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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124352832 | 12435283 | 2 | F | 201502 | 20160708 | 20160603 | 20160713 | EXP | FR-BIOGEN-2016BI00198964 | BIOGEN | 29.91 | YR | F | Y | 0.00000 | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124352832 | 12435283 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Unknown | U | 11469 | UNKNOWN | |||||||||
| 124352832 | 12435283 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Unknown | U | 11469 | UNKNOWN | |||||||||
| 124352832 | 12435283 | 3 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 124352832 | 12435283 | 4 | C | Speciafoldine | FOLIC ACID | 1 | Unknown | 0 | 5 | MG | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124352832 | 12435283 | 1 | Multiple sclerosis |
| 124352832 | 12435283 | 3 | Product used for unknown indication |
| 124352832 | 12435283 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124352832 | 12435283 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124352832 | 12435283 | Cytomegalovirus test positive | |
| 124352832 | 12435283 | Drug ineffective | |
| 124352832 | 12435283 | Immune reconstitution inflammatory syndrome | |
| 124352832 | 12435283 | Multiple sclerosis relapse | |
| 124352832 | 12435283 | Musculoskeletal disorder | |
| 124352832 | 12435283 | Neurological decompensation |
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 |
|---|---|---|---|---|---|---|
| 124352832 | 12435283 | 1 | 201506 | 20160226 | 0 | |
| 124352832 | 12435283 | 2 | 2008 | 2010 | 0 |