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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118531636 | 11853163 | 6 | F | 201212 | 20160726 | 20151218 | 20160728 | EXP | US-BIOGEN-2014BI093800 | BIOGEN | 60.68 | YR | F | Y | 0.00000 | 20160728 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118531636 | 11853163 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118531636 | 11853163 | 2 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118531636 | 11853163 | 3 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118531636 | 11853163 | 4 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118531636 | 11853163 | 5 | SS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | Y | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 118531636 | 11853163 | 6 | SS | TYSABRI | NATALIZUMAB | 1 | Unknown | Y | 125104 | UNKNOWN | |||||||||
| 118531636 | 11853163 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 118531636 | 11853163 | 8 | C | ARMOUR THYROID | THYROID, PORCINE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118531636 | 11853163 | 1 | Multiple sclerosis |
| 118531636 | 11853163 | 7 | Product used for unknown indication |
| 118531636 | 11853163 | 8 | Hyperthyroidism |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118531636 | 11853163 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118531636 | 11853163 | Adverse reaction | |
| 118531636 | 11853163 | Asthenia | |
| 118531636 | 11853163 | Balance disorder | |
| 118531636 | 11853163 | Bronchitis | |
| 118531636 | 11853163 | Burning sensation | |
| 118531636 | 11853163 | Chills | |
| 118531636 | 11853163 | Confusional state | |
| 118531636 | 11853163 | Cough | |
| 118531636 | 11853163 | Decreased immune responsiveness | |
| 118531636 | 11853163 | Dizziness | |
| 118531636 | 11853163 | Dysstasia | |
| 118531636 | 11853163 | Fall | |
| 118531636 | 11853163 | Fatigue | |
| 118531636 | 11853163 | Gait disturbance | |
| 118531636 | 11853163 | General physical health deterioration | |
| 118531636 | 11853163 | Hypoaesthesia | |
| 118531636 | 11853163 | Immune reconstitution inflammatory syndrome | |
| 118531636 | 11853163 | Limb discomfort | |
| 118531636 | 11853163 | Lower respiratory tract infection | |
| 118531636 | 11853163 | Memory impairment | |
| 118531636 | 11853163 | Multiple sclerosis | |
| 118531636 | 11853163 | Musculoskeletal stiffness | |
| 118531636 | 11853163 | Nasal congestion | |
| 118531636 | 11853163 | Pain in extremity | |
| 118531636 | 11853163 | Paraesthesia | |
| 118531636 | 11853163 | Pneumonia | |
| 118531636 | 11853163 | Renal cancer recurrent | |
| 118531636 | 11853163 | Rhinorrhoea | |
| 118531636 | 11853163 | Sinus headache | |
| 118531636 | 11853163 | Sinusitis | |
| 118531636 | 11853163 | Stress | |
| 118531636 | 11853163 | Vision blurred | |
| 118531636 | 11853163 | Visual impairment |
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 |
|---|---|---|---|---|---|---|
| 118531636 | 11853163 | 1 | 20121011 | 0 | ||
| 118531636 | 11853163 | 2 | 2013 | 0 | ||
| 118531636 | 11853163 | 3 | 20141210 | 0 | ||
| 118531636 | 11853163 | 4 | 201502 | 0 | ||
| 118531636 | 11853163 | 5 | 20151014 | 20151015 | 0 | |
| 118531636 | 11853163 | 6 | 201511 | 0 |