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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108570287 | 10857028 | 7 | F | 19950129 | 20160722 | 20150223 | 20160804 | EXP | US-APOTEX-2014AP001153 | APOTEX | 0.00 | DY | F | Y | 0.00000 | 20160804 | CN | GB | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 108570287 | 10857028 | 1 | PS | PAXIL | PAROXETINE HYDROCHLORIDE | 1 | Transplacental | UNK | 20031 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 108570287 | 10857028 | 1 | Depression |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 108570287 | 10857028 | CA |
| 108570287 | 10857028 | OT |
| 108570287 | 10857028 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 108570287 | 10857028 | Anxiety | |
| 108570287 | 10857028 | Aorta hypoplasia | |
| 108570287 | 10857028 | Aortic valve incompetence | |
| 108570287 | 10857028 | Arnold-Chiari malformation | |
| 108570287 | 10857028 | Bicuspid aortic valve | |
| 108570287 | 10857028 | Coarctation of the aorta | |
| 108570287 | 10857028 | Congenital aortic valve incompetence | |
| 108570287 | 10857028 | Congenital aortic valve stenosis | |
| 108570287 | 10857028 | Depression | |
| 108570287 | 10857028 | Foetal exposure during pregnancy | |
| 108570287 | 10857028 | Myocardial bridging | |
| 108570287 | 10857028 | Patent ductus arteriosus | |
| 108570287 | 10857028 | Pulmonary valve incompetence | |
| 108570287 | 10857028 | Rib deformity | |
| 108570287 | 10857028 | Tricuspid valve incompetence |
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 |
|---|---|---|---|---|---|---|
| 108570287 | 10857028 | 1 | 1994 | 1995 | 0 |