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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118737423 | 11873742 | 3 | F | 201504 | 20160921 | 20151229 | 20160928 | EXP | CO-BIOGEN-2015BI067269 | BIOGEN | 39.45 | YR | M | Y | 63.00000 | KG | 20160928 | CN | CO | CO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118737423 | 11873742 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 118737423 | 11873742 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||
| 118737423 | 11873742 | 3 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Unknown | 0 | 500 | MG | UNKNOWN | QD | |||||||
| 118737423 | 11873742 | 4 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118737423 | 11873742 | 1 | Multiple sclerosis |
| 118737423 | 11873742 | 3 | Product used for unknown indication |
| 118737423 | 11873742 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118737423 | 11873742 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118737423 | 11873742 | Amnesia | |
| 118737423 | 11873742 | Diplopia | |
| 118737423 | 11873742 | Disorientation | |
| 118737423 | 11873742 | Hypoaesthesia | |
| 118737423 | 11873742 | Influenza | |
| 118737423 | 11873742 | Loss of consciousness | |
| 118737423 | 11873742 | Syncope | |
| 118737423 | 11873742 | Vertigo | |
| 118737423 | 11873742 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 118737423 | 11873742 | 1 | 20150313 | 201509 | 0 | |
| 118737423 | 11873742 | 2 | 20160123 | 0 | ||
| 118737423 | 11873742 | 4 | 201510 | 0 |