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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351342 | 12535134 | 2 | F | 20140103 | 20160824 | 20160707 | 20160901 | PER | US-BIOGEN-2016BI00259246 | BIOGEN | 55.97 | YR | F | Y | 0.00000 | 20160901 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125351342 | 12535134 | 1 | PS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | MAINTENANCE DOSE | U | 204063 | 240 | MG | PROLONGED-RELEASE CAPSULE | BID | |||||
| 125351342 | 12535134 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125351342 | 12535134 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | ||||||
| 125351342 | 12535134 | 4 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125351342 | 12535134 | 1 | Multiple sclerosis |
| 125351342 | 12535134 | 2 | Multiple sclerosis |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125351342 | 12535134 | Drug ineffective | |
| 125351342 | 12535134 | Multiple sclerosis relapse | |
| 125351342 | 12535134 | Trigeminal neuralgia |
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 |
|---|---|---|---|---|---|---|
| 125351342 | 12535134 | 1 | 20140103 | 20160529 | 0 | |
| 125351342 | 12535134 | 2 | 20070302 | 20090227 | 0 | |
| 125351342 | 12535134 | 3 | 20090424 | 20131129 | 0 | |
| 125351342 | 12535134 | 4 | 20160610 | 0 |