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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125493442 | 12549344 | 2 | F | 201606 | 20160718 | 20160712 | 20160721 | EXP | US-BIOGEN-2016BI00262260 | BIOGEN | 62.62 | YR | F | Y | 0.00000 | 20160721 | OT | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
125493442 | 12549344 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
125493442 | 12549344 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
Event ID | CASEID | INDI DRUG SEQ | INDI PT |
---|---|---|---|
125493442 | 12549344 | 1 | Multiple sclerosis |
Outcome of event
Event ID | CASEID | OUTC COD |
---|---|---|
125493442 | 12549344 | HO |
Reactions reported
Event ID | CASEID | DRUG REC ACT | PT |
---|---|---|---|
125493442 | 12549344 | Pneumonia | |
125493442 | 12549344 | Sepsis | |
125493442 | 12549344 | Urinary tract infection |
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 |
---|---|---|---|---|---|---|
125493442 | 12549344 | 1 | 20081121 | 20101019 | 0 | |
125493442 | 12549344 | 2 | 20110930 | 0 |