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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125528456 | 12552845 | 6 | F | 20141203 | 20160811 | 20160713 | 20160816 | EXP | PHHY2016US095255 | SANDOZ | 36.00 | YR | F | Y | 0.00000 | 20160816 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125528456 | 12552845 | 1 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 4 MG, UNK | Y | 0 | 4 | MG | |||||||
| 125528456 | 12552845 | 2 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Y | 0 | |||||||||||
| 125528456 | 12552845 | 3 | SS | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | 5 MG, UNK | U | 0 | 5 | MG | |||||||
| 125528456 | 12552845 | 4 | PS | INDOMETHACIN. | INDOMETHACIN | 1 | Oral | 50 MG, UNK | U | 70673 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125528456 | 12552845 | 1 | Nausea |
| 125528456 | 12552845 | 2 | Vomiting |
| 125528456 | 12552845 | 3 | Pain |
| 125528456 | 12552845 | 4 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125528456 | 12552845 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125528456 | 12552845 | Cardiac arrest | |
| 125528456 | 12552845 | Heart rate decreased | |
| 125528456 | 12552845 | Maternal exposure during pregnancy | |
| 125528456 | 12552845 | Sinus bradycardia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |