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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125446153 | 12544615 | 3 | F | 20160610 | 20160727 | 20160711 | 20160801 | EXP | US-BIOGEN-2016BI00258748 | BIOGEN | 34.35 | YR | F | Y | 0.00000 | 20160801 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125446153 | 12544615 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125446153 | 12544615 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125446153 | 12544615 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||||||
| 125446153 | 12544615 | 4 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | 125104 | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125446153 | 12544615 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125446153 | 12544615 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125446153 | 12544615 | Cephalo-pelvic disproportion | |
| 125446153 | 12544615 | Maternal exposure during pregnancy | |
| 125446153 | 12544615 | Prolonged labour |
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 |
|---|---|---|---|---|---|---|
| 125446153 | 12544615 | 1 | 20080715 | 20120409 | 0 | |
| 125446153 | 12544615 | 2 | 20121129 | 201505 | 0 | |
| 125446153 | 12544615 | 3 | 20150716 | 0 | ||
| 125446153 | 12544615 | 4 | 20160712 | 0 |