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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117137696 | 11713769 | 6 | F | 20160916 | 20151109 | 20160923 | EXP | PHEH2015US022967 | NOVARTIS | 0.00 | F | Y | 58.96000 | KG | 20160923 | LW | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117137696 | 11713769 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | AS NEEDED (PRN) | 20103 | TABLET | |||||||||
| 117137696 | 11713769 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | UNK | 20103 | TABLET | |||||||||
| 117137696 | 11713769 | 3 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | UNK | 0 | SOLUTION FOR INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117137696 | 11713769 | 1 | Vomiting in pregnancy |
| 117137696 | 11713769 | 2 | Product used for unknown indication |
| 117137696 | 11713769 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117137696 | 11713769 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117137696 | 11713769 | Anhedonia | |
| 117137696 | 11713769 | Anxiety | |
| 117137696 | 11713769 | Emotional distress | |
| 117137696 | 11713769 | Hypertension | |
| 117137696 | 11713769 | Injury | |
| 117137696 | 11713769 | Maternal exposure during pregnancy | |
| 117137696 | 11713769 | Pain | |
| 117137696 | 11713769 | Product use issue | |
| 117137696 | 11713769 | Proteinuria | |
| 117137696 | 11713769 | Scar |
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 |
|---|---|---|---|---|---|---|
| 117137696 | 11713769 | 1 | 201209 | 201304 | 0 | |
| 117137696 | 11713769 | 2 | 201209 | 201303 | 0 | |
| 117137696 | 11713769 | 3 | 201209 | 201303 | 0 |