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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116957964 | 11695796 | 4 | F | 20160914 | 20151104 | 20160921 | EXP | PHEH2015US022025 | NOVARTIS | 0.00 | M | Y | 0.00000 | 20160921 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116957964 | 11695796 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Transplacental | MOTHER'S DOSE: 4 MG, UNK | D | 20007 | |||||||||
| 116957964 | 11695796 | 2 | SS | ONDANSETRON | ONDANSETRON | 1 | Transplacental | D | 0 | TABLET | |||||||||
| 116957964 | 11695796 | 3 | SS | ONDANSETRON | ONDANSETRON | 1 | Transplacental | MOTHER'S DOSE: 4 MG, PRN | D | 0 | DISPERSIBLE TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116957964 | 11695796 | 1 | Foetal exposure during pregnancy |
| 116957964 | 11695796 | 2 | Foetal exposure during pregnancy |
| 116957964 | 11695796 | 3 | Foetal exposure during pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116957964 | 11695796 | CA |
| 116957964 | 11695796 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116957964 | 11695796 | Anhedonia | |
| 116957964 | 11695796 | Anxiety | |
| 116957964 | 11695796 | Cardiac disorder | |
| 116957964 | 11695796 | Congenital anomaly | |
| 116957964 | 11695796 | Developmental delay | |
| 116957964 | 11695796 | Emotional distress | |
| 116957964 | 11695796 | Fatigue | |
| 116957964 | 11695796 | Foetal exposure during pregnancy | |
| 116957964 | 11695796 | Heart disease congenital | |
| 116957964 | 11695796 | Hypoplastic left heart syndrome | |
| 116957964 | 11695796 | Pain |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |