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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118834382 | 11883438 | 2 | F | 201505 | 20160627 | 20151231 | 20160706 | EXP | CO-BIOGEN-2015BI074333 | BIOGEN | 40.00 | YR | F | Y | 0.00000 | 20160706 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118834382 | 11883438 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 118834382 | 11883438 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | UNKNOWN | |||||||
| 118834382 | 11883438 | 3 | C | PREGABALIN. | PREGABALIN | 1 | Oral | 0 | 150 | MG | UNKNOWN | QID | |||||||
| 118834382 | 11883438 | 4 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0 | 50 | UG | UNKNOWN | ||||||||
| 118834382 | 11883438 | 5 | C | LEVOTHYROXINE. | LEVOTHYROXINE | 1 | Oral | 0 | 100 | UG | UNKNOWN | ||||||||
| 118834382 | 11883438 | 6 | C | FOLIC ACID. | FOLIC ACID | 1 | Oral | 0 | 2 | MG | UNKNOWN | QD | |||||||
| 118834382 | 11883438 | 7 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 2000 | IU | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118834382 | 11883438 | 1 | Relapsing-remitting multiple sclerosis |
| 118834382 | 11883438 | 3 | Product used for unknown indication |
| 118834382 | 11883438 | 4 | Product used for unknown indication |
| 118834382 | 11883438 | 6 | Product used for unknown indication |
| 118834382 | 11883438 | 7 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118834382 | 11883438 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118834382 | 11883438 | General physical health deterioration | |
| 118834382 | 11883438 | Multiple sclerosis relapse | |
| 118834382 | 11883438 | Muscular weakness | |
| 118834382 | 11883438 | Paraesthesia | |
| 118834382 | 11883438 | Paresis | |
| 118834382 | 11883438 | Reflexes abnormal |
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 |
|---|---|---|---|---|---|---|
| 118834382 | 11883438 | 1 | 20150521 | 0 | ||
| 118834382 | 11883438 | 2 | 20130830 | 0 | ||
| 118834382 | 11883438 | 3 | 2013 | 0 | ||
| 118834382 | 11883438 | 4 | 2002 | 0 | ||
| 118834382 | 11883438 | 6 | 2012 | 0 | ||
| 118834382 | 11883438 | 7 | 2014 | 0 |