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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118930353 | 11893035 | 3 | F | 201510 | 20160905 | 20160106 | 20160915 | EXP | DE-BIOGEN-2015BI137216 | BIOGEN | 50.55 | YR | F | Y | 0.00000 | 20160915 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118930353 | 11893035 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | CONCENTRATE FOR SOLUTION FOR INFUSION | /month | ||||||||
| 118930353 | 11893035 | 2 | C | VIMPAT | LACOSAMIDE | 1 | Oral | 0 | 100 | MG | PREPARATION FOR ORAL USE(NOS) | BID | |||||||
| 118930353 | 11893035 | 3 | C | VIMPAT | LACOSAMIDE | 1 | Unknown | 0 | 200 | MG | UNKNOWN | QD | |||||||
| 118930353 | 11893035 | 4 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 10 | MG | PREPARATION FOR ORAL USE(NOS) | TID | |||||||
| 118930353 | 11893035 | 5 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 5 | MG | TABLETS | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118930353 | 11893035 | 1 | Multiple sclerosis |
| 118930353 | 11893035 | 2 | Product used for unknown indication |
| 118930353 | 11893035 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118930353 | 11893035 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118930353 | 11893035 | Immune reconstitution inflammatory syndrome | |
| 118930353 | 11893035 | Prescribed underdose | |
| 118930353 | 11893035 | 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 |
|---|---|---|---|---|---|---|
| 118930353 | 11893035 | 1 | 20150729 | 0 | ||
| 118930353 | 11893035 | 2 | 20091121 | 0 | ||
| 118930353 | 11893035 | 3 | 20150922 | 0 | ||
| 118930353 | 11893035 | 5 | 20150922 | 0 |