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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121305654 | 12130565 | 4 | F | 2013 | 20160707 | 20160301 | 20160718 | EXP | US-BIOGEN-2013BI042122 | BIOGEN | MARTINELLI V, DALLA COSTA G, MOIOLA L, PAVAN G, DIOTTI R, DE RIZ M, GEREVINI S, COMI G. PROGRESSIVE ATAXIA IN A NATALIZUMAB-TREATED MULTIPLE SCLEROSIS PATIENT: THE DARK SIDE OF JC VIRUS INFECTION. EUROPEAN JOURNAL OF NEUROLOGY. 2016;39-40. | 0.00 | M | Y | 0.00000 | 20160718 | MD | IT | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 121305654 | 12130565 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INJECTION | /month | ||||||
| 121305654 | 12130565 | 2 | C | AMPYRA | DALFAMPRIDINE | 1 | Unknown | 22250 | UNKNOWN | ||||||||||
| 121305654 | 12130565 | 3 | C | ANDROGEL | TESTOSTERONE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121305654 | 12130565 | 4 | C | Pantoprazole | PANTOPRAZOLE SODIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121305654 | 12130565 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121305654 | 12130565 | 6 | C | DIPHENHYDRAMINE. | DIPHENHYDRAMINE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121305654 | 12130565 | 7 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 121305654 | 12130565 | 8 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 121305654 | 12130565 | 1 | Multiple sclerosis |
| 121305654 | 12130565 | 2 | Product used for unknown indication |
| 121305654 | 12130565 | 3 | Product used for unknown indication |
| 121305654 | 12130565 | 4 | Product used for unknown indication |
| 121305654 | 12130565 | 5 | Product used for unknown indication |
| 121305654 | 12130565 | 6 | Product used for unknown indication |
| 121305654 | 12130565 | 7 | Product used for unknown indication |
| 121305654 | 12130565 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 121305654 | 12130565 | OT |
| 121305654 | 12130565 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 121305654 | 12130565 | Central nervous system lesion | |
| 121305654 | 12130565 | Fall | |
| 121305654 | 12130565 | Immune reconstitution inflammatory syndrome | |
| 121305654 | 12130565 | JC virus granule cell neuronopathy | |
| 121305654 | 12130565 | Progressive multifocal leukoencephalopathy | |
| 121305654 | 12130565 | Sinus disorder |
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 |
|---|---|---|---|---|---|---|
| 121305654 | 12130565 | 1 | 20080314 | 20130405 | 0 |