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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120908583 | 12090858 | 3 | F | 201601 | 20160809 | 20160218 | 20160815 | EXP | US-BIOGEN-2016BI00187915 | BIOGEN | 55.62 | YR | F | Y | 71.28000 | KG | 20160815 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 120908583 | 12090858 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 120908583 | 12090858 | 2 | C | AMPYRA | DALFAMPRIDINE | 1 | Oral | 22250 | 10 | MG | UNKNOWN | BID | |||||||
| 120908583 | 12090858 | 3 | C | BACLOFEN. | BACLOFEN | 1 | Oral | 0 | 10 | MG | TABLETS | ||||||||
| 120908583 | 12090858 | 4 | C | EFFEXOR | VENLAFAXINE HYDROCHLORIDE | 1 | Oral | 0 | 75 | MG | CAPSULE | QD | |||||||
| 120908583 | 12090858 | 5 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | Intramuscular | UP TO 1000 MCG | 0 | INJECTION | |||||||||
| 120908583 | 12090858 | 6 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | 81 | MG | TABLETS | QD | |||||||
| 120908583 | 12090858 | 7 | C | VITAMIN C | ASCORBIC ACID | 1 | Oral | 0 | 1000 | MG | TABLETS | QD | |||||||
| 120908583 | 12090858 | 8 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Oral | 0 | 2000 | IU | UNKNOWN | QD | |||||||
| 120908583 | 12090858 | 9 | C | FLAXSEED | FLAX SEED | 1 | Oral | 0 | TABLETS | QD | |||||||||
| 120908583 | 12090858 | 10 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Oral | 0 | 400 | IU | CAPSULE | QD | |||||||
| 120908583 | 12090858 | 11 | C | COENZYME Q10 | UBIDECARENONE | 1 | Oral | 0 | 300 | MG | TABLETS | ||||||||
| 120908583 | 12090858 | 12 | C | ACIDOPHILUS | LACTOBACILLUS ACIDOPHILUS | 1 | Oral | 0 | TABLETS | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 120908583 | 12090858 | 1 | Multiple sclerosis |
| 120908583 | 12090858 | 2 | Gait disturbance |
| 120908583 | 12090858 | 3 | Product used for unknown indication |
| 120908583 | 12090858 | 4 | Product used for unknown indication |
| 120908583 | 12090858 | 5 | Product used for unknown indication |
| 120908583 | 12090858 | 6 | Product used for unknown indication |
| 120908583 | 12090858 | 7 | Product used for unknown indication |
| 120908583 | 12090858 | 8 | Product used for unknown indication |
| 120908583 | 12090858 | 9 | Product used for unknown indication |
| 120908583 | 12090858 | 10 | Product used for unknown indication |
| 120908583 | 12090858 | 11 | Product used for unknown indication |
| 120908583 | 12090858 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 120908583 | 12090858 | OT |
| 120908583 | 12090858 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 120908583 | 12090858 | Malignant melanoma | |
| 120908583 | 12090858 | 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 |
|---|---|---|---|---|---|---|
| 120908583 | 12090858 | 1 | 20060824 | 0 |