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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116214328 | 11621432 | 8 | F | 201412 | 20160721 | 20151012 | 20160727 | EXP | PHHY2015BR117452 | NOVARTIS | 40.65 | YR | M | Y | 76.00000 | KG | 20160727 | CN | COUNTRY NOT SPECIFIED | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116214328 | 11621432 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SA656 | 22527 | .5 | MG | CAPSULE | QD | |||||
| 116214328 | 11621432 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | SC679 | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116214328 | 11621432 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116214328 | 11621432 | HO |
| 116214328 | 11621432 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116214328 | 11621432 | Asthenia | |
| 116214328 | 11621432 | Chest pain | |
| 116214328 | 11621432 | Choking | |
| 116214328 | 11621432 | Condition aggravated | |
| 116214328 | 11621432 | Decreased immune responsiveness | |
| 116214328 | 11621432 | Diplopia | |
| 116214328 | 11621432 | Dysarthria | |
| 116214328 | 11621432 | Dysphagia | |
| 116214328 | 11621432 | Fall | |
| 116214328 | 11621432 | Fatigue | |
| 116214328 | 11621432 | Gait disturbance | |
| 116214328 | 11621432 | Headache | |
| 116214328 | 11621432 | Hemiplegia | |
| 116214328 | 11621432 | Hypoaesthesia | |
| 116214328 | 11621432 | Hypokinesia | |
| 116214328 | 11621432 | Multiple sclerosis relapse | |
| 116214328 | 11621432 | Muscular weakness | |
| 116214328 | 11621432 | Pain | |
| 116214328 | 11621432 | Paraesthesia | |
| 116214328 | 11621432 | Paresis | |
| 116214328 | 11621432 | Pseudoneurologic symptom | |
| 116214328 | 11621432 | Speech disorder | |
| 116214328 | 11621432 | Vision blurred | |
| 116214328 | 11621432 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 116214328 | 11621432 | 1 | 20140720 | 0 | ||
| 116214328 | 11621432 | 2 | 20140720 | 0 |