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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119814674 | 11981467 | 4 | F | 20160309 | 20160926 | 20160130 | 20160930 | PER | PHEH2016US001869 | NOVARTIS | 46.20 | YR | F | Y | 0.00000 | 20160930 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119814674 | 11981467 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 119814674 | 11981467 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119814674 | 11981467 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119814674 | 11981467 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119814674 | 11981467 | Anxiety | |
| 119814674 | 11981467 | Balance disorder | |
| 119814674 | 11981467 | Cough | |
| 119814674 | 11981467 | Dizziness | |
| 119814674 | 11981467 | Fall | |
| 119814674 | 11981467 | Hypoaesthesia | |
| 119814674 | 11981467 | Influenza | |
| 119814674 | 11981467 | Malaise | |
| 119814674 | 11981467 | Mobility decreased | |
| 119814674 | 11981467 | Multiple sclerosis relapse | |
| 119814674 | 11981467 | Nasopharyngitis | |
| 119814674 | 11981467 | Oropharyngeal pain | |
| 119814674 | 11981467 | Skin lesion | |
| 119814674 | 11981467 | Speech disorder | |
| 119814674 | 11981467 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 119814674 | 11981467 | 1 | 2012 | 0 | ||
| 119814674 | 11981467 | 2 | 20150219 | 0 |