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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124939835 | 12493983 | 5 | F | 2014 | 20160825 | 20160623 | 20160902 | EXP | US-BIOGEN-2016BI00255014 | BIOGEN | 0.00 | F | Y | 0.00000 | 20160902 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124939835 | 12493983 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | N | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124939835 | 12493983 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | N | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124939835 | 12493983 | 3 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | U | 204063 | 240 | MG | PROLONGED-RELEASE CAPSULE | BID | ||||||
| 124939835 | 12493983 | 4 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | U | 204063 | 120 | MG | UNKNOWN | BID | ||||||
| 124939835 | 12493983 | 5 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | U | 204063 | 240 | MG | UNKNOWN | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124939835 | 12493983 | 1 | Multiple sclerosis |
| 124939835 | 12493983 | 3 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124939835 | 12493983 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124939835 | 12493983 | Colon cancer | |
| 124939835 | 12493983 | Malaise | |
| 124939835 | 12493983 | Nausea |
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 |
|---|---|---|---|---|---|---|
| 124939835 | 12493983 | 1 | 20141209 | 20160529 | 0 | |
| 124939835 | 12493983 | 2 | 20141209 | 20160517 | 0 | |
| 124939835 | 12493983 | 3 | 20130910 | 20140101 | 0 | |
| 124939835 | 12493983 | 4 | 20130821 | 0 | ||
| 124939835 | 12493983 | 5 | 20141112 | 0 |