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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113796024 | 11379602 | 4 | F | 20140915 | 20160926 | 20150814 | 20160929 | PER | PHHY2015US027521 | NOVARTIS | 47.03 | YR | M | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113796024 | 11379602 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | UNK | 22527 | CAPSULE | |||||||||
| 113796024 | 11379602 | 2 | C | MODAFINIL. | MODAFINIL | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113796024 | 11379602 | 1 | Multiple sclerosis |
| 113796024 | 11379602 | 2 | Fatigue |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113796024 | 11379602 | Balance disorder | |
| 113796024 | 11379602 | Blood cholesterol increased | |
| 113796024 | 11379602 | Blood glucose increased | |
| 113796024 | 11379602 | Blood triglycerides increased | |
| 113796024 | 11379602 | Liver function test abnormal | |
| 113796024 | 11379602 | Lymphocyte count decreased | |
| 113796024 | 11379602 | Multiple sclerosis relapse | |
| 113796024 | 11379602 | Muscular weakness | |
| 113796024 | 11379602 | Nausea | |
| 113796024 | 11379602 | Neck pain | |
| 113796024 | 11379602 | Vertigo | |
| 113796024 | 11379602 | 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 |
|---|---|---|---|---|---|---|
| 113796024 | 11379602 | 2 | 20140915 | 20150622 | 0 |