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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119818835 | 11981883 | 5 | F | 20160913 | 20160201 | 20160920 | PER | PHEH2015US011363 | NOVARTIS | 0.00 | F | Y | 72.56000 | KG | 20160920 | CN | COUNTRY NOT SPECIFIED | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119818835 | 11981883 | 1 | PS | GILENYA | FINGOLIMOD HYDROCHLORIDE | 1 | Oral | 0.5 MG, QD | Y | F0008/F0011 | 22527 | .5 | MG | CAPSULE | QD | ||||
| 119818835 | 11981883 | 2 | C | NUVIGIL | ARMODAFINIL | 1 | Unknown | UNK | U | 0 | |||||||||
| 119818835 | 11981883 | 3 | C | TIZANIDINE HCL | TIZANIDINE HYDROCHLORIDE | 1 | Unknown | UNK | U | 0 | |||||||||
| 119818835 | 11981883 | 4 | C | VICODIN | ACETAMINOPHENHYDROCODONE BITARTRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 119818835 | 11981883 | 5 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Unknown | UNK | U | 0 | |||||||||
| 119818835 | 11981883 | 6 | C | VITAMIN D3 | CHOLECALCIFEROL | 1 | Unknown | U | 0 | ||||||||||
| 119818835 | 11981883 | 7 | C | NEURONTIN | GABAPENTIN | 1 | Unknown | U | 0 | ||||||||||
| 119818835 | 11981883 | 8 | C | CRANBERRY//VACCINIUM MACROCARPON | CRANBERRY | 1 | Unknown | U | 0 | ||||||||||
| 119818835 | 11981883 | 9 | C | BIOTININ | 2 | Unknown | U | 0 | |||||||||||
| 119818835 | 11981883 | 10 | C | IBUPROFEN. | IBUPROFEN | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119818835 | 11981883 | 1 | Multiple sclerosis |
| 119818835 | 11981883 | 2 | Product used for unknown indication |
| 119818835 | 11981883 | 3 | Product used for unknown indication |
| 119818835 | 11981883 | 4 | Product used for unknown indication |
| 119818835 | 11981883 | 5 | Product used for unknown indication |
| 119818835 | 11981883 | 6 | Product used for unknown indication |
| 119818835 | 11981883 | 7 | Product used for unknown indication |
| 119818835 | 11981883 | 8 | Product used for unknown indication |
| 119818835 | 11981883 | 9 | Product used for unknown indication |
| 119818835 | 11981883 | 10 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119818835 | 11981883 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119818835 | 11981883 | Fall | |
| 119818835 | 11981883 | JC virus test positive | |
| 119818835 | 11981883 | Peripheral arthritis | |
| 119818835 | 11981883 | Skin discolouration | |
| 119818835 | 11981883 | Urinary tract infection | |
| 119818835 | 11981883 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 119818835 | 11981883 | 1 | 20141117 | 0 |