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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125430672 | 12543067 | 2 | F | 20160209 | 20160909 | 20160710 | 20160922 | PER | US-BIOGEN-2016BI00260903 | BIOGEN | 46.58 | YR | F | Y | 0.00000 | 20160922 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125430672 | 12543067 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Unknown | Y | 125104 | UNKNOWN | |||||||||
| 125430672 | 12543067 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | UNKNOWN | |||||||
| 125430672 | 12543067 | 3 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 22250 | 10 | MG | PROLONGED-RELEASE TABLET | BID | |||||||
| 125430672 | 12543067 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125430672 | 12543067 | 5 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125430672 | 12543067 | 6 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125430672 | 12543067 | 7 | C | VESICARE | SOLIFENACIN SUCCINATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125430672 | 12543067 | 8 | C | COLACE | DOCUSATE SODIUM | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125430672 | 12543067 | 1 | Multiple sclerosis |
| 125430672 | 12543067 | 2 | Multiple sclerosis |
| 125430672 | 12543067 | 3 | Gait disturbance |
| 125430672 | 12543067 | 4 | Product used for unknown indication |
| 125430672 | 12543067 | 5 | Product used for unknown indication |
| 125430672 | 12543067 | 6 | Product used for unknown indication |
| 125430672 | 12543067 | 7 | Product used for unknown indication |
| 125430672 | 12543067 | 8 | Product used for unknown indication |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125430672 | 12543067 | Drug ineffective | |
| 125430672 | 12543067 | Gait disturbance | |
| 125430672 | 12543067 | Multiple sclerosis relapse |
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 |
|---|---|---|---|---|---|---|
| 125430672 | 12543067 | 1 | 201510 | 201604 | 0 | |
| 125430672 | 12543067 | 2 | 20151110 | 20160405 | 0 | |
| 125430672 | 12543067 | 3 | 201510 | 201512 | 0 |