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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124622443 | 12462244 | 3 | F | 201605 | 20160627 | 20160613 | 20160701 | EXP | US-BIOGEN-2016BI00248082 | BIOGEN | 46.77 | YR | F | Y | 0.00000 | 20160701 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124622443 | 12462244 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Unknown | INFUSED OVER 1 HOUR | 125104 | UNKNOWN | |||||||||
| 124622443 | 12462244 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124622443 | 12462244 | 3 | C | FENTANYL. | FENTANYL | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 124622443 | 12462244 | 4 | C | FENTANYL. | FENTANYL | 1 | 0 | ||||||||||||
| 124622443 | 12462244 | 5 | C | VERSED | MIDAZOLAM HYDROCHLORIDE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124622443 | 12462244 | 1 | Multiple sclerosis |
| 124622443 | 12462244 | 3 | Aspiration |
| 124622443 | 12462244 | 4 | Hypoxia |
| 124622443 | 12462244 | 5 | Agitation |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124622443 | 12462244 | HO |
| 124622443 | 12462244 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124622443 | 12462244 | Depression | |
| 124622443 | 12462244 | Dysphagia | |
| 124622443 | 12462244 | Malnutrition | |
| 124622443 | 12462244 | Multiple sclerosis | |
| 124622443 | 12462244 | Pneumonia aspiration | |
| 124622443 | 12462244 | Suicide attempt | |
| 124622443 | 12462244 | Underweight |
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 |
|---|---|---|---|---|---|---|
| 124622443 | 12462244 | 1 | 20151106 | 0 |