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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124934573 | 12493457 | 3 | F | 20160711 | 20160623 | 20160714 | EXP | US-BIOGEN-2016BI00254345 | BIOGEN | 0.00 | F | Y | 0.00000 | 20160714 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124934573 | 12493457 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124934573 | 12493457 | 1 | Multiple sclerosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124934573 | 12493457 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124934573 | 12493457 | Anaemia | |
| 124934573 | 12493457 | Anal incontinence | |
| 124934573 | 12493457 | Asthenia | |
| 124934573 | 12493457 | Blood potassium decreased | |
| 124934573 | 12493457 | Blood urine present | |
| 124934573 | 12493457 | Confusional state | |
| 124934573 | 12493457 | Dehydration | |
| 124934573 | 12493457 | Dizziness | |
| 124934573 | 12493457 | Drug dose omission | |
| 124934573 | 12493457 | Flank pain | |
| 124934573 | 12493457 | Headache | |
| 124934573 | 12493457 | Lethargy | |
| 124934573 | 12493457 | Muscle spasms | |
| 124934573 | 12493457 | Nephrolithiasis | |
| 124934573 | 12493457 | Pain in extremity | |
| 124934573 | 12493457 | Paraesthesia | |
| 124934573 | 12493457 | Platelet count decreased | |
| 124934573 | 12493457 | Pyrexia | |
| 124934573 | 12493457 | Urinary incontinence | |
| 124934573 | 12493457 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 124934573 | 12493457 | 1 | 20160325 | 0 |