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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
119219764 | 11921976 | 4 | F | 201512 | 20160721 | 20160115 | 20160801 | EXP | ES-BIOGEN-2016BI00168848 | BIOGEN | 51.00 | YR | F | Y | 0.00000 | 20160801 | MD | ES | ES |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
119219764 | 11921976 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | ||||||
119219764 | 11921976 | 2 | C | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Unknown | Y | 0 | UNKNOWN | |||||||||
119219764 | 11921976 | 3 | C | COPAXONE | GLATIRAMER ACETATE | 1 | Unknown | 0 | 40 | MG | UNKNOWN | TIW |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
119219764 | 11921976 | 1 | Multiple sclerosis |
119219764 | 11921976 | 2 | Multiple sclerosis |
119219764 | 11921976 | 3 | Multiple sclerosis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
119219764 | 11921976 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
119219764 | 11921976 | Immune reconstitution inflammatory syndrome | |
119219764 | 11921976 | Progressive multifocal leukoencephalopathy |
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 |
---|---|---|---|---|---|---|
119219764 | 11921976 | 1 | 201504 | 0 | ||
119219764 | 11921976 | 2 | 201508 | 201512 | 0 | |
119219764 | 11921976 | 3 | 20160406 | 0 |