEUTICALS INC.-E2B_00005725 | LUPIN | 0.00 | DY | M | Y | 2.47000 | KG | 20160704 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125244641 | 12524464 | 1 | SS | OLANZAPINE. | OLANZAPINE | 1 | Transplacental | 10 [MG/D] | UNKNOWN | 0 | 10 | MG | QD | ||||||
| 125244641 | 12524464 | 2 | SS | RISPERIDONE. | RISPERIDONE | 1 | Transplacental | 1 [MG/D] | UNKNOWN | 0 | 1 | MG | QD | ||||||
| 125244641 | 12524464 | 3 | SS | PAROXETINE. | PAROXETINE | 1 | Transplacental | 40 [MG/D] | UNKNOWN | 0 | 40 | MG | QD | ||||||
| 125244641 | 12524464 | 4 | PS | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Transplacental | 50 [MG/D] | UNKNOWN | 77670 | 50 | MG | QD | ||||||
| 125244641 | 12524464 | 5 | C | Vitaverlan | 2 | Transplacental | 0.4 [MG/D] | UNKNOWN | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125244641 | 12524464 | 1 | Schizophrenia |
| 125244641 | 12524464 | 2 | Schizophrenia |
| 125244641 | 12524464 | 3 | Schizophrenia |
| 125244641 | 12524464 | 4 | Schizophrenia |
| 125244641 | 12524464 | 5 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125244641 | 12524464 | OT |
| 125244641 | 12524464 | CA |
| 125244641 | 12524464 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125244641 | 12524464 | Atrial septal defect | |
| 125244641 | 12524464 | Drug withdrawal syndrome neonatal | |
| 125244641 | 12524464 | Foetal exposure during pregnancy | |
| 125244641 | 12524464 | Small for dates baby | |
| 125244641 | 12524464 | 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 |
|---|---|---|---|---|---|---|
| 125244641 | 12524464 | 1 | 20141222 | 20150908 | 0 | |
| 125244641 | 12524464 | 2 | 20141222 | 20150908 | 0 | |
| 125244641 | 12524464 | 3 | 20141222 | 20150302 | 0 | |
| 125244641 | 12524464 | 4 | 20150303 | 20150908 | 0 |