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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123866064 | 12386606 | 4 | F | 2014 | 20160721 | 20160519 | 20160726 | EXP | US-BIOGEN-2014BI027640 | BIOGEN | 50.60 | YR | F | Y | 0.00000 | 20160726 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123866064 | 12386606 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 123866064 | 12386606 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Unknown | U | 125104 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123866064 | 12386606 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123866064 | 12386606 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123866064 | 12386606 | Central nervous system lesion | |
| 123866064 | 12386606 | Dementia | |
| 123866064 | 12386606 | Depression | |
| 123866064 | 12386606 | Diplegia | |
| 123866064 | 12386606 | Dysarthria | |
| 123866064 | 12386606 | Dysphagia | |
| 123866064 | 12386606 | Fear | |
| 123866064 | 12386606 | Groin pain | |
| 123866064 | 12386606 | Hallucination, visual | |
| 123866064 | 12386606 | Hypoaesthesia | |
| 123866064 | 12386606 | Memory impairment | |
| 123866064 | 12386606 | Mobility decreased | |
| 123866064 | 12386606 | Multiple sclerosis relapse | |
| 123866064 | 12386606 | Musculoskeletal stiffness | |
| 123866064 | 12386606 | Nightmare | |
| 123866064 | 12386606 | Peripheral swelling | |
| 123866064 | 12386606 | Speech disorder | |
| 123866064 | 12386606 | Thrombosis | |
| 123866064 | 12386606 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 123866064 | 12386606 | 1 | 20101110 | 20140117 | 0 |