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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123822933 | 12382293 | 3 | F | 20160228 | 20160704 | 20160518 | 20160708 | EXP | BR-BIOGEN-2016BI00238610 | BIOGEN | 47.45 | YR | M | Y | 0.00000 | 20160708 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 123822933 | 12382293 | 1 | PS | TYSABRI | NATALIZUMAB | 1 | Unknown | Y | 125104 | CONCENTRATE FOR SOLUTION FOR INFUSION | |||||||||
| 123822933 | 12382293 | 2 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | 1 HOUR BEFORE INFUSION | 0 | UNKNOWN | |||||||||
| 123822933 | 12382293 | 3 | C | SERTRALINE | SERTRALINE HYDROCHLORIDE | 1 | Unknown | 0 | UNKNOWN | QD | |||||||||
| 123822933 | 12382293 | 4 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | 120000 | IU | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 123822933 | 12382293 | 1 | Multiple sclerosis |
| 123822933 | 12382293 | 2 | Premedication |
| 123822933 | 12382293 | 3 | Product used for unknown indication |
| 123822933 | 12382293 | 4 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 123822933 | 12382293 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 123822933 | 12382293 | Hypersensitivity | |
| 123822933 | 12382293 | Laryngeal oedema | |
| 123822933 | 12382293 | Multiple sclerosis | |
| 123822933 | 12382293 | Osteoarthritis | |
| 123822933 | 12382293 | Seizure | |
| 123822933 | 12382293 | Temperature regulation disorder | |
| 123822933 | 12382293 | Underdose | |
| 123822933 | 12382293 | Vitamin C increased | |
| 123822933 | 12382293 | Vitamin D 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 |
|---|---|---|---|---|---|---|
| 123822933 | 12382293 | 1 | 20151228 | 2016 | 0 | |
| 123822933 | 12382293 | 4 | 201601 | 2016 | 0 |