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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118278114 | 11827811 | 4 | F | 201501 | 20160830 | 20151211 | 20160913 | EXP | AT-BIOGEN-2015BI118342 | BIOGEN | 58.20 | YR | M | Y | 0.00000 | 20160913 | MD | AT | AT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118278114 | 11827811 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | ||||||
| 118278114 | 11827811 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118278114 | 11827811 | 3 | C | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0 | .5 | MG | PREPARATION FOR ORAL USE(NOS) | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118278114 | 11827811 | 1 | Multiple sclerosis |
| 118278114 | 11827811 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118278114 | 11827811 | OT |
| 118278114 | 11827811 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118278114 | 11827811 | Immune reconstitution inflammatory syndrome | |
| 118278114 | 11827811 | Multiple sclerosis relapse | |
| 118278114 | 11827811 | Prescribed underdose | |
| 118278114 | 11827811 | 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 |
|---|---|---|---|---|---|---|
| 118278114 | 11827811 | 1 | 201310 | 201501 | 0 | |
| 118278114 | 11827811 | 2 | 201306 | 201506 | 0 | |
| 118278114 | 11827811 | 3 | 20150804 | 20150812 | 0 |