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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124089274 | 12408927 | 4 | F | 201508 | 20160719 | 20160526 | 20160725 | EXP | US-BIOGEN-2016BI00242174 | BIOGEN | 53.92 | YR | F | Y | 0.00000 | 20160725 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124089274 | 12408927 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Intravenous (not otherwise specified) | INFUSED OVER 1 HOUR | 125104 | 300 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||
| 124089274 | 12408927 | 2 | C | AMBIEN | ZOLPIDEM TARTRATE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124089274 | 12408927 | 1 | Multiple sclerosis |
| 124089274 | 12408927 | 2 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124089274 | 12408927 | HO |
| 124089274 | 12408927 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124089274 | 12408927 | Agitation | |
| 124089274 | 12408927 | Anaesthesia procedure | |
| 124089274 | 12408927 | Anxiety | |
| 124089274 | 12408927 | Cardiac disorder | |
| 124089274 | 12408927 | Chills | |
| 124089274 | 12408927 | Cognitive disorder | |
| 124089274 | 12408927 | Dental caries | |
| 124089274 | 12408927 | Depressed mood | |
| 124089274 | 12408927 | Dysphemia | |
| 124089274 | 12408927 | Dysstasia | |
| 124089274 | 12408927 | Emotional distress | |
| 124089274 | 12408927 | Fall | |
| 124089274 | 12408927 | Feeling abnormal | |
| 124089274 | 12408927 | Gait disturbance | |
| 124089274 | 12408927 | General symptom | |
| 124089274 | 12408927 | Hallucination | |
| 124089274 | 12408927 | Hallucination, auditory | |
| 124089274 | 12408927 | Hypertension | |
| 124089274 | 12408927 | Infection | |
| 124089274 | 12408927 | Ligament sprain | |
| 124089274 | 12408927 | Memory impairment | |
| 124089274 | 12408927 | Myocardial infarction | |
| 124089274 | 12408927 | Nervousness | |
| 124089274 | 12408927 | Oral infection | |
| 124089274 | 12408927 | Pyrexia | |
| 124089274 | 12408927 | Schizophrenia | |
| 124089274 | 12408927 | Soliloquy | |
| 124089274 | 12408927 | Suicidal ideation | |
| 124089274 | 12408927 | Syncope | |
| 124089274 | 12408927 | Tremor | |
| 124089274 | 12408927 | Vein disorder | |
| 124089274 | 12408927 | 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 |
|---|---|---|---|---|---|---|
| 124089274 | 12408927 | 1 | 20141030 | 0 |