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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95563878 | 9556387 | 8 | F | 20130831 | 20160824 | 20130926 | 20160901 | EXP | PHHY2013BE099367 | NOVARTIS | 35.43 | YR | F | Y | 0.00000 | 20160901 | OT | BE | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 95563878 | 9556387 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 22527 | .5 | MG | CAPSULE | QD | ||||||
| 95563878 | 9556387 | 2 | C | HYABAK | 2 | Unknown | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 95563878 | 9556387 | 1 | Multiple sclerosis |
| 95563878 | 9556387 | 2 | Dry eye |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 95563878 | 9556387 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 95563878 | 9556387 | Acne | |
| 95563878 | 9556387 | Blister | |
| 95563878 | 9556387 | Burning sensation | |
| 95563878 | 9556387 | Dermatitis bullous | |
| 95563878 | 9556387 | Dermatosis | |
| 95563878 | 9556387 | Erythema | |
| 95563878 | 9556387 | Fatigue | |
| 95563878 | 9556387 | Fibroma | |
| 95563878 | 9556387 | Hyperaesthesia | |
| 95563878 | 9556387 | Malaise | |
| 95563878 | 9556387 | Night sweats | |
| 95563878 | 9556387 | Pain | |
| 95563878 | 9556387 | Parosmia | |
| 95563878 | 9556387 | Pruritus | |
| 95563878 | 9556387 | Skin lesion |
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 |
|---|---|---|---|---|---|---|
| 95563878 | 9556387 | 1 | 20130107 | 0 | ||
| 95563878 | 9556387 | 2 | 20140121 | 20140331 | 0 |