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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
119070662 | 11907066 | 2 | F | 201411 | 20160707 | 20160111 | 20160720 | EXP | SK-BIOGEN-2015BI003177 | BIOGEN | KOVACOVA S. PROGRESSIVE MULTIFOCAL ENCEPHALOPATHY IN A PATIENT TREATED WITH NATALIZUMAB- THE FIRST CONFIRMED CASE IN SLOVAKIA. ANNUAL NEUROSCIENCE DIALOGUE. 2016;26:23-26. | 48.00 | YR | F | Y | 0.00000 | 20160720 | MD | SK | SK |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
119070662 | 11907066 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
119070662 | 11907066 | 1 | Multiple sclerosis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
119070662 | 11907066 | HO |
119070662 | 11907066 | OT |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
119070662 | 11907066 | Fall | |
119070662 | 11907066 | Immune reconstitution inflammatory syndrome | |
119070662 | 11907066 | Limb injury | |
119070662 | 11907066 | 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 |
---|---|---|---|---|---|---|
119070662 | 11907066 | 1 | 20121002 | 20141212 | 0 |