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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125564632 | 12556463 | 2 | F | 20160618 | 20160725 | 20160714 | 20160728 | EXP | NZ-BIOGEN-2016BI00261691 | BIOGEN | 45.28 | YR | F | Y | 0.00000 | 20160728 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125564632 | 12556463 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1HOUR | 125104 | 300 | UG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125564632 | 12556463 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125564632 | 12556463 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125564632 | 12556463 | Calcinosis | |
| 125564632 | 12556463 | Cognitive disorder | |
| 125564632 | 12556463 | Diarrhoea | |
| 125564632 | 12556463 | Fatigue | |
| 125564632 | 12556463 | Headache | |
| 125564632 | 12556463 | Hypoaesthesia | |
| 125564632 | 12556463 | Infection | |
| 125564632 | 12556463 | Nasopharyngitis | |
| 125564632 | 12556463 | Pain in extremity | |
| 125564632 | 12556463 | Pain in jaw | |
| 125564632 | 12556463 | Paraesthesia |
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 |
|---|---|---|---|---|---|---|
| 125564632 | 12556463 | 1 | 20160405 | 0 |