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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97615868 | 9761586 | 8 | F | 20130418 | 20160809 | 20131216 | 20160811 | EXP | PHHY2013BE133061 | NOVARTIS | 38.00 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 97615868 | 9761586 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | 188.160004 | MG | Y | 22527 | .5 | MG | CAPSULE | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 97615868 | 9761586 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 97615868 | 9761586 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 97615868 | 9761586 | Alanine aminotransferase increased | |
| 97615868 | 9761586 | Amylase decreased | |
| 97615868 | 9761586 | Arthralgia | |
| 97615868 | 9761586 | Aspartate aminotransferase increased | |
| 97615868 | 9761586 | Bilirubin conjugated increased | |
| 97615868 | 9761586 | Blood albumin decreased | |
| 97615868 | 9761586 | Blood alkaline phosphatase increased | |
| 97615868 | 9761586 | Blood bilirubin increased | |
| 97615868 | 9761586 | Blood phosphorus decreased | |
| 97615868 | 9761586 | Blood uric acid decreased | |
| 97615868 | 9761586 | C-reactive protein increased | |
| 97615868 | 9761586 | Eosinophil count decreased | |
| 97615868 | 9761586 | Epstein-Barr virus antibody positive | |
| 97615868 | 9761586 | Gamma-glutamyltransferase increased | |
| 97615868 | 9761586 | Gastroenteritis | |
| 97615868 | 9761586 | Globulins increased | |
| 97615868 | 9761586 | Haptoglobin increased | |
| 97615868 | 9761586 | High density lipoprotein increased | |
| 97615868 | 9761586 | Liver function test abnormal | |
| 97615868 | 9761586 | Lymphocyte count decreased | |
| 97615868 | 9761586 | Neutrophil count increased | |
| 97615868 | 9761586 | Nitrite urine present | |
| 97615868 | 9761586 | Protein urine present | |
| 97615868 | 9761586 | Red blood cell sedimentation rate increased | |
| 97615868 | 9761586 | Respiratory tract infection | |
| 97615868 | 9761586 | Serum ferritin increased | |
| 97615868 | 9761586 | Vitamin D deficiency | |
| 97615868 | 9761586 | White blood cell count increased | |
| 97615868 | 9761586 | White blood cells urine positive |
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 |
|---|---|---|---|---|---|---|
| 97615868 | 9761586 | 1 | 20121107 | 20140130 | 0 |