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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115807315 | 11580731 | 5 | F | 20150817 | 20160707 | 20150930 | 20160708 | PER | PHEH2015US017437 | NOVARTIS | 56.15 | YR | F | Y | 64.85000 | KG | 20160709 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115807315 | 11580731 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | F0011 | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115807315 | 11580731 | 1 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115807315 | 11580731 | Body height decreased | |
| 115807315 | 11580731 | Diplopia | |
| 115807315 | 11580731 | Dysarthria | |
| 115807315 | 11580731 | Eye disorder | |
| 115807315 | 11580731 | Fatigue | |
| 115807315 | 11580731 | Feeling abnormal | |
| 115807315 | 11580731 | Gait disturbance | |
| 115807315 | 11580731 | Headache | |
| 115807315 | 11580731 | Insomnia | |
| 115807315 | 11580731 | Memory impairment | |
| 115807315 | 11580731 | Multiple sclerosis relapse | |
| 115807315 | 11580731 | Nasopharyngitis | |
| 115807315 | 11580731 | Pain | |
| 115807315 | 11580731 | Respiratory disorder | |
| 115807315 | 11580731 | Speech disorder | |
| 115807315 | 11580731 | Therapeutic response unexpected | |
| 115807315 | 11580731 | Upper respiratory tract infection | |
| 115807315 | 11580731 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 115807315 | 11580731 | 1 | 20150406 | 0 |