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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117144416 | 11714441 | 6 | F | 20141105 | 20160915 | 20151109 | 20160919 | EXP | PHEH2015US022669 | NOVARTIS | 26.98 | YR | F | Y | 50.79000 | KG | 20160919 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117144416 | 11714441 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | U | 20007 | ||||||||||
| 117144416 | 11714441 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 4 TO 8 MG, UNK | U | 20007 | 8 | MG | DISPERSIBLE TABLET | ||||||
| 117144416 | 11714441 | 3 | SS | ONDANSETRON. | ONDANSETRON | 1 | Unknown | 4 MG TO 8 MG, UNK | 0 | 8 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117144416 | 11714441 | 1 | Vomiting in pregnancy |
| 117144416 | 11714441 | 2 | Product used for unknown indication |
| 117144416 | 11714441 | 3 | Vomiting in pregnancy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117144416 | 11714441 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117144416 | 11714441 | Anxiety | |
| 117144416 | 11714441 | Emotional distress | |
| 117144416 | 11714441 | Injury | |
| 117144416 | 11714441 | Malaise | |
| 117144416 | 11714441 | Maternal exposure during pregnancy | |
| 117144416 | 11714441 | Pain | |
| 117144416 | 11714441 | Product use issue | |
| 117144416 | 11714441 | Stillbirth | |
| 117144416 | 11714441 | Urinary tract infection | |
| 117144416 | 11714441 | Vulvovaginal candidiasis |
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 |
|---|---|---|---|---|---|---|
| 117144416 | 11714441 | 3 | 201406 | 201411 | 0 |