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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118573066 | 11857306 | 6 | F | 20150831 | 20160905 | 20151221 | 20160914 | EXP | DE-BIOGEN-2015BI121217 | BIOGEN | 40.50 | YR | F | Y | 64.00000 | KG | 20160914 | MD | DE | DE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118573066 | 11857306 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118573066 | 11857306 | 2 | I | TYSABRI | NATALIZUMAB | 1 | Unknown | 85 INFUSIONS | Y | 125104 | UNKNOWN | ||||||||
| 118573066 | 11857306 | 3 | C | CLEXANE | ENOXAPARIN SODIUM | 1 | Subcutaneous | 0 | 20 | MG | INJECTION | QD | |||||||
| 118573066 | 11857306 | 4 | C | PANTOZOL | PANTOPRAZOLE SODIUM | 1 | Oral | 0 | TABLETS | QD | |||||||||
| 118573066 | 11857306 | 5 | C | KALINOR BUBBLING | 2 | Oral | 0 | TABLETS | QD | ||||||||||
| 118573066 | 11857306 | 6 | C | CALCIUM FORTE BUBBLING | 2 | Oral | 0 | TABLETS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118573066 | 11857306 | 1 | Multiple sclerosis |
| 118573066 | 11857306 | 3 | Thrombosis prophylaxis |
| 118573066 | 11857306 | 4 | Prophylaxis |
| 118573066 | 11857306 | 5 | Product used for unknown indication |
| 118573066 | 11857306 | 6 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118573066 | 11857306 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118573066 | 11857306 | Immune reconstitution inflammatory syndrome | |
| 118573066 | 11857306 | Multiple sclerosis relapse | |
| 118573066 | 11857306 | Progressive multifocal leukoencephalopathy |
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 |
|---|---|---|---|---|---|---|
| 118573066 | 11857306 | 1 | 20080117 | 20150907 | 0 | |
| 118573066 | 11857306 | 2 | 20150820 | 0 | ||
| 118573066 | 11857306 | 3 | 20150801 | 20150925 | 0 | |
| 118573066 | 11857306 | 4 | 20150901 | 20150905 | 0 | |
| 118573066 | 11857306 | 5 | 20150901 | 20150905 | 0 | |
| 118573066 | 11857306 | 6 | 20150901 | 20150905 | 0 |