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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123557553 | 12355755 | 3 | F | 201603 | 20160711 | 20160511 | 20160718 | EXP | AU-BIOGEN-2016BI00212506 | BIOGEN | 43.49 | YR | F | Y | 0.00000 | 20160718 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123557553 | 12355755 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 123557553 | 12355755 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123557553 | 12355755 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123557553 | 12355755 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123557553 | 12355755 | Asthenia | |
| 123557553 | 12355755 | Bladder catheterisation | |
| 123557553 | 12355755 | Cystitis | |
| 123557553 | 12355755 | Diarrhoea | |
| 123557553 | 12355755 | Drug dose omission | |
| 123557553 | 12355755 | Fatigue | |
| 123557553 | 12355755 | Gastric disorder | |
| 123557553 | 12355755 | Malaise | |
| 123557553 | 12355755 | 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 |
|---|---|---|---|---|---|---|
| 123557553 | 12355755 | 1 | 20160220 | 20160416 | 0 | |
| 123557553 | 12355755 | 2 | 20160514 | 0 |