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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125367504 | 12536750 | 4 | F | 20160824 | 20160707 | 20160906 | PER | PHHY2016US092237 | NOVARTIS | 0.00 | F | Y | 82.54000 | KG | 20160906 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125367504 | 12536750 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 5 DF (5 TABLET) | 20007 | 5 | DF | TABLET | |||||||
| 125367504 | 12536750 | 2 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | 10 DF (10 TABLET) | 20007 | 10 | DF | TABLET | |||||||
| 125367504 | 12536750 | 3 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 4 MG, QD | 20007 | 4 | MG | SOLUTION FOR INJECTION | QD | ||||||
| 125367504 | 12536750 | 4 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 8 MG, QD | 20007 | 8 | MG | SOLUTION FOR INJECTION | QD | ||||||
| 125367504 | 12536750 | 5 | SS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 4 MG, QD | 20007 | 4 | MG | SOLUTION FOR INJECTION | QD | ||||||
| 125367504 | 12536750 | 6 | SS | ONDANSETRON | ONDANSETRON | 1 | Oral | 10 DF (10 TABLET) | U | 20007 | 10 | DF | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125367504 | 12536750 | 1 | Vomiting in pregnancy |
| 125367504 | 12536750 | 3 | Vomiting in pregnancy |
| 125367504 | 12536750 | 6 | Vomiting in pregnancy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125367504 | 12536750 | Anxiety | |
| 125367504 | 12536750 | Asthenia | |
| 125367504 | 12536750 | Constipation | |
| 125367504 | 12536750 | Decreased appetite | |
| 125367504 | 12536750 | Dehydration | |
| 125367504 | 12536750 | Dizziness | |
| 125367504 | 12536750 | Emotional distress | |
| 125367504 | 12536750 | Fatigue | |
| 125367504 | 12536750 | Feeling guilty | |
| 125367504 | 12536750 | Maternal exposure during pregnancy | |
| 125367504 | 12536750 | Product use issue |
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 |
|---|---|---|---|---|---|---|
| 125367504 | 12536750 | 1 | 20061022 | 0 | ||
| 125367504 | 12536750 | 2 | 20061111 | 0 | ||
| 125367504 | 12536750 | 3 | 20061022 | 20061022 | 0 | |
| 125367504 | 12536750 | 4 | 20061107 | 20061107 | 0 | |
| 125367504 | 12536750 | 5 | 20061201 | 20061201 | 0 | |
| 125367504 | 12536750 | 6 | 20070328 | 0 |