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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498732 | 12549873 | 2 | F | 201605 | 20160719 | 20160712 | 20160725 | EXP | NZ-BIOGEN-2016BI00250872 | BIOGEN | 31.95 | YR | F | Y | 0.00000 | 20160725 | CN | NZ | NZ |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125498732 | 12549873 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | UG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125498732 | 12549873 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | UG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125498732 | 12549873 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125498732 | 12549873 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125498732 | 12549873 | Balance disorder | |
| 125498732 | 12549873 | Central nervous system lesion | |
| 125498732 | 12549873 | Cognitive disorder | |
| 125498732 | 12549873 | Diplopia | |
| 125498732 | 12549873 | Dysphagia | |
| 125498732 | 12549873 | Dysuria | |
| 125498732 | 12549873 | Heart rate increased | |
| 125498732 | 12549873 | Mobility decreased | |
| 125498732 | 12549873 | Muscle spasticity | |
| 125498732 | 12549873 | Musculoskeletal pain | |
| 125498732 | 12549873 | Pain in extremity |
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 |
|---|---|---|---|---|---|---|
| 125498732 | 12549873 | 1 | 20160418 | 20160515 | 0 | |
| 125498732 | 12549873 | 2 | 20160516 | 0 |