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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120787893 | 12078789 | 3 | F | 20160202 | 20160907 | 20160216 | 20160913 | EXP | PHEH2016US003679 | NOVARTIS | 40.59 | YR | M | Y | 0.00000 | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120787893 | 12078789 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 14.9680004 | MG | Y | 22527 | .5 | MG | CAPSULE | QD | |||
| 120787893 | 12078789 | 2 | C | LEXAPRO | ESCITALOPRAM OXALATE | 1 | Oral | 20 MG, QD | 0 | 20 | MG | QD | |||||||
| 120787893 | 12078789 | 3 | C | ATIVAN | LORAZEPAM | 1 | Unknown | 0.5 MG, PRN | 0 | .5 | MG | ||||||||
| 120787893 | 12078789 | 4 | C | MIRAPEX | PRAMIPEXOLE DIHYDROCHLORIDE | 1 | Unknown | 0.5 MG, QHS | 0 | .5 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120787893 | 12078789 | 1 | Relapsing-remitting multiple sclerosis |
| 120787893 | 12078789 | 2 | Depression |
| 120787893 | 12078789 | 3 | Anxiety |
| 120787893 | 12078789 | 4 | Restless legs syndrome |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120787893 | 12078789 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120787893 | 12078789 | Dizziness | |
| 120787893 | 12078789 | Fungal skin infection | |
| 120787893 | 12078789 | Heart rate decreased | |
| 120787893 | 12078789 | Hypotension | |
| 120787893 | 12078789 | Syncope |
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 |
|---|---|---|---|---|---|---|
| 120787893 | 12078789 | 1 | 20160131 | 20160209 | 0 |