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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123191174 | 12319117 | 4 | F | 201603 | 20160712 | 20160429 | 20160719 | EXP | AU-BIOGEN-2016BI00228792 | BIOGEN | 54.15 | YR | F | Y | 0.00000 | 20160719 | CN | AU | AU |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123191174 | 12319117 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 123191174 | 12319117 | 2 | C | ASPIRIN. | ASPIRIN | 1 | Oral | 0 | UNKNOWN | QD | |||||||||
| 123191174 | 12319117 | 3 | C | LYRICA | PREGABALIN | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123191174 | 12319117 | 1 | Multiple sclerosis |
| 123191174 | 12319117 | 2 | Antiphospholipid syndrome |
| 123191174 | 12319117 | 3 | Plantar fasciitis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123191174 | 12319117 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123191174 | 12319117 | Balance disorder | |
| 123191174 | 12319117 | Dry throat | |
| 123191174 | 12319117 | Eating disorder | |
| 123191174 | 12319117 | Emotional distress | |
| 123191174 | 12319117 | Fall | |
| 123191174 | 12319117 | Fatigue | |
| 123191174 | 12319117 | Feeling abnormal | |
| 123191174 | 12319117 | Influenza like illness | |
| 123191174 | 12319117 | Mouth ulceration | |
| 123191174 | 12319117 | Multiple sclerosis relapse | |
| 123191174 | 12319117 | Musculoskeletal stiffness | |
| 123191174 | 12319117 | Neck pain | |
| 123191174 | 12319117 | Optic nerve injury | |
| 123191174 | 12319117 | Pain | |
| 123191174 | 12319117 | Pain in extremity | |
| 123191174 | 12319117 | Tongue ulceration | |
| 123191174 | 12319117 | Viral infection | |
| 123191174 | 12319117 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 123191174 | 12319117 | 1 | 20160304 | 0 |