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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122506253 | 12250625 | 3 | F | 20160725 | 20160408 | 20160728 | EXP | US-BIOGEN-2016BI00203654 | BIOGEN | 0.00 | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122506253 | 12250625 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 122506253 | 12250625 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 122506253 | 12250625 | 3 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122506253 | 12250625 | 1 | Multiple sclerosis |
| 122506253 | 12250625 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122506253 | 12250625 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122506253 | 12250625 | Blindness transient | |
| 122506253 | 12250625 | Central nervous system lesion | |
| 122506253 | 12250625 | Cerebral disorder | |
| 122506253 | 12250625 | Cognitive disorder | |
| 122506253 | 12250625 | Dizziness | |
| 122506253 | 12250625 | Gait disturbance | |
| 122506253 | 12250625 | General physical health deterioration | |
| 122506253 | 12250625 | Hypotension | |
| 122506253 | 12250625 | Incontinence | |
| 122506253 | 12250625 | Laceration | |
| 122506253 | 12250625 | Loss of consciousness | |
| 122506253 | 12250625 | Mobility decreased | |
| 122506253 | 12250625 | Muscle spasms | |
| 122506253 | 12250625 | Musculoskeletal disorder | |
| 122506253 | 12250625 | Nausea | |
| 122506253 | 12250625 | Restless legs syndrome | |
| 122506253 | 12250625 | Stupor |
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 |
|---|---|---|---|---|---|---|
| 122506253 | 12250625 | 1 | 20080123 | 20150911 | 0 | |
| 122506253 | 12250625 | 2 | 20151111 | 0 |