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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117130954 | 11713095 | 4 | F | 20160914 | 20151109 | 20160927 | PER | PHEH2015US022875 | NOVARTIS | 0.00 | F | Y | 0.00000 | 20160927 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117130954 | 11713095 | 1 | PS | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Oral | UNK | U | 20007 | |||||||||
| 117130954 | 11713095 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Oral | UNK | U | 0 | DISPERSIBLE TABLET | ||||||||
| 117130954 | 11713095 | 3 | SS | ONDANSETRON DR REDDY | ONDANSETRON | 1 | Oral | 4 MG | 0 | 4 | MG | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117130954 | 11713095 | 1 | Vomiting in pregnancy |
| 117130954 | 11713095 | 2 | Product used for unknown indication |
| 117130954 | 11713095 | 3 | Vomiting in pregnancy |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117130954 | 11713095 | Anxiety | |
| 117130954 | 11713095 | Emotional distress | |
| 117130954 | 11713095 | Injury | |
| 117130954 | 11713095 | Maternal exposure during pregnancy | |
| 117130954 | 11713095 | Pain | |
| 117130954 | 11713095 | 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 |
|---|---|---|---|---|---|---|
| 117130954 | 11713095 | 3 | 201309 | 201311 | 0 |