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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124409352 | 12440935 | 2 | F | 20150616 | 20160704 | 20160607 | 20160708 | EXP | CH-BIOGEN-2015BI097754 | BIOGEN | 33.63 | YR | F | Y | 0.00000 | 20160708 | MD | CH | CH |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124409352 | 12440935 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124409352 | 12440935 | 2 | C | andreafol | 2 | Unknown | 0 | 400 | UG | UNKNOWN | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124409352 | 12440935 | 1 | Multiple sclerosis |
| 124409352 | 12440935 | 2 | Prophylaxis of neural tube defect |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124409352 | 12440935 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124409352 | 12440935 | Maternal exposure during pregnancy | |
| 124409352 | 12440935 | Postpartum uterine subinvolution |
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 |
|---|---|---|---|---|---|---|
| 124409352 | 12440935 | 1 | 200903 | 20150611 | 0 |