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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125621531 | 12562153 | 1 | I | 201308 | 20140520 | 20160715 | 20160715 | EXP | US-BIOGEN-2014BI051476 | BIOGEN | 52.15 | YR | F | Y | 0.00000 | 20160715 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125621531 | 12562153 | 1 | PS | TECFIDERA | DIMETHYL FUMARATE | 1 | Oral | U | 204063 | 240 | MG | PROLONGED-RELEASE CAPSULE | BID | ||||||
| 125621531 | 12562153 | 2 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Unknown | U | 204063 | UNKNOWN | |||||||||
| 125621531 | 12562153 | 3 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Unknown | U | 204063 | UNKNOWN | |||||||||
| 125621531 | 12562153 | 4 | SS | TECFIDERA | DIMETHYL FUMARATE | 1 | Unknown | U | 204063 | UNKNOWN | |||||||||
| 125621531 | 12562153 | 5 | SS | TYSABRI | NATALIZUMAB | 1 | Unknown | U | 125104 | UNKNOWN | |||||||||
| 125621531 | 12562153 | 6 | C | DIAZEPAM. | DIAZEPAM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 7 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 8 | C | ASPIRIN. | ASPIRIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 9 | C | BACLOFEN. | BACLOFEN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 10 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 11 | C | TIMOLOL. | TIMOLOL | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 12 | C | PRAVASTATIN. | PRAVASTATIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 13 | C | VITAMIN D | CHOLECALCIFEROL | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 14 | C | Probiotic | PROBIOTICS NOS | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 15 | C | Magnesium | MAGNESIUM | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125621531 | 12562153 | 16 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125621531 | 12562153 | 1 | Multiple sclerosis |
| 125621531 | 12562153 | 5 | Multiple sclerosis |
| 125621531 | 12562153 | 6 | Product used for unknown indication |
| 125621531 | 12562153 | 7 | Product used for unknown indication |
| 125621531 | 12562153 | 8 | Product used for unknown indication |
| 125621531 | 12562153 | 9 | Product used for unknown indication |
| 125621531 | 12562153 | 10 | Product used for unknown indication |
| 125621531 | 12562153 | 11 | Product used for unknown indication |
| 125621531 | 12562153 | 12 | Product used for unknown indication |
| 125621531 | 12562153 | 13 | Product used for unknown indication |
| 125621531 | 12562153 | 14 | Product used for unknown indication |
| 125621531 | 12562153 | 15 | Product used for unknown indication |
| 125621531 | 12562153 | 16 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125621531 | 12562153 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125621531 | 12562153 | Blood glucose increased | |
| 125621531 | 12562153 | Flushing | |
| 125621531 | 12562153 | Heart rate increased | |
| 125621531 | 12562153 | Malaise | |
| 125621531 | 12562153 | Nausea | |
| 125621531 | 12562153 | Pain | |
| 125621531 | 12562153 | Rhinorrhoea |
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 |
|---|---|---|---|---|---|---|
| 125621531 | 12562153 | 1 | 20140211 | 0 | ||
| 125621531 | 12562153 | 2 | 20130820 | 20140120 | 0 | |
| 125621531 | 12562153 | 3 | 20140120 | 20140211 | 0 | |
| 125621531 | 12562153 | 4 | 20160331 | 0 | ||
| 125621531 | 12562153 | 5 | 20100728 | 20130819 | 0 |