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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121007813 | 12100781 | 3 | F | 20141014 | 20160816 | 20160222 | 20160829 | EXP | PHEH2016US004091 | NOVARTIS | 0.00 | N | F | Y | 0.00000 | 20160829 | MD | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121007813 | 12100781 | 1 | PS | ZOFRAN ODT | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | 20007 | DISPERSIBLE TABLET | ||||||||||
| 121007813 | 12100781 | 2 | SS | ONDANSETRON | ONDANSETRON | 1 | Transplacental | 20007 | DISPERSIBLE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121007813 | 12100781 | 1 | Foetal exposure during pregnancy |
| 121007813 | 12100781 | 2 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121007813 | 12100781 | LT |
| 121007813 | 12100781 | OT |
| 121007813 | 12100781 | CA |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121007813 | 12100781 | Anhedonia | |
| 121007813 | 12100781 | Anxiety | |
| 121007813 | 12100781 | Cardiomegaly | |
| 121007813 | 12100781 | Congenital anomaly | |
| 121007813 | 12100781 | Congenital tricuspid valve atresia | |
| 121007813 | 12100781 | Ebstein's anomaly | |
| 121007813 | 12100781 | Emotional distress | |
| 121007813 | 12100781 | Foetal exposure during pregnancy | |
| 121007813 | 12100781 | Heart disease congenital | |
| 121007813 | 12100781 | Injury | |
| 121007813 | 12100781 | Pain |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |