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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117913549 | 11791354 | 9 | F | 201310 | 20160824 | 20151201 | 20160830 | EXP | PHHY2014JP107747 | NOVARTIS | TAGAWA A, OGAWA T, HASHIMOTO R, KATO H, TEZUKA S, OTSUKA M ET AL.. HEPATITIS C VIRUS (HCV) REACTIVATION DURING FINGOLIMOD TREATMENT FOR RELAPSING AND REMITTING MULTIPLE SCLEROSIS. MULTIPLE SCLEROSIS AND RELATED DISORDERS. 2016;9:155-7 | 36.90 | YR | F | Y | 0.00000 | 20160830 | OT | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 117913549 | 11791354 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 117913549 | 11791354 | 2 | SS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | 22527 | .5 | MG | CAPSULE | QD | |||||
| 117913549 | 11791354 | 3 | C | TERNELIN | TIZANIDINE | 1 | Oral | 2 MG, UNK | 0 | 2 | MG | ||||||||
| 117913549 | 11791354 | 4 | C | MAGMITT | MAGNESIUM OXIDE | 1 | Oral | 1500 MG, UNK | 0 | 1500 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 117913549 | 11791354 | 1 | Relapsing-remitting multiple sclerosis |
| 117913549 | 11791354 | 3 | Paralysis |
| 117913549 | 11791354 | 4 | Constipation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 117913549 | 11791354 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 117913549 | 11791354 | Central nervous system lesion | |
| 117913549 | 11791354 | Hepatic function abnormal | |
| 117913549 | 11791354 | Hepatitis C | |
| 117913549 | 11791354 | Lymphocyte count decreased | |
| 117913549 | 11791354 | Multiple sclerosis relapse | |
| 117913549 | 11791354 | Myelopathy |
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 |
|---|---|---|---|---|---|---|
| 117913549 | 11791354 | 1 | 20130411 | 201407 | 0 | |
| 117913549 | 11791354 | 2 | 20140919 | 0 |