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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120122836 | 12012283 | 6 | F | 20151223 | 20160718 | 20160205 | 20160727 | EXP | FR-BIOGEN-2015BI00165276 | BIOGEN | 47.90 | YR | M | Y | 0.00000 | 20160727 | MD | FR | FR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120122836 | 12012283 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 11469 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 120122836 | 12012283 | 2 | C | Loxen | NICARDIPINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | PROLONGED-RELEASE CAPSULE | ||||||||
| 120122836 | 12012283 | 3 | C | FENOFIBRATE. | FENOFIBRATE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120122836 | 12012283 | 1 | Relapsing-remitting multiple sclerosis |
| 120122836 | 12012283 | 2 | Product used for unknown indication |
| 120122836 | 12012283 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120122836 | 12012283 | HO |
| 120122836 | 12012283 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120122836 | 12012283 | Immune reconstitution inflammatory syndrome | |
| 120122836 | 12012283 | 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 |
|---|---|---|---|---|---|---|
| 120122836 | 12012283 | 1 | 2010 | 20151127 | 0 |