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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81201243 | 8120124 | 3 | F | 20110812 | 20131217 | 20110905 | 20131231 | EXP | PHEH2011US02539 | NOVARTIS | 17.94 | YR | M | Y | 0.00000 | 20131230 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 81201243 | 8120124 | 1 | PS | GILENYA | 1 | ORAL | 0.5 MG, QD | 12.5 | MG | U | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 81201243 | 8120124 | 1 | Relapsing-remitting multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 81201243 | 8120124 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 81201243 | 8120124 | Albumin globulin ratio increased | |
| 81201243 | 8120124 | Blood creatinine increased | |
| 81201243 | 8120124 | Blood urea increased | |
| 81201243 | 8120124 | Central nervous system lesion | |
| 81201243 | 8120124 | Coordination abnormal | |
| 81201243 | 8120124 | Diplopia | |
| 81201243 | 8120124 | Drug administered to patient of inappropriate age | |
| 81201243 | 8120124 | Eosinophil count increased | |
| 81201243 | 8120124 | Facial paresis | |
| 81201243 | 8120124 | Haematocrit increased | |
| 81201243 | 8120124 | Haemoglobin distribution width decreased | |
| 81201243 | 8120124 | Haemoglobin increased | |
| 81201243 | 8120124 | Hypoaesthesia | |
| 81201243 | 8120124 | Lymphocyte count decreased | |
| 81201243 | 8120124 | Mean cell volume increased | |
| 81201243 | 8120124 | Multiple sclerosis relapse | |
| 81201243 | 8120124 | Muscular weakness | |
| 81201243 | 8120124 | Neutrophil count increased | |
| 81201243 | 8120124 | Pain | |
| 81201243 | 8120124 | Paraesthesia | |
| 81201243 | 8120124 | Paranasal sinus mucosal hypertrophy | |
| 81201243 | 8120124 | Paresis | |
| 81201243 | 8120124 | Sensation of heaviness | |
| 81201243 | 8120124 | Stress | |
| 81201243 | 8120124 | VIIth nerve paralysis | |
| 81201243 | 8120124 | VIth nerve paralysis | |
| 81201243 | 8120124 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 81201243 | 8120124 | 1 | 20110719 | 20120122 | 0 |