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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123107534 | 12310753 | 4 | F | 201309 | 20160808 | 20160427 | 20160811 | EXP | BR-BIOGEN-2016BI00225716 | BIOGEN | 52.39 | YR | F | Y | 0.00000 | 20160811 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123107534 | 12310753 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Unknown | INFUSED OVER 1 HOUR | Y | 125104 | UNKNOWN | ||||||||
| 123107534 | 12310753 | 2 | C | METFORMIN | METFORMIN HYDROCHLORIDE | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123107534 | 12310753 | 1 | Multiple sclerosis |
| 123107534 | 12310753 | 2 | Diabetes mellitus |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123107534 | 12310753 | HO |
| 123107534 | 12310753 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123107534 | 12310753 | Cognitive disorder | |
| 123107534 | 12310753 | Drug abuse | |
| 123107534 | 12310753 | Gastritis | |
| 123107534 | 12310753 | Hypoaesthesia | |
| 123107534 | 12310753 | Insomnia | |
| 123107534 | 12310753 | Mental disorder | |
| 123107534 | 12310753 | Multiple sclerosis relapse | |
| 123107534 | 12310753 | Muscle disorder | |
| 123107534 | 12310753 | Neurosyphilis | |
| 123107534 | 12310753 | Pain in extremity | |
| 123107534 | 12310753 | Paraesthesia | |
| 123107534 | 12310753 | Restlessness |
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 |
|---|---|---|---|---|---|---|
| 123107534 | 12310753 | 1 | 201308 | 201603 | 0 |