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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125223591 | 12522359 | 1 | I | 201511 | 20160627 | 20160701 | 20160701 | EXP | US-BIOGEN-2016BI00258759 | BIOGEN | 55.72 | YR | F | Y | 0.00000 | 20160701 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125223591 | 12522359 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 125223591 | 12522359 | 2 | C | REBIF | INTERFERON BETA-1A | 1 | Unknown | Y | 0 | UNKNOWN | |||||||||
| 125223591 | 12522359 | 3 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125223591 | 12522359 | 1 | Multiple sclerosis |
| 125223591 | 12522359 | 2 | Multiple sclerosis |
| 125223591 | 12522359 | 3 | Gastrooesophageal reflux disease |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125223591 | 12522359 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125223591 | 12522359 | Back pain | |
| 125223591 | 12522359 | Memory impairment | |
| 125223591 | 12522359 | Pharyngeal mass | |
| 125223591 | 12522359 | Pharyngeal oedema | |
| 125223591 | 12522359 | Vocal cord thickening |
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 |
|---|---|---|---|---|---|---|
| 125223591 | 12522359 | 1 | 20110325 | 0 |