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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114448063 | 11444806 | 3 | F | 20150729 | 20160726 | 20150902 | 20160727 | PER | PHEH2015US015770 | NOVARTIS | 55.96 | YR | F | Y | 0.00000 | 20160727 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 114448063 | 11444806 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | U | UNKNOWN | 22527 | .5 | MG | CAPSULE | QD | ||||
| 114448063 | 11444806 | 2 | C | VALSARTAN. | VALSARTAN | 1 | Unknown | UNK | U | 0 | |||||||||
| 114448063 | 11444806 | 3 | C | RANITIDINE. | RANITIDINE | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 4 | C | CALCIUM | CALCIUM | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 5 | C | ORACEA | DOXYCYCLINE | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 6 | C | BISOPROLOL | BISOPROLOL | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 7 | C | NEXIUM | ESOMEPRAZOLE MAGNESIUM | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 8 | C | VALTREX | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 9 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 10 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | U | 0 | ||||||||||
| 114448063 | 11444806 | 11 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 114448063 | 11444806 | 1 | Multiple sclerosis |
| 114448063 | 11444806 | 2 | Product used for unknown indication |
| 114448063 | 11444806 | 3 | Product used for unknown indication |
| 114448063 | 11444806 | 4 | Product used for unknown indication |
| 114448063 | 11444806 | 5 | Product used for unknown indication |
| 114448063 | 11444806 | 6 | Product used for unknown indication |
| 114448063 | 11444806 | 7 | Product used for unknown indication |
| 114448063 | 11444806 | 8 | Product used for unknown indication |
| 114448063 | 11444806 | 9 | Product used for unknown indication |
| 114448063 | 11444806 | 10 | Product used for unknown indication |
| 114448063 | 11444806 | 11 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 114448063 | 11444806 | Asthenia | |
| 114448063 | 11444806 | Blood potassium decreased | |
| 114448063 | 11444806 | Fatigue | |
| 114448063 | 11444806 | Glycosuria | |
| 114448063 | 11444806 | Headache | |
| 114448063 | 11444806 | Heart rate increased | |
| 114448063 | 11444806 | Hypertension | |
| 114448063 | 11444806 | Joint swelling | |
| 114448063 | 11444806 | Nervousness | |
| 114448063 | 11444806 | Peripheral swelling | |
| 114448063 | 11444806 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 114448063 | 11444806 | 1 | 20150721 | 0 |