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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119347832 | 11934783 | 2 | F | 20150626 | 20160623 | 20160121 | 20160706 | EXP | RO-BIOGEN-2015BI089916 | BIOGEN | 34.92 | YR | F | Y | 0.00000 | 20160706 | MD | RO | RO |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119347832 | 11934783 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 140602A | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | ||||||
| 119347832 | 11934783 | 2 | C | COPAXONE | GLATIRAMER ACETATE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119347832 | 11934783 | 1 | Multiple sclerosis |
| 119347832 | 11934783 | 2 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119347832 | 11934783 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119347832 | 11934783 | Immune reconstitution inflammatory syndrome | |
| 119347832 | 11934783 | Progressive multifocal leukoencephalopathy |
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 |
|---|---|---|---|---|---|---|
| 119347832 | 11934783 | 1 | 201006 | 20150616 | 0 | |
| 119347832 | 11934783 | 2 | 2015 | 0 |