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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120949776 | 12094977 | 6 | F | 20150910 | 20160912 | 20160219 | 20160919 | EXP | BR-BIOGEN-2016BI00189569 | BIOGEN | 59.67 | YR | F | Y | 0.00000 | 20160919 | OT | BR | BR |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120949776 | 12094977 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 11469 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 120949776 | 12094977 | 2 | C | Manditan (amantadine) | 2 | Unknown | 0 | UNKNOWN | |||||||||||
| 120949776 | 12094977 | 3 | C | Cymbalta (duoloxetine) | 2 | Unknown | 0 | 30 | MG | UNKNOWN | |||||||||
| 120949776 | 12094977 | 4 | C | LOSARTAN. | LOSARTAN | 1 | Unknown | 0 | 25 | MG | UNKNOWN | ||||||||
| 120949776 | 12094977 | 5 | C | RIVOTRIL | CLONAZEPAM | 1 | Unknown | 0 | 4 | MG | UNKNOWN | ||||||||
| 120949776 | 12094977 | 6 | C | acetylsalicylic acid | ASPIRIN | 1 | Unknown | 0 | 100 | MG | UNKNOWN | ||||||||
| 120949776 | 12094977 | 7 | C | Clopin (clopidogrel) | 2 | Unknown | 0 | UNKNOWN | |||||||||||
| 120949776 | 12094977 | 8 | C | CLONAZEPAM. | CLONAZEPAM | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120949776 | 12094977 | 1 | Multiple sclerosis |
| 120949776 | 12094977 | 2 | Product used for unknown indication |
| 120949776 | 12094977 | 3 | Product used for unknown indication |
| 120949776 | 12094977 | 4 | Product used for unknown indication |
| 120949776 | 12094977 | 5 | Product used for unknown indication |
| 120949776 | 12094977 | 6 | Product used for unknown indication |
| 120949776 | 12094977 | 7 | Blood disorder |
| 120949776 | 12094977 | 8 | Insomnia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120949776 | 12094977 | HO |
| 120949776 | 12094977 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120949776 | 12094977 | Anxiety | |
| 120949776 | 12094977 | Blister | |
| 120949776 | 12094977 | Blood pressure decreased | |
| 120949776 | 12094977 | Carotid artery aneurysm | |
| 120949776 | 12094977 | Cholelithiasis | |
| 120949776 | 12094977 | Constipation | |
| 120949776 | 12094977 | Erythema | |
| 120949776 | 12094977 | Facial pain | |
| 120949776 | 12094977 | Fall | |
| 120949776 | 12094977 | Gait disturbance | |
| 120949776 | 12094977 | Gastrointestinal disorder | |
| 120949776 | 12094977 | Headache | |
| 120949776 | 12094977 | Hypothermia | |
| 120949776 | 12094977 | Memory impairment | |
| 120949776 | 12094977 | Multiple sclerosis relapse | |
| 120949776 | 12094977 | Nervousness | |
| 120949776 | 12094977 | Pain | |
| 120949776 | 12094977 | Pain in extremity | |
| 120949776 | 12094977 | Poor venous access | |
| 120949776 | 12094977 | Post procedural complication | |
| 120949776 | 12094977 | Sedation | |
| 120949776 | 12094977 | Speech disorder | |
| 120949776 | 12094977 | Stress | |
| 120949776 | 12094977 | Urinary tract disorder | |
| 120949776 | 12094977 | Urinary tract infection |
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 |
|---|---|---|---|---|---|---|
| 120949776 | 12094977 | 1 | 20150901 | 0 |