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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125323591 | 12532359 | 1 | I | 20150619 | 20160624 | 20160706 | 20160706 | EXP | DE-MYLANLABS-2016M1027377 | MYLAN | 0.00 | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125323591 | 12532359 | 1 | PS | SIMVASTATIN. | SIMVASTATIN | 1 | Transplacental | 20 [MG/D ] | 90868 | 20 | MG | QD | |||||||
| 125323591 | 12532359 | 2 | SS | ZIPRASIDONE. | ZIPRASIDONE | 1 | Transplacental | 160 [MG/D ] | 0 | 80 | MG | BID | |||||||
| 125323591 | 12532359 | 3 | SS | LEPONEX | CLOZAPINE | 1 | Transplacental | 300 [MG/D ] | 66000 | MG | 0 | 300 | MG | QD | |||||
| 125323591 | 12532359 | 4 | SS | INSIDON | OPIPRAMOL HYDROCHLORIDE | 1 | Transplacental | 300 [MG/D ] | 66000 | MG | 0 | 100 | MG | TID | |||||
| 125323591 | 12532359 | 5 | SS | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Transplacental | 20 [MG/D ] | 4400 | MG | 0 | 20 | MG | QD | |||||
| 125323591 | 12532359 | 6 | SS | SEROQUEL | QUETIAPINE FUMARATE | 1 | Transplacental | DOSAGE UNKNOWN | 0 | ||||||||||
| 125323591 | 12532359 | 7 | C | FOLSAEURE | FOLIC ACID | 1 | Transplacental | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125323591 | 12532359 | 1 | Product used for unknown indication |
| 125323591 | 12532359 | 2 | Schizophrenia |
| 125323591 | 12532359 | 3 | Schizophrenia |
| 125323591 | 12532359 | 4 | Anxiety disorder |
| 125323591 | 12532359 | 5 | Product used for unknown indication |
| 125323591 | 12532359 | 6 | Schizophrenia |
| 125323591 | 12532359 | 7 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125323591 | 12532359 | CA |
| 125323591 | 12532359 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125323591 | 12532359 | Abnormal palmar/plantar creases | |
| 125323591 | 12532359 | Developmental delay | |
| 125323591 | 12532359 | Dysmorphism | |
| 125323591 | 12532359 | Foetal exposure during pregnancy | |
| 125323591 | 12532359 | Hyperbilirubinaemia neonatal | |
| 125323591 | 12532359 | Hypotonia neonatal | |
| 125323591 | 12532359 | Neonatal respiratory distress syndrome | |
| 125323591 | 12532359 | Premature baby | |
| 125323591 | 12532359 | 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 |
|---|---|---|---|---|---|---|
| 125323591 | 12532359 | 3 | 20141112 | 20150619 | 0 | |
| 125323591 | 12532359 | 4 | 20141112 | 20150619 | 0 | |
| 125323591 | 12532359 | 5 | 20141112 | 20150619 | 0 |