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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125683864 | 12568386 | 4 | F | 2016 | 20160801 | 20160718 | 20160811 | EXP | US-BIOGEN-2016BI00264632 | BIOGEN | 48.16 | YR | F | Y | 0.00000 | 20160811 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125683864 | 12568386 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125683864 | 12568386 | 2 | C | COPAXONE | GLATIRAMER ACETATE | 1 | Subcutaneous | 0 | 20 | MG | INJECTION | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125683864 | 12568386 | 1 | Multiple sclerosis |
| 125683864 | 12568386 | 2 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125683864 | 12568386 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125683864 | 12568386 | Abdominal distension | |
| 125683864 | 12568386 | Abdominal pain | |
| 125683864 | 12568386 | Haemoglobin decreased | |
| 125683864 | 12568386 | Herpes zoster | |
| 125683864 | 12568386 | Hypoaesthesia | |
| 125683864 | 12568386 | Infection | |
| 125683864 | 12568386 | Intervertebral disc protrusion | |
| 125683864 | 12568386 | Intestinal obstruction | |
| 125683864 | 12568386 | Nausea | |
| 125683864 | 12568386 | Nerve root compression | |
| 125683864 | 12568386 | Pain in extremity | |
| 125683864 | 12568386 | Paraesthesia | |
| 125683864 | 12568386 | Poor venous access | |
| 125683864 | 12568386 | Procedural haemorrhage | |
| 125683864 | 12568386 | Sepsis | |
| 125683864 | 12568386 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 125683864 | 12568386 | 1 | 20160216 | 0 | ||
| 125683864 | 12568386 | 2 | 20101001 | 0 |