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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126134703 | 12613470 | 3 | F | 2016 | 20160830 | 20160802 | 20160901 | EXP | PHHY2016DE104575 | NOVARTIS | 39.84 | YR | F | Y | 0.00000 | 20160901 | CN | COUNTRY NOT SPECIFIED | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126134703 | 12613470 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 126134703 | 12613470 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, 6 TIMES/WEEK (NOT ON SUNDAY) | Y | 22527 | .5 | MG | CAPSULE | ||||||
| 126134703 | 12613470 | 3 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, 5 TIMES/WEEK (NOT ON WEDNESDAY AND SUNDAY) | Y | S0143 | 22527 | .5 | MG | CAPSULE | |||||
| 126134703 | 12613470 | 4 | SS | ATORVASTATIN | ATORVASTATIN | 1 | Unknown | 10 MG, QD | Y | 0 | 10 | MG | QD | ||||||
| 126134703 | 12613470 | 5 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 1000 MG, TID | U | 0 | 1000 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126134703 | 12613470 | 1 | Multiple sclerosis |
| 126134703 | 12613470 | 4 | Blood cholesterol increased |
| 126134703 | 12613470 | 5 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126134703 | 12613470 | HO |
| 126134703 | 12613470 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126134703 | 12613470 | Apathy | |
| 126134703 | 12613470 | Chest pain | |
| 126134703 | 12613470 | Electrocardiogram T wave inversion | |
| 126134703 | 12613470 | Hyperlipidaemia | |
| 126134703 | 12613470 | Lymphocyte count decreased | |
| 126134703 | 12613470 | Myalgia | |
| 126134703 | 12613470 | Prescribed underdose |
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 |
|---|---|---|---|---|---|---|
| 126134703 | 12613470 | 1 | 20160315 | 201604 | 0 | |
| 126134703 | 12613470 | 2 | 201604 | 201606 | 0 | |
| 126134703 | 12613470 | 3 | 201606 | 0 |