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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121552912 | 12155291 | 2 | F | 201105 | 20160627 | 20160307 | 20160711 | EXP | DE-BIOGEN-2013BI015394 | BIOGEN | MENKE A, LUCKNER K, WITTKUGEL O, TERBORG C, ROSENKRANZ T. BENIGN COURSE OF JC VIRUS-ASSOCIATED CEREBELLAR ATROPHY AFTER LONG-TERM TREATMENT WITH NATALIZUMAB IN A PATIENT WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS. AKT NEUROL. 2016;43:318-321. | 40.94 | YR | F | Y | 74.00000 | KG | 20160711 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121552912 | 12155291 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 121552912 | 12155291 | 2 | C | thyroxin-jodid | 2 | Unknown | 0 | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121552912 | 12155291 | 1 | Multiple sclerosis |
| 121552912 | 12155291 | 2 | Hypothyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121552912 | 12155291 | HO |
| 121552912 | 12155291 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121552912 | 12155291 | Gait disturbance | |
| 121552912 | 12155291 | Gastritis | |
| 121552912 | 12155291 | Immune reconstitution inflammatory syndrome | |
| 121552912 | 12155291 | JC virus granule cell neuronopathy | |
| 121552912 | 12155291 | Myelitis | |
| 121552912 | 12155291 | Progressive multifocal leukoencephalopathy | |
| 121552912 | 12155291 | Vertigo | |
| 121552912 | 12155291 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 121552912 | 12155291 | 1 | 20080130 | 20130207 | 0 |