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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122329403 | 12232940 | 3 | F | 2014 | 20160718 | 20160402 | 20160721 | EXP | US-BIOGEN-2014BI064677 | BIOGEN | 37.46 | YR | F | Y | 84.90000 | KG | 20160721 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 122329403 | 12232940 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 122329403 | 12232940 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 122329403 | 12232940 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | U | 125104 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 122329403 | 12232940 | 4 | C | ZONEGRAN | ZONISAMIDE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 122329403 | 12232940 | 1 | Multiple sclerosis |
| 122329403 | 12232940 | 4 | Seizure |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 122329403 | 12232940 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 122329403 | 12232940 | Aspartate aminotransferase increased | |
| 122329403 | 12232940 | Chromaturia | |
| 122329403 | 12232940 | Feeling abnormal | |
| 122329403 | 12232940 | Hepatic enzyme increased | |
| 122329403 | 12232940 | Hepatitis toxic | |
| 122329403 | 12232940 | Liver function test increased | |
| 122329403 | 12232940 | Liver injury | |
| 122329403 | 12232940 | Multiple sclerosis | |
| 122329403 | 12232940 | Pain | |
| 122329403 | 12232940 | Vomiting projectile |
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 |
|---|---|---|---|---|---|---|
| 122329403 | 12232940 | 1 | 20130625 | 20140507 | 0 | |
| 122329403 | 12232940 | 2 | 20150710 | 20150710 | 0 | |
| 122329403 | 12232940 | 3 | 201504 | 0 |