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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127894531 | 12789453 | 1 | I | 20160922 | 20160928 | 20160928 | EXP | PHHY2016US132381 | NOVARTIS | GUMMIN DD, MOELLER JR, NELSON TJ, DRENDEL AL, SHAH BK, BERGER S. RISK OF VENTRICULAR ARRHYTHMIAS AND ASSOCIATION WITH ONDANSETRON. JOURNAL OF PEDIATRICS. 2016;1-6 | 9.00 | WK | Y | 0.00000 | 20160928 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127894531 | 12789453 | 1 | PS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | U | 20007 | ||||||||||
| 127894531 | 12789453 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | U | 0 | ||||||||||
| 127894531 | 12789453 | 3 | C | MYCOPHENOLATE | MYCOPHENOLIC ACID | 1 | Unknown | U | 0 | ||||||||||
| 127894531 | 12789453 | 4 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127894531 | 12789453 | 1 | Product used for unknown indication |
| 127894531 | 12789453 | 2 | Heart transplant |
| 127894531 | 12789453 | 3 | Heart transplant |
| 127894531 | 12789453 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127894531 | 12789453 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127894531 | 12789453 | Ventricular tachyarrhythmia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |