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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124430912 | 12443091 | 2 | F | 20160519 | 20160811 | 20160607 | 20160816 | EXP | CA-BIOGEN-2016BI00245324 | BIOGEN | 39.04 | YR | M | Y | 0.00000 | 20160816 | MD | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124430912 | 12443091 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124430912 | 12443091 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124430912 | 12443091 | 3 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | MAINTENANCE DOSE | U | 204063 | 240 | MG | PROLONGED-RELEASE CAPSULE | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124430912 | 12443091 | 1 | Multiple sclerosis |
| 124430912 | 12443091 | 3 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124430912 | 12443091 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124430912 | 12443091 | Deafness unilateral | |
| 124430912 | 12443091 | Fatigue | |
| 124430912 | 12443091 | Headache | |
| 124430912 | 12443091 | Hemianaesthesia | |
| 124430912 | 12443091 | Pain in extremity | |
| 124430912 | 12443091 | Tinnitus |
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 |
|---|---|---|---|---|---|---|
| 124430912 | 12443091 | 1 | 20160516 | 0 | ||
| 124430912 | 12443091 | 2 | 20160519 | 0 | ||
| 124430912 | 12443091 | 3 | 20150418 | 20160518 | 0 |