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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120128822 | 12012882 | 2 | F | 201410 | 20160818 | 20160205 | 20160829 | EXP | US-BIOGEN-2014BI116641 | BIOGEN | 56.28 | YR | F | Y | 0.00000 | 20160829 | OT | US | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120128822 | 12012882 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120128822 | 12012882 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120128822 | 12012882 | OT |
| 120128822 | 12012882 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120128822 | 12012882 | Ageusia | |
| 120128822 | 12012882 | Blood pressure abnormal | |
| 120128822 | 12012882 | Cardiac disorder | |
| 120128822 | 12012882 | Decreased appetite | |
| 120128822 | 12012882 | Device expulsion | |
| 120128822 | 12012882 | Gait disturbance | |
| 120128822 | 12012882 | Hypersensitivity | |
| 120128822 | 12012882 | Hypertension | |
| 120128822 | 12012882 | Kidney infection | |
| 120128822 | 12012882 | Loss of consciousness | |
| 120128822 | 12012882 | Multiple sclerosis | |
| 120128822 | 12012882 | Multiple sclerosis relapse | |
| 120128822 | 12012882 | Musculoskeletal disorder | |
| 120128822 | 12012882 | Optic neuritis | |
| 120128822 | 12012882 | Pain | |
| 120128822 | 12012882 | Pyrexia | |
| 120128822 | 12012882 | Renal failure | |
| 120128822 | 12012882 | Respiratory arrest | |
| 120128822 | 12012882 | Seizure | |
| 120128822 | 12012882 | Sepsis | |
| 120128822 | 12012882 | Suicidal ideation | |
| 120128822 | 12012882 | Tooth infection | |
| 120128822 | 12012882 | Tremor | |
| 120128822 | 12012882 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 120128822 | 12012882 | 1 | 20140512 | 20151102 | 0 |