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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124080624 | 12408062 | 4 | F | 20160912 | 20160526 | 20160919 | EXP | IT-BIOGEN-2015BI072082 | BIOGEN | 0.00 | F | Y | 0.00000 | 20160919 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124080624 | 12408062 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | D | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | ||||||
| 124080624 | 12408062 | 2 | C | FLUOXETINE | FLUOXETINE HYDROCHLORIDE | 1 | Unknown | 0 | 20 | MG | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124080624 | 12408062 | 1 | Multiple sclerosis |
| 124080624 | 12408062 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124080624 | 12408062 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124080624 | 12408062 | Gestational diabetes | |
| 124080624 | 12408062 | Maternal exposure during pregnancy | |
| 124080624 | 12408062 | Neurological decompensation |
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 |
|---|---|---|---|---|---|---|
| 124080624 | 12408062 | 1 | 20130608 | 20150420 | 0 | |
| 124080624 | 12408062 | 2 | 2011 | 0 |