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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123396535 | 12339653 | 5 | F | 20151113 | 20160802 | 20160505 | 20160804 | EXP | US-BIOGEN-2015BI151988 | BIOGEN | 40.68 | YR | F | Y | 0.00000 | 20160804 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123396535 | 12339653 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123396535 | 12339653 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123396535 | 12339653 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123396535 | 12339653 | Adverse drug reaction | |
| 123396535 | 12339653 | Anger | |
| 123396535 | 12339653 | Anxiety | |
| 123396535 | 12339653 | Balance disorder | |
| 123396535 | 12339653 | Blindness transient | |
| 123396535 | 12339653 | Decreased immune responsiveness | |
| 123396535 | 12339653 | Dizziness | |
| 123396535 | 12339653 | Feeling abnormal | |
| 123396535 | 12339653 | General physical health deterioration | |
| 123396535 | 12339653 | Headache | |
| 123396535 | 12339653 | Multiple sclerosis | |
| 123396535 | 12339653 | Multiple sclerosis relapse | |
| 123396535 | 12339653 | Optic neuritis | |
| 123396535 | 12339653 | Tremor | |
| 123396535 | 12339653 | Urinary tract infection | |
| 123396535 | 12339653 | Vaginal infection | |
| 123396535 | 12339653 | Viral infection | |
| 123396535 | 12339653 | Vision blurred |
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 |
|---|---|---|---|---|---|---|
| 123396535 | 12339653 | 1 | 20151113 | 20160321 | 0 |